-
Notifications
You must be signed in to change notification settings - Fork 0
Expand file tree
/
Copy pathdefine.Rhtml
More file actions
846 lines (757 loc) · 338 KB
/
Copy pathdefine.Rhtml
File metadata and controls
846 lines (757 loc) · 338 KB
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192
193
194
195
196
197
198
199
200
201
202
203
204
205
206
207
208
209
210
211
212
213
214
215
216
217
218
219
220
221
222
223
224
225
226
227
228
229
230
231
232
233
234
235
236
237
238
239
240
241
242
243
244
245
246
247
248
249
250
251
252
253
254
255
256
257
258
259
260
261
262
263
264
265
266
267
268
269
270
271
272
273
274
275
276
277
278
279
280
281
282
283
284
285
286
287
288
289
290
291
292
293
294
295
296
297
298
299
300
301
302
303
304
305
306
307
308
309
310
311
312
313
314
315
316
317
318
319
320
321
322
323
324
325
326
327
328
329
330
331
332
333
334
335
336
337
338
339
340
341
342
343
344
345
346
347
348
349
350
351
352
353
354
355
356
357
358
359
360
361
362
363
364
365
366
367
368
369
370
371
372
373
374
375
376
377
378
379
380
381
382
383
384
385
386
387
388
389
390
391
392
393
394
395
396
397
398
399
400
401
402
403
404
405
406
407
408
409
410
411
412
413
414
415
416
417
418
419
420
421
422
423
424
425
426
427
428
429
430
431
432
433
434
435
436
437
438
439
440
441
442
443
444
445
446
447
448
449
450
451
452
453
454
455
456
457
458
459
460
461
462
463
464
465
466
467
468
469
470
471
472
473
474
475
476
477
478
479
480
481
482
483
484
485
486
487
488
489
490
491
492
493
494
495
496
497
498
499
500
501
502
503
504
505
506
507
508
509
510
511
512
513
514
515
516
517
518
519
520
521
522
523
524
525
526
527
528
529
530
531
532
533
534
535
536
537
538
539
540
541
542
543
544
545
546
547
548
549
550
551
552
553
554
555
556
557
558
559
560
561
562
563
564
565
566
567
568
569
570
571
572
573
574
575
576
577
578
579
580
581
582
583
584
585
586
587
588
589
590
591
592
593
594
595
596
597
598
599
600
601
602
603
604
605
606
607
608
609
610
611
612
613
614
615
616
617
618
619
620
621
622
623
624
625
626
627
628
629
630
631
632
633
634
635
636
637
638
639
640
641
642
643
644
645
646
647
648
649
650
651
652
653
654
655
656
657
658
659
660
661
662
663
664
665
666
667
668
669
670
671
672
673
674
675
676
677
678
679
680
681
682
683
684
685
686
687
688
689
690
691
692
693
694
695
696
697
698
699
700
701
702
703
704
705
706
707
708
709
710
711
712
713
714
715
716
717
718
719
720
721
722
723
724
725
726
727
728
729
730
731
732
733
734
735
736
737
738
739
740
741
742
743
744
745
746
747
748
749
750
751
752
753
754
755
756
757
758
759
760
761
762
763
764
765
766
767
768
769
770
771
772
773
774
775
776
777
778
779
780
781
782
783
784
785
786
787
788
789
790
791
792
793
794
795
796
797
798
799
800
801
802
803
804
805
806
807
808
809
810
811
812
813
814
815
816
817
818
819
820
821
822
823
824
825
826
827
828
829
830
831
832
833
834
835
836
837
838
839
840
841
842
843
844
845
846
<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.01//EN" "http://www.w3.org/TR/html4/strict.dtd">
<!-- saved from url=(0084)file:///C:/Users/kolosod/AppData/Roaming/Visual%20Define-XML%20Editor/defineHtml.xml -->
<html lang="en"><!--
xsl:version = "1.0"
xsl:vendor = "libxslt"
xsl:vendor-url = "http://xmlsoft.org/XSLT/"
--><head><meta http-equiv="Content-Type" content="text/html; charset=UTF-8">
<meta http-equiv="Content-Script-Type" content="text/javascript">
<meta http-equiv="Content-Style-Type" content="text/css">
<title>TDF_ADaM, ADaM-IG1.0</title>
<script type="text/javascript">
<!--
/**
* With one argument, return the textContent or innerText of the element.
* With two arguments, set the textContent or innerText of element to value.
*/
function textContent(element, value) {
"use strict";
var rtn;
var content = element.textContent; // Check if textContent is defined
if (value === undefined) { // No value passed, so return current text
if (content !== undefined) {
rtn = content;
} else {
rtn = element.innerText;
}
return rtn;
}
else { // A value was passed, so set text
if (content !== undefined) {
element.textContent = value;
} else {
element.innerText = value;
}
}
}
var ITEM = '\u00A0';
var CLOSE = '\u25BA';
var OPEN = '\u25BC';
function toggle_submenu(e) {
"use strict";
if (textContent(e)===OPEN) {
textContent(e, CLOSE);
}
else {
textContent(e, OPEN);
}
var i;
for (i=0; i < e.parentNode.childNodes.length; i++) {
var c;
c=e.parentNode.childNodes[i];
if (c.tagName==='UL') {c.style.display=(c.style.display==='none') ? 'block' : 'none';}
}
}
function reset_menus() {
"use strict";
var li;
var c;
var i;
var j;
var li_tags = document.getElementsByTagName('LI');
for (i=0; i < li_tags.length; i++) {
li=li_tags[i];
if ( li.className.match('hmenu-item') ){
for (j=0; j < li.childNodes.length; j++) {
c=li.childNodes[j];
if ( c.tagName === 'SPAN' && c.className.match('hmenu-bullet') ) {textContent(c, ITEM);}
}
}
if ( li.className.match('hmenu-submenu') ) {
for (j=0; j < li.childNodes.length; j++) {
c=li.childNodes[j];
if ( c.tagName === 'SPAN' && c.className.match('hmenu-bullet') ) {textContent(c, CLOSE);}
else if ( c.tagName === 'UL' ) { c.style.display = 'none'; }
}
}
}
}
function toggle_vlm(element) {
var child_id = element.childNodes[0].getAttribute("id");
var vlm_rows = document.getElementsByClassName(child_id);
for (j=0; j < vlm_rows.length; j++) {
if (vlm_rows[j].style.display==='none') {
vlm_rows[j].style.display=''; }
else {
vlm_rows[j].style.display='none';
}
}
}
function expand_all_vlm() {
var vlm_rows = document.getElementsByClassName("vlm");
for (j=0; j < vlm_rows.length; j++) {
vlm_rows[j].style.display='';
}
}
function collapse_all_vlm() {
var vlm_rows = document.getElementsByClassName("vlm");
for (j=0; j < vlm_rows.length; j++) {
vlm_rows[j].style.display='none';
}
}
/**
* Open external documents (PDFs, ...) in a new window.
*/
document.onclick = function(e)
{
var target = e ? e.target : window.event.srcElement;
while (target && !/^(a|body)$/i.test(target.nodeName))
{
target = target.parentNode;
}
if (target && target.className.match('external'))
{
var external = window.open(target.href);
return external.closed;
}
}
//-->
</script>
<style type="text/css">
.external-link-gif{
background:
url(data:image/gif;base64,iVBORw0KGgoAAAANSUhEUgAAAAoAAAAKCAYAAACNMs+9AAAAAXNSR0IArs4c6QAAAAlwSFlzAAALEwAACxMBAJqcGAAAAAd0SU1FB9gCGhErDWL4mOoAAAB6SURBVBjTbVCxDcAgDHNRP2KDY9gYO5YbWNno1mPY6E3pAJEIYCmCOCQOPogII6wNkug4d49KiXMz1EiUEg8uLBN3Ui7FVduYmxjG3JRru+facubVuIdLEV4Dzwe8V4BYg7t4Ap+d57qUnuWICBzi116v1ggfd3bM+AEZWXFvnym8EwAAAABJRU5ErkJggg==)
no-repeat
right center;
padding: 8px;
}
body{
background-color: #FFFFFF;
font-family: Verdana, Arial, Helvetica, sans-serif;
font-size: 62.5%;
margin: 0;
padding: 30px;
}
h1{
font-size: 1.6em;
margin-left: 0;
font-weight: bolder;
text-align: left;
color: #696969;
}
h1.header{
text-align: center;
}
ul{
margin-left: 0px;
}
a{
color: #0000FF;
text-decoration: underline;
}
a.visited{
color: #551A8B;
text-decoration: underline;
}
a:hover{
color: #FF9900;
text-decoration: underline;
}
a.tocItem{
color: #004A95;
text-decoration: none;
margin-top: 2px;
font-size: 1.4em;
}
.tocItem{
text-decoration: none;
margin-top: 2px;
font-size: 1.4em;
}
#menu{
position: fixed;
left: 0px;
top: 10px;
width: 20%;
height: 96%;
bottom: 0px;
overflow: auto;
background-color: #FFFFFF;
color: #000000;
border: 0px;
text-align: left;
white-space: nowrap;
}
.hmenu li{
list-style-type: none;
line-height: 200%;
padding-left: 0;
}
.hmenu ul{
padding-left: 14px;
margin-left: 0;
}
.hmenu-item{
}
.hmenu-submenu{
}
.hmenu-bullet{
float: left;
width: 16px;
color: #AAAAAA;
font-size: 1.2em;
}
div.buttons {
padding: 5px 0 5px 40px;
display: inline-block;
}
div.button {
padding: 5px 0 5px 0;
}
button {
width: 100%;
-webkit-border-radius: 10px;
-moz-border-radius: 10px;
border-radius: 10px;
-webkit-box-shadow: 3px 3px 2px #888;
-moz-box-shadow: 3px 3px 2px #888;
box-shadow: 3px 3px 2px #888;
padding: 4px 16px 4px 16px;
display:block;
cursor: pointer;
}
#main{
position: absolute;
left: 22%;
top: 0px;
overflow: auto;
background-color: #FFFFFF;
color: #000000;
float: none !important;
}
ul.codelist{
padding: 1px;
margin-left: 1px;
margin-right: 1px;
margin-top: 1px;
margin-bottom: 1px;
}
.codelist li{
list-style-type:none;
line-height: 200%;
padding-left: 0;
text-indent: -4px;
}
.codelist-caption{
font-size: 1.4em;
margin-top: 20px;
margin-bottom: 10px;
margin-left: 0;
font-weight: bolder;
text-align: left;
color: #696969;
}
.codelist-item{
list-style-type: disk;
list-style-position: inside;
padding-left: 0;
padding-right: 0;
margin: 0 0 0 0;
}
.codelist-item-decode{
white-space: pre; /* CSS 2.0 */
white-space: pre-wrap; /* CSS 2.1 */
/* CSS 3.0 */
white-space: -pre-wrap; /* Opera 4-6 */
white-space: -o-pre-wrap; /* Opera 7 */
white-space: -moz-pre-wrap; /* Mozilla */
white-space: -hp-pre-wrap; /* HP Printers */
word-wrap: break-word; /* IE 5+ */
}
ul.SubClass {
list-style-type: '- ';
padding-left: 5;
margin: 0 0 0 0;
}
ul.SubClass.li {}
#main .docinfo{
width: 95%;
text-align: right;
padding: 0px 5px;
}
div.containerbox{
padding: 0px;
margin: 10px auto;
border: 0px;
page-break-after: always;
}
.study-name{
font-size: 1.6em;
font-weight: bold;
text-align: left;
padding: 15px;
margin-left: 20px;
margin-top: 40px;
margin-right: 20px;
margin-bottom: 20px;
color: #696969;
border: 0px;
}
div.study-metadata{
font-size: 1.6em;
font-weight: bold;
text-align: left;
padding: 0px;
margin-left: 0px;
margin-top: 00px;
margin-right: 0px;
margin-bottom: 0px;
color: #696969;
border: 0px;
}
dl.study-metadata{
width: 95%;
padding: 5px 0px;
font-size: 0.8em;
color: black;
}
dl.study-metadata dt{
clear: left;
float: left;
width: 200px;
margin: 0;
padding: 5px 5px 5px 0px;
font-weight: bold;
}
dl.study-metadata dd{
margin-left: 210px;
padding: 5px;
font-weight: normal;
min-height: 20px;
}
div.codelist{
page-break-after: avoid;
}
div.qval-indent {
margin-left: 20px;
}
div.qval-indent2 {
margin-left: 40px;
}
table{
width: 95%;
border-spacing: 4px;
border: 1px solid #000000;
background-color: #EEEEEE;
margin-top: 5px;
border-collapse: collapse;
padding: 5px;
empty-cells: show;
}
table caption{
border: 0px;
left: 20px;
font-size: 1.4em;
font-weight: bolder;
color: #696969;
margin: 10px auto;
text-align: left;
}
.description{
margin-left: 0px;
color: black;
font-weight: normal;
font-size: 0.85em;
}
table caption .dataset{
font-weight: normal;
float: right;
}
table caption.header{
font-size: 1.6em;
margin-left: 0;
font-weight: bolder;
text-align: center;
color: #696969;
}
table tr{
border: 1px solid #000000;
}
table tr.header{
background-color: #6699CC;
color: #FFFFFF;
font-weight: bold;
}
table th{
font-weight: bold;
vertical-align: top;
text-align: left;
padding: 5px;
border: 1px solid #000000;
font-size: 1.3em;
}
table th.codedvalue{
width: 20%;
}
table th.length{
width: 7%;
}
table th.label{
width: 13%;
}
table td{
vertical-align: top;
padding: 5px;
border: 1px solid #000000;
font-size: 1.2em;
line-height: 150%;
}
table td.datatype{
text-align: left;
}
table td.role{
text-align: left;
}
table td.number{
text-align: right;
}
tr.tablerowodd{
background-color: #FFFFFF;
}
tr.tableroweven{
background-color: #EEEEEE;
}
.linebreakcell{
vertical-align: top;
margin-top: 3px;
margin-bottom: 3px;
}
.nci,
.extended{
font-style: italic;
}
.super{
vertical-align: super;
}
.footnote{
font-size: 1.2em;
}
.valuelist-reference{
vertical-align: super;
font-size: 0.8em;
padding-left: 5px;
cursor: pointer;
}
.valuelist-no-reference{
vertical-align: super;
font-size: 0.8em;
padding-left: 5px;
}
div.formalexpression{
margin-top: 6px;
margin-bottom: 6px;
}
span.label{
font-weight: bold;
}
.formalexpression-reference{
vertical-align: super;
font-size: 0.8em;
padding-left: 5px;
}
.formalexpression-code{
font-family:"Courier New", monospace, serif;
font-size:1.2em;
line-height:120%;
display:block;
vertical-align:top;
margin: 0px;
padding: 5px 0 0 20px;
white-space:pre; /* CSS 2.0 */
white-space: pre-wrap; /* CSS 2.1 */
/* CSS 3.0 */
white-space: -pre-wrap; /* Opera 4-6 */
white-space: -o-pre-wrap; /* Opera 7 */
white-space: -moz-pre-wrap; /* Mozilla */
white-space: -hp-pre-wrap; /* HP Printers */
word-wrap: break-word; /* IE 5+ */
}
.method-code{
vertical-align: top;
white-space: pre; /* CSS 2.0 */
white-space: pre-wrap; /* CSS 2.1 */
/* CSS 3.0 */
white-space: -pre-wrap; /* Opera 4-6 */
white-space: -o-pre-wrap; /* Opera 7 */
white-space: -moz-pre-wrap; /* Mozilla */
white-space: -hp-pre-wrap; /* HP Printers */
word-wrap: break-word; /* IE 5+ */
}
.linktop{
font-size: 1.2em;
margin-top: 5px;
}
.documentinfo,
.stylesheetinfo{
font-size: 1.1em;
line-height: 60%;
}
.invisible{
display: none;
}
.standard-refeference {
width: 95%;
font-size: 1.0em;
font-weight: bold;
padding: 5px;
color: #696969;
white-space: nowrap;
}
.nodata{
width: 95%;
font-size: 1.0em;
font-weight: bold;
padding: 5px;
color: #000000;
white-space: nowrap;
}
span.unresolved{
color: #000000;
}
td.unresolved{
color: #000000;
}
td.span.unresolved{
color: #000000;
}
span.prefix{
font-weight: normal;
}
.arm-summary{
width: 95%;
border-spacing: 5px;
border-width: 1px;
border-color: #000000;
border-style: solid solid none solid;
background-color: #EEEEEE;
font-size: 1.2em;
line-height: 150%;
vertical-align: top;
}
.arm-summary-resultdisplay{
margin: 0px 0px 0px 0px;
padding: 10px 10px 10px 10px;
border-spacing: 5px;
border-width: 1px;
border-color #000000;
border-style: none none solid none;
}
.arm-display-title{
margin-left: 5pt;
}
.table.analysisresults-detail{
background-color: #EEEEEE;
}
.arm-summary-result{
margin-left: 20px;
margin-top: 5px;
margin-bottom: 5px;
}
th span.arm-displaytitle{
font-weight: bold;
}
td span.arm-resulttitle{
font-weight: bold;
}
tr.arm-analysisresult{
background-color: #6699CC;
color: #FFFFFF;
font-weight: bold;
border: 1px solid #000000;
}
td.arm-label{
font-weight: bold;
}
p.arm-analysisvariable{
margin-top: 5px;
margin-bottom: 5px;
}
.arm-data-reference{
margin-top: 5px;
margin-bottom: 5px;
}
.arm-code-context{
padding: 5px 0px;
}
.arm-code-ref{
font-size: 1.2em;
line-height: 150%;
padding: 5px;
}
.arm-code{
font-family:"Courier New", monospace, serif;
font-size:1.2em;
line-height:120%;
display:block;
vertical-align:top;
margin: 0px;
padding:0px;
white-space:pre; /* CSS 2.0 */
white-space: pre-wrap; /* CSS 2.1 */
/* CSS 3.0 */
white-space: -pre-wrap; /* Opera 4-6 */
white-space: -o-pre-wrap; /* Opera 7 */
white-space: -moz-pre-wrap; /* Mozilla */
white-space: -hp-pre-wrap; /* HP Printers */
word-wrap: break-word; /* IE 5+ */
}
@media print{
@page {
margin: 1.5cm;
}
body,
h1,
table caption,
table caption.header{
color: #000;
background: #fff;
float: none !important;
}
div.containerbox{
padding: 0px;
border: 0px;
page-break-after: always;
}
a:link,
a:visited{
background: transparent;
text-decoration: none;
color: black;
}
a.external:link:after,
#main a:visited:after{
content: " (" attr(href) ") ";
font-size: 100%;
text-decoration: underline;
font-weight: normal;
color: black;
}
.external-link-gif,
.formalexpression-reference
.valuelist-reference{
display: none !important;
width: 0px;
}
table{
border-width: 2px;
}
table tr.vlm{
display: table-row !important;
}
#menu,
.linktop{
display: none !important;
width: 0px;
}
#main{
left: 2cm;
float: none !important;
}
span.prefix{
font-weight: normal;
}
row, ul, img {
page-break-inside: avoid;
}
}
</style>
</head><body onload="reset_menus();"><div id="menu"><a name="top" class="invisible" href="#main">Skip Navigation Link</a><span class="study-name">TDF_ADaM</span><ul class="hmenu"><li class="hmenu-submenu"><span onclick="toggle_submenu(this);" class="hmenu-bullet">►</span><a class="tocItem">Supplemental Documents</a><ul style="display: none;"><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="external tocItem" href="./adrg.pdf">Analysis Data Reviewer’s Guide</a><span class="external-link-gif"></span></li></ul></li><li class="hmenu-submenu"><span class="hmenu-bullet" onclick="toggle_submenu(this);">►</span><a class="tocItem" href="#datasets">Datasets</a><ul style="display: none;"><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#IG.IG.ADADAS">ADADAS (ADAS-Cog Analysis)</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#IG.IG.ADAE">ADAE (Adverse Events Analysis Dataset)</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#IG.IG.ADLBC">ADLBC (Analysis Dataset Lab Blood Chemistry)</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#IG.IG.ADLBH">ADLBH (Analysis Dataset Lab Hematology)</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#IG.IG.ADLBHY">ADLBHY (Analysis Dataset Lab Hy's Law)</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#IG.IG.ADSL">ADSL (Subject-Level Analysis Dataset)</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#IG.IG.ADTTE">ADTTE (AE Time To 1st Derm. Event Analysis)</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#IG.IG.ADVS">ADVS (Vital Signs Analysis Dataset)</a></li></ul></li><li class="hmenu-submenu"><span onclick="toggle_submenu(this);" class="hmenu-bullet">►</span><a href="#decodelist" class="tocItem">Controlled Terminology</a><ul style="display: none;"><li class="hmenu-submenu"><span class="hmenu-bullet" onclick="toggle_submenu(this);">►</span><a class="tocItem" href="#decodelist">CodeLists</a><ul style="display: none;"><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.ADLBCAT">ADLBCAT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.AECAUS">AECAUS</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.AGEGR1">AGEGR1</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.AGEGR1N">AGEGR1N</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.AGEU">AGEU</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.ARM">ARM</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.ARMN">ARMN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.ATPT">ATPT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.AVISIT">AVISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.AVISITN">AVISITN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.AWU">AWU</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.BMICAT">BMICAT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.CENSOR">CENSOR</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.DISCCD">DISCCD</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.DISCREAS">DISCREAS</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.DTYPE">DTYPE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.DURDISC">DURDISC</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.ETHNIC">ETHNIC</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.LBNRIND">LBNRIND</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.LNH">LNH</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.OUT">OUT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.PARAM_ADLBC">PARAM_ADLBC</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.PARAM_ADLBH">PARAM_ADLBH</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.PARAM_ADLBHY">PARAM_ADLBHY</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.PARAM_ADTTE">PARAM_ADTTE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.PARAM_ADVS">PARAM_ADVS</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.PARAMCD_ADLBC">PARAMCD_ADLBC</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.PARAMCD_ADLBH">PARAMCD_ADLBH</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.PARAMCD_ADLBHY">PARAMCD_ADLBHY</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.PARAMCD_ADTTE">PARAMCD_ADTTE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.PARAMCD_ADVS">PARAMCD_ADVS</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.PARAMN_ADLBC">PARAMN_ADLBC</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.PARAMN_ADLBH">PARAMN_ADLBH</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.PARAMN_ADLBHY">PARAMN_ADLBHY</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.PARAMN_ADVS">PARAMN_ADVS</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.PARAMTYP">PARAMTYP</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.RACE">RACE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.RACEN">RACEN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.SEX">SEX</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.SHIFT">SHIFT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.SHIFTN">SHIFTN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.VISIT">VISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.VISITNUM">VISITNUM</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.Y_BLANK">Y_BLANK</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.YN">YN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.YNN">YNN</a></li></ul></li><li class="hmenu-submenu"><span class="hmenu-bullet" onclick="toggle_submenu(this);">►</span><a class="tocItem" href="#externaldictionary">External Dictionaries</a><ul style="display: none;"><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#CL.CL.AEDICT">ADVERSE EVENT DICTIONARY</a></li></ul></li></ul></li><li class="hmenu-submenu"><span class="hmenu-bullet" onclick="toggle_submenu(this);">►</span><a class="tocItem" href="#compmethod">Methods</a><ul style="display: none;"><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.ADURN">Algorithm to derive ADAE.ADURN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.ADURU">Algorithm to derive ADAE.ADURU</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AEACN">Algorithm to derive ADAE.AEACN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AEBODSYS">Algorithm to derive ADAE.AEBODSYS</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AEDECOD">Algorithm to derive ADAE.AEDECOD</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AEHLGT">Algorithm to derive ADAE.AEHLGT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AEHLGTCD">Algorithm to derive ADAE.AEHLGTCD</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AEHLT">Algorithm to derive ADAE.AEHLT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AEHLTCD">Algorithm to derive ADAE.AEHLTCD</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AELLT">Algorithm to derive ADAE.AELLT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AELLTCD">Algorithm to derive ADAE.AELLTCD</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AENDT">Algorithm to derive ADAE.AENDT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AENDY">Algorithm to derive ADAE.AENDY</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AEOUT">Algorithm to derive ADAE.AEOUT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AEPTCD">Algorithm to derive ADAE.AEPTCD</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AEREL">Algorithm to derive ADAE.AEREL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AESCAN">Algorithm to derive ADAE.AESCAN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AESCONG">Algorithm to derive ADAE.AESCONG</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AESDISAB">Algorithm to derive ADAE.AESDISAB</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AESDTH">Algorithm to derive ADAE.AESDTH</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AESEQ">Algorithm to derive ADAE.AESEQ</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AESER">Algorithm to derive ADAE.AESER</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AESEV">Algorithm to derive ADAE.AESEV</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AESHOSP">Algorithm to derive ADAE.AESHOSP</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AESLIFE">Algorithm to derive ADAE.AESLIFE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AESOC">Algorithm to derive ADAE.AESOC</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AESOCCD">Algorithm to derive ADAE.AESOCCD</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AESOD">Algorithm to derive ADAE.AESOD</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AETERM">Algorithm to derive ADAE.AETERM</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AGE">Algorithm to derive ADAE.AGE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AGEGR1">Algorithm to derive ADAE.AGEGR1</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AGEGR1N">Algorithm to derive ADAE.AGEGR1N</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AOCC01FL">Algorithm to derive ADAE.AOCC01FL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AOCC02FL">Algorithm to derive ADAE.AOCC02FL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AOCC03FL">Algorithm to derive ADAE.AOCC03FL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AOCC04FL">Algorithm to derive ADAE.AOCC04FL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AOCCFL">Algorithm to derive ADAE.AOCCFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AOCCPFL">Algorithm to derive ADAE.AOCCPFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.AOCCSFL">Algorithm to derive ADAE.AOCCSFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.ASTDT">Algorithm to derive ADAE.ASTDT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.ASTDTF">Algorithm to derive ADAE.ASTDTF</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.ASTDY">Algorithm to derive ADAE.ASTDY</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.CQ01NAM">Algorithm to derive ADAE.CQ01NAM</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.RACE">Algorithm to derive ADAE.RACE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.RACEN">Algorithm to derive ADAE.RACEN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.SAFFL">Algorithm to derive ADAE.SAFFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.SEX">Algorithm to derive ADAE.SEX</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.SITEID">Algorithm to derive ADAE.SITEID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.STUDYID">Algorithm to derive ADAE.STUDYID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.TRTA">Algorithm to derive ADAE.TRTA</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.TRTAN">Algorithm to derive ADAE.TRTAN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.TRTEDT">Algorithm to derive ADAE.TRTEDT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.TRTEMFL">Algorithm to derive ADAE.TRTEMFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.TRTSDT">Algorithm to derive ADAE.TRTSDT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADAE.USUBJID">Algorithm to derive ADAE.USUBJID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.A1HI">Algorithm to derive ADLBC.A1HI</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.A1LO">Algorithm to derive ADLBC.A1LO</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.ABLFL">Algorithm to derive ADLBC.ABLFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.ADT">Algorithm to derive ADLBC.ADT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.ADY">Algorithm to derive ADLBC.ADY</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.AENTMTFL">Algorithm to derive ADLBC.AENTMTFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.AGE">Algorithm to derive ADLBC.AGE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.AGEGR1">Algorithm to derive ADLBC.AGEGR1</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.AGEGR1N">Algorithm to derive ADLBC.AGEGR1N</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.ALBTRVAL">Algorithm to derive ADLBC.ALBTRVAL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.ANL01FL">Algorithm to derive ADLBC.ANL01FL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.ANRIND">Algorithm to derive ADLBC.ANRIND</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.AVAL">Algorithm to derive ADLBC.AVAL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.AVISIT">Algorithm to derive ADLBC.AVISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.AVISITN">Algorithm to derive ADLBC.AVISITN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.BASE">Algorithm to derive ADLBC.BASE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.BNRIND">Algorithm to derive ADLBC.BNRIND</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.BR2A1HI">Algorithm to derive ADLBC.BR2A1HI</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.BR2A1LO">Algorithm to derive ADLBC.BR2A1LO</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.CHG">Algorithm to derive ADLBC.CHG</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.COMP24FL">Algorithm to derive ADLBC.COMP24FL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.DSRAEFL">Algorithm to derive ADLBC.DSRAEFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.LBNRIND">Algorithm to derive ADLBC.LBNRIND</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.LBSEQ">Algorithm to derive ADLBC.LBSEQ</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.LBSTRESN">Algorithm to derive ADLBC.LBSTRESN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.PARAM">Algorithm to derive ADLBC.PARAM</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.PARAMCD">Algorithm to derive ADLBC.PARAMCD</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.PARAMN">Algorithm to derive ADLBC.PARAMN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.PARCAT1">Algorithm to derive ADLBC.PARCAT1</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.R2A1HI">Algorithm to derive ADLBC.R2A1HI</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.R2A1LO">Algorithm to derive ADLBC.R2A1LO</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.RACE">Algorithm to derive ADLBC.RACE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.RACEN">Algorithm to derive ADLBC.RACEN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.SAFFL">Algorithm to derive ADLBC.SAFFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.SEX">Algorithm to derive ADLBC.SEX</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.STUDYID">Algorithm to derive ADLBC.STUDYID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.SUBJID">Algorithm to derive ADLBC.SUBJID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.TRTA">Algorithm to derive ADLBC.TRTA</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.TRTAN">Algorithm to derive ADLBC.TRTAN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.TRTEDT">Algorithm to derive ADLBC.TRTEDT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.TRTP">Algorithm to derive ADLBC.TRTP</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.TRTPN">Algorithm to derive ADLBC.TRTPN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.TRTSDT">Algorithm to derive ADLBC.TRTSDT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.USUBJID">Algorithm to derive ADLBC.USUBJID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.VISIT">Algorithm to derive ADLBC.VISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBC.VISITNUM">Algorithm to derive ADLBC.VISITNUM</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.A1HI">Algorithm to derive ADLBH.A1HI</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.A1LO">Algorithm to derive ADLBH.A1LO</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.ABLFL">Algorithm to derive ADLBH.ABLFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.ADT">Algorithm to derive ADLBH.ADT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.ADY">Algorithm to derive ADLBH.ADY</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.AENTMTFL">Algorithm to derive ADLBH.AENTMTFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.AGE">Algorithm to derive ADLBH.AGE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.AGEGR1">Algorithm to derive ADLBH.AGEGR1</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.AGEGR1N">Algorithm to derive ADLBH.AGEGR1N</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.ALBTRVAL">Algorithm to derive ADLBH.ALBTRVAL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.ANL01FL">Algorithm to derive ADLBH.ANL01FL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.ANRIND">Algorithm to derive ADLBH.ANRIND</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.AVAL">Algorithm to derive ADLBH.AVAL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.AVISIT">Algorithm to derive ADLBH.AVISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.AVISITN">Algorithm to derive ADLBH.AVISITN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.BASE">Algorithm to derive ADLBH.BASE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.BNRIND">Algorithm to derive ADLBH.BNRIND</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.BR2A1HI">Algorithm to derive ADLBH.BR2A1HI</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.BR2A1LO">Algorithm to derive ADLBH.BR2A1LO</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.CHG">Algorithm to derive ADLBH.CHG</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.COMP24FL">Algorithm to derive ADLBH.COMP24FL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.DSRAEFL">Algorithm to derive ADLBH.DSRAEFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.LBNRIND">Algorithm to derive ADLBH.LBNRIND</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.LBSEQ">Algorithm to derive ADLBH.LBSEQ</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.LBSTRESN">Algorithm to derive ADLBH.LBSTRESN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.PARAM">Algorithm to derive ADLBH.PARAM</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.PARAMCD">Algorithm to derive ADLBH.PARAMCD</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.PARAMN">Algorithm to derive ADLBH.PARAMN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.PARCAT1">Algorithm to derive ADLBH.PARCAT1</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.R2A1HI">Algorithm to derive ADLBH.R2A1HI</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.R2A1LO">Algorithm to derive ADLBH.R2A1LO</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.RACE">Algorithm to derive ADLBH.RACE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.RACEN">Algorithm to derive ADLBH.RACEN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.SAFFL">Algorithm to derive ADLBH.SAFFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.SEX">Algorithm to derive ADLBH.SEX</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.STUDYID">Algorithm to derive ADLBH.STUDYID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.SUBJID">Algorithm to derive ADLBH.SUBJID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.TRTA">Algorithm to derive ADLBH.TRTA</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.TRTAN">Algorithm to derive ADLBH.TRTAN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.TRTEDT">Algorithm to derive ADLBH.TRTEDT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.TRTP">Algorithm to derive ADLBH.TRTP</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.TRTPN">Algorithm to derive ADLBH.TRTPN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.TRTSDT">Algorithm to derive ADLBH.TRTSDT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.USUBJID">Algorithm to derive ADLBH.USUBJID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.VISIT">Algorithm to derive ADLBH.VISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBH.VISITNUM">Algorithm to derive ADLBH.VISITNUM</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.A1HI">Algorithm to derive ADLBHY.A1HI</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.A1LO">Algorithm to derive ADLBHY.A1LO</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.ABLFL">Algorithm to derive ADLBHY.ABLFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.ADT">Algorithm to derive ADLBHY.ADT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.ADY">Algorithm to derive ADLBHY.ADY</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.AGE">Algorithm to derive ADLBHY.AGE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.AGEGR1">Algorithm to derive ADLBHY.AGEGR1</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.AGEGR1N">Algorithm to derive ADLBHY.AGEGR1N</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.AVAL">Algorithm to derive ADLBHY.AVAL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.AVISIT">Algorithm to derive ADLBHY.AVISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.AVISITN">Algorithm to derive ADLBHY.AVISITN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.BASE">Algorithm to derive ADLBHY.BASE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.BR2A1HI">Algorithm to derive ADLBHY.BR2A1HI</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.BR2A1LO">Algorithm to derive ADLBHY.BR2A1LO</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.COMP24FL">Algorithm to derive ADLBHY.COMP24FL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.CRIT1">Algorithm to derive ADLBHY.CRIT1</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.CRIT1FL">Algorithm to derive ADLBHY.CRTI1FL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.CRIT1FN">Algorithm to derive ADLBHY.CRIT1FN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.DSRAEFL">Algorithm to derive ADLBHY.DSRAEFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.PARAM">Algorithm to derive ADLBHY.PARAM</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.PARAMCD">Algorithm to derive ADLBHY.PARAMCD</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.PARAMN">Algorithm to derive ADLBHY.PARAMN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.PARAMTYP">Algorithm to derive ADLBHY.PARAMTYP</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.PARCAT1">Algorithm to derive ADLBHY.PARCAT1</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.R2A1HI">Algorithm to derive ADLBHY.R2A1HI</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.R2A1LO">Algorithm to derive ADLBHY.R2A1LO</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.RACE">Algorithm to derive ADLBHY.RACE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.RACEN">Algorithm to derive ADLBHY.RACEN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.SAFFL">Algorithm to derive ADLBHY.SAFFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.SEX">Algorithm to derive ADLBHY.SEX</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.SHIFT1">Algorithm to derive ADLBHY.SHIFT1</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.SHIFT1N">Algorithm to derive ADLBHY.SHIFT1N</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.STUDYID">Algorithm to derive ADLBHY.STUDYID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.SUBJID">Algorithm to derive ADLBHY.SUBJID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.TRTA">Algorithm to derive ADLBHY.TRTA</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.TRTAN">Algorithm to derive ADLBHY.TRTAN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.TRTEDT">Algorithm to derive ADLBHY.TRTEDT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.TRTP">Algorithm to derive ADLBHY.TRTP</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.TRTPN">Algorithm to derive ADLBHY.TRTPN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.TRTSDT">Algorithm to derive ADLBHY.TRTSDT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.USUBJID">Algorithm to derive ADLBHY.USUBJID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.VISIT">Algorithm to derive ADLBHY.VISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADLBHY.VISITNUM">Algorithm to derive ADLBHY.VISITNUM</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.AGE">Algorithm to derive ADSL.AGE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.AGEGR1">Algorithm to derive ADSL.AGEGR1</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.AGEGR1N">Algorithm to derive ADSL.AGEGR1N</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.AGEU">Algorithm to derive ADSL.AGEU</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.ARM">Algorithm to derive ADSL.ARM</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.AVGDD">Algorithm to derive ADSL.AVGDD</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.BMIBL">Algorithm to derive ADSL.BMIBL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.BMIBLGR1">Algorithm to derive ADSL.BMIBLGR1</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.COMP16FL">Algorithm to derive ADSL.COMP16FL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.COMP24FL">Algorithm to derive ADSL.COMP24FL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.COMP8FL">Algorithm to derive ADSL.COMP8FL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.CUMDOSE">Algorithm to derive ADSL.CUMDOSE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.DCDECOD">Algorithm to derive ADSL.DCDECOD</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.DCREASCD">Algorithm to derive ADSL.DCREASCD</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.DISCONFL">Algorithm to derive ADSL.DISCONFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.DISONSDT">Algorithm to derive ADSL.DISONSDT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.DSRAEFL">Algorithm to derive ADSL.DSRAEFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.DTHFL">Algorithm to derive ADSL.DTHFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.DURDIS">Algorithm to derive ADSL.DURDIS</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.DURDSGR1">Algorithm to derive ADSL.DURDSGR1</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.EDUCLVL">Algorithm to derive ADSL.EDUCLVL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.EFFFL">Algorithm to derive ADSL.EFFFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.EOSSTT">Algorithm to derive ADSL.EOSSTT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.ETHNIC">Algorithm to derive ADSL.ETHNIC</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.HEIGHTBL">Algorithm to derive ADSL.HEIGHTBL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.ITTFL">Algorithm to derive ADSL.ITTFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.MMSETOT">Algorithm to derive ADSL.MMSETOT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.RACE">Algorithm to derive ADSL.RACE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.RACEN">Algorithm to derive ADSL.RACEN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.RFENDT">Algorithm to derive ADSL.RFENDT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.RFENDTC">Algorithm to derive ADSL.RFENDTC</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.RFSTDTC">Algorithm to derive ADSL.RFSTDTC</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.SAFFL">Algorithm to derive ADSL.SAFFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.SEX">Algorithm to derive ADSL.SEX</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.SITEGR1">Algorithm to derive ADSL.SITEGR1</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.SITEID">Algorithm to derive ADSL.SITEID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.STUDYID">Algorithm to derive ADSL.STUDYID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.SUBJID">Algorithm to derive ADSL.SUBJID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.TRT01A">Algorithm to derive ADSL.TRT01A</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.TRT01AN">Algorithm to derive ADSL.TRT01AN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.TRT01P">Algorithm to derive ADSL.TRT01P</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.TRT01PN">Algorithm to derive ADSL.TRT01PN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.TRTDUR">Algorithm to derive ADSL.TRTDUR</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.TRTEDT">Algorithm to derive ADSL.TRTEDT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.TRTSDT">Algorithm to derive ADSL.TRTSDT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.USUBJID">Algorithm to derive ADSL.USUBJID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.VISIT1DT">Algorithm to derive ADSL.VISIT1DT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.VISNUMEN">Algorithm to derive ADSL.VISNUMEN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADSL.WEIGHTBL">Algorithm to derive ADSL.WEIGHTBL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.ADT">Algorithm to derive ADTTE.ADT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.AGE">Algorithm to derive ADTTE.AGE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.AGEGR1">Algorithm to derive ADTTE.AGEGR1</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.AGEGR1N">Algorithm to derive ADTTE.AGEGR1N</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.AVAL">Algorithm to derive ADTTE.AVAL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.CNSR">Algorithm to derive ADTTE.CNSR</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.EVNTDESC">Algorithm to derive ADTTE.EVNTDESC</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.PARAM">Algorithm to derive ADTTE.PARAM</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.PARAMCD">Algorithm to derive ADTTE.PARAMCD</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.RACE">Algorithm to derive ADTTE.RACE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.RACEN">Algorithm to derive ADTTE.RACEN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.SAFFL">Algorithm to derive ADTTE.SAFFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.SEX">Algorithm to derive ADTTE.SEX</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.SITEID">Algorithm to derive ADTTE.SITEID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.SRCDOM">Algorithm to derive ADTTE.SRCDOM</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.SRCSEQ">Algorithm to derive ADTTE.SRCSEQ</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.SRCVAR">Algorithm to derive ADTTE.SRCVAR</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.STARTDT">Algorithm to derive ADTTE.STARTDT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.STUDYID">Algorithm to derive ADTTE.STUDYID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.TRTA">Algorithm to derive ADTTE.TRTA</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.TRTAN">Algorithm to derive ADTTE.TRTAN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.TRTDUR">Algorithm to derive ADTTE.TRTDUR</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.TRTEDT">Algorithm to derive ADTTE.TRTEDT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.TRTP">Algorithm to derive ADTTE.TRTP</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.TRTSDT">Algorithm to derive ADTTE.TRTSDT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADTTE.USUBJID">Algorithm to derive ADTTE.USUBJID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.ABLFL">Algorithm to derive ADVS.ABLFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.ADT">Algorithm to derive ADVS.ADT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.ADY">Algorithm to derive ADVS.ADY</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.AGE">Algorithm to derive ADVS.AGE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.AGEGR1">Algorithm to derive ADVS.AGEGR1</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.AGEGR1N">Algorithm to derive ADVS.AGEGR1N</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.ANL01FL">Algorithm to derive ADVS.ANL01FL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.ATPT">Algorithm to derive ADVS.ATPT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.ATPTN">Algorithm to derive ADVS.ATPTN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.AVAL">Algorithm to derive ADVS.AVAL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.AVISIT">Algorithm to derive ADVS.AVISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.AVISITN">Algorithm to derive ADVS.AVISITN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.BASE">Algorithm to derive ADVS.BASE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.BASETYPE">Algorithm to derive ADVS.BASETYPE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.CHG">Algorithm to derive ADVS.CHG</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.PARAM">Algorithm to derive ADVS.PARAM</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.PARAMCD">Algorithm to derive ADVS.PARAMCD</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.PARAMN">Algorithm to derive ADVS.PARAMN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.PCHG">Algorithm to derive ADVS.PCHG</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.RACE">Algorithm to derive ADVS.RACE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.RACEN">Algorithm to derive ADVS.RACEN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.SAFFL">Algorithm to derive ADVS.SAFFL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.SEX">Algorithm to derive ADVS.SEX</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.SITEID">Algorithm to derive ADVS.SITEID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.STUDYID">Algorithm to derive ADVS.STUDYID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.TRTA">Algorithm to derive ADVS.TRTA</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.TRTAN">Algorithm to derive ADVS.TRTAN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.TRTEDT">Algorithm to derive ADVS.TRTEDT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.TRTP">Algorithm to derive ADVS.TRTP</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.TRTPN">Algorithm to derive ADVS.TRTPN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.TRTSDT">Algorithm to derive ADVS.TRTSDT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.USUBJID">Algorithm to derive ADVS.USUBJID</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.VISIT">Algorithm to derive ADVS.VISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.VISITNUM">Algorithm to derive ADVS.VISITNUM</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADVS.VSSEQ">Algorithm to derive ADVS.VSSEQ</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADADAS.AVISIT">Algorithm to derive ADADAS.AVISIT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADADAS.AVISITN">Algorithm to derive ADADAS.AVISITN</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADADAS.ADY">Algorithm to derive ADADAS.ADY</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADADAS.ADT">Algorithm to derive ADADAS.ADT</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADADAS.BASE">Algorithm to derive ADADAS.BASE</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADADAS.CHG">Algorithm to derive ADADAS.CHG</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADADAS.PCHG">Algorithm to derive ADADAS.PCHG</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADADAS.ANL01FL">Algorithm to derive ADADAS.ANL01FL</a></li><li class="hmenu-item"><span class="hmenu-bullet"> </span><a class="tocItem" href="#MT.MT.ADADAS.DTYPE">Algorithm to derive ADADAS.DTYPE</a></li></ul></li></ul></div><div id="main"><div class="docinfo"><p class="documentinfo">Date/Time of Define-XML document generation: 2023-01-26T21:07:29</p><p class="documentinfo">Define-XML version: 2.0.0</p><p class="stylesheetinfo">Stylesheet version: 2018-11-21</p></div><div class="study-metadata"><dl class="study-metadata"><dt>Standard</dt><dd>ADaM-IG 1.0</dd><dt>Study Name</dt><dd>TDF_ADaM</dd><dt>Study Description</dt><dd>Test datasets created by updating existing CDISCPILOT ADaM datasets</dd><dt>Protocol Name</dt><dd>TDF_Datasets</dd><dt>Metadata Name</dt><dd>Study TDF_ADaM Data Definitions</dd></dl></div><a id="datasets"></a><h1 class="invisible">Datasets</h1><div class="containerbox"><table summary="Data Definition Tables"><caption class="header">Datasets</caption><tbody><tr class="header"><th scope="col">Dataset</th><th scope="col">Description</th><th scope="col">Class
</th><th scope="col">Structure</th><th scope="col">Purpose</th><th scope="col">Keys</th><th scope="col">Documentation</th><th scope="col">Location</th></tr><tr class="tablerowodd" id="IG.ADADAS"><td><a href="#IG.IG.ADADAS">ADADAS</a></td><td>ADAS-Cog Analysis (ADAD)</td><td>BASIC DATA STRUCTURE</td><td>One record per subject per parameter per analysis visit per analysis date</td><td></td><td>USUBJID, PARAMCD, AVISIT, ADT</td><td></td><td><a class="external" href="./adadas.xpt">adadas.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.ADAE"><td><a href="#IG.IG.ADAE">ADAE</a></td><td>Adverse Events Analysis Dataset (AD)</td><td>ADAM OTHER</td><td>One record per subject per adverse event</td><td></td><td>USUBJID, AETERM, ASTDT, AESEQ</td><td></td><td><a class="external" href="./adae.xpt">adae.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.ADLBC"><td><a href="#IG.IG.ADLBC">ADLBC</a></td><td>Analysis Dataset Lab Blood Chemistry</td><td>BASIC DATA STRUCTURE</td><td>One record per subject per parameter per analysis visit</td><td></td><td>USUBJID, PARAMCD, AVISIT, LBSEQ</td><td></td><td><a class="external" href="./adlbc.xpt">adlbc.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.ADLBH"><td><a href="#IG.IG.ADLBH">ADLBH</a></td><td>Analysis Dataset Lab Hematology</td><td>BASIC DATA STRUCTURE</td><td>One record per subject per parameter per analysis visit</td><td></td><td>USUBJID, PARAMCD, AVISIT, LBSEQ</td><td></td><td><a class="external" href="./adlbh.xpt">adlbh.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.ADLBHY"><td><a href="#IG.IG.ADLBHY">ADLBHY</a></td><td>Analysis Dataset Lab Hy's Law (ADLB)</td><td>BASIC DATA STRUCTURE</td><td>One record per subject per parameter per analysis visit</td><td></td><td>USUBJID, PARAMCD, AVISIT</td><td></td><td><a class="external" href="./adlbhy.xpt">adlbhy.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.ADSL"><td><a href="#IG.IG.ADSL">ADSL</a></td><td>Subject-Level Analysis Dataset (AD)</td><td>SUBJECT LEVEL ANALYSIS DATASET</td><td>One record per subject. Screen Failures are excluded.</td><td></td><td>USUBJID</td><td></td><td><a class="external" href="./adsl.xpt">adsl.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tablerowodd" id="IG.ADTTE"><td><a href="#IG.IG.ADTTE">ADTTE</a></td><td>AE Time To 1st Derm. Event Analysis</td><td>BASIC DATA STRUCTURE</td><td>One record per subject per parameter</td><td></td><td>USUBJID, PARAMCD</td><td></td><td><a class="external" href="./adtte.xpt">adtte.xpt</a><span class="external-link-gif"></span> </td></tr><tr class="tableroweven" id="IG.ADVS"><td><a href="#IG.IG.ADVS">ADVS</a></td><td>Vital Signs Analysis Dataset (AD)</td><td>BASIC DATA STRUCTURE</td><td>One record per subject per parameter per analysis visit per analysis timepoint</td><td></td><td>USUBJID, PARAMCD, AVISIT, ATPT</td><td></td><td><a class="external" href="./advs.xpt">advs.xpt</a><span class="external-link-gif"></span> </td></tr></tbody></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADADAS"></a><div class="containerbox"><h1 class="invisible">ADAS-Cog Analysis (ADADAS) </h1><table summary="ItemGroup IG.IG.ADADAS"><caption><span>ADADAS (ADAS-Cog Analysis, ADAD) - BASIC DATA STRUCTURE <span class="dataset">Location: <a class="external" href="./adadas.xpt">adadas.xpt</a><span class="external-link-gif"></span> </span></span></caption><tbody><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">DM.STUDYID</p></div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.SITEID"></a>SITEID</td><td>Study Site Identifier</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">DM.SITEID</p></div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.SITEGR1"></a>SITEGR1</td><td>Pooled Site Group 1</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">ADSL.SITEGR1</p></div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">DM.USUBJID</p></div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.TRTSDT"></a>TRTSDT</td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">ADSL.TRTSDT</p></div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.TRTEDT"></a>TRTEDT</td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">ADSL.TRTEDT</p></div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.TRTP"></a>TRTP</td><td>Planned Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">ARM</a></span><ul class="codelist"><li class="codelist-item">• "Placebo" = "Placebo"</li><li class="codelist-item">• "Xanomeline Low Dose" = "Xanomeline Low Dose"</li><li class="codelist-item">• "Xanomeline High Dose" = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">DM.ARM</p></div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.TRTPN"></a>TRTPN</td><td>Planned Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">ARMN</a></span><ul class="codelist"><li class="codelist-item">• 0 = "Placebo"</li><li class="codelist-item">• 54 = "Xanomeline Low Dose"</li><li class="codelist-item">• 81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">ADSL.TRT01PN</p></div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.AGE"></a>AGE</td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">DM.AGE</p></div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.AGEGR1"></a>AGEGR1</td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">AGEGR1</a></span><ul class="codelist"><li class="codelist-item">• "<65" = "<65"</li><li class="codelist-item">• "65-80" = "65-80"</li><li class="codelist-item">• ">80" = ">80"</li></ul></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">ADSL.AGEGR1</p></div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.AGEGR1N"></a>AGEGR1N</td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">AGEGR1N</a></span><ul class="codelist"><li class="codelist-item">• 1 = "<65"</li><li class="codelist-item">• 2 = "65-80"</li><li class="codelist-item">• 3 = ">80"</li></ul></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">ADSL.AGEGR1N</p></div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.RACE"></a>RACE</td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">RACE</a></span><ul class="codelist"><li class="codelist-item">• "AMERICAN INDIAN OR ALASKA NATIVE" = "1"</li><li class="codelist-item">• "ASIAN" = "2"</li><li class="codelist-item">• "BLACK OR AFRICAN AMERICAN" = "3"</li><li class="codelist-item">• "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "5"</li><li class="codelist-item">• "WHITE" = "6"</li></ul></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">DM.RACE</p></div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.RACEN"></a>RACEN</td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">RACEN</a></span><ul class="codelist"><li class="codelist-item">• 1 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">• 2 = "ASIAN"</li><li class="codelist-item">• 3 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">• 5 = "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER"</li><li class="codelist-item">• 6 = "WHITE"</li></ul></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">ADSL.RACEN</p></div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.SEX"></a>SEX</td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">SEX</a></span><ul class="codelist"><li class="codelist-item">• "M"</li><li class="codelist-item">• "F"</li></ul></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">DM.SEX</p></div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.ITTFL"></a>ITTFL</td><td>Intent-to-Treat Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">ADSL.ITTFL</p></div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.EFFFL"></a>EFFFL</td><td>Efficacy Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">ADSL.EFFFL</p></div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.COMP24FL"></a>COMP24FL</td><td>Completers of Week 24 Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">ADSL.COMP24FL</p></div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.AVISIT"></a>AVISIT</td><td>Analysis Visit</td><td class="datatype">text</td><td class="number">16</td><td><a href="#CL.CL.AVISIT">AVISIT</a><p class="linebreakcell">
[16 Terms]
</p></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Derived based on windowing algorithm described in SAP, Section 8.2</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.AVISITN"></a>AVISITN</td><td>Analysis Visit (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.AVISITN">AVISITN</a><p class="linebreakcell">
[16 Terms]
</p></td><td><div class="linebreakcell">ASSIGNED</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.VISIT"></a>VISIT</td><td>Visit Name</td><td class="datatype">text</td><td class="number">19</td><td><a href="#CL.CL.VISIT">VISIT</a><p class="linebreakcell">
[37 Terms]
</p></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">QS.VISIT</p></div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.VISITNUM"></a>VISITNUM</td><td>Visit Number</td><td class="datatype">float</td><td class="number">8</td><td><a href="#CL.CL.VISITNUM">VISITNUM</a><p class="linebreakcell">
[37 Terms]
</p></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">QS.VISITNUM</p></div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.ADY"></a>ADY</td><td>Analysis Relative Day</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">ADY = ADT - TRTSDT + 1, if ADT>=TRTSDT. ADY =
ADT - TRTSDT, if ADT<TRTSDT.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.ADT"></a>ADT</td><td>Analysis Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">SAS date from QS.QSDTC</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.PARAM"></a>PARAM</td><td>Parameter</td><td class="datatype">text</td><td class="number">100</td><td></td><td><div class="linebreakcell">ASSIGNED</div><p class="linebreakcell">Decoded value for PARAMCD</p></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.PARAMCD"></a>PARAMCD</td><td>Parameter Code</td><td class="datatype">text</td><td class="number">8</td><td></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">QS.QSTESTCD</p></div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.PARAMN"></a>PARAMN</td><td>Parameter (N)</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">ASSIGNED</div><p class="linebreakcell">Assign a numeric code for each value of PARAMCD (see codelist PARAMN_ADQSADAS)</p></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.AVAL"></a>AVAL</td><td>Analysis Value</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">ASSIGNED</div><p class="linebreakcell">see Value Level Metadata</p></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.BASE"></a>BASE</td><td>Baseline Value</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">QS.QSSTRESN when QS.QSBLFL=Y (QS.VISITNUM=3)</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.CHG"></a>CHG</td><td>Change from Baseline</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">AVAL - BASE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.PCHG"></a>PCHG</td><td>Percent Change from Baseline</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">100* (CHG/BASE)</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.ABLFL"></a>ABLFL</td><td>Baseline Record Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">QS.QSBLFL</p></div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.ANL01FL"></a>ANL01FL</td><td>Analysis Record Flag 01</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">If multiple visits fall into the same visit window, then the one closest to the target date is chosen for analysis. These are flagged with ANL01FL="Y".</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.DTYPE"></a>DTYPE</td><td>Derivation Type</td><td class="datatype">text</td><td class="number">7</td><td><span class="linebreakcell"><a href="#CL.CL.DTYPE">DTYPE</a></span><ul class="codelist"><li class="codelist-item">• "LOCF" = "Last Observation Carried Forward"</li><li class="codelist-item">• "AVERAGE" = "Average"</li></ul></td><td><div class="linebreakcell">DERIVED</div><div class="method-code">Set to "LOCF" if a record is imputated when PARAMCD="ACTOT"; otherwise, set to missing</div></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.AWRANGE"></a>AWRANGE</td><td>Analysis Window Valid Relative Range</td><td class="datatype">text</td><td class="number">9</td><td></td><td><div class="linebreakcell">ASSIGNED</div><p class="linebreakcell">Window range, specified in the SAP.</p></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.AWTARGET"></a>AWTARGET</td><td>Analysis Window Target</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">ASSIGNED</div><p class="linebreakcell">Target day within the window, specified in the SAP.</p></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.AWTDIFF"></a>AWTDIFF</td><td>Analysis Window Diff from Target</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">ASSIGNED</div><p class="linebreakcell">Absolute difference between AWTARGET and ADY</p></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.AWLO"></a>AWLO</td><td>Analysis Window Beginning Timepoint</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">ASSIGNED</div><p class="linebreakcell">Start day of the window, specified in the SAP.</p></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.AWHI"></a>AWHI</td><td>Analysis Window Ending Timepoint</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">ASSIGNED</div><p class="linebreakcell">End day of the window, specified in the SAP.</p></td></tr><tr class="tablerowodd"><td><a id="IG.ADADAS.IT.ADADAS.AWU"></a>AWU</td><td>Analysis Window Unit</td><td class="datatype">text</td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.AWU">AWU</a></span><ul class="codelist"><li class="codelist-item">• "DAYS" = "DAYS"</li></ul></td><td><div class="linebreakcell">ASSIGNED</div><p class="linebreakcell">Assigned as "DAYS".</p></td></tr><tr class="tableroweven"><td><a id="IG.ADADAS.IT.ADADAS.QSSEQ"></a>QSSEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">PREDECESSOR<p class="linebreakcell">QS.QSSEQ</p></div></td></tr></tbody></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADAE"></a><div class="containerbox"><h1 class="invisible">Adverse Events Analysis Dataset (ADAE) </h1><table summary="ItemGroup IG.IG.ADAE"><caption><span>ADAE (Adverse Events Analysis Dataset, AD) - ADAM OTHER <span class="dataset">Location: <a class="external" href="./adae.xpt">adae.xpt</a><span class="external-link-gif"></span> </span></span></caption><tbody><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.STUDYID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.SITEID"></a>SITEID</td><td>Study Site Identifier</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.SITEID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.USUBJID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.TRTA"></a>TRTA</td><td>Actual Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">ARM</a></span><ul class="codelist"><li class="codelist-item">• "Placebo" = "Placebo"</li><li class="codelist-item">• "Xanomeline Low Dose" = "Xanomeline Low Dose"</li><li class="codelist-item">• "Xanomeline High Dose" = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01A</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.TRTAN"></a>TRTAN</td><td>Actual Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">ARMN</a></span><ul class="codelist"><li class="codelist-item">• 0 = "Placebo"</li><li class="codelist-item">• 54 = "Xanomeline Low Dose"</li><li class="codelist-item">• 81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01AN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AGE"></a>AGE</td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.AGE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AGEGR1"></a>AGEGR1</td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">AGEGR1</a></span><ul class="codelist"><li class="codelist-item">• "<65" = "<65"</li><li class="codelist-item">• "65-80" = "65-80"</li><li class="codelist-item">• ">80" = ">80"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.AGEGR1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AGEGR1N"></a>AGEGR1N</td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">AGEGR1N</a></span><ul class="codelist"><li class="codelist-item">• 1 = "<65"</li><li class="codelist-item">• 2 = "65-80"</li><li class="codelist-item">• 3 = ">80"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.AGEGR1N</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.RACE"></a>RACE</td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">RACE</a></span><ul class="codelist"><li class="codelist-item">• "AMERICAN INDIAN OR ALASKA NATIVE" = "1"</li><li class="codelist-item">• "ASIAN" = "2"</li><li class="codelist-item">• "BLACK OR AFRICAN AMERICAN" = "3"</li><li class="codelist-item">• "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "5"</li><li class="codelist-item">• "WHITE" = "6"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.RACE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.RACEN"></a>RACEN</td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">RACEN</a></span><ul class="codelist"><li class="codelist-item">• 1 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">• 2 = "ASIAN"</li><li class="codelist-item">• 3 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">• 5 = "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER"</li><li class="codelist-item">• 6 = "WHITE"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.RACEN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.SEX"></a>SEX</td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">SEX</a></span><ul class="codelist"><li class="codelist-item">• "M"</li><li class="codelist-item">• "F"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.SEX</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.SAFFL"></a>SAFFL</td><td>Safety Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.SAFFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.TRTSDT"></a>TRTSDT</td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRTSDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.TRTEDT"></a>TRTEDT</td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRTEDT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.ASTDT"></a>ASTDT</td><td>Analysis Start Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AESTDTC, converted to a numeric SAS date. Some events with partial dates are imputed in a conservative manner. If the day component is missing, a value of '01' is used. If both the month and day are missing no imputation is performed as these dates clearly indicate a start prior to the beginning of treatment. There are no events with completely missing start dates.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.ASTDTF"></a>ASTDTF</td><td>Analysis Start Date Imputation Flag</td><td class="datatype">text</td><td class="number">1</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ASTDTF='D' if the day value within the character date is imputed. Note that only day values needed to be imputed for this study.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.ASTDY"></a>ASTDY</td><td>Analysis Start Relative Day</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">IF ASTDT>=TRTSDT>MISSING then ASTDY=ASTDT-TRTSDT+1 Else if TRTSDT>ASTDT>MISSING then ASTDY=ASTDT-TRTSDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AENDT"></a>AENDT</td><td>Analysis End Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AEENDTC, converted to a numeric SAS date</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AENDY"></a>AENDY</td><td>Analysis End Relative Day</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">IF AENDT>=TRTSDT>MISSING then AENDY=AENDT-TRTSDT+1 Else if TRTSDT>AENDT>MISSING then AENDY=AENDT-TRTSDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.ADURN"></a>ADURN</td><td>AE Duration (N)</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADURN=AENDT-ASTDT+1</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.ADURU"></a>ADURU</td><td>AE Duration Units</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">If ADURN is not missing then ADURU='DAY'</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AETERM"></a>AETERM</td><td>Reported Term for the Adverse Event</td><td class="datatype">text</td><td class="number">46</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AETERM</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AELLT"></a>AELLT</td><td>Lowest Level Term</td><td class="datatype">text</td><td class="number">46</td><td><a href="#CL.CL.AEDICT">ADVERSE EVENT DICTIONARY</a><p class="linebreakcell">MedDRA 8.0</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AELLT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AELLTCD"></a>AELLTCD</td><td>Lowest Level Term Code</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AELLTCD</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AEDECOD"></a>AEDECOD</td><td>Dictionary-Derived Term</td><td class="datatype">text</td><td class="number">46</td><td><a href="#CL.CL.AEDICT">ADVERSE EVENT DICTIONARY</a><p class="linebreakcell">MedDRA 8.0</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AEDECOD</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AEPTCD"></a>AEPTCD</td><td>Preferred Term Code</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AEPTCD</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AEHLT"></a>AEHLT</td><td>High Level Term</td><td class="datatype">text</td><td class="number">8</td><td><a href="#CL.CL.AEDICT">ADVERSE EVENT DICTIONARY</a><p class="linebreakcell">MedDRA 8.0</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AEHLT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AEHLTCD"></a>AEHLTCD</td><td>High Level Term Code</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AEHLTCD</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AEHLGT"></a>AEHLGT</td><td>High Level Group Term</td><td class="datatype">text</td><td class="number">9</td><td><a href="#CL.CL.AEDICT">ADVERSE EVENT DICTIONARY</a><p class="linebreakcell">MedDRA 8.0</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AEHLGT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AEHLGTCD"></a>AEHLGTCD</td><td>High Level Group Term Code</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AEHLGTCD</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AEBODSYS"></a>AEBODSYS</td><td>Body System or Organ Class</td><td class="datatype">text</td><td class="number">67</td><td><a href="#CL.CL.AEDICT">ADVERSE EVENT DICTIONARY</a><p class="linebreakcell">MedDRA 8.0</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AEBODSYS</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AESOC"></a>AESOC</td><td>Primary System Organ Class</td><td class="datatype">text</td><td class="number">67</td><td><a href="#CL.CL.AEDICT">ADVERSE EVENT DICTIONARY</a><p class="linebreakcell">MedDRA 8.0</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AESOC</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AESOCCD"></a>AESOCCD</td><td>Primary System Organ Class Code</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AESOCCD</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AESEV"></a>AESEV</td><td>Severity/Intensity</td><td class="datatype">text</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AESEV</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AESER"></a>AESER</td><td>Serious Event</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AESER</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AESCAN"></a>AESCAN</td><td>Involves Cancer</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AESCAN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AESCONG"></a>AESCONG</td><td>Congenital Anomaly or Birth Defect</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AESCONG</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AESDISAB"></a>AESDISAB</td><td>Persist or Signif Disability/Incapacity</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AESDISAB</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AESDTH"></a>AESDTH</td><td>Results in Death</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AESDTH</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AESHOSP"></a>AESHOSP</td><td>Requires or Prolongs Hospitalization</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AESHOSP</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AESLIFE"></a>AESLIFE</td><td>Is Life Threatening</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AESLIFE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AESOD"></a>AESOD</td><td>Occurred with Overdose</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AESOD</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AEREL"></a>AEREL</td><td>Causality</td><td class="datatype">text</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AECAUS">AECAUS</a></span><ul class="codelist"><li class="codelist-item">• "NONE" = "NONE"</li><li class="codelist-item">• "POSSIBLE" = "POSSIBLE"</li><li class="codelist-item">• "PROBABLE" = "PROBABLE"</li><li class="codelist-item">• "REMOTE" = "REMOTE"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AEREL</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AEACN"></a>AEACN</td><td>Action Taken with Study Treatment</td><td class="datatype">text</td><td class="number">1</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AEACN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AEOUT"></a>AEOUT</td><td>Outcome of Adverse Event</td><td class="datatype">text</td><td class="number">26</td><td><span class="linebreakcell"><a href="#CL.CL.OUT">OUT</a></span><ul class="codelist"><li class="codelist-item">• "RECOVERED/RESOLVED" = "RECOVERED/RESOLVED"</li><li class="codelist-item">• "NOT RECOVERED/NOT RESOLVED" = "NOT RECOVERED/NOT RESOLVED"</li><li class="codelist-item">• "FATAL" = "FATAL"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AEOUT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AESEQ"></a>AESEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AE.AESEQ</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.TRTEMFL"></a>TRTEMFL</td><td>Treatment Emergent Analysis Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">If ASTDT >= TRTSDT > . then TRTEMFL='Y'. Otherwise TRTEMFL='N'</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AOCCFL"></a>AOCCFL</td><td>1st Occurrence of Any AE Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Subset to TRTEMFL='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCFL=?Y?) within each Subject</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AOCCSFL"></a>AOCCSFL</td><td>1st Occurrence of SOC Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Subset to TRTEMFL='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCSFL=?Y?) within each Subject and SOC</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AOCCPFL"></a>AOCCPFL</td><td>1st Occurrence of Preferred Term Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Subset to TRTEMFL='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Preferred Term (AEDECOD), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCPFL=?Y?) within each Subject, SOC, and PT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AOCC02FL"></a>AOCC02FL</td><td>1st Occurrence 02 Flag for Serious</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC02FL=?Y?) within each Subject</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.AOCC03FL"></a>AOCC03FL</td><td>1st Occurrence 03 Flag for Serious SOC</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC03FL=?Y?) within each Subject and SOC</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AOCC04FL"></a>AOCC04FL</td><td>1st Occurrence 04 Flag for Serious PT</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Preferred Term (AEDECOD), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC04FL=?Y?) within each Subject, SOC, and PT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADAE.IT.ADAE.CQ01NAM"></a>CQ01NAM</td><td>Customized Query 01 Name</td><td class="datatype">text</td><td class="number">19</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">If AEDECOD contains any of the character strings of ('APPLICATION', 'DERMATITIS', 'ERYTHEMA', 'BLISTER') OR if AEBODSYS='SKIN AND SUBC UTANEOUS TISSUE DISORDERS' but AEDECOD is not in ('COLD SWEAT', 'HYPERHIDROSIS', 'ALOPECIA') then CQ01NAM='DERMATOLOGIC EVENTS' Otherwise CQ01NAM=NULL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADAE.IT.ADAE.AOCC01FL"></a>AOCC01FL</td><td>1st Occurrence 01 Flag for CQ01</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Subset to CQ01NAM='' and TRTEMFL='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC01FL=?Y?) within each Subject (Flag First Treatment Emergent Dermatological Event for Time to Event Analysis)</div></td></tr></tbody></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADLBC"></a><div class="containerbox"><h1 class="invisible">Analysis Dataset Lab Blood Chemistry (ADLBC) </h1><table summary="ItemGroup IG.IG.ADLBC"><caption><span>ADLBC (Analysis Dataset Lab Blood Chemistry) - BASIC DATA STRUCTURE <span class="dataset">Location: <a class="external" href="./adlbc.xpt">adlbc.xpt</a><span class="external-link-gif"></span> </span></span></caption><tbody><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.STUDYID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.SUBJID"></a>SUBJID</td><td>Subject Identifier for the Study</td><td class="datatype">text</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.SUBJID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.USUBJID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.TRTP"></a>TRTP</td><td>Planned Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">ARM</a></span><ul class="codelist"><li class="codelist-item">• "Placebo" = "Placebo"</li><li class="codelist-item">• "Xanomeline Low Dose" = "Xanomeline Low Dose"</li><li class="codelist-item">• "Xanomeline High Dose" = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01P</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.TRTPN"></a>TRTPN</td><td>Planned Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">ARMN</a></span><ul class="codelist"><li class="codelist-item">• 0 = "Placebo"</li><li class="codelist-item">• 54 = "Xanomeline Low Dose"</li><li class="codelist-item">• 81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01PN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.TRTA"></a>TRTA</td><td>Actual Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">ARM</a></span><ul class="codelist"><li class="codelist-item">• "Placebo" = "Placebo"</li><li class="codelist-item">• "Xanomeline Low Dose" = "Xanomeline Low Dose"</li><li class="codelist-item">• "Xanomeline High Dose" = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01A</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.TRTAN"></a>TRTAN</td><td>Actual Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">ARMN</a></span><ul class="codelist"><li class="codelist-item">• 0 = "Placebo"</li><li class="codelist-item">• 54 = "Xanomeline Low Dose"</li><li class="codelist-item">• 81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01AN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.TRTSDT"></a>TRTSDT</td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRTSDT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.TRTEDT"></a>TRTEDT</td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRTEDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.AGE"></a>AGE</td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.AGE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.AGEGR1"></a>AGEGR1</td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">AGEGR1</a></span><ul class="codelist"><li class="codelist-item">• "<65" = "<65"</li><li class="codelist-item">• "65-80" = "65-80"</li><li class="codelist-item">• ">80" = ">80"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.AGEGR1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.AGEGR1N"></a>AGEGR1N</td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">AGEGR1N</a></span><ul class="codelist"><li class="codelist-item">• 1 = "<65"</li><li class="codelist-item">• 2 = "65-80"</li><li class="codelist-item">• 3 = ">80"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.AGEGR1N</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.RACE"></a>RACE</td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">RACE</a></span><ul class="codelist"><li class="codelist-item">• "AMERICAN INDIAN OR ALASKA NATIVE" = "1"</li><li class="codelist-item">• "ASIAN" = "2"</li><li class="codelist-item">• "BLACK OR AFRICAN AMERICAN" = "3"</li><li class="codelist-item">• "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "5"</li><li class="codelist-item">• "WHITE" = "6"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.RACE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.RACEN"></a>RACEN</td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">RACEN</a></span><ul class="codelist"><li class="codelist-item">• 1 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">• 2 = "ASIAN"</li><li class="codelist-item">• 3 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">• 5 = "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER"</li><li class="codelist-item">• 6 = "WHITE"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.RACEN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.SEX"></a>SEX</td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">SEX</a></span><ul class="codelist"><li class="codelist-item">• "M"</li><li class="codelist-item">• "F"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.SEX</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.COMP24FL"></a>COMP24FL</td><td>Completers of Week 24 Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.COMP24FL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.DSRAEFL"></a>DSRAEFL</td><td>Discontinued due to AE?</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.DSRAEFL</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.SAFFL"></a>SAFFL</td><td>Safety Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.SAFFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.AVISIT"></a>AVISIT</td><td>Analysis Visit</td><td class="datatype">text</td><td class="number">16</td><td><a href="#CL.CL.AVISIT">AVISIT</a><p class="linebreakcell">
[16 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">Analysis Visit</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.AVISITN"></a>AVISITN</td><td>Analysis Visit (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.AVISITN">AVISITN</a><p class="linebreakcell">
[16 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for AVISIT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.ADY"></a>ADY</td><td>Analysis Relative Day</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBDY</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.ADT"></a>ADT</td><td>Analysis Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBDTC converted to SAS date</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.VISIT"></a>VISIT</td><td>Visit Name</td><td class="datatype">text</td><td class="number">19</td><td><a href="#CL.CL.VISIT">VISIT</a><p class="linebreakcell">
[37 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.VISIT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.VISITNUM"></a>VISITNUM</td><td>Visit Number</td><td class="datatype">float</td><td class="number">8</td><td><a href="#CL.CL.VISITNUM">VISITNUM</a><p class="linebreakcell">
[37 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.VISITNUM</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.PARAM"></a>PARAM</td><td>Parameter</td><td class="datatype">text</td><td class="number">100</td><td><a href="#CL.CL.PARAM_ADLBC">PARAM_ADLBC</a><p class="linebreakcell">
[36 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">For PARAMN<100: same as LB.LBTEST concatenated with LB.LBSTRESU. For PARAMN>100: LB.LBTEST concatenated with LB.LBSTRESU concatenated with " change from previous visit, relative to normal range"</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.PARAMCD"></a>PARAMCD</td><td>Parameter Code</td><td class="datatype">text</td><td class="number">8</td><td><a href="#CL.CL.PARAMCD_ADLBC">PARAMCD_ADLBC</a><p class="linebreakcell">
[36 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">For PARAMN<100: same as LBTESTCD, For PARAMN>100: _ + LBTESTCD</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.PARAMN"></a>PARAMN</td><td>Parameter (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.PARAMN_ADLBC">PARAMN_ADLBC</a><p class="linebreakcell">
[36 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for Parameter</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.PARCAT1"></a>PARCAT1</td><td>Parameter Category 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.ADLBCAT">ADLBCAT</a></span><ul class="codelist"><li class="codelist-item">• "CHEM" = "Chemistry"</li><li class="codelist-item">• "HEM" = "Hematology"</li><li class="codelist-item">• "HYLAW" = "Hy's Law"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">harcoded to 'CHEM'</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.AVAL"></a>AVAL</td><td>Analysis Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBSTNRHI</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.BASE"></a>BASE</td><td>Baseline Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBSTNRHI</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.CHG"></a>CHG</td><td>Change from Baseline</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBSTNRHI</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.A1LO"></a>A1LO</td><td>Analysis Range 1 Lower Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBSTNRLO</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.A1HI"></a>A1HI</td><td>Analysis Range 1 Upper Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBSTNRHI</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.R2A1LO"></a>R2A1LO</td><td>Ratio to Analysis Range 1 Lower Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AVAL / A1HI</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.R2A1HI"></a>R2A1HI</td><td>Ratio to Analysis Range 1 Upper Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AVAL / A1LO</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.BR2A1LO"></a>BR2A1LO</td><td>Base Ratio to Analysis Range 1 Lower Lim</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AVAL / A1HI at baseline</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.BR2A1HI"></a>BR2A1HI</td><td>Base Ratio to Analysis Range 1 Upper Lim</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AVAL / A1LO at baseline</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.ANL01FL"></a>ANL01FL</td><td>Analysis Flag 01</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBSTNRHI</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.ALBTRVAL"></a>ALBTRVAL</td><td>Amount Threshold Range</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">Maximum of [LBSTRESN-(1.5*ULN)] and [(.5*LLN) - LBSTRESN]</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.ANRIND"></a>ANRIND</td><td>Analysis Reference Range Indicator</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.LNH">LNH</a></span><ul class="codelist"><li class="codelist-item">• "L" = "Low"</li><li class="codelist-item">• "N" = "Normal"</li><li class="codelist-item">• "H" = "High"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBSTNRHI</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.BNRIND"></a>BNRIND</td><td>Baseline Reference Range Indicator</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.LNH">LNH</a></span><ul class="codelist"><li class="codelist-item">• "L" = "Low"</li><li class="codelist-item">• "N" = "Normal"</li><li class="codelist-item">• "H" = "High"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBSTNRHI</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.ABLFL"></a>ABLFL</td><td>Baseline Record Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Y if VISITNUM=1, null otherwise</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.AENTMTFL"></a>AENTMTFL</td><td>Last value in treatment visit</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Last observed value for this lab parameter during treatment phase: 'Y' if VISITNUM=12, if subject discontinues prior to VISIT 12, then this variable is set to 'Y' if this is the last assessment of this analyte for the subject</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.LBSEQ"></a>LBSEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBSEQ</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBC.IT.ADLBC.LBNRIND"></a>LBNRIND</td><td>Reference Range Indicator</td><td class="datatype">text</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.LBNRIND">LBNRIND</a></span><ul class="codelist"><li class="codelist-item">• "LOW" = "LOW"</li><li class="codelist-item">• "NORMAL" = "NORMAL"</li><li class="codelist-item">• "HIGH" = "HIGH"</li><li class="codelist-item">• "ABNORMAL" = "HIGH"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBNRIND</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBC.IT.ADLBC.LBSTRESN"></a>LBSTRESN</td><td>Numeric Result/Finding in Standard Units</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBSTRESN</div></td></tr></tbody></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADLBH"></a><div class="containerbox"><h1 class="invisible">Analysis Dataset Lab Hematology (ADLBH) </h1><table summary="ItemGroup IG.IG.ADLBH"><caption><span>ADLBH (Analysis Dataset Lab Hematology) - BASIC DATA STRUCTURE <span class="dataset">Location: <a class="external" href="./adlbh.xpt">adlbh.xpt</a><span class="external-link-gif"></span> </span></span></caption><tbody><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.STUDYID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.SUBJID"></a>SUBJID</td><td>Subject Identifier for the Study</td><td class="datatype">text</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.SUBJID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.USUBJID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.TRTP"></a>TRTP</td><td>Planned Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">ARM</a></span><ul class="codelist"><li class="codelist-item">• "Placebo" = "Placebo"</li><li class="codelist-item">• "Xanomeline Low Dose" = "Xanomeline Low Dose"</li><li class="codelist-item">• "Xanomeline High Dose" = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01P</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.TRTPN"></a>TRTPN</td><td>Planned Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">ARMN</a></span><ul class="codelist"><li class="codelist-item">• 0 = "Placebo"</li><li class="codelist-item">• 54 = "Xanomeline Low Dose"</li><li class="codelist-item">• 81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01PN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.TRTA"></a>TRTA</td><td>Actual Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">ARM</a></span><ul class="codelist"><li class="codelist-item">• "Placebo" = "Placebo"</li><li class="codelist-item">• "Xanomeline Low Dose" = "Xanomeline Low Dose"</li><li class="codelist-item">• "Xanomeline High Dose" = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01A</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.TRTAN"></a>TRTAN</td><td>Actual Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">ARMN</a></span><ul class="codelist"><li class="codelist-item">• 0 = "Placebo"</li><li class="codelist-item">• 54 = "Xanomeline Low Dose"</li><li class="codelist-item">• 81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01AN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.TRTSDT"></a>TRTSDT</td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRTSDT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.TRTEDT"></a>TRTEDT</td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRTEDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.AGE"></a>AGE</td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.AGE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.AGEGR1"></a>AGEGR1</td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">AGEGR1</a></span><ul class="codelist"><li class="codelist-item">• "<65" = "<65"</li><li class="codelist-item">• "65-80" = "65-80"</li><li class="codelist-item">• ">80" = ">80"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.AGEGR1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.AGEGR1N"></a>AGEGR1N</td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">AGEGR1N</a></span><ul class="codelist"><li class="codelist-item">• 1 = "<65"</li><li class="codelist-item">• 2 = "65-80"</li><li class="codelist-item">• 3 = ">80"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.AGEGR1N</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.RACE"></a>RACE</td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">RACE</a></span><ul class="codelist"><li class="codelist-item">• "AMERICAN INDIAN OR ALASKA NATIVE" = "1"</li><li class="codelist-item">• "ASIAN" = "2"</li><li class="codelist-item">• "BLACK OR AFRICAN AMERICAN" = "3"</li><li class="codelist-item">• "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "5"</li><li class="codelist-item">• "WHITE" = "6"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.RACE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.RACEN"></a>RACEN</td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">RACEN</a></span><ul class="codelist"><li class="codelist-item">• 1 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">• 2 = "ASIAN"</li><li class="codelist-item">• 3 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">• 5 = "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER"</li><li class="codelist-item">• 6 = "WHITE"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.RACEN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.SEX"></a>SEX</td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">SEX</a></span><ul class="codelist"><li class="codelist-item">• "M"</li><li class="codelist-item">• "F"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.SEX</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.COMP24FL"></a>COMP24FL</td><td>Completers of Week 24 Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.COMP24FL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.DSRAEFL"></a>DSRAEFL</td><td>Discontinued due to AE?</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.DSRAEFL</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.SAFFL"></a>SAFFL</td><td>Safety Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.SAFFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.AVISIT"></a>AVISIT</td><td>Analysis Visit</td><td class="datatype">text</td><td class="number">16</td><td><a href="#CL.CL.AVISIT">AVISIT</a><p class="linebreakcell">
[16 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">Analysis Visit</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.AVISITN"></a>AVISITN</td><td>Analysis Visit (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.AVISITN">AVISITN</a><p class="linebreakcell">
[16 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for AVISIT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.ADY"></a>ADY</td><td>Analysis Relative Day</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBDY</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.ADT"></a>ADT</td><td>Analysis Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBDTC converted to SAS date</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.VISIT"></a>VISIT</td><td>Visit Name</td><td class="datatype">text</td><td class="number">19</td><td><a href="#CL.CL.VISIT">VISIT</a><p class="linebreakcell">
[37 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.VISIT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.VISITNUM"></a>VISITNUM</td><td>Visit Number</td><td class="datatype">float</td><td class="number">8</td><td><a href="#CL.CL.VISITNUM">VISITNUM</a><p class="linebreakcell">
[37 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.VISITNUM</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.PARAM"></a>PARAM</td><td>Parameter</td><td class="datatype">text</td><td class="number">100</td><td><a href="#CL.CL.PARAM_ADLBH">PARAM_ADLBH</a><p class="linebreakcell">
[34 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">For PARAMN<100: same as LBTEST concatenated with LBSTRESU For PARAMN>100: LBTEST concatenated with LB.LBSTRESU concatenated with "change from previous visit, relative to normal range"</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.PARAMCD"></a>PARAMCD</td><td>Parameter Code</td><td class="datatype">text</td><td class="number">8</td><td><a href="#CL.CL.PARAMCD_ADLBH">PARAMCD_ADLBH</a><p class="linebreakcell">
[34 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">For PARAMN<100: same as LBTESTCD For PARAMN>100: _ + LBTESTCD</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.PARAMN"></a>PARAMN</td><td>Parameter (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.PARAMN_ADLBH">PARAMN_ADLBH</a><p class="linebreakcell">
[34 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for Parameter</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.PARCAT1"></a>PARCAT1</td><td>Parameter Category 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.ADLBCAT">ADLBCAT</a></span><ul class="codelist"><li class="codelist-item">• "CHEM" = "Chemistry"</li><li class="codelist-item">• "HEM" = "Hematology"</li><li class="codelist-item">• "HYLAW" = "Hy's Law"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">harcoded to 'HEM'</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.AVAL"></a>AVAL</td><td>Analysis Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.VISITNUM</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.BASE"></a>BASE</td><td>Baseline Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.VISITNUM</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.CHG"></a>CHG</td><td>Change from Baseline</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.VISITNUM</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.A1LO"></a>A1LO</td><td>Analysis Range 1 Lower Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.VISITNUM</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.A1HI"></a>A1HI</td><td>Analysis Range 1 Upper Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBSTNRHI</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.R2A1LO"></a>R2A1LO</td><td>Ratio to Analysis Range 1 Lower Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AVAL / A1HI</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.R2A1HI"></a>R2A1HI</td><td>Ratio to Analysis Range 1 Upper Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AVAL / A1LO</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.BR2A1LO"></a>BR2A1LO</td><td>Base Ratio to Analysis Range 1 Lower Lim</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AVAL / A1HI at baseline</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.BR2A1HI"></a>BR2A1HI</td><td>Base Ratio to Analysis Range 1 Upper Lim</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AVAL / A1LO at baseline</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.ANL01FL"></a>ANL01FL</td><td>Analysis Flag 01</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.VISITNUM</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.ALBTRVAL"></a>ALBTRVAL</td><td>Amount Threshold Range</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">Maximum of [LBSTRESN-(1.5*ULN)] and [(.5*LLN) - LBSTRESN]</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.ANRIND"></a>ANRIND</td><td>Analysis Reference Range Indicator</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.LNH">LNH</a></span><ul class="codelist"><li class="codelist-item">• "L" = "Low"</li><li class="codelist-item">• "N" = "Normal"</li><li class="codelist-item">• "H" = "High"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.VISITNUM</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.BNRIND"></a>BNRIND</td><td>Baseline Reference Range Indicator</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.LNH">LNH</a></span><ul class="codelist"><li class="codelist-item">• "L" = "Low"</li><li class="codelist-item">• "N" = "Normal"</li><li class="codelist-item">• "H" = "High"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.VISITNUM</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.ABLFL"></a>ABLFL</td><td>Baseline Record Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.VISITNUM</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.AENTMTFL"></a>AENTMTFL</td><td>Last value in treatment visit</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Last observed value for this lab test during treatment phase: 'Y' if VISITNUM=12, if subject discontinues prior to VISIT 12, then this variable is set to 'Y' if this is the last assessment of this analyte for the subject</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.LBSEQ"></a>LBSEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBSEQ</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBH.IT.ADLBH.LBNRIND"></a>LBNRIND</td><td>Reference Range Indicator</td><td class="datatype">text</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.LBNRIND">LBNRIND</a></span><ul class="codelist"><li class="codelist-item">• "LOW" = "LOW"</li><li class="codelist-item">• "NORMAL" = "NORMAL"</li><li class="codelist-item">• "HIGH" = "HIGH"</li><li class="codelist-item">• "ABNORMAL" = "HIGH"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBNRIND</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBH.IT.ADLBH.LBSTRESN"></a>LBSTRESN</td><td>Numeric Result/Finding in Standard Units</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBSTRESN</div></td></tr></tbody></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADLBHY"></a><div class="containerbox"><h1 class="invisible">Analysis Dataset Lab Hy's Law (ADLBHY) </h1><table summary="ItemGroup IG.IG.ADLBHY"><caption><span>ADLBHY (Analysis Dataset Lab Hy's Law, ADLB) - BASIC DATA STRUCTURE <span class="dataset">Location: <a class="external" href="./adlbhy.xpt">adlbhy.xpt</a><span class="external-link-gif"></span> </span></span></caption><tbody><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.STUDYID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.SUBJID"></a>SUBJID</td><td>Subject Identifier for the Study</td><td class="datatype">text</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.SUBJID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.USUBJID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.TRTP"></a>TRTP</td><td>Planned Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">ARM</a></span><ul class="codelist"><li class="codelist-item">• "Placebo" = "Placebo"</li><li class="codelist-item">• "Xanomeline Low Dose" = "Xanomeline Low Dose"</li><li class="codelist-item">• "Xanomeline High Dose" = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01P</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.TRTPN"></a>TRTPN</td><td>Planned Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">ARMN</a></span><ul class="codelist"><li class="codelist-item">• 0 = "Placebo"</li><li class="codelist-item">• 54 = "Xanomeline Low Dose"</li><li class="codelist-item">• 81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01PN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.TRTA"></a>TRTA</td><td>Actual Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">ARM</a></span><ul class="codelist"><li class="codelist-item">• "Placebo" = "Placebo"</li><li class="codelist-item">• "Xanomeline Low Dose" = "Xanomeline Low Dose"</li><li class="codelist-item">• "Xanomeline High Dose" = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01A</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.TRTAN"></a>TRTAN</td><td>Actual Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">ARMN</a></span><ul class="codelist"><li class="codelist-item">• 0 = "Placebo"</li><li class="codelist-item">• 54 = "Xanomeline Low Dose"</li><li class="codelist-item">• 81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01AN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.TRTSDT"></a>TRTSDT</td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRTSDT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.TRTEDT"></a>TRTEDT</td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRTEDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.AGE"></a>AGE</td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.AGE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.AGEGR1"></a>AGEGR1</td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">AGEGR1</a></span><ul class="codelist"><li class="codelist-item">• "<65" = "<65"</li><li class="codelist-item">• "65-80" = "65-80"</li><li class="codelist-item">• ">80" = ">80"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.AGEGR1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.AGEGR1N"></a>AGEGR1N</td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">AGEGR1N</a></span><ul class="codelist"><li class="codelist-item">• 1 = "<65"</li><li class="codelist-item">• 2 = "65-80"</li><li class="codelist-item">• 3 = ">80"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.AGEGR1N</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.RACE"></a>RACE</td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">RACE</a></span><ul class="codelist"><li class="codelist-item">• "AMERICAN INDIAN OR ALASKA NATIVE" = "1"</li><li class="codelist-item">• "ASIAN" = "2"</li><li class="codelist-item">• "BLACK OR AFRICAN AMERICAN" = "3"</li><li class="codelist-item">• "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "5"</li><li class="codelist-item">• "WHITE" = "6"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.RACE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.RACEN"></a>RACEN</td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">RACEN</a></span><ul class="codelist"><li class="codelist-item">• 1 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">• 2 = "ASIAN"</li><li class="codelist-item">• 3 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">• 5 = "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER"</li><li class="codelist-item">• 6 = "WHITE"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.RACEN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.SEX"></a>SEX</td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">SEX</a></span><ul class="codelist"><li class="codelist-item">• "M"</li><li class="codelist-item">• "F"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.SEX</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.COMP24FL"></a>COMP24FL</td><td>Completers of Week 24 Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.COMP24FL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.DSRAEFL"></a>DSRAEFL</td><td>Discontinued due to AE?</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.DSRAEFL</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.SAFFL"></a>SAFFL</td><td>Safety Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.SAFFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.AVISIT"></a>AVISIT</td><td>Analysis Visit</td><td class="datatype">text</td><td class="number">16</td><td><a href="#CL.CL.AVISIT">AVISIT</a><p class="linebreakcell">
[16 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">Analysis Visit</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.AVISITN"></a>AVISITN</td><td>Analysis Visit (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.AVISITN">AVISITN</a><p class="linebreakcell">
[16 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for AVISIT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.ADY"></a>ADY</td><td>Analysis Relative Day</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBDY</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.ADT"></a>ADT</td><td>Analysis Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.LBDTC converted to SAS date</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.VISIT"></a>VISIT</td><td>Visit Name</td><td class="datatype">text</td><td class="number">19</td><td><a href="#CL.CL.VISIT">VISIT</a><p class="linebreakcell">
[37 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.VISIT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.VISITNUM"></a>VISITNUM</td><td>Visit Number</td><td class="datatype">float</td><td class="number">8</td><td><a href="#CL.CL.VISITNUM">VISITNUM</a><p class="linebreakcell">
[37 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">LB.VISITNUM</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.PARAMTYP"></a>PARAMTYP</td><td>Parameter Type</td><td class="datatype">text</td><td class="number">7</td><td><span class="linebreakcell"><a href="#CL.CL.PARAMTYP">PARAMTYP</a></span><ul class="codelist"><li class="codelist-item">• "DERIVED" = "DERIVED"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for Parameter</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.PARAM"></a>PARAM</td><td>Parameter</td><td class="datatype">text</td><td class="number">100</td><td><a href="#CL.CL.PARAM_ADLBHY">PARAM_ADLBHY</a><p class="linebreakcell">
[6 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">same as LBTEST concatenated with LBSTRESU except for hylaw params</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.PARAMCD"></a>PARAMCD</td><td>Parameter Code</td><td class="datatype">text</td><td class="number">8</td><td><a href="#CL.CL.PARAMCD_ADLBHY">PARAMCD_ADLBHY</a><p class="linebreakcell">
[6 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for Parameter</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.PARAMN"></a>PARAMN</td><td>Parameter (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.PARAMN_ADLBHY">PARAMN_ADLBHY</a><p class="linebreakcell">
[6 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for Parameter</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.PARCAT1"></a>PARCAT1</td><td>Parameter Category 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.ADLBCAT">ADLBCAT</a></span><ul class="codelist"><li class="codelist-item">• "CHEM" = "Chemistry"</li><li class="codelist-item">• "HEM" = "Hematology"</li><li class="codelist-item">• "HYLAW" = "Hy's Law"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for Parameter</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.AVAL"></a>AVAL</td><td>Analysis Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for Parameter</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.BASE"></a>BASE</td><td>Baseline Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for Parameter</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.A1LO"></a>A1LO</td><td>Analysis Range 1 Lower Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for Parameter</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.A1HI"></a>A1HI</td><td>Analysis Range 1 Upper Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for Parameter</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.R2A1LO"></a>R2A1LO</td><td>Ratio to Analysis Range 1 Lower Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for Parameter</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.R2A1HI"></a>R2A1HI</td><td>Ratio to Analysis Range 1 Upper Limit</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for Parameter</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.BR2A1LO"></a>BR2A1LO</td><td>Base Ratio to Analysis Range 1 Lower Lim</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for Parameter</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.BR2A1HI"></a>BR2A1HI</td><td>Base Ratio to Analysis Range 1 Upper Lim</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for Parameter</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.ABLFL"></a>ABLFL</td><td>Baseline Record Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADLBC.ABLFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.SHIFT1"></a>SHIFT1</td><td>Shift 1</td><td class="datatype">text</td><td class="number">16</td><td><span class="linebreakcell"><a href="#CL.CL.SHIFT">SHIFT</a></span><ul class="codelist"><li class="codelist-item">• "High to Normal" = "High to Normal"</li><li class="codelist-item">• "Normal to Normal" = "Normal to Normal"</li><li class="codelist-item">• "Normal to High" = "Normal to High"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for Parameter</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.SHIFT1N"></a>SHIFT1N</td><td>Shift 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.SHIFTN">SHIFTN</a></span><ul class="codelist"><li class="codelist-item">• 0 = "High to Normal"</li><li class="codelist-item">• 1 = "Normal to Normal"</li><li class="codelist-item">• 2 = "Normal to High"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for SHIFT1</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.CRIT1"></a>CRIT1</td><td>Analysis Criterion 1</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for Parameter</div></td></tr><tr class="tableroweven"><td><a id="IG.ADLBHY.IT.ADLBHY.CRIT1FL"></a>CRIT1FL</td><td>Criterion 1 Evaluation Result Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for Parameter</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADLBHY.IT.ADLBHY.CRIT1FN"></a>CRIT1FN</td><td>Criterion 1 Evaluation Result Flag (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.YNN">YNN</a></span><ul class="codelist"><li class="codelist-item">• 0 = "No"</li><li class="codelist-item">• 1 = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric Code for CRIT1FL</div></td></tr></tbody></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADSL"></a><div class="containerbox"><h1 class="invisible">Subject-Level Analysis Dataset (ADSL) </h1><table summary="ItemGroup IG.IG.ADSL"><caption><span>ADSL (Subject-Level Analysis Dataset, AD) - SUBJECT LEVEL ANALYSIS DATASET <span class="dataset">Location: <a class="external" href="./adsl.xpt">adsl.xpt</a><span class="external-link-gif"></span> </span></span></caption><tbody><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">DM.STUDYID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">DM.USUBJID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.SUBJID"></a>SUBJID</td><td>Subject Identifier for the Study</td><td class="datatype">text</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">DM.SUBJID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.SITEID"></a>SITEID</td><td>Study Site Identifier</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">DM.SITEID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.SITEGR1"></a>SITEGR1</td><td>Pooled Site Group 1</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">refer to SAP, Section 7.1 - if not pooled then SITEGR1=SITEID. If pooled, SITEGR1 will be 900</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.ARM"></a>ARM</td><td>Description of Planned Arm</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">ARM</a></span><ul class="codelist"><li class="codelist-item">• "Placebo" = "Placebo"</li><li class="codelist-item">• "Xanomeline Low Dose" = "Xanomeline Low Dose"</li><li class="codelist-item">• "Xanomeline High Dose" = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">DM.ARM</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.TRT01P"></a>TRT01P</td><td>Planned Treatment for Period 01</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">ARM</a></span><ul class="codelist"><li class="codelist-item">• "Placebo" = "Placebo"</li><li class="codelist-item">• "Xanomeline Low Dose" = "Xanomeline Low Dose"</li><li class="codelist-item">• "Xanomeline High Dose" = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">DM.ARM</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.TRT01PN"></a>TRT01PN</td><td>Planned Treatment for Period 01 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">ARMN</a></span><ul class="codelist"><li class="codelist-item">• 0 = "Placebo"</li><li class="codelist-item">• 54 = "Xanomeline Low Dose"</li><li class="codelist-item">• 81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for TRT01P which corresponds to the randomized dose</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.TRT01A"></a>TRT01A</td><td>Actual Treatment for Period 01</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">ARM</a></span><ul class="codelist"><li class="codelist-item">• "Placebo" = "Placebo"</li><li class="codelist-item">• "Xanomeline Low Dose" = "Xanomeline Low Dose"</li><li class="codelist-item">• "Xanomeline High Dose" = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">TRT01A=TRT01P, i.e., no difference between actual and randomized treatment in this study.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.TRT01AN"></a>TRT01AN</td><td>Actual Treatment for Period 01 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">ARMN</a></span><ul class="codelist"><li class="codelist-item">• 0 = "Placebo"</li><li class="codelist-item">• 54 = "Xanomeline Low Dose"</li><li class="codelist-item">• 81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for TRT01A which corresponds to the randomized dose</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.TRTSDT"></a>TRTSDT</td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">SV.SVSTDTC when SV.VISITNUM=3, converted to SAS date</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.TRTEDT"></a>TRTEDT</td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">The date of final dose (from the CRF) is EX.EXENDTC on the subject's last EX record. If the date of final dose is missing for the subject and the subject discontinued after visit 3, use the date of discontinuation as the date of last dose. Convert the date to a SAS date.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.TRTDURD"></a>TRTDURD</td><td>Total Treatment Duration (Days)</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">TRTEDT-TRTSDT+1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.AVGDD"></a>AVGDD</td><td>Avg Daily Dose (as planned)</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">CUMDOSE/TRTDURD</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.CUMDOSE"></a>CUMDOSE</td><td>Cumulative Dose (as planned)</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">For ARMN=0 or 1: CUMDOSE=TRT01PN*TRTDUR. --- For ARMN=2: CUMDOSE will be based on 54mg per day for the # of days subj was in 1st dosing interval (i.e., visit4date-TRTSTDT+1 if 1st interval completed, TRTEDT-TRTSTDT+1 if subj discontinued <=visit 4 and > visit 3), 81mg per day for the # of days subj was in 2nd dosing interval (i.e., visit12date-visit4date if 2nd interval completed, TRTEDT-visit4date if subj discontinued <= visit 12 and > visit 4), and 54mg per day for the # of days subj was in 3rd dosing interval (i.e., TRTEDT - visit12date if subj continued after visit 12).</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.AGE"></a>AGE</td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">DM.AGE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.AGEGR1"></a>AGEGR1</td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">AGEGR1</a></span><ul class="codelist"><li class="codelist-item">• "<65" = "<65"</li><li class="codelist-item">• "65-80" = "65-80"</li><li class="codelist-item">• ">80" = ">80"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Character variable derived from ADSL.AGEGR1N</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.AGEGR1N"></a>AGEGR1N</td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">AGEGR1N</a></span><ul class="codelist"><li class="codelist-item">• 1 = "<65"</li><li class="codelist-item">• 2 = "65-80"</li><li class="codelist-item">• 3 = ">80"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">AGEGR1 = 1 if AGE <65. AGEGR1 = 2 if AGE 65-80. AGEGR1 = 3 if AGE >80.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.AGEU"></a>AGEU</td><td>Age Units</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEU">AGEU</a></span><ul class="codelist"><li class="codelist-item">• "YEARS"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">DM.AGEU</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.RACE"></a>RACE</td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">RACE</a></span><ul class="codelist"><li class="codelist-item">• "AMERICAN INDIAN OR ALASKA NATIVE" = "1"</li><li class="codelist-item">• "ASIAN" = "2"</li><li class="codelist-item">• "BLACK OR AFRICAN AMERICAN" = "3"</li><li class="codelist-item">• "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "5"</li><li class="codelist-item">• "WHITE" = "6"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">DM.RACE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.RACEN"></a>RACEN</td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">RACEN</a></span><ul class="codelist"><li class="codelist-item">• 1 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">• 2 = "ASIAN"</li><li class="codelist-item">• 3 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">• 5 = "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER"</li><li class="codelist-item">• 6 = "WHITE"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for RACE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.SEX"></a>SEX</td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">SEX</a></span><ul class="codelist"><li class="codelist-item">• "M"</li><li class="codelist-item">• "F"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">DM.SEX</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.ETHNIC"></a>ETHNIC</td><td>Ethnicity</td><td class="datatype">text</td><td class="number">22</td><td><span class="linebreakcell"><a href="#CL.CL.ETHNIC">ETHNIC</a></span><ul class="codelist"><li class="codelist-item">• "HISPANIC OR LATINO" = "1"</li><li class="codelist-item">• "NOT HISPANIC OR LATINO" = "2"</li><li class="codelist-item">• "NOT REPORTED" = "3"</li><li class="codelist-item">• "UNKNOWN" = "4"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">DM.ETHNIC</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.SAFFL"></a>SAFFL</td><td>Safety Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Y if ITTFL='Y' and TRTSDT ne missing. N otherwise</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.ITTFL"></a>ITTFL</td><td>Intent-To-Treat Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Y if ARMCD ne ' '. N otherwise</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.EFFFL"></a>EFFFL</td><td>Efficacy Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Y if SAFFL='Y AND subject has at least one record in QS for ADAS-Cog with VISITNUM>3 AND at least one record in QS for CIBIC+ with VISITNUM>3, N otherwise</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.COMP8FL"></a>COMP8FL</td><td>Completers of Week 8 Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Y if subject has a SV.VISITNUM=8 and ENDDT >= date of visit 8, N otherwise</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.COMP16FL"></a>COMP16FL</td><td>Completers of Week 16 Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Y if subject has a SV.VISITNUM=10 and ENDDT>=date of visit 10, N otherwise</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.COMP24FL"></a>COMP24FL</td><td>Completers of Week 24 Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Y if subject has a SV.VISITNUM=12 and ENDDT>= date of visit 12 , N otherwise</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.DISCONFL"></a>DISCONFL</td><td>Did the Subject Discontinue the Study?</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Y if DCREASCD ^= 'Completed'. Null otherwise</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.DSRAEFL"></a>DSRAEFL</td><td>Discontinued due to AE?</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">Y if DCREASCD='Adverse Event'. Null otherwise</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.DTHFL"></a>DTHFL</td><td>Subject Died?</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">DM.DTHFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.BMIBL"></a>BMIBL</td><td>Baseline BMI (kg/m^2)</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">WEIGHTBL / ((HEIGHTBL/100)**2)</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.BMIBLGR1"></a>BMIBLGR1</td><td>Pooled Baseline BMI Group 1</td><td class="datatype">text</td><td class="number">6</td><td><span class="linebreakcell"><a href="#CL.CL.BMICAT">BMICAT</a></span><ul class="codelist"><li class="codelist-item">• "<25" = "Normal"</li><li class="codelist-item">• "25-<30" = "Overweight"</li><li class="codelist-item">• ">=30" = "Obese"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">BMIBLGR1="<25" if . < BMIBL <25.
BMIBLGR1="25-<30" if 25 <=BMIBL <30.
BMIBLGR1=">=30"if BMIBL >=30.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.HEIGHTBL"></a>HEIGHTBL</td><td>Baseline Height (cm)</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">VSSTRESN when VS.VSTESTCD='HEIGHT' and VS.VISITNUM=1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.WEIGHTBL"></a>WEIGHTBL</td><td>Baseline Weight (kg)</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">VSSTRESN when VS.VSTESTCD='WEIGHT' and VS.VISITNUM=3</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.EDUCLVL"></a>EDUCLVL</td><td>Years of Education</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">SC.SCSTRESN where SC.SCTESTCD=EDLEVEL</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.DISONSDT"></a>DISONSDT</td><td>Date of Onset of Disease</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">MH.MHSTDTC where MHCAT='PRIMARY DIAGNOSIS' converted to SAS date</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.DURDIS"></a>DURDIS</td><td>Duration of Disease (Months)</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">number of months between VISIT1DT and DISONSET</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.DURDSGR1"></a>DURDSGR1</td><td>Pooled Disease Duration Group 1</td><td class="datatype">text</td><td class="number">4</td><td><span class="linebreakcell"><a href="#CL.CL.DURDISC">DURDISC</a></span><ul class="codelist"><li class="codelist-item">• "<12" = "<12"</li><li class="codelist-item">• ">=12" = ">=12"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">grouping DURDIS values as <12 and >=12</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.VISIT1DT"></a>VISIT1DT</td><td>Date of Visit 1</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">SV.SVSTDTC when SV.VISITNUM=1, converted to SAS date</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.RFSTDTC"></a>RFSTDTC</td><td>Subject Reference Start Date/Time</td><td class="datatype">text</td><td class="number">20</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">DM.RFSTDTC</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.RFENDTC"></a>RFENDTC</td><td>Subject Reference End Date/Time</td><td class="datatype">text</td><td class="number">20</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">DM.RFENDTC</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.VISNUMEN"></a>VISNUMEN</td><td>End of Trt Visit (Vis 12 or Early Term.)</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">if DS.VISITNUM=13 where DSTERM='PROTCOL COMPLETED' then VISNUMEN=12, otherwise VISNUMEN=DS.VISITNUM where DSTERM='PROTCOL COMPLETED'</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.RFENDT"></a>RFENDT</td><td>Date of Discontinuation/Completion</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">RFENDTC converted to SAS date</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.DCDECOD"></a>DCDECOD</td><td>Standardized Disposition Term</td><td class="datatype">text</td><td class="number">27</td><td><a href="#CL.CL.DISCCD">DISCCD</a><p class="linebreakcell">
[9 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">DS.DSDECOD where DSCAT='DISPOSITION EVENT'</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.EOSSTT"></a>EOSSTT</td><td>End of Study Status</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">COMPLETED if ADSL.DCDECOD='COMPLETED'. DISCONTINUED if ADSL.DCDECOD not equal to COMPLETED.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADSL.IT.ADSL.DCSREAS"></a>DCSREAS</td><td>Reason for Discontinuation from Study</td><td class="datatype">text</td><td class="number">18</td><td><a href="#CL.CL.DISCREAS">DISCREAS</a><p class="linebreakcell">
[10 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">Grouping of DCDECOD values to support summarizing study completion status and reason for discontinuation</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADSL.IT.ADSL.MMSETOT"></a>MMSETOT</td><td>MMSE Total</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">sum of QS.QSORRES values for the subject when QSCAT = MINI-MENTAL STATE</div></td></tr></tbody></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADTTE"></a><div class="containerbox"><h1 class="invisible">AE Time To 1st Derm. Event Analysis (ADTTE) </h1><table summary="ItemGroup IG.IG.ADTTE"><caption><span>ADTTE (AE Time To 1st Derm. Event Analysis) - BASIC DATA STRUCTURE <span class="dataset">Location: <a class="external" href="./adtte.xpt">adtte.xpt</a><span class="external-link-gif"></span> </span></span></caption><tbody><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.STUDYID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.SITEID"></a>SITEID</td><td>Study Site Identifier</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.SITEID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.USUBJID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.AGE"></a>AGE</td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.AGE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.AGEGR1"></a>AGEGR1</td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">AGEGR1</a></span><ul class="codelist"><li class="codelist-item">• "<65" = "<65"</li><li class="codelist-item">• "65-80" = "65-80"</li><li class="codelist-item">• ">80" = ">80"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.AGEGR1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.AGEGR1N"></a>AGEGR1N</td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">AGEGR1N</a></span><ul class="codelist"><li class="codelist-item">• 1 = "<65"</li><li class="codelist-item">• 2 = "65-80"</li><li class="codelist-item">• 3 = ">80"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.AGEGR1N</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.RACE"></a>RACE</td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">RACE</a></span><ul class="codelist"><li class="codelist-item">• "AMERICAN INDIAN OR ALASKA NATIVE" = "1"</li><li class="codelist-item">• "ASIAN" = "2"</li><li class="codelist-item">• "BLACK OR AFRICAN AMERICAN" = "3"</li><li class="codelist-item">• "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "5"</li><li class="codelist-item">• "WHITE" = "6"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.RACE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.RACEN"></a>RACEN</td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">RACEN</a></span><ul class="codelist"><li class="codelist-item">• 1 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">• 2 = "ASIAN"</li><li class="codelist-item">• 3 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">• 5 = "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER"</li><li class="codelist-item">• 6 = "WHITE"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.RACEN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.SEX"></a>SEX</td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">SEX</a></span><ul class="codelist"><li class="codelist-item">• "M"</li><li class="codelist-item">• "F"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.SEX</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.TRTSDT"></a>TRTSDT</td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRTSDT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.TRTEDT"></a>TRTEDT</td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRTEDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.TRTDUR"></a>TRTDUR</td><td>Duration of treatment (days)</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRTDUR</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.TRTP"></a>TRTP</td><td>Planned Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">ARM</a></span><ul class="codelist"><li class="codelist-item">• "Placebo" = "Placebo"</li><li class="codelist-item">• "Xanomeline Low Dose" = "Xanomeline Low Dose"</li><li class="codelist-item">• "Xanomeline High Dose" = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01P</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.TRTA"></a>TRTA</td><td>Actual Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">ARM</a></span><ul class="codelist"><li class="codelist-item">• "Placebo" = "Placebo"</li><li class="codelist-item">• "Xanomeline Low Dose" = "Xanomeline Low Dose"</li><li class="codelist-item">• "Xanomeline High Dose" = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01A</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.TRTAN"></a>TRTAN</td><td>Actual Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">ARMN</a></span><ul class="codelist"><li class="codelist-item">• 0 = "Placebo"</li><li class="codelist-item">• 54 = "Xanomeline Low Dose"</li><li class="codelist-item">• 81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01AN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.PARAM"></a>PARAM</td><td>Parameter</td><td class="datatype">text</td><td class="number">100</td><td><span class="linebreakcell"><a href="#CL.CL.PARAM_ADTTE">PARAM_ADTTE</a></span><ul class="codelist"><li class="codelist-item">• "Time to First Dermatologic Event" = "Time to Derm. Event or End of Study"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">PARAM="Time to First Dermatologic Event"</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.PARAMCD"></a>PARAMCD</td><td>Parameter Code</td><td class="datatype">text</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.PARAMCD_ADTTE">PARAMCD_ADTTE</a></span><ul class="codelist"><li class="codelist-item">• "TTDE" = "Time to Derm. Event or End of Study"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">PARAMCD="TTDE"</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.AVAL"></a>AVAL</td><td>Analysis Value</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADT-STARTDT+1</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.STARTDT"></a>STARTDT</td><td>Time to Event Origin Date for Subject</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.RFSTDTC</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.ADT"></a>ADT</td><td>Analysis Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">if ADAE.ASTDT is not missing and occurred after TRTSDT then ADAE.ASTDT else convert ADSL.RFENDTC to a SAS numeric date</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.CNSR"></a>CNSR</td><td>Censor</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.CENSOR">CENSOR</a></span><ul class="codelist"><li class="codelist-item">• 0 = "Event"</li><li class="codelist-item">• 1 = "Censored"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">if ADAE.TRTEMFL ="Y" then CNSR=0, else CNSR=1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.EVNTDESC"></a>EVNTDESC</td><td>Event or Censoring Description</td><td class="datatype">text</td><td class="number">25</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">if ADTTE.CNSR = 0 then "Dematologic Event Occured", else if ADTTE.CNSR =1 then "Study Completion Date"</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.SRCDOM"></a>SRCDOM</td><td>Source Domain</td><td class="datatype">text</td><td class="number">4</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">The Source domain referred to in order to populate ADT (either ADAE or ADSL)</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.SRCVAR"></a>SRCVAR</td><td>Source Variable</td><td class="datatype">text</td><td class="number">6</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">The Source variable referred to in order to populate ADT (either ASTDT or RFENDT)</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADTTE.IT.ADTTE.SRCSEQ"></a>SRCSEQ</td><td>Source Sequence Number</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">The value of ADAE.AESEQ if SRCDOM=ADAE, otherwise null.</div></td></tr><tr class="tableroweven"><td><a id="IG.ADTTE.IT.ADTTE.SAFFL"></a>SAFFL</td><td>Safety Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.SAFFL</div></td></tr></tbody></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="IG.IG.ADVS"></a><div class="containerbox"><h1 class="invisible">Vital Signs Analysis Dataset (ADVS) </h1><table summary="ItemGroup IG.IG.ADVS"><caption><span>ADVS (Vital Signs Analysis Dataset, AD) - BASIC DATA STRUCTURE <span class="dataset">Location: <a class="external" href="./advs.xpt">advs.xpt</a><span class="external-link-gif"></span> </span></span></caption><tbody><tr class="header"><th scope="col">Variable</th><th scope="col">Label / Description</th><th scope="col">Type</th><th scope="col" class="length">Length or Display Format</th><th scope="col" abbr="Format">Controlled Terms or ISO Format</th><th scope="col">Origin / Source / Method / Comment</th></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.STUDYID"></a>STUDYID</td><td>Study Identifier</td><td class="datatype">text</td><td class="number">12</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.STUDYID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.SITEID"></a>SITEID</td><td>Study Site Identifier</td><td class="datatype">text</td><td class="number">3</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.SITEID</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.USUBJID"></a>USUBJID</td><td>Unique Subject Identifier</td><td class="datatype">text</td><td class="number">11</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.USUBJID</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.AGE"></a>AGE</td><td>Age</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.AGE</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.AGEGR1"></a>AGEGR1</td><td>Pooled Age Group 1</td><td class="datatype">text</td><td class="number">5</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1">AGEGR1</a></span><ul class="codelist"><li class="codelist-item">• "<65" = "<65"</li><li class="codelist-item">• "65-80" = "65-80"</li><li class="codelist-item">• ">80" = ">80"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.AGEGR1</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.AGEGR1N"></a>AGEGR1N</td><td>Pooled Age Group 1 (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.AGEGR1N">AGEGR1N</a></span><ul class="codelist"><li class="codelist-item">• 1 = "<65"</li><li class="codelist-item">• 2 = "65-80"</li><li class="codelist-item">• 3 = ">80"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.AGEGR1N</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.RACE"></a>RACE</td><td>Race</td><td class="datatype">text</td><td class="number">32</td><td><span class="linebreakcell"><a href="#CL.CL.RACE">RACE</a></span><ul class="codelist"><li class="codelist-item">• "AMERICAN INDIAN OR ALASKA NATIVE" = "1"</li><li class="codelist-item">• "ASIAN" = "2"</li><li class="codelist-item">• "BLACK OR AFRICAN AMERICAN" = "3"</li><li class="codelist-item">• "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER" = "5"</li><li class="codelist-item">• "WHITE" = "6"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.RACE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.RACEN"></a>RACEN</td><td>Race (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.RACEN">RACEN</a></span><ul class="codelist"><li class="codelist-item">• 1 = "AMERICAN INDIAN OR ALASKA NATIVE"</li><li class="codelist-item">• 2 = "ASIAN"</li><li class="codelist-item">• 3 = "BLACK OR AFRICAN AMERICAN"</li><li class="codelist-item">• 5 = "NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER"</li><li class="codelist-item">• 6 = "WHITE"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.RACEN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.SEX"></a>SEX</td><td>Sex</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.SEX">SEX</a></span><ul class="codelist"><li class="codelist-item">• "M"</li><li class="codelist-item">• "F"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.SEX</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.SAFFL"></a>SAFFL</td><td>Safety Population Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.YN">YN</a></span><ul class="codelist"><li class="codelist-item">• "Y"</li><li class="codelist-item">• "N"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.SAFFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.TRTSDT"></a>TRTSDT</td><td>Date of First Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRTSDT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.TRTEDT"></a>TRTEDT</td><td>Date of Last Exposure to Treatment</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRTEDT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.TRTP"></a>TRTP</td><td>Planned Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">ARM</a></span><ul class="codelist"><li class="codelist-item">• "Placebo" = "Placebo"</li><li class="codelist-item">• "Xanomeline Low Dose" = "Xanomeline Low Dose"</li><li class="codelist-item">• "Xanomeline High Dose" = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01P</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.TRTPN"></a>TRTPN</td><td>Planned Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">ARMN</a></span><ul class="codelist"><li class="codelist-item">• 0 = "Placebo"</li><li class="codelist-item">• 54 = "Xanomeline Low Dose"</li><li class="codelist-item">• 81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01PN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.TRTA"></a>TRTA</td><td>Actual Treatment</td><td class="datatype">text</td><td class="number">20</td><td><span class="linebreakcell"><a href="#CL.CL.ARM">ARM</a></span><ul class="codelist"><li class="codelist-item">• "Placebo" = "Placebo"</li><li class="codelist-item">• "Xanomeline Low Dose" = "Xanomeline Low Dose"</li><li class="codelist-item">• "Xanomeline High Dose" = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01AN</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.TRTAN"></a>TRTAN</td><td>Actual Treatment (N)</td><td class="datatype">integer</td><td class="number">8</td><td><span class="linebreakcell"><a href="#CL.CL.ARMN">ARMN</a></span><ul class="codelist"><li class="codelist-item">• 0 = "Placebo"</li><li class="codelist-item">• 54 = "Xanomeline Low Dose"</li><li class="codelist-item">• 81 = "Xanomeline High Dose"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ADSL.TRT01AN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.PARAMCD"></a>PARAMCD</td><td>Parameter Code</td><td class="datatype">text</td><td class="number">8</td><td><a href="#CL.CL.PARAMCD_ADVS">PARAMCD_ADVS</a><p class="linebreakcell">
[6 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">VS.VSTESTCD</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.PARAM"></a>PARAM</td><td>Parameter</td><td class="datatype">text</td><td class="number">100</td><td><a href="#CL.CL.PARAM_ADVS">PARAM_ADVS</a><p class="linebreakcell">
[6 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">VS.VSBLFL</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.PARAMN"></a>PARAMN</td><td>Parameter (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.PARAMN_ADVS">PARAMN_ADVS</a><p class="linebreakcell">
[6 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for Parameter</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.ADT"></a>ADT</td><td>Analysis Date</td><td class="datatype">integer</td><td class="number">DATE9.</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">the date part of VS.VSDTC converted to a SAS date</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.ADY"></a>ADY</td><td>Analysis Relative Day</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">VS.VSDY</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.ATPTN"></a>ATPTN</td><td>Analysis Timepoint (N)</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for ATPT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.ATPT"></a>ATPT</td><td>Analysis Timepoint</td><td class="datatype">text</td><td class="number">30</td><td><span class="linebreakcell"><a href="#CL.CL.ATPT">ATPT</a></span><ul class="codelist"><li class="codelist-item">• "AFTER LYING DOWN FOR 5 MINUTES" = "AFTER LYING DOWN FOR 5 MINUTES"</li><li class="codelist-item">• "AFTER STANDING FOR 1 MINUTE" = "AFTER STANDING FOR 1 MINUTE"</li><li class="codelist-item">• "AFTER STANDING FOR 3 MINUTES" = "AFTER STANDING FOR 3 MINUTES"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">VS.VSTPT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.AVISIT"></a>AVISIT</td><td>Analysis Visit</td><td class="datatype">text</td><td class="number">16</td><td><a href="#CL.CL.AVISIT">AVISIT</a><p class="linebreakcell">
[16 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">Derived from VS.VISIT for values to be included in a per visit analysis. AVISIT is missing for values from SDTM screening visits, unscheduled visits, and event related visits, e.g. "AMBUL ECG REMOVAL", which are not included in a per visit analysis.</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.AVISITN"></a>AVISITN</td><td>Analysis Visit (N)</td><td class="datatype">integer</td><td class="number">8</td><td><a href="#CL.CL.AVISITN">AVISITN</a><p class="linebreakcell">
[16 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">Numeric code for AVISIT</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.AVAL"></a>AVAL</td><td>Analysis Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">VS.VSSTRESN</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.BASE"></a>BASE</td><td>Baseline Value</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">VS.VSSTRESN where VSBLFL="Y"</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.BASETYPE"></a>BASETYPE</td><td>Baseline Type</td><td class="datatype">text</td><td class="number">30</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">VS.VSTPT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.CHG"></a>CHG</td><td>Change from Baseline</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">AVAL-BASE</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.PCHG"></a>PCHG</td><td>Percent Change from Baseline</td><td class="datatype">float</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">100* (CHG/BASE)</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.VISITNUM"></a>VISITNUM</td><td>Visit Number</td><td class="datatype">float</td><td class="number">8</td><td><a href="#CL.CL.VISITNUM">VISITNUM</a><p class="linebreakcell">
[37 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">VS.VISITNUM</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.VISIT"></a>VISIT</td><td>Visit Name</td><td class="datatype">text</td><td class="number">19</td><td><a href="#CL.CL.VISIT">VISIT</a><p class="linebreakcell">
[37 Terms]
</p></td><td><div class="linebreakcell">Derived</div><div class="method-code">VS.VISIT</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.VSSEQ"></a>VSSEQ</td><td>Sequence Number</td><td class="datatype">integer</td><td class="number">8</td><td></td><td><div class="linebreakcell">Derived</div><div class="method-code">VS.VSSEQ</div></td></tr><tr class="tableroweven"><td><a id="IG.ADVS.IT.ADVS.ANL01FL"></a>ANL01FL</td><td>Analysis Flag 01</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">ANL01FL="Y" if the value is to be included in a per visit analysis. ANL01FL is missing for values from SDTM screening visits, unscheduled visits, and event related visits, e.g. "AMBUL ECG REMOVAL"</div></td></tr><tr class="tablerowodd"><td><a id="IG.ADVS.IT.ADVS.ABLFL"></a>ABLFL</td><td>Baseline Record Flag</td><td class="datatype">text</td><td class="number">1</td><td><span class="linebreakcell"><a href="#CL.CL.Y_BLANK">Y_BLANK</a></span><ul class="codelist"><li class="codelist-item">• "Y" = "Yes"</li></ul></td><td><div class="linebreakcell">Derived</div><div class="method-code">VS.VSBLFL</div></td></tr></tbody></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="decodelist"></a><div class="containerbox"><h1 class="header">CodeLists</h1><div class="codelist" id="CL.CL.ADLBCAT"><div class="codelist-caption">ADLBCAT</div><table summary="Controlled Term - ADLBCAT"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>CHEM</td><td class="codelist-item-decode">Chemistry</td></tr><tr class="tableroweven"><td>HEM</td><td class="codelist-item-decode">Hematology</td></tr><tr class="tablerowodd"><td>HYLAW</td><td class="codelist-item-decode">Hy's Law</td></tr></tbody></table></div><div class="codelist" id="CL.CL.AECAUS"><div class="codelist-caption">AECAUS</div><table summary="Controlled Term - AECAUS"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>NONE</td><td class="codelist-item-decode">NONE</td></tr><tr class="tableroweven"><td>POSSIBLE</td><td class="codelist-item-decode">POSSIBLE</td></tr><tr class="tablerowodd"><td>PROBABLE</td><td class="codelist-item-decode">PROBABLE</td></tr><tr class="tableroweven"><td>REMOTE</td><td class="codelist-item-decode">REMOTE</td></tr></tbody></table></div><div class="codelist" id="CL.CL.AGEGR1"><div class="codelist-caption">AGEGR1</div><table summary="Controlled Term - AGEGR1"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td><65</td><td class="codelist-item-decode"><65</td></tr><tr class="tableroweven"><td>65-80</td><td class="codelist-item-decode">65-80</td></tr><tr class="tablerowodd"><td>>80</td><td class="codelist-item-decode">>80</td></tr></tbody></table></div><div class="codelist" id="CL.CL.AGEGR1N"><div class="codelist-caption">AGEGR1N</div><table summary="Controlled Term - AGEGR1N"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode"><65</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">65-80</td></tr><tr class="tablerowodd"><td>3</td><td class="codelist-item-decode">>80</td></tr></tbody></table></div><div class="codelist" id="CL.CL.AGEU"><div class="codelist-caption">AGEU</div><table summary="Code List - AGEU"><tbody><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>YEARS</td></tr></tbody></table></div><div class="codelist" id="CL.CL.ARM"><div class="codelist-caption">ARM</div><table summary="Controlled Term - ARM"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>Placebo</td><td class="codelist-item-decode">Placebo</td></tr><tr class="tableroweven"><td>Xanomeline Low Dose</td><td class="codelist-item-decode">Xanomeline Low Dose</td></tr><tr class="tablerowodd"><td>Xanomeline High Dose</td><td class="codelist-item-decode">Xanomeline High Dose</td></tr></tbody></table></div><div class="codelist" id="CL.CL.ARMN"><div class="codelist-caption">ARMN</div><table summary="Controlled Term - ARMN"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Placebo</td></tr><tr class="tableroweven"><td>54</td><td class="codelist-item-decode">Xanomeline Low Dose</td></tr><tr class="tablerowodd"><td>81</td><td class="codelist-item-decode">Xanomeline High Dose</td></tr></tbody></table></div><div class="codelist" id="CL.CL.ATPT"><div class="codelist-caption">ATPT</div><table summary="Controlled Term - ATPT"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>AFTER LYING DOWN FOR 5 MINUTES</td><td class="codelist-item-decode">AFTER LYING DOWN FOR 5 MINUTES</td></tr><tr class="tableroweven"><td>AFTER STANDING FOR 1 MINUTE</td><td class="codelist-item-decode">AFTER STANDING FOR 1 MINUTE</td></tr><tr class="tablerowodd"><td>AFTER STANDING FOR 3 MINUTES</td><td class="codelist-item-decode">AFTER STANDING FOR 3 MINUTES</td></tr></tbody></table></div><div class="codelist" id="CL.CL.AVISIT"><div class="codelist-caption">AVISIT</div><table summary="Controlled Term - AVISIT"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>Baseline</td><td class="codelist-item-decode">Baseline</td></tr><tr class="tableroweven"><td>Week 2</td><td class="codelist-item-decode">Week 2</td></tr><tr class="tablerowodd"><td>Week 4</td><td class="codelist-item-decode">Week 4</td></tr><tr class="tableroweven"><td>Week 6</td><td class="codelist-item-decode">Week 6</td></tr><tr class="tablerowodd"><td>Week 8</td><td class="codelist-item-decode">Week 8</td></tr><tr class="tableroweven"><td>Week 10</td><td class="codelist-item-decode">Week 10</td></tr><tr class="tablerowodd"><td>Week 12</td><td class="codelist-item-decode">Week 12</td></tr><tr class="tableroweven"><td>Week 14</td><td class="codelist-item-decode">Week 14</td></tr><tr class="tablerowodd"><td>Week 16</td><td class="codelist-item-decode">Week 16</td></tr><tr class="tableroweven"><td>Week 18</td><td class="codelist-item-decode">Week 18</td></tr><tr class="tablerowodd"><td>Week 20</td><td class="codelist-item-decode">Week 20</td></tr><tr class="tableroweven"><td>Week 22</td><td class="codelist-item-decode">Week 22</td></tr><tr class="tablerowodd"><td>Week 24</td><td class="codelist-item-decode">Week 24</td></tr><tr class="tableroweven"><td>Week 26</td><td class="codelist-item-decode">Week 26</td></tr><tr class="tablerowodd"><td>Weeks 4-24</td><td class="codelist-item-decode">Weeks 4-24</td></tr><tr class="tableroweven"><td>End of Treatment</td><td class="codelist-item-decode">End of Treatment</td></tr></tbody></table></div><div class="codelist" id="CL.CL.AVISITN"><div class="codelist-caption">AVISITN</div><table summary="Controlled Term - AVISITN"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Baseline</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">Week 2</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">Week 4</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">Week 6</td></tr><tr class="tablerowodd"><td>8</td><td class="codelist-item-decode">Week 8</td></tr><tr class="tableroweven"><td>10</td><td class="codelist-item-decode">Week 10</td></tr><tr class="tablerowodd"><td>12</td><td class="codelist-item-decode">Week 12</td></tr><tr class="tableroweven"><td>14</td><td class="codelist-item-decode">Week 14</td></tr><tr class="tablerowodd"><td>16</td><td class="codelist-item-decode">Week 16</td></tr><tr class="tableroweven"><td>18</td><td class="codelist-item-decode">Week 18</td></tr><tr class="tablerowodd"><td>20</td><td class="codelist-item-decode">Week 20</td></tr><tr class="tableroweven"><td>22</td><td class="codelist-item-decode">Week 22</td></tr><tr class="tablerowodd"><td>24</td><td class="codelist-item-decode">Week 24</td></tr><tr class="tableroweven"><td>26</td><td class="codelist-item-decode">Week 26</td></tr><tr class="tablerowodd"><td>98</td><td class="codelist-item-decode">Weeks 4-24</td></tr><tr class="tableroweven"><td>99</td><td class="codelist-item-decode">End of Treatment</td></tr></tbody></table></div><div class="codelist" id="CL.CL.AWU"><div class="codelist-caption">AWU</div><table summary="Controlled Term - AWU"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>DAYS</td><td class="codelist-item-decode">DAYS</td></tr></tbody></table></div><div class="codelist" id="CL.CL.BMICAT"><div class="codelist-caption">BMICAT</div><table summary="Controlled Term - BMICAT"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td><25</td><td class="codelist-item-decode">Normal</td></tr><tr class="tableroweven"><td>25-<30</td><td class="codelist-item-decode">Overweight</td></tr><tr class="tablerowodd"><td>>=30</td><td class="codelist-item-decode">Obese</td></tr></tbody></table></div><div class="codelist" id="CL.CL.CENSOR"><div class="codelist-caption">CENSOR</div><table summary="Controlled Term - CENSOR"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">Event</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Censored</td></tr></tbody></table></div><div class="codelist" id="CL.CL.DISCCD"><div class="codelist-caption">DISCCD</div><table summary="Controlled Term - DISCCD"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>COMPLETED</td><td class="codelist-item-decode">COMPLETED</td></tr><tr class="tableroweven"><td>ADVERSE EVENT</td><td class="codelist-item-decode">ADVERSE EVENT</td></tr><tr class="tablerowodd"><td>DEATH</td><td class="codelist-item-decode">DEATH</td></tr><tr class="tableroweven"><td>LACK OF EFFICACY</td><td class="codelist-item-decode">LACK OF EFFICACY</td></tr><tr class="tablerowodd"><td>LOST TO FOLLOW-UP</td><td class="codelist-item-decode">LOST TO FOLLOW-UP</td></tr><tr class="tableroweven"><td>WITHDRAWAL BY SUBJECT</td><td class="codelist-item-decode">WITHDRAWAL BY SUBJECT</td></tr><tr class="tablerowodd"><td>STUDY TERMINATED BY SPONSOR</td><td class="codelist-item-decode">STUDY TERMINATED BY SPONSOR</td></tr><tr class="tableroweven"><td>PHYSICIAN DECISION</td><td class="codelist-item-decode">PHYSICIAN DECISION</td></tr><tr class="tablerowodd"><td>PROTOCOL VIOLATION</td><td class="codelist-item-decode">PROTOCOL VIOLATION</td></tr></tbody></table></div><div class="codelist" id="CL.CL.DISCREAS"><div class="codelist-caption">DISCREAS</div><table summary="Controlled Term - DISCREAS"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>Completed</td><td class="codelist-item-decode">Completed</td></tr><tr class="tableroweven"><td>Adverse Event</td><td class="codelist-item-decode">Adverse Event</td></tr><tr class="tablerowodd"><td>Death</td><td class="codelist-item-decode">Death</td></tr><tr class="tableroweven"><td>I/E Not Met</td><td class="codelist-item-decode">I/E Not Met</td></tr><tr class="tablerowodd"><td>Lack of Efficacy</td><td class="codelist-item-decode">Lack of Efficacy</td></tr><tr class="tableroweven"><td>Lost to Follow-up</td><td class="codelist-item-decode">Lost to Follow-up</td></tr><tr class="tablerowodd"><td>Physician Decision</td><td class="codelist-item-decode">Physician Decision</td></tr><tr class="tableroweven"><td>Protocol Violation</td><td class="codelist-item-decode">Protocol Violation</td></tr><tr class="tablerowodd"><td>Sponsor Decision</td><td class="codelist-item-decode">Sponsor Decision</td></tr><tr class="tableroweven"><td>Withdrew Consent</td><td class="codelist-item-decode">Withdrew Consent</td></tr></tbody></table></div><div class="codelist" id="CL.CL.DTYPE"><div class="codelist-caption">DTYPE</div><table summary="Controlled Term - DTYPE"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>LOCF</td><td class="codelist-item-decode">Last Observation Carried Forward</td></tr><tr class="tableroweven"><td>AVERAGE</td><td class="codelist-item-decode">Average</td></tr></tbody></table></div><div class="codelist" id="CL.CL.DURDISC"><div class="codelist-caption">DURDISC</div><table summary="Controlled Term - DURDISC"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td><12</td><td class="codelist-item-decode"><12</td></tr><tr class="tableroweven"><td>>=12</td><td class="codelist-item-decode">>=12</td></tr></tbody></table></div><div class="codelist" id="CL.CL.ETHNIC"><div class="codelist-caption">ETHNIC</div><table summary="Controlled Term - ETHNIC"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>HISPANIC OR LATINO</td><td class="codelist-item-decode">1</td></tr><tr class="tableroweven"><td>NOT HISPANIC OR LATINO</td><td class="codelist-item-decode">2</td></tr><tr class="tablerowodd"><td>NOT REPORTED</td><td class="codelist-item-decode">3</td></tr><tr class="tableroweven"><td>UNKNOWN</td><td class="codelist-item-decode">4</td></tr></tbody></table></div><div class="codelist" id="CL.CL.LBNRIND"><div class="codelist-caption">LBNRIND</div><table summary="Controlled Term - LBNRIND"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>LOW</td><td class="codelist-item-decode">LOW</td></tr><tr class="tableroweven"><td>NORMAL</td><td class="codelist-item-decode">NORMAL</td></tr><tr class="tablerowodd"><td>HIGH</td><td class="codelist-item-decode">HIGH</td></tr><tr class="tableroweven"><td>ABNORMAL</td><td class="codelist-item-decode">HIGH</td></tr></tbody></table></div><div class="codelist" id="CL.CL.LNH"><div class="codelist-caption">LNH</div><table summary="Controlled Term - LNH"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>L</td><td class="codelist-item-decode">Low</td></tr><tr class="tableroweven"><td>N</td><td class="codelist-item-decode">Normal</td></tr><tr class="tablerowodd"><td>H</td><td class="codelist-item-decode">High</td></tr></tbody></table></div><div class="codelist" id="CL.CL.OUT"><div class="codelist-caption">OUT</div><table summary="Controlled Term - OUT"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>RECOVERED/RESOLVED</td><td class="codelist-item-decode">RECOVERED/RESOLVED</td></tr><tr class="tableroweven"><td>NOT RECOVERED/NOT RESOLVED</td><td class="codelist-item-decode">NOT RECOVERED/NOT RESOLVED</td></tr><tr class="tablerowodd"><td>FATAL</td><td class="codelist-item-decode">FATAL</td></tr></tbody></table></div><div class="codelist" id="CL.CL.PARAM_ADLBC"><div class="codelist-caption">PARAM_ADLBC</div><table summary="Controlled Term - PARAM_ADLBC"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>Albumin (g/L)</td><td class="codelist-item-decode">Albumin (g/L)</td></tr><tr class="tableroweven"><td>Alkaline Phosphatase (U/L)</td><td class="codelist-item-decode">Alkaline Phosphatase (U/L)</td></tr><tr class="tablerowodd"><td>Alanine Aminotransferase (U/L)</td><td class="codelist-item-decode">Alanine Aminotransferase (U/L)</td></tr><tr class="tableroweven"><td>Aspartate Aminotransferase (U/L)</td><td class="codelist-item-decode">Aspartate Aminotransferase (U/L)</td></tr><tr class="tablerowodd"><td>Bilirubin (umol/L)</td><td class="codelist-item-decode">Bilirubin (umol/L)</td></tr><tr class="tableroweven"><td>Blood Urea Nitrogen (mmol/L)</td><td class="codelist-item-decode">Blood Urea Nitrogen (mmol/L)</td></tr><tr class="tablerowodd"><td>Calcium (mmol/L)</td><td class="codelist-item-decode">Calcium (mmol/L)</td></tr><tr class="tableroweven"><td>Cholesterol (mmol/L)</td><td class="codelist-item-decode">Cholesterol (mmol/L)</td></tr><tr class="tablerowodd"><td>Creatine Kinase (U/L)</td><td class="codelist-item-decode">Creatine Kinase (U/L)</td></tr><tr class="tableroweven"><td>Chloride (mmol/L)</td><td class="codelist-item-decode">Chloride (mmol/L)</td></tr><tr class="tablerowodd"><td>Creatinine (umol/L)</td><td class="codelist-item-decode">Creatinine (umol/L)</td></tr><tr class="tableroweven"><td>Gamma Glutamyl Transferase (U/L)</td><td class="codelist-item-decode">Gamma Glutamyl Transferase (U/L)</td></tr><tr class="tablerowodd"><td>Glucose (mmol/L)</td><td class="codelist-item-decode">Glucose (mmol/L)</td></tr><tr class="tableroweven"><td>Potassium (mmol/L)</td><td class="codelist-item-decode">Potassium (mmol/L)</td></tr><tr class="tablerowodd"><td>Phosphate (mmol/L)</td><td class="codelist-item-decode">Phosphate (mmol/L)</td></tr><tr class="tableroweven"><td>Protein (g/L)</td><td class="codelist-item-decode">Protein (g/L)</td></tr><tr class="tablerowodd"><td>Sodium (mmol/L)</td><td class="codelist-item-decode">Sodium (mmol/L)</td></tr><tr class="tableroweven"><td>Urate (umol/L)</td><td class="codelist-item-decode">Urate (umol/L)</td></tr><tr class="tablerowodd"><td>Albumin (g/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Albumin (g/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Alkaline Phosphatase (U/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Alkaline Phosphatase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Alanine Aminotransferase (U/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Alanine Aminotransferase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Aspartate Aminotransferase (U/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Aspartate Aminotransferase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Bilirubin (umol/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Bilirubin (umol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Blood Urea Nitrogen (mmol/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Blood Urea Nitrogen (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Calcium (mmol/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Calcium (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Cholesterol (mmol/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Cholesterol (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Creatine Kinase (U/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Creatine Kinase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Chloride (mmol/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Chloride (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Creatinine (umol/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Creatinine (umol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Gamma Glutamyl Transferase (U/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Gamma Glutamyl Transferase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Glucose (mmol/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Glucose (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Potassium (mmol/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Potassium (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Phosphate (mmol/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Phosphate (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Protein (g/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Protein (g/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Sodium (mmol/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Sodium (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Urate (umol/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Urate (umol/L) change from previous visit, relative to normal range</td></tr></tbody></table></div><div class="codelist" id="CL.CL.PARAM_ADLBH"><div class="codelist-caption">PARAM_ADLBH</div><table summary="Controlled Term - PARAM_ADLBH"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>Anisocytes</td><td class="codelist-item-decode">Anisocytes</td></tr><tr class="tableroweven"><td>Basophils (GI/L)</td><td class="codelist-item-decode">Basophils (GI/L)</td></tr><tr class="tablerowodd"><td>Eosinophils (GI/L)</td><td class="codelist-item-decode">Eosinophils (GI/L)</td></tr><tr class="tableroweven"><td>Hematocrit</td><td class="codelist-item-decode">Hematocrit</td></tr><tr class="tablerowodd"><td>Hemoglobin (mmol/L)</td><td class="codelist-item-decode">Hemoglobin (mmol/L)</td></tr><tr class="tableroweven"><td>Lymphocytes (GI/L)</td><td class="codelist-item-decode">Lymphocytes (GI/L)</td></tr><tr class="tablerowodd"><td>Macrocytes</td><td class="codelist-item-decode">Macrocytes</td></tr><tr class="tableroweven"><td>Ery. Mean Corpuscular Hemoglobin (fmol(Fe))</td><td class="codelist-item-decode">Ery. Mean Corpuscular Hemoglobin (fmol(Fe))</td></tr><tr class="tablerowodd"><td>Ery. Mean Corpuscular HGB Concentration (mmol/L)</td><td class="codelist-item-decode">Ery. Mean Corpuscular HGB Concentration (mmol/L)</td></tr><tr class="tableroweven"><td>Ery. Mean Corpuscular Volume (fL)</td><td class="codelist-item-decode">Ery. Mean Corpuscular Volume (fL)</td></tr><tr class="tablerowodd"><td>Microcytes</td><td class="codelist-item-decode">Microcytes</td></tr><tr class="tableroweven"><td>Monocytes (GI/L)</td><td class="codelist-item-decode">Monocytes (GI/L)</td></tr><tr class="tablerowodd"><td>Platelet (GI/L)</td><td class="codelist-item-decode">Platelet (GI/L)</td></tr><tr class="tableroweven"><td>Poikilocytes</td><td class="codelist-item-decode">Poikilocytes</td></tr><tr class="tablerowodd"><td>Polychromasia</td><td class="codelist-item-decode">Polychromasia</td></tr><tr class="tableroweven"><td>Erythrocytes (TI/L)</td><td class="codelist-item-decode">Erythrocytes (TI/L)</td></tr><tr class="tablerowodd"><td>Leukocytes (GI/L)</td><td class="codelist-item-decode">Leukocytes (GI/L)</td></tr><tr class="tableroweven"><td>Anisocytes change from previous visit, relative to normal range</td><td class="codelist-item-decode">Anisocytes change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Basophils (GI/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Basophils (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Eosinophils (GI/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Eosinophils (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Hematocrit change from previous visit, relative to normal range</td><td class="codelist-item-decode">Hematocrit change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Hemoglobin (mmol/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Hemoglobin (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Lymphocytes (GI/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Lymphocytes (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Macrocytes change from previous visit, relative to normal range</td><td class="codelist-item-decode">Macrocytes change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Ery. Mean Corpuscular HGB Concentration (mmol/L) change from previous visit, relative to normal rang</td><td class="codelist-item-decode">Ery. Mean Corpuscular HGB Concentration (mmol/L) change from previous visit, relative to normal rang</td></tr><tr class="tablerowodd"><td>Ery. Mean Corpuscular Volume (fL) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Ery. Mean Corpuscular Volume (fL) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Microcytes change from previous visit, relative to normal range</td><td class="codelist-item-decode">Microcytes change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Monocytes (GI/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Monocytes (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Platelet (GI/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Platelet (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Poikilocytes change from previous visit, relative to normal range</td><td class="codelist-item-decode">Poikilocytes change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Polychromasia change from previous visit, relative to normal range</td><td class="codelist-item-decode">Polychromasia change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>Erythrocytes (TI/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Erythrocytes (TI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>Leukocytes (GI/L) change from previous visit, relative to normal range</td><td class="codelist-item-decode">Leukocytes (GI/L) change from previous visit, relative to normal range</td></tr></tbody></table></div><div class="codelist" id="CL.CL.PARAM_ADLBHY"><div class="codelist-caption">PARAM_ADLBHY</div><table summary="Controlled Term - PARAM_ADLBHY"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>Alanine Aminotransferase (U/L)</td><td class="codelist-item-decode">Alanine Aminotransferase (U/L)</td></tr><tr class="tableroweven"><td>Aspartate Aminotransferase (U/L)</td><td class="codelist-item-decode">Aspartate Aminotransferase (U/L)</td></tr><tr class="tablerowodd"><td>Bilirubin (umol/L)</td><td class="codelist-item-decode">Bilirubin (umol/L)</td></tr><tr class="tableroweven"><td>Bilirubin 1.5 x ULN</td><td class="codelist-item-decode">Bilirubin 1.5 x ULN</td></tr><tr class="tablerowodd"><td>Transaminase 1.5 x ULN</td><td class="codelist-item-decode">Transaminase 1.5 x ULN</td></tr><tr class="tableroweven"><td>Total Bili 1.5 x ULN and Transaminase 1.5 x ULN</td><td class="codelist-item-decode">Total Bili 1.5 x ULN and Transaminase 1.5 x ULN</td></tr></tbody></table></div><div class="codelist" id="CL.CL.PARAM_ADTTE"><div class="codelist-caption">PARAM_ADTTE</div><table summary="Controlled Term - PARAM_ADTTE"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>Time to First Dermatologic Event</td><td class="codelist-item-decode">Time to Derm. Event or End of Study</td></tr></tbody></table></div><div class="codelist" id="CL.CL.PARAM_ADVS"><div class="codelist-caption">PARAM_ADVS</div><table summary="Controlled Term - PARAM_ADVS"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>Systolic Blood Pressure (mmHg)</td><td class="codelist-item-decode">Systolic Blood Pressure (mmHg)</td></tr><tr class="tableroweven"><td>Diastolic Blood Pressure (mmHg)</td><td class="codelist-item-decode">Diastolic Blood Pressure (mmHg)</td></tr><tr class="tablerowodd"><td>Pulse Rate (beats/min)</td><td class="codelist-item-decode">Pulse Rate (beats/min)</td></tr><tr class="tableroweven"><td>Weight (kg)</td><td class="codelist-item-decode">Weight (kg)</td></tr><tr class="tablerowodd"><td>Height (cm)</td><td class="codelist-item-decode">Height (cm)</td></tr><tr class="tableroweven"><td>Temperature (C)</td><td class="codelist-item-decode">Temperature (C)</td></tr></tbody></table></div><div class="codelist" id="CL.CL.PARAMCD_ADLBC"><div class="codelist-caption">PARAMCD_ADLBC</div><table summary="Controlled Term - PARAMCD_ADLBC"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>ALB</td><td class="codelist-item-decode">Albumin (g/L)</td></tr><tr class="tableroweven"><td>ALP</td><td class="codelist-item-decode">Alkaline Phosphatase (U/L)</td></tr><tr class="tablerowodd"><td>ALT</td><td class="codelist-item-decode">Alanine Aminotransferase (U/L)</td></tr><tr class="tableroweven"><td>AST</td><td class="codelist-item-decode">Aspartate Aminotransferase (U/L)</td></tr><tr class="tablerowodd"><td>BILI</td><td class="codelist-item-decode">Bilirubin (umol/L)</td></tr><tr class="tableroweven"><td>BUN</td><td class="codelist-item-decode">Blood Urea Nitrogen (mmol/L)</td></tr><tr class="tablerowodd"><td>CA</td><td class="codelist-item-decode">Calcium (mmol/L)</td></tr><tr class="tableroweven"><td>CHOL</td><td class="codelist-item-decode">Cholesterol (mmol/L)</td></tr><tr class="tablerowodd"><td>CK</td><td class="codelist-item-decode">Creatine Kinase (U/L)</td></tr><tr class="tableroweven"><td>CL</td><td class="codelist-item-decode">Chloride (mmol/L)</td></tr><tr class="tablerowodd"><td>CREAT</td><td class="codelist-item-decode">Creatinine (umol/L)</td></tr><tr class="tableroweven"><td>GGT</td><td class="codelist-item-decode">Gamma Glutamyl Transferase (U/L)</td></tr><tr class="tablerowodd"><td>GLUC</td><td class="codelist-item-decode">Glucose (mmol/L)</td></tr><tr class="tableroweven"><td>K</td><td class="codelist-item-decode">Potassium (mmol/L)</td></tr><tr class="tablerowodd"><td>PHOS</td><td class="codelist-item-decode">Phosphate (mmol/L)</td></tr><tr class="tableroweven"><td>PROT</td><td class="codelist-item-decode">Protein (g/L)</td></tr><tr class="tablerowodd"><td>SODIUM</td><td class="codelist-item-decode">Sodium (mmol/L)</td></tr><tr class="tableroweven"><td>URATE</td><td class="codelist-item-decode">Urate (umol/L)</td></tr><tr class="tablerowodd"><td>_ALB</td><td class="codelist-item-decode">Albumin (g/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_ALP</td><td class="codelist-item-decode">Alkaline Phosphatase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_ALT</td><td class="codelist-item-decode">Alanine Aminotransferase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_AST</td><td class="codelist-item-decode">Aspartate Aminotransferase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_BILI</td><td class="codelist-item-decode">Bilirubin (umol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_BUN</td><td class="codelist-item-decode">Blood Urea Nitrogen (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_CA</td><td class="codelist-item-decode">Calcium (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_CHOL</td><td class="codelist-item-decode">Cholesterol (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_CK</td><td class="codelist-item-decode">Creatine Kinase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_CL</td><td class="codelist-item-decode">Chloride (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_CREAT</td><td class="codelist-item-decode">Creatinine (umol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_GGT</td><td class="codelist-item-decode">Gamma Glutamyl Transferase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_GLUC</td><td class="codelist-item-decode">Glucose (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_K</td><td class="codelist-item-decode">Potassium (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_PHOS</td><td class="codelist-item-decode">Phosphate (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_PROT</td><td class="codelist-item-decode">Protein (g/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_SODIUM</td><td class="codelist-item-decode">Sodium (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_URATE</td><td class="codelist-item-decode">Urate (umol/L) change from previous visit, relative to normal range</td></tr></tbody></table></div><div class="codelist" id="CL.CL.PARAMCD_ADLBH"><div class="codelist-caption">PARAMCD_ADLBH</div><table summary="Controlled Term - PARAMCD_ADLBH"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>ANISO</td><td class="codelist-item-decode">Anisocytes</td></tr><tr class="tableroweven"><td>BASO</td><td class="codelist-item-decode">Basophils (GI/L)</td></tr><tr class="tablerowodd"><td>EOS</td><td class="codelist-item-decode">Eosinophils (GI/L)</td></tr><tr class="tableroweven"><td>HCT</td><td class="codelist-item-decode">Hematocrit</td></tr><tr class="tablerowodd"><td>HGB</td><td class="codelist-item-decode">Hemoglobin (mmol/L)</td></tr><tr class="tableroweven"><td>LYM</td><td class="codelist-item-decode">Lymphocytes (GI/L)</td></tr><tr class="tablerowodd"><td>MACROCY</td><td class="codelist-item-decode">Macrocytes</td></tr><tr class="tableroweven"><td>MCH</td><td class="codelist-item-decode">Ery. Mean Corpuscular Hemoglobin (fmol(Fe))</td></tr><tr class="tablerowodd"><td>MCHC</td><td class="codelist-item-decode">Ery. Mean Corpuscular HGB Concentration (mmol/L)</td></tr><tr class="tableroweven"><td>MCV</td><td class="codelist-item-decode">Ery. Mean Corpuscular Volume (fL)</td></tr><tr class="tablerowodd"><td>MICROCY</td><td class="codelist-item-decode">Microcytes</td></tr><tr class="tableroweven"><td>MONO</td><td class="codelist-item-decode">Monocytes (GI/L)</td></tr><tr class="tablerowodd"><td>PLAT</td><td class="codelist-item-decode">Platelet (GI/L)</td></tr><tr class="tableroweven"><td>POIKILO</td><td class="codelist-item-decode">Poikilocytes</td></tr><tr class="tablerowodd"><td>POLYCHR</td><td class="codelist-item-decode">Polychromasia</td></tr><tr class="tableroweven"><td>RBC</td><td class="codelist-item-decode">Erythrocytes (TI/L)</td></tr><tr class="tablerowodd"><td>WBC</td><td class="codelist-item-decode">Leukocytes (GI/L)</td></tr><tr class="tableroweven"><td>_ANISO</td><td class="codelist-item-decode">Anisocytes change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_BASO</td><td class="codelist-item-decode">Basophils (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_EOS</td><td class="codelist-item-decode">Eosinophils (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_HCT</td><td class="codelist-item-decode">Hematocrit change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_HGB</td><td class="codelist-item-decode">Hemoglobin (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_LYM</td><td class="codelist-item-decode">Lymphocytes (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_MACROCY</td><td class="codelist-item-decode">Macrocytes change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_MCH</td><td class="codelist-item-decode">Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_MCHC</td><td class="codelist-item-decode">Ery. Mean Corpuscular HGB Concentration (mmol/L) change from previous visit, relative to normal rang</td></tr><tr class="tablerowodd"><td>_MCV</td><td class="codelist-item-decode">Ery. Mean Corpuscular Volume (fL) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_MICROCY</td><td class="codelist-item-decode">Microcytes change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_MONO</td><td class="codelist-item-decode">Monocytes (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_PLAT</td><td class="codelist-item-decode">Platelet (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_POIKILO</td><td class="codelist-item-decode">Poikilocytes change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_POLYCHR</td><td class="codelist-item-decode">Polychromasia change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>_RBC</td><td class="codelist-item-decode">Erythrocytes (TI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>_WBC</td><td class="codelist-item-decode">Leukocytes (GI/L) change from previous visit, relative to normal range</td></tr></tbody></table></div><div class="codelist" id="CL.CL.PARAMCD_ADLBHY"><div class="codelist-caption">PARAMCD_ADLBHY</div><table summary="Controlled Term - PARAMCD_ADLBHY"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>ALT</td><td class="codelist-item-decode">Alanine Aminotransferase (U/L)</td></tr><tr class="tableroweven"><td>AST</td><td class="codelist-item-decode">Aspartate Aminotransferase (U/L)</td></tr><tr class="tablerowodd"><td>BILI</td><td class="codelist-item-decode">Bilirubin (umol/L)</td></tr><tr class="tableroweven"><td>BILIHY</td><td class="codelist-item-decode">Bilirubin 1.5 x ULN</td></tr><tr class="tablerowodd"><td>TRANSHY</td><td class="codelist-item-decode">Transaminase 1.5 x ULN</td></tr><tr class="tableroweven"><td>HYLAW</td><td class="codelist-item-decode">Total Bili 1.5 x ULN and Transaminase 1.5 x ULN</td></tr></tbody></table></div><div class="codelist" id="CL.CL.PARAMCD_ADTTE"><div class="codelist-caption">PARAMCD_ADTTE</div><table summary="Controlled Term - PARAMCD_ADTTE"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>TTDE</td><td class="codelist-item-decode">Time to Derm. Event or End of Study</td></tr></tbody></table></div><div class="codelist" id="CL.CL.PARAMCD_ADVS"><div class="codelist-caption">PARAMCD_ADVS</div><table summary="Controlled Term - PARAMCD_ADVS"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>SYSBP</td><td class="codelist-item-decode">Systolic Blood Pressure (mmHg)</td></tr><tr class="tableroweven"><td>DIABP</td><td class="codelist-item-decode">Diastolic Blood Pressure (mmHg)</td></tr><tr class="tablerowodd"><td>PULSE</td><td class="codelist-item-decode">Pulse Rate (beats/min)</td></tr><tr class="tableroweven"><td>WEIGHT</td><td class="codelist-item-decode">Weight (kg)</td></tr><tr class="tablerowodd"><td>HEIGHT</td><td class="codelist-item-decode">Height (cm)</td></tr><tr class="tableroweven"><td>TEMP</td><td class="codelist-item-decode">Temperature (C)</td></tr></tbody></table></div><div class="codelist" id="CL.CL.PARAMN_ADLBC"><div class="codelist-caption">PARAMN_ADLBC</div><table summary="Controlled Term - PARAMN_ADLBC"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>18</td><td class="codelist-item-decode">Sodium (mmol/L)</td></tr><tr class="tableroweven"><td>19</td><td class="codelist-item-decode">Potassium (mmol/L)</td></tr><tr class="tablerowodd"><td>20</td><td class="codelist-item-decode">Chloride (mmol/L)</td></tr><tr class="tableroweven"><td>21</td><td class="codelist-item-decode">Bilirubin (umol/L)</td></tr><tr class="tablerowodd"><td>22</td><td class="codelist-item-decode">Alkaline Phosphatase (U/L)</td></tr><tr class="tableroweven"><td>23</td><td class="codelist-item-decode">Gamma Glutamyl Transferase (U/L)</td></tr><tr class="tablerowodd"><td>24</td><td class="codelist-item-decode">Alanine Aminotransferase (U/L)</td></tr><tr class="tableroweven"><td>25</td><td class="codelist-item-decode">Aspartate Aminotransferase (U/L)</td></tr><tr class="tablerowodd"><td>26</td><td class="codelist-item-decode">Blood Urea Nitrogen (mmol/L)</td></tr><tr class="tableroweven"><td>27</td><td class="codelist-item-decode">Creatinine (umol/L)</td></tr><tr class="tablerowodd"><td>28</td><td class="codelist-item-decode">Urate (umol/L)</td></tr><tr class="tableroweven"><td>29</td><td class="codelist-item-decode">Phosphate (mmol/L)</td></tr><tr class="tablerowodd"><td>30</td><td class="codelist-item-decode">Calcium (mmol/L)</td></tr><tr class="tableroweven"><td>31</td><td class="codelist-item-decode">Glucose (mmol/L)</td></tr><tr class="tablerowodd"><td>32</td><td class="codelist-item-decode">Protein (g/L)</td></tr><tr class="tableroweven"><td>33</td><td class="codelist-item-decode">Albumin (g/L)</td></tr><tr class="tablerowodd"><td>34</td><td class="codelist-item-decode">Cholesterol (mmol/L)</td></tr><tr class="tableroweven"><td>35</td><td class="codelist-item-decode">Creatine Kinase (U/L)</td></tr><tr class="tablerowodd"><td>118</td><td class="codelist-item-decode">Sodium (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>119</td><td class="codelist-item-decode">Potassium (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>120</td><td class="codelist-item-decode">Chloride (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>121</td><td class="codelist-item-decode">Bilirubin (umol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>122</td><td class="codelist-item-decode">Alkaline Phosphatase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>123</td><td class="codelist-item-decode">Gamma Glutamyl Transferase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>124</td><td class="codelist-item-decode">Alanine Aminotransferase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>125</td><td class="codelist-item-decode">Aspartate Aminotransferase (U/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>126</td><td class="codelist-item-decode">Blood Urea Nitrogen (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>127</td><td class="codelist-item-decode">Creatinine (umol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>128</td><td class="codelist-item-decode">Urate (umol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>129</td><td class="codelist-item-decode">Phosphate (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>130</td><td class="codelist-item-decode">Calcium (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>131</td><td class="codelist-item-decode">Glucose (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>132</td><td class="codelist-item-decode">Protein (g/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>133</td><td class="codelist-item-decode">Albumin (g/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>134</td><td class="codelist-item-decode">Cholesterol (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>135</td><td class="codelist-item-decode">Creatine Kinase (U/L) change from previous visit, relative to normal range</td></tr></tbody></table></div><div class="codelist" id="CL.CL.PARAMN_ADLBH"><div class="codelist-caption">PARAMN_ADLBH</div><table summary="Controlled Term - PARAMN_ADLBH"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">Hemoglobin (mmol/L)</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">Hematocrit</td></tr><tr class="tablerowodd"><td>3</td><td class="codelist-item-decode">Ery. Mean Corpuscular Volume (fL)</td></tr><tr class="tableroweven"><td>4</td><td class="codelist-item-decode">Ery. Mean Corpuscular Hemoglobin (fmol(Fe))</td></tr><tr class="tablerowodd"><td>5</td><td class="codelist-item-decode">Ery. Mean Corpuscular HGB Concentration (mmol/L)</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">Leukocytes (GI/L)</td></tr><tr class="tablerowodd"><td>7</td><td class="codelist-item-decode">Lymphocytes (GI/L)</td></tr><tr class="tableroweven"><td>8</td><td class="codelist-item-decode">Monocytes (GI/L)</td></tr><tr class="tablerowodd"><td>9</td><td class="codelist-item-decode">Eosinophils (GI/L)</td></tr><tr class="tableroweven"><td>10</td><td class="codelist-item-decode">Basophils (GI/L)</td></tr><tr class="tablerowodd"><td>11</td><td class="codelist-item-decode">Platelet (GI/L)</td></tr><tr class="tableroweven"><td>12</td><td class="codelist-item-decode">Erythrocytes (TI/L)</td></tr><tr class="tablerowodd"><td>13</td><td class="codelist-item-decode">Anisocytes</td></tr><tr class="tableroweven"><td>14</td><td class="codelist-item-decode">Macrocytes</td></tr><tr class="tablerowodd"><td>15</td><td class="codelist-item-decode">Microcytes</td></tr><tr class="tableroweven"><td>16</td><td class="codelist-item-decode">Poikilocytes</td></tr><tr class="tablerowodd"><td>17</td><td class="codelist-item-decode">Polychromasia</td></tr><tr class="tableroweven"><td>101</td><td class="codelist-item-decode">Hemoglobin (mmol/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>102</td><td class="codelist-item-decode">Hematocrit change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>103</td><td class="codelist-item-decode">Ery. Mean Corpuscular Volume (fL) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>104</td><td class="codelist-item-decode">Ery. Mean Corpuscular Hemoglobin (fmol(Fe)) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>105</td><td class="codelist-item-decode">Ery. Mean Corpuscular HGB Concentration (mmol/L) change from previous visit, relative to normal rang</td></tr><tr class="tablerowodd"><td>106</td><td class="codelist-item-decode">Leukocytes (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>107</td><td class="codelist-item-decode">Lymphocytes (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>108</td><td class="codelist-item-decode">Monocytes (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>109</td><td class="codelist-item-decode">Eosinophils (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>110</td><td class="codelist-item-decode">Basophils (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>111</td><td class="codelist-item-decode">Platelet (GI/L) change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>112</td><td class="codelist-item-decode">Erythrocytes (TI/L) change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>113</td><td class="codelist-item-decode">Anisocytes change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>114</td><td class="codelist-item-decode">Macrocytes change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>115</td><td class="codelist-item-decode">Microcytes change from previous visit, relative to normal range</td></tr><tr class="tablerowodd"><td>116</td><td class="codelist-item-decode">Poikilocytes change from previous visit, relative to normal range</td></tr><tr class="tableroweven"><td>117</td><td class="codelist-item-decode">Polychromasia change from previous visit, relative to normal range</td></tr></tbody></table></div><div class="codelist" id="CL.CL.PARAMN_ADLBHY"><div class="codelist-caption">PARAMN_ADLBHY</div><table summary="Controlled Term - PARAMN_ADLBHY"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">Alanine Aminotransferase (U/L)</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">Aspartate Aminotransferase (U/L)</td></tr><tr class="tablerowodd"><td>3</td><td class="codelist-item-decode">Bilirubin (umol/L)</td></tr><tr class="tableroweven"><td>4</td><td class="codelist-item-decode">Bilirubin 1.5 x ULN</td></tr><tr class="tablerowodd"><td>5</td><td class="codelist-item-decode">Transaminase 1.5 x ULN</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">Total Bili 1.5 x ULN and Transaminase 1.5 x ULN</td></tr></tbody></table></div><div class="codelist" id="CL.CL.PARAMN_ADVS"><div class="codelist-caption">PARAMN_ADVS</div><table summary="Controlled Term - PARAMN_ADVS"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">Systolic Blood Pressure (mmHg)</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">Diastolic Blood Pressure (mmHg)</td></tr><tr class="tablerowodd"><td>3</td><td class="codelist-item-decode">Pulse Rate (beats/min)</td></tr><tr class="tableroweven"><td>4</td><td class="codelist-item-decode">Weight (kg)</td></tr><tr class="tablerowodd"><td>5</td><td class="codelist-item-decode">Height (cm)</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">Temperature (C)</td></tr></tbody></table></div><div class="codelist" id="CL.CL.PARAMTYP"><div class="codelist-caption">PARAMTYP</div><table summary="Controlled Term - PARAMTYP"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>DERIVED</td><td class="codelist-item-decode">DERIVED</td></tr></tbody></table></div><div class="codelist" id="CL.CL.RACE"><div class="codelist-caption">RACE</div><table summary="Controlled Term - RACE"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>AMERICAN INDIAN OR ALASKA NATIVE</td><td class="codelist-item-decode">1</td></tr><tr class="tableroweven"><td>ASIAN</td><td class="codelist-item-decode">2</td></tr><tr class="tablerowodd"><td>BLACK OR AFRICAN AMERICAN</td><td class="codelist-item-decode">3</td></tr><tr class="tableroweven"><td>NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER</td><td class="codelist-item-decode">5</td></tr><tr class="tablerowodd"><td>WHITE</td><td class="codelist-item-decode">6</td></tr></tbody></table></div><div class="codelist" id="CL.CL.RACEN"><div class="codelist-caption">RACEN</div><table summary="Controlled Term - RACEN"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">AMERICAN INDIAN OR ALASKA NATIVE</td></tr><tr class="tableroweven"><td>2</td><td class="codelist-item-decode">ASIAN</td></tr><tr class="tablerowodd"><td>3</td><td class="codelist-item-decode">BLACK OR AFRICAN AMERICAN</td></tr><tr class="tableroweven"><td>5</td><td class="codelist-item-decode">NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER</td></tr><tr class="tablerowodd"><td>6</td><td class="codelist-item-decode">WHITE</td></tr></tbody></table></div><div class="codelist" id="CL.CL.SEX"><div class="codelist-caption">SEX</div><table summary="Code List - SEX"><tbody><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>M</td></tr><tr class="tableroweven"><td>F</td></tr></tbody></table></div><div class="codelist" id="CL.CL.SHIFT"><div class="codelist-caption">SHIFT</div><table summary="Controlled Term - SHIFT"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>High to Normal</td><td class="codelist-item-decode">High to Normal</td></tr><tr class="tableroweven"><td>Normal to Normal</td><td class="codelist-item-decode">Normal to Normal</td></tr><tr class="tablerowodd"><td>Normal to High</td><td class="codelist-item-decode">Normal to High</td></tr></tbody></table></div><div class="codelist" id="CL.CL.SHIFTN"><div class="codelist-caption">SHIFTN</div><table summary="Controlled Term - SHIFTN"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">High to Normal</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Normal to Normal</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">Normal to High</td></tr></tbody></table></div><div class="codelist" id="CL.CL.VISIT"><div class="codelist-caption">VISIT</div><table summary="Controlled Term - VISIT"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>SCREENING 1</td><td class="codelist-item-decode">SCREENING 1</td></tr><tr class="tableroweven"><td>UNSCHEDULED 1.1</td><td class="codelist-item-decode">UNSCHEDULED 1.1</td></tr><tr class="tablerowodd"><td>UNSCHEDULED 1.2</td><td class="codelist-item-decode">UNSCHEDULED 1.2</td></tr><tr class="tableroweven"><td>UNSCHEDULED 1.3</td><td class="codelist-item-decode">UNSCHEDULED 1.3</td></tr><tr class="tablerowodd"><td>SCREENING 2</td><td class="codelist-item-decode">SCREENING 2</td></tr><tr class="tableroweven"><td>BASELINE</td><td class="codelist-item-decode">BASELINE</td></tr><tr class="tablerowodd"><td>UNSCHEDULED 3.1</td><td class="codelist-item-decode">UNSCHEDULED 3.1</td></tr><tr class="tableroweven"><td>AMBUL ECG PLACEMENT</td><td class="codelist-item-decode">AMBUL ECG PLACEMENT</td></tr><tr class="tablerowodd"><td>WEEK 2</td><td class="codelist-item-decode">WEEK 2</td></tr><tr class="tableroweven"><td>UNSCHEDULED 4.1</td><td class="codelist-item-decode">UNSCHEDULED 4.1</td></tr><tr class="tablerowodd"><td>UNSCHEDULED 4.2</td><td class="codelist-item-decode">UNSCHEDULED 4.2</td></tr><tr class="tableroweven"><td>WEEK 4</td><td class="codelist-item-decode">WEEK 4</td></tr><tr class="tablerowodd"><td>UNSCHEDULED 5.1</td><td class="codelist-item-decode">UNSCHEDULED 5.1</td></tr><tr class="tableroweven"><td>AMBUL ECG REMOVAL</td><td class="codelist-item-decode">AMBUL ECG REMOVAL</td></tr><tr class="tablerowodd"><td>UNSCHEDULED 6.1</td><td class="codelist-item-decode">UNSCHEDULED 6.1</td></tr><tr class="tableroweven"><td>WEEK 6</td><td class="codelist-item-decode">WEEK 6</td></tr><tr class="tablerowodd"><td>UNSCHEDULED 7.1</td><td class="codelist-item-decode">UNSCHEDULED 7.1</td></tr><tr class="tableroweven"><td>WEEK 8</td><td class="codelist-item-decode">WEEK 8</td></tr><tr class="tablerowodd"><td>WEEK 10 (T)</td><td class="codelist-item-decode">WEEK 10 (T)</td></tr><tr class="tableroweven"><td>UNSCHEDULED 8.2</td><td class="codelist-item-decode">UNSCHEDULED 8.2</td></tr><tr class="tablerowodd"><td>WEEK 12</td><td class="codelist-item-decode">WEEK 12</td></tr><tr class="tableroweven"><td>WEEK 14 (T)</td><td class="codelist-item-decode">WEEK 14 (T)</td></tr><tr class="tablerowodd"><td>UNSCHEDULED 9.2</td><td class="codelist-item-decode">UNSCHEDULED 9.2</td></tr><tr class="tableroweven"><td>UNSCHEDULED 9.3</td><td class="codelist-item-decode">UNSCHEDULED 9.3</td></tr><tr class="tablerowodd"><td>WEEK 16</td><td class="codelist-item-decode">WEEK 16</td></tr><tr class="tableroweven"><td>WEEK 18 (T)</td><td class="codelist-item-decode">WEEK 18 (T)</td></tr><tr class="tablerowodd"><td>UNSCHEDULED 10.2</td><td class="codelist-item-decode">UNSCHEDULED 10.2</td></tr><tr class="tableroweven"><td>WEEK 20</td><td class="codelist-item-decode">WEEK 20</td></tr><tr class="tablerowodd"><td>WEEK 22 (T)</td><td class="codelist-item-decode">WEEK 22 (T)</td></tr><tr class="tableroweven"><td>UNSCHEDULED 11.2</td><td class="codelist-item-decode">UNSCHEDULED 11.2</td></tr><tr class="tablerowodd"><td>WEEK 24</td><td class="codelist-item-decode">WEEK 24</td></tr><tr class="tableroweven"><td>UNSCHEDULED 12.1</td><td class="codelist-item-decode">UNSCHEDULED 12.1</td></tr><tr class="tablerowodd"><td>WEEK 26</td><td class="codelist-item-decode">WEEK 26</td></tr><tr class="tableroweven"><td>UNSCHEDULED 13.1</td><td class="codelist-item-decode">UNSCHEDULED 13.1</td></tr><tr class="tablerowodd"><td>AE FOLLOW-UP</td><td class="codelist-item-decode">AE FOLLOW-UP</td></tr><tr class="tableroweven"><td>RETRIEVAL</td><td class="codelist-item-decode">RETRIEVAL</td></tr><tr class="tablerowodd"><td>Rash followup</td><td class="codelist-item-decode">Rash followup</td></tr></tbody></table></div><div class="codelist" id="CL.CL.VISITNUM"><div class="codelist-caption">VISITNUM</div><table summary="Controlled Term - VISITNUM"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>1</td><td class="codelist-item-decode">SCREENING 1</td></tr><tr class="tableroweven"><td>1.1</td><td class="codelist-item-decode">UNSCHEDULED 1.1</td></tr><tr class="tablerowodd"><td>1.2</td><td class="codelist-item-decode">UNSCHEDULED 1.2</td></tr><tr class="tableroweven"><td>1.3</td><td class="codelist-item-decode">UNSCHEDULED 1.3</td></tr><tr class="tablerowodd"><td>2</td><td class="codelist-item-decode">SCREENING 2</td></tr><tr class="tableroweven"><td>3</td><td class="codelist-item-decode">BASELINE</td></tr><tr class="tablerowodd"><td>3.1</td><td class="codelist-item-decode">UNSCHEDULED 3.1</td></tr><tr class="tableroweven"><td>3.5</td><td class="codelist-item-decode">AMBUL ECG PLACEMENT</td></tr><tr class="tablerowodd"><td>4</td><td class="codelist-item-decode">WEEK 2</td></tr><tr class="tableroweven"><td>4.1</td><td class="codelist-item-decode">UNSCHEDULED 4.1</td></tr><tr class="tablerowodd"><td>4.2</td><td class="codelist-item-decode">UNSCHEDULED 4.2</td></tr><tr class="tableroweven"><td>5</td><td class="codelist-item-decode">WEEK 4</td></tr><tr class="tablerowodd"><td>5.1</td><td class="codelist-item-decode">UNSCHEDULED 5.1</td></tr><tr class="tableroweven"><td>6</td><td class="codelist-item-decode">AMBUL ECG REMOVAL</td></tr><tr class="tablerowodd"><td>6.1</td><td class="codelist-item-decode">UNSCHEDULED 6.1</td></tr><tr class="tableroweven"><td>7</td><td class="codelist-item-decode">WEEK 6</td></tr><tr class="tablerowodd"><td>7.1</td><td class="codelist-item-decode">UNSCHEDULED 7.1</td></tr><tr class="tableroweven"><td>8</td><td class="codelist-item-decode">WEEK 8</td></tr><tr class="tablerowodd"><td>8.1</td><td class="codelist-item-decode">WEEK 10 (T)</td></tr><tr class="tableroweven"><td>8.2</td><td class="codelist-item-decode">UNSCHEDULED 8.2</td></tr><tr class="tablerowodd"><td>9</td><td class="codelist-item-decode">WEEK 12</td></tr><tr class="tableroweven"><td>9.1</td><td class="codelist-item-decode">WEEK 14 (T)</td></tr><tr class="tablerowodd"><td>9.2</td><td class="codelist-item-decode">UNSCHEDULED 9.2</td></tr><tr class="tableroweven"><td>9.3</td><td class="codelist-item-decode">UNSCHEDULED 9.3</td></tr><tr class="tablerowodd"><td>10</td><td class="codelist-item-decode">WEEK 16</td></tr><tr class="tableroweven"><td>10.1</td><td class="codelist-item-decode">WEEK 18 (T)</td></tr><tr class="tablerowodd"><td>10.2</td><td class="codelist-item-decode">UNSCHEDULED 10.2</td></tr><tr class="tableroweven"><td>11</td><td class="codelist-item-decode">WEEK 20</td></tr><tr class="tablerowodd"><td>11.1</td><td class="codelist-item-decode">WEEK 22 (T)</td></tr><tr class="tableroweven"><td>11.2</td><td class="codelist-item-decode">UNSCHEDULED 11.2</td></tr><tr class="tablerowodd"><td>12</td><td class="codelist-item-decode">WEEK 24</td></tr><tr class="tableroweven"><td>12.1</td><td class="codelist-item-decode">UNSCHEDULED 12.1</td></tr><tr class="tablerowodd"><td>13</td><td class="codelist-item-decode">WEEK 26</td></tr><tr class="tableroweven"><td>13.1</td><td class="codelist-item-decode">UNSCHEDULED 13.1</td></tr><tr class="tablerowodd"><td>101</td><td class="codelist-item-decode">AE FOLLOW-UP</td></tr><tr class="tableroweven"><td>201</td><td class="codelist-item-decode">RETRIEVAL</td></tr><tr class="tablerowodd"><td>501</td><td class="codelist-item-decode">Rash followup</td></tr></tbody></table></div><div class="codelist" id="CL.CL.Y_BLANK"><div class="codelist-caption">Y_BLANK</div><table summary="Controlled Term - Y_BLANK"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>Y</td><td class="codelist-item-decode">Yes</td></tr></tbody></table></div><div class="codelist" id="CL.CL.YN"><div class="codelist-caption">YN</div><table summary="Code List - YN"><tbody><tr class="header"><th scope="col">Permitted Value (Code)</th></tr><tr class="tablerowodd"><td>Y</td></tr><tr class="tableroweven"><td>N</td></tr></tbody></table></div><div class="codelist" id="CL.CL.YNN"><div class="codelist-caption">YNN</div><table summary="Controlled Term - YNN"><tbody><tr class="header"><th scope="col" class="codedvalue">Permitted Value (Code)</th><th scope="col">Display Value (Decode)</th></tr><tr class="tablerowodd"><td>0</td><td class="codelist-item-decode">No</td></tr><tr class="tableroweven"><td>1</td><td class="codelist-item-decode">Yes</td></tr></tbody></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br></div><a id="externaldictionary"></a><h1 class="invisible">External Dictionaries</h1><div class="containerbox"><table summary="External Dictionaries (MedDra, WHODRUG, ...)"><caption class="header">External Dictionaries</caption><tbody><tr class="header"><th scope="col">Reference Name</th><th scope="col">External Dictionary</th><th scope="col">Dictionary Version</th></tr><tr id="CL.CL.AEDICT" class="tablerowodd"><td>ADVERSE EVENT DICTIONARY</td><td>MedDRA</td><td>8.0</td></tr></tbody></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br><a id="compmethod"></a><div class="containerbox"><h1 class="invisible">Methods</h1><table summary="Methods"><caption class="header">Methods</caption><tbody><tr class="header"><th scope="col">Method</th><th scope="col">Type</th><th scope="col">Description</th></tr><tr id="MT.MT.ADAE.ADURN" class="tablerowodd"><td>Algorithm to derive ADAE.ADURN</td><td>Computation</td><td><div class="method-code">ADURN=AENDT-ASTDT+1</div></td></tr><tr id="MT.MT.ADAE.ADURU" class="tableroweven"><td>Algorithm to derive ADAE.ADURU</td><td>Computation</td><td><div class="method-code">If ADURN is not missing then ADURU='DAY'</div></td></tr><tr id="MT.MT.ADAE.AEACN" class="tablerowodd"><td>Algorithm to derive ADAE.AEACN</td><td>Computation</td><td><div class="method-code">AE.AEACN</div></td></tr><tr id="MT.MT.ADAE.AEBODSYS" class="tableroweven"><td>Algorithm to derive ADAE.AEBODSYS</td><td>Computation</td><td><div class="method-code">AE.AEBODSYS</div></td></tr><tr id="MT.MT.ADAE.AEDECOD" class="tablerowodd"><td>Algorithm to derive ADAE.AEDECOD</td><td>Computation</td><td><div class="method-code">AE.AEDECOD</div></td></tr><tr id="MT.MT.ADAE.AEHLGT" class="tableroweven"><td>Algorithm to derive ADAE.AEHLGT</td><td>Computation</td><td><div class="method-code">AE.AEHLGT</div></td></tr><tr id="MT.MT.ADAE.AEHLGTCD" class="tablerowodd"><td>Algorithm to derive ADAE.AEHLGTCD</td><td>Computation</td><td><div class="method-code">AE.AEHLGTCD</div></td></tr><tr id="MT.MT.ADAE.AEHLT" class="tableroweven"><td>Algorithm to derive ADAE.AEHLT</td><td>Computation</td><td><div class="method-code">AE.AEHLT</div></td></tr><tr id="MT.MT.ADAE.AEHLTCD" class="tablerowodd"><td>Algorithm to derive ADAE.AEHLTCD</td><td>Computation</td><td><div class="method-code">AE.AEHLTCD</div></td></tr><tr id="MT.MT.ADAE.AELLT" class="tableroweven"><td>Algorithm to derive ADAE.AELLT</td><td>Computation</td><td><div class="method-code">AE.AELLT</div></td></tr><tr id="MT.MT.ADAE.AELLTCD" class="tablerowodd"><td>Algorithm to derive ADAE.AELLTCD</td><td>Computation</td><td><div class="method-code">AE.AELLTCD</div></td></tr><tr id="MT.MT.ADAE.AENDT" class="tableroweven"><td>Algorithm to derive ADAE.AENDT</td><td>Computation</td><td><div class="method-code">AE.AEENDTC, converted to a numeric SAS date</div></td></tr><tr id="MT.MT.ADAE.AENDY" class="tablerowodd"><td>Algorithm to derive ADAE.AENDY</td><td>Computation</td><td><div class="method-code">IF AENDT>=TRTSDT>MISSING then AENDY=AENDT-TRTSDT+1 Else if TRTSDT>AENDT>MISSING then AENDY=AENDT-TRTSDT</div></td></tr><tr id="MT.MT.ADAE.AEOUT" class="tableroweven"><td>Algorithm to derive ADAE.AEOUT</td><td>Computation</td><td><div class="method-code">AE.AEOUT</div></td></tr><tr id="MT.MT.ADAE.AEPTCD" class="tablerowodd"><td>Algorithm to derive ADAE.AEPTCD</td><td>Computation</td><td><div class="method-code">AE.AEPTCD</div></td></tr><tr id="MT.MT.ADAE.AEREL" class="tableroweven"><td>Algorithm to derive ADAE.AEREL</td><td>Computation</td><td><div class="method-code">AE.AEREL</div></td></tr><tr id="MT.MT.ADAE.AESCAN" class="tablerowodd"><td>Algorithm to derive ADAE.AESCAN</td><td>Computation</td><td><div class="method-code">AE.AESCAN</div></td></tr><tr id="MT.MT.ADAE.AESCONG" class="tableroweven"><td>Algorithm to derive ADAE.AESCONG</td><td>Computation</td><td><div class="method-code">AE.AESCONG</div></td></tr><tr id="MT.MT.ADAE.AESDISAB" class="tablerowodd"><td>Algorithm to derive ADAE.AESDISAB</td><td>Computation</td><td><div class="method-code">AE.AESDISAB</div></td></tr><tr id="MT.MT.ADAE.AESDTH" class="tableroweven"><td>Algorithm to derive ADAE.AESDTH</td><td>Computation</td><td><div class="method-code">AE.AESDTH</div></td></tr><tr id="MT.MT.ADAE.AESEQ" class="tablerowodd"><td>Algorithm to derive ADAE.AESEQ</td><td>Computation</td><td><div class="method-code">AE.AESEQ</div></td></tr><tr id="MT.MT.ADAE.AESER" class="tableroweven"><td>Algorithm to derive ADAE.AESER</td><td>Computation</td><td><div class="method-code">AE.AESER</div></td></tr><tr id="MT.MT.ADAE.AESEV" class="tablerowodd"><td>Algorithm to derive ADAE.AESEV</td><td>Computation</td><td><div class="method-code">AE.AESEV</div></td></tr><tr id="MT.MT.ADAE.AESHOSP" class="tableroweven"><td>Algorithm to derive ADAE.AESHOSP</td><td>Computation</td><td><div class="method-code">AE.AESHOSP</div></td></tr><tr id="MT.MT.ADAE.AESLIFE" class="tablerowodd"><td>Algorithm to derive ADAE.AESLIFE</td><td>Computation</td><td><div class="method-code">AE.AESLIFE</div></td></tr><tr id="MT.MT.ADAE.AESOC" class="tableroweven"><td>Algorithm to derive ADAE.AESOC</td><td>Computation</td><td><div class="method-code">AE.AESOC</div></td></tr><tr id="MT.MT.ADAE.AESOCCD" class="tablerowodd"><td>Algorithm to derive ADAE.AESOCCD</td><td>Computation</td><td><div class="method-code">AE.AESOCCD</div></td></tr><tr id="MT.MT.ADAE.AESOD" class="tableroweven"><td>Algorithm to derive ADAE.AESOD</td><td>Computation</td><td><div class="method-code">AE.AESOD</div></td></tr><tr id="MT.MT.ADAE.AETERM" class="tablerowodd"><td>Algorithm to derive ADAE.AETERM</td><td>Computation</td><td><div class="method-code">AE.AETERM</div></td></tr><tr id="MT.MT.ADAE.AGE" class="tableroweven"><td>Algorithm to derive ADAE.AGE</td><td>Computation</td><td><div class="method-code">ADSL.AGE</div></td></tr><tr id="MT.MT.ADAE.AGEGR1" class="tablerowodd"><td>Algorithm to derive ADAE.AGEGR1</td><td>Computation</td><td><div class="method-code">ADSL.AGEGR1</div></td></tr><tr id="MT.MT.ADAE.AGEGR1N" class="tableroweven"><td>Algorithm to derive ADAE.AGEGR1N</td><td>Computation</td><td><div class="method-code">ADSL.AGEGR1N</div></td></tr><tr id="MT.MT.ADAE.AOCC01FL" class="tablerowodd"><td>Algorithm to derive ADAE.AOCC01FL</td><td>Computation</td><td><div class="method-code">Subset to CQ01NAM='' and TRTEMFL='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC01FL=?Y?) within each Subject (Flag First Treatment Emergent Dermatological Event for Time to Event Analysis)</div></td></tr><tr id="MT.MT.ADAE.AOCC02FL" class="tableroweven"><td>Algorithm to derive ADAE.AOCC02FL</td><td>Computation</td><td><div class="method-code">Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC02FL=?Y?) within each Subject</div></td></tr><tr id="MT.MT.ADAE.AOCC03FL" class="tablerowodd"><td>Algorithm to derive ADAE.AOCC03FL</td><td>Computation</td><td><div class="method-code">Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC03FL=?Y?) within each Subject and SOC</div></td></tr><tr id="MT.MT.ADAE.AOCC04FL" class="tableroweven"><td>Algorithm to derive ADAE.AOCC04FL</td><td>Computation</td><td><div class="method-code">Subset to TRTEMFL='Y' and AESER='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Preferred Term (AEDECOD), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCC04FL=?Y?) within each Subject, SOC, and PT</div></td></tr><tr id="MT.MT.ADAE.AOCCFL" class="tablerowodd"><td>Algorithm to derive ADAE.AOCCFL</td><td>Computation</td><td><div class="method-code">Subset to TRTEMFL='Y' and sort by Subject (USUBJID), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCFL=?Y?) within each Subject</div></td></tr><tr id="MT.MT.ADAE.AOCCPFL" class="tableroweven"><td>Algorithm to derive ADAE.AOCCPFL</td><td>Computation</td><td><div class="method-code">Subset to TRTEMFL='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Preferred Term (AEDECOD), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCPFL=?Y?) within each Subject, SOC, and PT</div></td></tr><tr id="MT.MT.ADAE.AOCCSFL" class="tablerowodd"><td>Algorithm to derive ADAE.AOCCSFL</td><td>Computation</td><td><div class="method-code">Subset to TRTEMFL='Y' and sort by Subject (USUBJID), System Organ Class (AEBODSYS), Start Date (ASTDT), and Sequence Number (AESEQ) and flag the first record (set AOCCSFL=?Y?) within each Subject and SOC</div></td></tr><tr id="MT.MT.ADAE.ASTDT" class="tableroweven"><td>Algorithm to derive ADAE.ASTDT</td><td>Computation</td><td><div class="method-code">AE.AESTDTC, converted to a numeric SAS date. Some events with partial dates are imputed in a conservative manner. If the day component is missing, a value of '01' is used. If both the month and day are missing no imputation is performed as these dates clearly indicate a start prior to the beginning of treatment. There are no events with completely missing start dates.</div></td></tr><tr id="MT.MT.ADAE.ASTDTF" class="tablerowodd"><td>Algorithm to derive ADAE.ASTDTF</td><td>Computation</td><td><div class="method-code">ASTDTF='D' if the day value within the character date is imputed. Note that only day values needed to be imputed for this study.</div></td></tr><tr id="MT.MT.ADAE.ASTDY" class="tableroweven"><td>Algorithm to derive ADAE.ASTDY</td><td>Computation</td><td><div class="method-code">IF ASTDT>=TRTSDT>MISSING then ASTDY=ASTDT-TRTSDT+1 Else if TRTSDT>ASTDT>MISSING then ASTDY=ASTDT-TRTSDT</div></td></tr><tr id="MT.MT.ADAE.CQ01NAM" class="tablerowodd"><td>Algorithm to derive ADAE.CQ01NAM</td><td>Computation</td><td><div class="method-code">If AEDECOD contains any of the character strings of ('APPLICATION', 'DERMATITIS', 'ERYTHEMA', 'BLISTER') OR if AEBODSYS='SKIN AND SUBC UTANEOUS TISSUE DISORDERS' but AEDECOD is not in ('COLD SWEAT', 'HYPERHIDROSIS', 'ALOPECIA') then CQ01NAM='DERMATOLOGIC EVENTS' Otherwise CQ01NAM=NULL</div></td></tr><tr id="MT.MT.ADAE.RACE" class="tableroweven"><td>Algorithm to derive ADAE.RACE</td><td>Computation</td><td><div class="method-code">ADSL.RACE</div></td></tr><tr id="MT.MT.ADAE.RACEN" class="tablerowodd"><td>Algorithm to derive ADAE.RACEN</td><td>Computation</td><td><div class="method-code">ADSL.RACEN</div></td></tr><tr id="MT.MT.ADAE.SAFFL" class="tableroweven"><td>Algorithm to derive ADAE.SAFFL</td><td>Computation</td><td><div class="method-code">ADSL.SAFFL</div></td></tr><tr id="MT.MT.ADAE.SEX" class="tablerowodd"><td>Algorithm to derive ADAE.SEX</td><td>Computation</td><td><div class="method-code">ADSL.SEX</div></td></tr><tr id="MT.MT.ADAE.SITEID" class="tableroweven"><td>Algorithm to derive ADAE.SITEID</td><td>Computation</td><td><div class="method-code">ADSL.SITEID</div></td></tr><tr id="MT.MT.ADAE.STUDYID" class="tablerowodd"><td>Algorithm to derive ADAE.STUDYID</td><td>Computation</td><td><div class="method-code">ADSL.STUDYID</div></td></tr><tr id="MT.MT.ADAE.TRTA" class="tableroweven"><td>Algorithm to derive ADAE.TRTA</td><td>Computation</td><td><div class="method-code">ADSL.TRT01A</div></td></tr><tr id="MT.MT.ADAE.TRTAN" class="tablerowodd"><td>Algorithm to derive ADAE.TRTAN</td><td>Computation</td><td><div class="method-code">ADSL.TRT01AN</div></td></tr><tr id="MT.MT.ADAE.TRTEDT" class="tableroweven"><td>Algorithm to derive ADAE.TRTEDT</td><td>Computation</td><td><div class="method-code">ADSL.TRTEDT</div></td></tr><tr id="MT.MT.ADAE.TRTEMFL" class="tablerowodd"><td>Algorithm to derive ADAE.TRTEMFL</td><td>Computation</td><td><div class="method-code">If ASTDT >= TRTSDT > . then TRTEMFL='Y'. Otherwise TRTEMFL='N'</div></td></tr><tr id="MT.MT.ADAE.TRTSDT" class="tableroweven"><td>Algorithm to derive ADAE.TRTSDT</td><td>Computation</td><td><div class="method-code">ADSL.TRTSDT</div></td></tr><tr id="MT.MT.ADAE.USUBJID" class="tablerowodd"><td>Algorithm to derive ADAE.USUBJID</td><td>Computation</td><td><div class="method-code">ADSL.USUBJID</div></td></tr><tr id="MT.MT.ADLBC.A1HI" class="tableroweven"><td>Algorithm to derive ADLBC.A1HI</td><td>Computation</td><td><div class="method-code">LB.LBSTNRHI</div></td></tr><tr id="MT.MT.ADLBC.A1LO" class="tablerowodd"><td>Algorithm to derive ADLBC.A1LO</td><td>Computation</td><td><div class="method-code">LB.LBSTNRLO</div></td></tr><tr id="MT.MT.ADLBC.ABLFL" class="tableroweven"><td>Algorithm to derive ADLBC.ABLFL</td><td>Computation</td><td><div class="method-code">Y if VISITNUM=1, null otherwise</div></td></tr><tr id="MT.MT.ADLBC.ADT" class="tablerowodd"><td>Algorithm to derive ADLBC.ADT</td><td>Computation</td><td><div class="method-code">LB.LBDTC converted to SAS date</div></td></tr><tr id="MT.MT.ADLBC.ADY" class="tableroweven"><td>Algorithm to derive ADLBC.ADY</td><td>Computation</td><td><div class="method-code">LB.LBDY</div></td></tr><tr id="MT.MT.ADLBC.AENTMTFL" class="tablerowodd"><td>Algorithm to derive ADLBC.AENTMTFL</td><td>Computation</td><td><div class="method-code">Last observed value for this lab parameter during treatment phase: 'Y' if VISITNUM=12, if subject discontinues prior to VISIT 12, then this variable is set to 'Y' if this is the last assessment of this analyte for the subject</div></td></tr><tr id="MT.MT.ADLBC.AGE" class="tableroweven"><td>Algorithm to derive ADLBC.AGE</td><td>Computation</td><td><div class="method-code">ADSL.AGE</div></td></tr><tr id="MT.MT.ADLBC.AGEGR1" class="tablerowodd"><td>Algorithm to derive ADLBC.AGEGR1</td><td>Computation</td><td><div class="method-code">ADSL.AGEGR1</div></td></tr><tr id="MT.MT.ADLBC.AGEGR1N" class="tableroweven"><td>Algorithm to derive ADLBC.AGEGR1N</td><td>Computation</td><td><div class="method-code">ADSL.AGEGR1N</div></td></tr><tr id="MT.MT.ADLBC.ALBTRVAL" class="tablerowodd"><td>Algorithm to derive ADLBC.ALBTRVAL</td><td>Computation</td><td><div class="method-code">Maximum of [LBSTRESN-(1.5*ULN)] and [(.5*LLN) - LBSTRESN]</div></td></tr><tr id="MT.MT.ADLBC.ANL01FL" class="tableroweven"><td>Algorithm to derive ADLBC.ANL01FL</td><td>Computation</td><td><div class="method-code">LB.LBSTNRHI</div></td></tr><tr id="MT.MT.ADLBC.ANRIND" class="tablerowodd"><td>Algorithm to derive ADLBC.ANRIND</td><td>Computation</td><td><div class="method-code">LB.LBSTNRHI</div></td></tr><tr id="MT.MT.ADLBC.AVAL" class="tableroweven"><td>Algorithm to derive ADLBC.AVAL</td><td>Computation</td><td><div class="method-code">LB.LBSTNRHI</div></td></tr><tr id="MT.MT.ADLBC.AVISIT" class="tablerowodd"><td>Algorithm to derive ADLBC.AVISIT</td><td>Computation</td><td><div class="method-code">Analysis Visit</div></td></tr><tr id="MT.MT.ADLBC.AVISITN" class="tableroweven"><td>Algorithm to derive ADLBC.AVISITN</td><td>Computation</td><td><div class="method-code">Numeric code for AVISIT</div></td></tr><tr id="MT.MT.ADLBC.BASE" class="tablerowodd"><td>Algorithm to derive ADLBC.BASE</td><td>Computation</td><td><div class="method-code">LB.LBSTNRHI</div></td></tr><tr id="MT.MT.ADLBC.BNRIND" class="tableroweven"><td>Algorithm to derive ADLBC.BNRIND</td><td>Computation</td><td><div class="method-code">LB.LBSTNRHI</div></td></tr><tr id="MT.MT.ADLBC.BR2A1HI" class="tablerowodd"><td>Algorithm to derive ADLBC.BR2A1HI</td><td>Computation</td><td><div class="method-code">AVAL / A1LO at baseline</div></td></tr><tr id="MT.MT.ADLBC.BR2A1LO" class="tableroweven"><td>Algorithm to derive ADLBC.BR2A1LO</td><td>Computation</td><td><div class="method-code">AVAL / A1HI at baseline</div></td></tr><tr id="MT.MT.ADLBC.CHG" class="tablerowodd"><td>Algorithm to derive ADLBC.CHG</td><td>Computation</td><td><div class="method-code">LB.LBSTNRHI</div></td></tr><tr id="MT.MT.ADLBC.COMP24FL" class="tableroweven"><td>Algorithm to derive ADLBC.COMP24FL</td><td>Computation</td><td><div class="method-code">ADSL.COMP24FL</div></td></tr><tr id="MT.MT.ADLBC.DSRAEFL" class="tablerowodd"><td>Algorithm to derive ADLBC.DSRAEFL</td><td>Computation</td><td><div class="method-code">ADSL.DSRAEFL</div></td></tr><tr id="MT.MT.ADLBC.LBNRIND" class="tableroweven"><td>Algorithm to derive ADLBC.LBNRIND</td><td>Computation</td><td><div class="method-code">LB.LBNRIND</div></td></tr><tr id="MT.MT.ADLBC.LBSEQ" class="tablerowodd"><td>Algorithm to derive ADLBC.LBSEQ</td><td>Computation</td><td><div class="method-code">LB.LBSEQ</div></td></tr><tr id="MT.MT.ADLBC.LBSTRESN" class="tableroweven"><td>Algorithm to derive ADLBC.LBSTRESN</td><td>Computation</td><td><div class="method-code">LB.LBSTRESN</div></td></tr><tr id="MT.MT.ADLBC.PARAM" class="tablerowodd"><td>Algorithm to derive ADLBC.PARAM</td><td>Computation</td><td><div class="method-code">For PARAMN<100: same as LB.LBTEST concatenated with LB.LBSTRESU. For PARAMN>100: LB.LBTEST concatenated with LB.LBSTRESU concatenated with " change from previous visit, relative to normal range"</div></td></tr><tr id="MT.MT.ADLBC.PARAMCD" class="tableroweven"><td>Algorithm to derive ADLBC.PARAMCD</td><td>Computation</td><td><div class="method-code">For PARAMN<100: same as LBTESTCD, For PARAMN>100: _ + LBTESTCD</div></td></tr><tr id="MT.MT.ADLBC.PARAMN" class="tablerowodd"><td>Algorithm to derive ADLBC.PARAMN</td><td>Computation</td><td><div class="method-code">Numeric code for Parameter</div></td></tr><tr id="MT.MT.ADLBC.PARCAT1" class="tableroweven"><td>Algorithm to derive ADLBC.PARCAT1</td><td>Computation</td><td><div class="method-code">harcoded to 'CHEM'</div></td></tr><tr id="MT.MT.ADLBC.R2A1HI" class="tablerowodd"><td>Algorithm to derive ADLBC.R2A1HI</td><td>Computation</td><td><div class="method-code">AVAL / A1LO</div></td></tr><tr id="MT.MT.ADLBC.R2A1LO" class="tableroweven"><td>Algorithm to derive ADLBC.R2A1LO</td><td>Computation</td><td><div class="method-code">AVAL / A1HI</div></td></tr><tr id="MT.MT.ADLBC.RACE" class="tablerowodd"><td>Algorithm to derive ADLBC.RACE</td><td>Computation</td><td><div class="method-code">ADSL.RACE</div></td></tr><tr id="MT.MT.ADLBC.RACEN" class="tableroweven"><td>Algorithm to derive ADLBC.RACEN</td><td>Computation</td><td><div class="method-code">ADSL.RACEN</div></td></tr><tr id="MT.MT.ADLBC.SAFFL" class="tablerowodd"><td>Algorithm to derive ADLBC.SAFFL</td><td>Computation</td><td><div class="method-code">ADSL.SAFFL</div></td></tr><tr id="MT.MT.ADLBC.SEX" class="tableroweven"><td>Algorithm to derive ADLBC.SEX</td><td>Computation</td><td><div class="method-code">ADSL.SEX</div></td></tr><tr id="MT.MT.ADLBC.STUDYID" class="tablerowodd"><td>Algorithm to derive ADLBC.STUDYID</td><td>Computation</td><td><div class="method-code">ADSL.STUDYID</div></td></tr><tr id="MT.MT.ADLBC.SUBJID" class="tableroweven"><td>Algorithm to derive ADLBC.SUBJID</td><td>Computation</td><td><div class="method-code">ADSL.SUBJID</div></td></tr><tr id="MT.MT.ADLBC.TRTA" class="tablerowodd"><td>Algorithm to derive ADLBC.TRTA</td><td>Computation</td><td><div class="method-code">ADSL.TRT01A</div></td></tr><tr id="MT.MT.ADLBC.TRTAN" class="tableroweven"><td>Algorithm to derive ADLBC.TRTAN</td><td>Computation</td><td><div class="method-code">ADSL.TRT01AN</div></td></tr><tr id="MT.MT.ADLBC.TRTEDT" class="tablerowodd"><td>Algorithm to derive ADLBC.TRTEDT</td><td>Computation</td><td><div class="method-code">ADSL.TRTEDT</div></td></tr><tr id="MT.MT.ADLBC.TRTP" class="tableroweven"><td>Algorithm to derive ADLBC.TRTP</td><td>Computation</td><td><div class="method-code">ADSL.TRT01P</div></td></tr><tr id="MT.MT.ADLBC.TRTPN" class="tablerowodd"><td>Algorithm to derive ADLBC.TRTPN</td><td>Computation</td><td><div class="method-code">ADSL.TRT01PN</div></td></tr><tr id="MT.MT.ADLBC.TRTSDT" class="tableroweven"><td>Algorithm to derive ADLBC.TRTSDT</td><td>Computation</td><td><div class="method-code">ADSL.TRTSDT</div></td></tr><tr id="MT.MT.ADLBC.USUBJID" class="tablerowodd"><td>Algorithm to derive ADLBC.USUBJID</td><td>Computation</td><td><div class="method-code">ADSL.USUBJID</div></td></tr><tr id="MT.MT.ADLBC.VISIT" class="tableroweven"><td>Algorithm to derive ADLBC.VISIT</td><td>Computation</td><td><div class="method-code">LB.VISIT</div></td></tr><tr id="MT.MT.ADLBC.VISITNUM" class="tablerowodd"><td>Algorithm to derive ADLBC.VISITNUM</td><td>Computation</td><td><div class="method-code">LB.VISITNUM</div></td></tr><tr id="MT.MT.ADLBH.A1HI" class="tableroweven"><td>Algorithm to derive ADLBH.A1HI</td><td>Computation</td><td><div class="method-code">LB.LBSTNRHI</div></td></tr><tr id="MT.MT.ADLBH.A1LO" class="tablerowodd"><td>Algorithm to derive ADLBH.A1LO</td><td>Computation</td><td><div class="method-code">LB.VISITNUM</div></td></tr><tr id="MT.MT.ADLBH.ABLFL" class="tableroweven"><td>Algorithm to derive ADLBH.ABLFL</td><td>Computation</td><td><div class="method-code">LB.VISITNUM</div></td></tr><tr id="MT.MT.ADLBH.ADT" class="tablerowodd"><td>Algorithm to derive ADLBH.ADT</td><td>Computation</td><td><div class="method-code">LB.LBDTC converted to SAS date</div></td></tr><tr id="MT.MT.ADLBH.ADY" class="tableroweven"><td>Algorithm to derive ADLBH.ADY</td><td>Computation</td><td><div class="method-code">LB.LBDY</div></td></tr><tr id="MT.MT.ADLBH.AENTMTFL" class="tablerowodd"><td>Algorithm to derive ADLBH.AENTMTFL</td><td>Computation</td><td><div class="method-code">Last observed value for this lab test during treatment phase: 'Y' if VISITNUM=12, if subject discontinues prior to VISIT 12, then this variable is set to 'Y' if this is the last assessment of this analyte for the subject</div></td></tr><tr id="MT.MT.ADLBH.AGE" class="tableroweven"><td>Algorithm to derive ADLBH.AGE</td><td>Computation</td><td><div class="method-code">ADSL.AGE</div></td></tr><tr id="MT.MT.ADLBH.AGEGR1" class="tablerowodd"><td>Algorithm to derive ADLBH.AGEGR1</td><td>Computation</td><td><div class="method-code">ADSL.AGEGR1</div></td></tr><tr id="MT.MT.ADLBH.AGEGR1N" class="tableroweven"><td>Algorithm to derive ADLBH.AGEGR1N</td><td>Computation</td><td><div class="method-code">ADSL.AGEGR1N</div></td></tr><tr id="MT.MT.ADLBH.ALBTRVAL" class="tablerowodd"><td>Algorithm to derive ADLBH.ALBTRVAL</td><td>Computation</td><td><div class="method-code">Maximum of [LBSTRESN-(1.5*ULN)] and [(.5*LLN) - LBSTRESN]</div></td></tr><tr id="MT.MT.ADLBH.ANL01FL" class="tableroweven"><td>Algorithm to derive ADLBH.ANL01FL</td><td>Computation</td><td><div class="method-code">LB.VISITNUM</div></td></tr><tr id="MT.MT.ADLBH.ANRIND" class="tablerowodd"><td>Algorithm to derive ADLBH.ANRIND</td><td>Computation</td><td><div class="method-code">LB.VISITNUM</div></td></tr><tr id="MT.MT.ADLBH.AVAL" class="tableroweven"><td>Algorithm to derive ADLBH.AVAL</td><td>Computation</td><td><div class="method-code">LB.VISITNUM</div></td></tr><tr id="MT.MT.ADLBH.AVISIT" class="tablerowodd"><td>Algorithm to derive ADLBH.AVISIT</td><td>Computation</td><td><div class="method-code">Analysis Visit</div></td></tr><tr id="MT.MT.ADLBH.AVISITN" class="tableroweven"><td>Algorithm to derive ADLBH.AVISITN</td><td>Computation</td><td><div class="method-code">Numeric code for AVISIT</div></td></tr><tr id="MT.MT.ADLBH.BASE" class="tablerowodd"><td>Algorithm to derive ADLBH.BASE</td><td>Computation</td><td><div class="method-code">LB.VISITNUM</div></td></tr><tr id="MT.MT.ADLBH.BNRIND" class="tableroweven"><td>Algorithm to derive ADLBH.BNRIND</td><td>Computation</td><td><div class="method-code">LB.VISITNUM</div></td></tr><tr id="MT.MT.ADLBH.BR2A1HI" class="tablerowodd"><td>Algorithm to derive ADLBH.BR2A1HI</td><td>Computation</td><td><div class="method-code">AVAL / A1LO at baseline</div></td></tr><tr id="MT.MT.ADLBH.BR2A1LO" class="tableroweven"><td>Algorithm to derive ADLBH.BR2A1LO</td><td>Computation</td><td><div class="method-code">AVAL / A1HI at baseline</div></td></tr><tr id="MT.MT.ADLBH.CHG" class="tablerowodd"><td>Algorithm to derive ADLBH.CHG</td><td>Computation</td><td><div class="method-code">LB.VISITNUM</div></td></tr><tr id="MT.MT.ADLBH.COMP24FL" class="tableroweven"><td>Algorithm to derive ADLBH.COMP24FL</td><td>Computation</td><td><div class="method-code">ADSL.COMP24FL</div></td></tr><tr id="MT.MT.ADLBH.DSRAEFL" class="tablerowodd"><td>Algorithm to derive ADLBH.DSRAEFL</td><td>Computation</td><td><div class="method-code">ADSL.DSRAEFL</div></td></tr><tr id="MT.MT.ADLBH.LBNRIND" class="tableroweven"><td>Algorithm to derive ADLBH.LBNRIND</td><td>Computation</td><td><div class="method-code">LB.LBNRIND</div></td></tr><tr id="MT.MT.ADLBH.LBSEQ" class="tablerowodd"><td>Algorithm to derive ADLBH.LBSEQ</td><td>Computation</td><td><div class="method-code">LB.LBSEQ</div></td></tr><tr id="MT.MT.ADLBH.LBSTRESN" class="tableroweven"><td>Algorithm to derive ADLBH.LBSTRESN</td><td>Computation</td><td><div class="method-code">LB.LBSTRESN</div></td></tr><tr id="MT.MT.ADLBH.PARAM" class="tablerowodd"><td>Algorithm to derive ADLBH.PARAM</td><td>Computation</td><td><div class="method-code">For PARAMN<100: same as LBTEST concatenated with LBSTRESU For PARAMN>100: LBTEST concatenated with LB.LBSTRESU concatenated with "change from previous visit, relative to normal range"</div></td></tr><tr id="MT.MT.ADLBH.PARAMCD" class="tableroweven"><td>Algorithm to derive ADLBH.PARAMCD</td><td>Computation</td><td><div class="method-code">For PARAMN<100: same as LBTESTCD For PARAMN>100: _ + LBTESTCD</div></td></tr><tr id="MT.MT.ADLBH.PARAMN" class="tablerowodd"><td>Algorithm to derive ADLBH.PARAMN</td><td>Computation</td><td><div class="method-code">Numeric code for Parameter</div></td></tr><tr id="MT.MT.ADLBH.PARCAT1" class="tableroweven"><td>Algorithm to derive ADLBH.PARCAT1</td><td>Computation</td><td><div class="method-code">harcoded to 'HEM'</div></td></tr><tr id="MT.MT.ADLBH.R2A1HI" class="tablerowodd"><td>Algorithm to derive ADLBH.R2A1HI</td><td>Computation</td><td><div class="method-code">AVAL / A1LO</div></td></tr><tr id="MT.MT.ADLBH.R2A1LO" class="tableroweven"><td>Algorithm to derive ADLBH.R2A1LO</td><td>Computation</td><td><div class="method-code">AVAL / A1HI</div></td></tr><tr id="MT.MT.ADLBH.RACE" class="tablerowodd"><td>Algorithm to derive ADLBH.RACE</td><td>Computation</td><td><div class="method-code">ADSL.RACE</div></td></tr><tr id="MT.MT.ADLBH.RACEN" class="tableroweven"><td>Algorithm to derive ADLBH.RACEN</td><td>Computation</td><td><div class="method-code">ADSL.RACEN</div></td></tr><tr id="MT.MT.ADLBH.SAFFL" class="tablerowodd"><td>Algorithm to derive ADLBH.SAFFL</td><td>Computation</td><td><div class="method-code">ADSL.SAFFL</div></td></tr><tr id="MT.MT.ADLBH.SEX" class="tableroweven"><td>Algorithm to derive ADLBH.SEX</td><td>Computation</td><td><div class="method-code">ADSL.SEX</div></td></tr><tr id="MT.MT.ADLBH.STUDYID" class="tablerowodd"><td>Algorithm to derive ADLBH.STUDYID</td><td>Computation</td><td><div class="method-code">ADSL.STUDYID</div></td></tr><tr id="MT.MT.ADLBH.SUBJID" class="tableroweven"><td>Algorithm to derive ADLBH.SUBJID</td><td>Computation</td><td><div class="method-code">ADSL.SUBJID</div></td></tr><tr id="MT.MT.ADLBH.TRTA" class="tablerowodd"><td>Algorithm to derive ADLBH.TRTA</td><td>Computation</td><td><div class="method-code">ADSL.TRT01A</div></td></tr><tr id="MT.MT.ADLBH.TRTAN" class="tableroweven"><td>Algorithm to derive ADLBH.TRTAN</td><td>Computation</td><td><div class="method-code">ADSL.TRT01AN</div></td></tr><tr id="MT.MT.ADLBH.TRTEDT" class="tablerowodd"><td>Algorithm to derive ADLBH.TRTEDT</td><td>Computation</td><td><div class="method-code">ADSL.TRTEDT</div></td></tr><tr id="MT.MT.ADLBH.TRTP" class="tableroweven"><td>Algorithm to derive ADLBH.TRTP</td><td>Computation</td><td><div class="method-code">ADSL.TRT01P</div></td></tr><tr id="MT.MT.ADLBH.TRTPN" class="tablerowodd"><td>Algorithm to derive ADLBH.TRTPN</td><td>Computation</td><td><div class="method-code">ADSL.TRT01PN</div></td></tr><tr id="MT.MT.ADLBH.TRTSDT" class="tableroweven"><td>Algorithm to derive ADLBH.TRTSDT</td><td>Computation</td><td><div class="method-code">ADSL.TRTSDT</div></td></tr><tr id="MT.MT.ADLBH.USUBJID" class="tablerowodd"><td>Algorithm to derive ADLBH.USUBJID</td><td>Computation</td><td><div class="method-code">ADSL.USUBJID</div></td></tr><tr id="MT.MT.ADLBH.VISIT" class="tableroweven"><td>Algorithm to derive ADLBH.VISIT</td><td>Computation</td><td><div class="method-code">LB.VISIT</div></td></tr><tr id="MT.MT.ADLBH.VISITNUM" class="tablerowodd"><td>Algorithm to derive ADLBH.VISITNUM</td><td>Computation</td><td><div class="method-code">LB.VISITNUM</div></td></tr><tr id="MT.MT.ADLBHY.A1HI" class="tableroweven"><td>Algorithm to derive ADLBHY.A1HI</td><td>Computation</td><td><div class="method-code">Numeric code for Parameter</div></td></tr><tr id="MT.MT.ADLBHY.A1LO" class="tablerowodd"><td>Algorithm to derive ADLBHY.A1LO</td><td>Computation</td><td><div class="method-code">Numeric code for Parameter</div></td></tr><tr id="MT.MT.ADLBHY.ABLFL" class="tableroweven"><td>Algorithm to derive ADLBHY.ABLFL</td><td>Computation</td><td><div class="method-code">ADLBC.ABLFL</div></td></tr><tr id="MT.MT.ADLBHY.ADT" class="tablerowodd"><td>Algorithm to derive ADLBHY.ADT</td><td>Computation</td><td><div class="method-code">LB.LBDTC converted to SAS date</div></td></tr><tr id="MT.MT.ADLBHY.ADY" class="tableroweven"><td>Algorithm to derive ADLBHY.ADY</td><td>Computation</td><td><div class="method-code">LB.LBDY</div></td></tr><tr id="MT.MT.ADLBHY.AGE" class="tablerowodd"><td>Algorithm to derive ADLBHY.AGE</td><td>Computation</td><td><div class="method-code">ADSL.AGE</div></td></tr><tr id="MT.MT.ADLBHY.AGEGR1" class="tableroweven"><td>Algorithm to derive ADLBHY.AGEGR1</td><td>Computation</td><td><div class="method-code">ADSL.AGEGR1</div></td></tr><tr id="MT.MT.ADLBHY.AGEGR1N" class="tablerowodd"><td>Algorithm to derive ADLBHY.AGEGR1N</td><td>Computation</td><td><div class="method-code">ADSL.AGEGR1N</div></td></tr><tr id="MT.MT.ADLBHY.AVAL" class="tableroweven"><td>Algorithm to derive ADLBHY.AVAL</td><td>Computation</td><td><div class="method-code">Numeric code for Parameter</div></td></tr><tr id="MT.MT.ADLBHY.AVISIT" class="tablerowodd"><td>Algorithm to derive ADLBHY.AVISIT</td><td>Computation</td><td><div class="method-code">Analysis Visit</div></td></tr><tr id="MT.MT.ADLBHY.AVISITN" class="tableroweven"><td>Algorithm to derive ADLBHY.AVISITN</td><td>Computation</td><td><div class="method-code">Numeric code for AVISIT</div></td></tr><tr id="MT.MT.ADLBHY.BASE" class="tablerowodd"><td>Algorithm to derive ADLBHY.BASE</td><td>Computation</td><td><div class="method-code">Numeric code for Parameter</div></td></tr><tr id="MT.MT.ADLBHY.BR2A1HI" class="tableroweven"><td>Algorithm to derive ADLBHY.BR2A1HI</td><td>Computation</td><td><div class="method-code">Numeric code for Parameter</div></td></tr><tr id="MT.MT.ADLBHY.BR2A1LO" class="tablerowodd"><td>Algorithm to derive ADLBHY.BR2A1LO</td><td>Computation</td><td><div class="method-code">Numeric code for Parameter</div></td></tr><tr id="MT.MT.ADLBHY.COMP24FL" class="tableroweven"><td>Algorithm to derive ADLBHY.COMP24FL</td><td>Computation</td><td><div class="method-code">ADSL.COMP24FL</div></td></tr><tr id="MT.MT.ADLBHY.CRIT1" class="tablerowodd"><td>Algorithm to derive ADLBHY.CRIT1</td><td>Computation</td><td><div class="method-code">Numeric code for Parameter</div></td></tr><tr id="MT.MT.ADLBHY.CRIT1FL" class="tableroweven"><td>Algorithm to derive ADLBHY.CRTI1FL</td><td>Computation</td><td><div class="method-code">Numeric code for Parameter</div></td></tr><tr id="MT.MT.ADLBHY.CRIT1FN" class="tablerowodd"><td>Algorithm to derive ADLBHY.CRIT1FN</td><td>Computation</td><td><div class="method-code">Numeric Code for CRIT1FL</div></td></tr><tr id="MT.MT.ADLBHY.DSRAEFL" class="tableroweven"><td>Algorithm to derive ADLBHY.DSRAEFL</td><td>Computation</td><td><div class="method-code">ADSL.DSRAEFL</div></td></tr><tr id="MT.MT.ADLBHY.PARAM" class="tablerowodd"><td>Algorithm to derive ADLBHY.PARAM</td><td>Computation</td><td><div class="method-code">same as LBTEST concatenated with LBSTRESU except for hylaw params</div></td></tr><tr id="MT.MT.ADLBHY.PARAMCD" class="tableroweven"><td>Algorithm to derive ADLBHY.PARAMCD</td><td>Computation</td><td><div class="method-code">Numeric code for Parameter</div></td></tr><tr id="MT.MT.ADLBHY.PARAMN" class="tablerowodd"><td>Algorithm to derive ADLBHY.PARAMN</td><td>Computation</td><td><div class="method-code">Numeric code for Parameter</div></td></tr><tr id="MT.MT.ADLBHY.PARAMTYP" class="tableroweven"><td>Algorithm to derive ADLBHY.PARAMTYP</td><td>Computation</td><td><div class="method-code">Numeric code for Parameter</div></td></tr><tr id="MT.MT.ADLBHY.PARCAT1" class="tablerowodd"><td>Algorithm to derive ADLBHY.PARCAT1</td><td>Computation</td><td><div class="method-code">Numeric code for Parameter</div></td></tr><tr id="MT.MT.ADLBHY.R2A1HI" class="tableroweven"><td>Algorithm to derive ADLBHY.R2A1HI</td><td>Computation</td><td><div class="method-code">Numeric code for Parameter</div></td></tr><tr id="MT.MT.ADLBHY.R2A1LO" class="tablerowodd"><td>Algorithm to derive ADLBHY.R2A1LO</td><td>Computation</td><td><div class="method-code">Numeric code for Parameter</div></td></tr><tr id="MT.MT.ADLBHY.RACE" class="tableroweven"><td>Algorithm to derive ADLBHY.RACE</td><td>Computation</td><td><div class="method-code">ADSL.RACE</div></td></tr><tr id="MT.MT.ADLBHY.RACEN" class="tablerowodd"><td>Algorithm to derive ADLBHY.RACEN</td><td>Computation</td><td><div class="method-code">ADSL.RACEN</div></td></tr><tr id="MT.MT.ADLBHY.SAFFL" class="tableroweven"><td>Algorithm to derive ADLBHY.SAFFL</td><td>Computation</td><td><div class="method-code">ADSL.SAFFL</div></td></tr><tr id="MT.MT.ADLBHY.SEX" class="tablerowodd"><td>Algorithm to derive ADLBHY.SEX</td><td>Computation</td><td><div class="method-code">ADSL.SEX</div></td></tr><tr id="MT.MT.ADLBHY.SHIFT1" class="tableroweven"><td>Algorithm to derive ADLBHY.SHIFT1</td><td>Computation</td><td><div class="method-code">Numeric code for Parameter</div></td></tr><tr id="MT.MT.ADLBHY.SHIFT1N" class="tablerowodd"><td>Algorithm to derive ADLBHY.SHIFT1N</td><td>Computation</td><td><div class="method-code">Numeric code for SHIFT1</div></td></tr><tr id="MT.MT.ADLBHY.STUDYID" class="tableroweven"><td>Algorithm to derive ADLBHY.STUDYID</td><td>Computation</td><td><div class="method-code">ADSL.STUDYID</div></td></tr><tr id="MT.MT.ADLBHY.SUBJID" class="tablerowodd"><td>Algorithm to derive ADLBHY.SUBJID</td><td>Computation</td><td><div class="method-code">ADSL.SUBJID</div></td></tr><tr id="MT.MT.ADLBHY.TRTA" class="tableroweven"><td>Algorithm to derive ADLBHY.TRTA</td><td>Computation</td><td><div class="method-code">ADSL.TRT01A</div></td></tr><tr id="MT.MT.ADLBHY.TRTAN" class="tablerowodd"><td>Algorithm to derive ADLBHY.TRTAN</td><td>Computation</td><td><div class="method-code">ADSL.TRT01AN</div></td></tr><tr id="MT.MT.ADLBHY.TRTEDT" class="tableroweven"><td>Algorithm to derive ADLBHY.TRTEDT</td><td>Computation</td><td><div class="method-code">ADSL.TRTEDT</div></td></tr><tr id="MT.MT.ADLBHY.TRTP" class="tablerowodd"><td>Algorithm to derive ADLBHY.TRTP</td><td>Computation</td><td><div class="method-code">ADSL.TRT01P</div></td></tr><tr id="MT.MT.ADLBHY.TRTPN" class="tableroweven"><td>Algorithm to derive ADLBHY.TRTPN</td><td>Computation</td><td><div class="method-code">ADSL.TRT01PN</div></td></tr><tr id="MT.MT.ADLBHY.TRTSDT" class="tablerowodd"><td>Algorithm to derive ADLBHY.TRTSDT</td><td>Computation</td><td><div class="method-code">ADSL.TRTSDT</div></td></tr><tr id="MT.MT.ADLBHY.USUBJID" class="tableroweven"><td>Algorithm to derive ADLBHY.USUBJID</td><td>Computation</td><td><div class="method-code">ADSL.USUBJID</div></td></tr><tr id="MT.MT.ADLBHY.VISIT" class="tablerowodd"><td>Algorithm to derive ADLBHY.VISIT</td><td>Computation</td><td><div class="method-code">LB.VISIT</div></td></tr><tr id="MT.MT.ADLBHY.VISITNUM" class="tableroweven"><td>Algorithm to derive ADLBHY.VISITNUM</td><td>Computation</td><td><div class="method-code">LB.VISITNUM</div></td></tr><tr id="MT.MT.ADSL.AGE" class="tablerowodd"><td>Algorithm to derive ADSL.AGE</td><td>Computation</td><td><div class="method-code">DM.AGE</div></td></tr><tr id="MT.MT.ADSL.AGEGR1" class="tableroweven"><td>Algorithm to derive ADSL.AGEGR1</td><td>Computation</td><td><div class="method-code">Character variable derived from ADSL.AGEGR1N</div></td></tr><tr id="MT.MT.ADSL.AGEGR1N" class="tablerowodd"><td>Algorithm to derive ADSL.AGEGR1N</td><td>Computation</td><td><div class="method-code">AGEGR1 = 1 if AGE <65. AGEGR1 = 2 if AGE 65-80. AGEGR1 = 3 if AGE >80.</div></td></tr><tr id="MT.MT.ADSL.AGEU" class="tableroweven"><td>Algorithm to derive ADSL.AGEU</td><td>Computation</td><td><div class="method-code">DM.AGEU</div></td></tr><tr id="MT.MT.ADSL.ARM" class="tablerowodd"><td>Algorithm to derive ADSL.ARM</td><td>Computation</td><td><div class="method-code">DM.ARM</div></td></tr><tr id="MT.MT.ADSL.AVGDD" class="tableroweven"><td>Algorithm to derive ADSL.AVGDD</td><td>Computation</td><td><div class="method-code">CUMDOSE/TRTDURD</div></td></tr><tr id="MT.MT.ADSL.BMIBL" class="tablerowodd"><td>Algorithm to derive ADSL.BMIBL</td><td>Computation</td><td><div class="method-code">WEIGHTBL / ((HEIGHTBL/100)**2)</div></td></tr><tr id="MT.MT.ADSL.BMIBLGR1" class="tableroweven"><td>Algorithm to derive ADSL.BMIBLGR1</td><td>Computation</td><td><div class="method-code">BMIBLGR1="<25" if . < BMIBL <25.
BMIBLGR1="25-<30" if 25 <=BMIBL <30.
BMIBLGR1=">=30"if BMIBL >=30.</div></td></tr><tr id="MT.MT.ADSL.COMP16FL" class="tablerowodd"><td>Algorithm to derive ADSL.COMP16FL</td><td>Computation</td><td><div class="method-code">Y if subject has a SV.VISITNUM=10 and ENDDT>=date of visit 10, N otherwise</div></td></tr><tr id="MT.MT.ADSL.COMP24FL" class="tableroweven"><td>Algorithm to derive ADSL.COMP24FL</td><td>Computation</td><td><div class="method-code">Y if subject has a SV.VISITNUM=12 and ENDDT>= date of visit 12 , N otherwise</div></td></tr><tr id="MT.MT.ADSL.COMP8FL" class="tablerowodd"><td>Algorithm to derive ADSL.COMP8FL</td><td>Computation</td><td><div class="method-code">Y if subject has a SV.VISITNUM=8 and ENDDT >= date of visit 8, N otherwise</div></td></tr><tr id="MT.MT.ADSL.CUMDOSE" class="tableroweven"><td>Algorithm to derive ADSL.CUMDOSE</td><td>Computation</td><td><div class="method-code">For ARMN=0 or 1: CUMDOSE=TRT01PN*TRTDUR. --- For ARMN=2: CUMDOSE will be based on 54mg per day for the # of days subj was in 1st dosing interval (i.e., visit4date-TRTSTDT+1 if 1st interval completed, TRTEDT-TRTSTDT+1 if subj discontinued <=visit 4 and > visit 3), 81mg per day for the # of days subj was in 2nd dosing interval (i.e., visit12date-visit4date if 2nd interval completed, TRTEDT-visit4date if subj discontinued <= visit 12 and > visit 4), and 54mg per day for the # of days subj was in 3rd dosing interval (i.e., TRTEDT - visit12date if subj continued after visit 12).</div></td></tr><tr id="MT.MT.ADSL.DCDECOD" class="tablerowodd"><td>Algorithm to derive ADSL.DCDECOD</td><td>Computation</td><td><div class="method-code">DS.DSDECOD where DSCAT='DISPOSITION EVENT'</div></td></tr><tr id="MT.MT.ADSL.DCREASCD" class="tableroweven"><td>Algorithm to derive ADSL.DCREASCD</td><td>Computation</td><td><div class="method-code">Grouping of DCDECOD values to support summarizing study completion status and reason for discontinuation</div></td></tr><tr id="MT.MT.ADSL.DISCONFL" class="tablerowodd"><td>Algorithm to derive ADSL.DISCONFL</td><td>Computation</td><td><div class="method-code">Y if DCREASCD ^= 'Completed'. Null otherwise</div></td></tr><tr id="MT.MT.ADSL.DISONSDT" class="tableroweven"><td>Algorithm to derive ADSL.DISONSDT</td><td>Computation</td><td><div class="method-code">MH.MHSTDTC where MHCAT='PRIMARY DIAGNOSIS' converted to SAS date</div></td></tr><tr id="MT.MT.ADSL.DSRAEFL" class="tablerowodd"><td>Algorithm to derive ADSL.DSRAEFL</td><td>Computation</td><td><div class="method-code">Y if DCREASCD='Adverse Event'. Null otherwise</div></td></tr><tr id="MT.MT.ADSL.DTHFL" class="tableroweven"><td>Algorithm to derive ADSL.DTHFL</td><td>Computation</td><td><div class="method-code">DM.DTHFL</div></td></tr><tr id="MT.MT.ADSL.DURDIS" class="tablerowodd"><td>Algorithm to derive ADSL.DURDIS</td><td>Computation</td><td><div class="method-code">number of months between VISIT1DT and DISONSET</div></td></tr><tr id="MT.MT.ADSL.DURDSGR1" class="tableroweven"><td>Algorithm to derive ADSL.DURDSGR1</td><td>Computation</td><td><div class="method-code">grouping DURDIS values as <12 and >=12</div></td></tr><tr id="MT.MT.ADSL.EDUCLVL" class="tablerowodd"><td>Algorithm to derive ADSL.EDUCLVL</td><td>Computation</td><td><div class="method-code">SC.SCSTRESN where SC.SCTESTCD=EDLEVEL</div></td></tr><tr id="MT.MT.ADSL.EFFFL" class="tableroweven"><td>Algorithm to derive ADSL.EFFFL</td><td>Computation</td><td><div class="method-code">Y if SAFFL='Y AND subject has at least one record in QS for ADAS-Cog with VISITNUM>3 AND at least one record in QS for CIBIC+ with VISITNUM>3, N otherwise</div></td></tr><tr id="MT.MT.ADSL.EOSSTT" class="tablerowodd"><td>Algorithm to derive ADSL.EOSSTT</td><td>Computation</td><td><div class="method-code">COMPLETED if ADSL.DCDECOD='COMPLETED'. DISCONTINUED if ADSL.DCDECOD not equal to COMPLETED.</div></td></tr><tr id="MT.MT.ADSL.ETHNIC" class="tableroweven"><td>Algorithm to derive ADSL.ETHNIC</td><td>Computation</td><td><div class="method-code">DM.ETHNIC</div></td></tr><tr id="MT.MT.ADSL.HEIGHTBL" class="tablerowodd"><td>Algorithm to derive ADSL.HEIGHTBL</td><td>Computation</td><td><div class="method-code">VSSTRESN when VS.VSTESTCD='HEIGHT' and VS.VISITNUM=1</div></td></tr><tr id="MT.MT.ADSL.ITTFL" class="tableroweven"><td>Algorithm to derive ADSL.ITTFL</td><td>Computation</td><td><div class="method-code">Y if ARMCD ne ' '. N otherwise</div></td></tr><tr id="MT.MT.ADSL.MMSETOT" class="tablerowodd"><td>Algorithm to derive ADSL.MMSETOT</td><td>Computation</td><td><div class="method-code">sum of QS.QSORRES values for the subject when QSCAT = MINI-MENTAL STATE</div></td></tr><tr id="MT.MT.ADSL.RACE" class="tableroweven"><td>Algorithm to derive ADSL.RACE</td><td>Computation</td><td><div class="method-code">DM.RACE</div></td></tr><tr id="MT.MT.ADSL.RACEN" class="tablerowodd"><td>Algorithm to derive ADSL.RACEN</td><td>Computation</td><td><div class="method-code">Numeric code for RACE</div></td></tr><tr id="MT.MT.ADSL.RFENDT" class="tableroweven"><td>Algorithm to derive ADSL.RFENDT</td><td>Computation</td><td><div class="method-code">RFENDTC converted to SAS date</div></td></tr><tr id="MT.MT.ADSL.RFENDTC" class="tablerowodd"><td>Algorithm to derive ADSL.RFENDTC</td><td>Computation</td><td><div class="method-code">DM.RFENDTC</div></td></tr><tr id="MT.MT.ADSL.RFSTDTC" class="tableroweven"><td>Algorithm to derive ADSL.RFSTDTC</td><td>Computation</td><td><div class="method-code">DM.RFSTDTC</div></td></tr><tr id="MT.MT.ADSL.SAFFL" class="tablerowodd"><td>Algorithm to derive ADSL.SAFFL</td><td>Computation</td><td><div class="method-code">Y if ITTFL='Y' and TRTSDT ne missing. N otherwise</div></td></tr><tr id="MT.MT.ADSL.SEX" class="tableroweven"><td>Algorithm to derive ADSL.SEX</td><td>Computation</td><td><div class="method-code">DM.SEX</div></td></tr><tr id="MT.MT.ADSL.SITEGR1" class="tablerowodd"><td>Algorithm to derive ADSL.SITEGR1</td><td>Computation</td><td><div class="method-code">refer to SAP, Section 7.1 - if not pooled then SITEGR1=SITEID. If pooled, SITEGR1 will be 900</div></td></tr><tr id="MT.MT.ADSL.SITEID" class="tableroweven"><td>Algorithm to derive ADSL.SITEID</td><td>Computation</td><td><div class="method-code">DM.SITEID</div></td></tr><tr id="MT.MT.ADSL.STUDYID" class="tablerowodd"><td>Algorithm to derive ADSL.STUDYID</td><td>Computation</td><td><div class="method-code">DM.STUDYID</div></td></tr><tr id="MT.MT.ADSL.SUBJID" class="tableroweven"><td>Algorithm to derive ADSL.SUBJID</td><td>Computation</td><td><div class="method-code">DM.SUBJID</div></td></tr><tr id="MT.MT.ADSL.TRT01A" class="tablerowodd"><td>Algorithm to derive ADSL.TRT01A</td><td>Computation</td><td><div class="method-code">TRT01A=TRT01P, i.e., no difference between actual and randomized treatment in this study.</div></td></tr><tr id="MT.MT.ADSL.TRT01AN" class="tableroweven"><td>Algorithm to derive ADSL.TRT01AN</td><td>Computation</td><td><div class="method-code">Numeric code for TRT01A which corresponds to the randomized dose</div></td></tr><tr id="MT.MT.ADSL.TRT01P" class="tablerowodd"><td>Algorithm to derive ADSL.TRT01P</td><td>Computation</td><td><div class="method-code">DM.ARM</div></td></tr><tr id="MT.MT.ADSL.TRT01PN" class="tableroweven"><td>Algorithm to derive ADSL.TRT01PN</td><td>Computation</td><td><div class="method-code">Numeric code for TRT01P which corresponds to the randomized dose</div></td></tr><tr id="MT.MT.ADSL.TRTDUR" class="tablerowodd"><td>Algorithm to derive ADSL.TRTDUR</td><td>Computation</td><td><div class="method-code">TRTEDT-TRTSDT+1</div></td></tr><tr id="MT.MT.ADSL.TRTEDT" class="tableroweven"><td>Algorithm to derive ADSL.TRTEDT</td><td>Computation</td><td><div class="method-code">The date of final dose (from the CRF) is EX.EXENDTC on the subject's last EX record. If the date of final dose is missing for the subject and the subject discontinued after visit 3, use the date of discontinuation as the date of last dose. Convert the date to a SAS date.</div></td></tr><tr id="MT.MT.ADSL.TRTSDT" class="tablerowodd"><td>Algorithm to derive ADSL.TRTSDT</td><td>Computation</td><td><div class="method-code">SV.SVSTDTC when SV.VISITNUM=3, converted to SAS date</div></td></tr><tr id="MT.MT.ADSL.USUBJID" class="tableroweven"><td>Algorithm to derive ADSL.USUBJID</td><td>Computation</td><td><div class="method-code">DM.USUBJID</div></td></tr><tr id="MT.MT.ADSL.VISIT1DT" class="tablerowodd"><td>Algorithm to derive ADSL.VISIT1DT</td><td>Computation</td><td><div class="method-code">SV.SVSTDTC when SV.VISITNUM=1, converted to SAS date</div></td></tr><tr id="MT.MT.ADSL.VISNUMEN" class="tableroweven"><td>Algorithm to derive ADSL.VISNUMEN</td><td>Computation</td><td><div class="method-code">if DS.VISITNUM=13 where DSTERM='PROTCOL COMPLETED' then VISNUMEN=12, otherwise VISNUMEN=DS.VISITNUM where DSTERM='PROTCOL COMPLETED'</div></td></tr><tr id="MT.MT.ADSL.WEIGHTBL" class="tablerowodd"><td>Algorithm to derive ADSL.WEIGHTBL</td><td>Computation</td><td><div class="method-code">VSSTRESN when VS.VSTESTCD='WEIGHT' and VS.VISITNUM=3</div></td></tr><tr id="MT.MT.ADTTE.ADT" class="tableroweven"><td>Algorithm to derive ADTTE.ADT</td><td>Computation</td><td><div class="method-code">if ADAE.ASTDT is not missing and occurred after TRTSDT then ADAE.ASTDT else convert ADSL.RFENDTC to a SAS numeric date</div></td></tr><tr id="MT.MT.ADTTE.AGE" class="tablerowodd"><td>Algorithm to derive ADTTE.AGE</td><td>Computation</td><td><div class="method-code">ADSL.AGE</div></td></tr><tr id="MT.MT.ADTTE.AGEGR1" class="tableroweven"><td>Algorithm to derive ADTTE.AGEGR1</td><td>Computation</td><td><div class="method-code">ADSL.AGEGR1</div></td></tr><tr id="MT.MT.ADTTE.AGEGR1N" class="tablerowodd"><td>Algorithm to derive ADTTE.AGEGR1N</td><td>Computation</td><td><div class="method-code">ADSL.AGEGR1N</div></td></tr><tr id="MT.MT.ADTTE.AVAL" class="tableroweven"><td>Algorithm to derive ADTTE.AVAL</td><td>Computation</td><td><div class="method-code">ADT-STARTDT+1</div></td></tr><tr id="MT.MT.ADTTE.CNSR" class="tablerowodd"><td>Algorithm to derive ADTTE.CNSR</td><td>Computation</td><td><div class="method-code">if ADAE.TRTEMFL ="Y" then CNSR=0, else CNSR=1</div></td></tr><tr id="MT.MT.ADTTE.EVNTDESC" class="tableroweven"><td>Algorithm to derive ADTTE.EVNTDESC</td><td>Computation</td><td><div class="method-code">if ADTTE.CNSR = 0 then "Dematologic Event Occured", else if ADTTE.CNSR =1 then "Study Completion Date"</div></td></tr><tr id="MT.MT.ADTTE.PARAM" class="tablerowodd"><td>Algorithm to derive ADTTE.PARAM</td><td>Computation</td><td><div class="method-code">PARAM="Time to First Dermatologic Event"</div></td></tr><tr id="MT.MT.ADTTE.PARAMCD" class="tableroweven"><td>Algorithm to derive ADTTE.PARAMCD</td><td>Computation</td><td><div class="method-code">PARAMCD="TTDE"</div></td></tr><tr id="MT.MT.ADTTE.RACE" class="tablerowodd"><td>Algorithm to derive ADTTE.RACE</td><td>Computation</td><td><div class="method-code">ADSL.RACE</div></td></tr><tr id="MT.MT.ADTTE.RACEN" class="tableroweven"><td>Algorithm to derive ADTTE.RACEN</td><td>Computation</td><td><div class="method-code">ADSL.RACEN</div></td></tr><tr id="MT.MT.ADTTE.SAFFL" class="tablerowodd"><td>Algorithm to derive ADTTE.SAFFL</td><td>Computation</td><td><div class="method-code">ADSL.SAFFL</div></td></tr><tr id="MT.MT.ADTTE.SEX" class="tableroweven"><td>Algorithm to derive ADTTE.SEX</td><td>Computation</td><td><div class="method-code">ADSL.SEX</div></td></tr><tr id="MT.MT.ADTTE.SITEID" class="tablerowodd"><td>Algorithm to derive ADTTE.SITEID</td><td>Computation</td><td><div class="method-code">ADSL.SITEID</div></td></tr><tr id="MT.MT.ADTTE.SRCDOM" class="tableroweven"><td>Algorithm to derive ADTTE.SRCDOM</td><td>Computation</td><td><div class="method-code">The Source domain referred to in order to populate ADT (either ADAE or ADSL)</div></td></tr><tr id="MT.MT.ADTTE.SRCSEQ" class="tablerowodd"><td>Algorithm to derive ADTTE.SRCSEQ</td><td>Computation</td><td><div class="method-code">The value of ADAE.AESEQ if SRCDOM=ADAE, otherwise null.</div></td></tr><tr id="MT.MT.ADTTE.SRCVAR" class="tableroweven"><td>Algorithm to derive ADTTE.SRCVAR</td><td>Computation</td><td><div class="method-code">The Source variable referred to in order to populate ADT (either ASTDT or RFENDT)</div></td></tr><tr id="MT.MT.ADTTE.STARTDT" class="tablerowodd"><td>Algorithm to derive ADTTE.STARTDT</td><td>Computation</td><td><div class="method-code">ADSL.RFSTDTC</div></td></tr><tr id="MT.MT.ADTTE.STUDYID" class="tableroweven"><td>Algorithm to derive ADTTE.STUDYID</td><td>Computation</td><td><div class="method-code">ADSL.STUDYID</div></td></tr><tr id="MT.MT.ADTTE.TRTA" class="tablerowodd"><td>Algorithm to derive ADTTE.TRTA</td><td>Computation</td><td><div class="method-code">ADSL.TRT01A</div></td></tr><tr id="MT.MT.ADTTE.TRTAN" class="tableroweven"><td>Algorithm to derive ADTTE.TRTAN</td><td>Computation</td><td><div class="method-code">ADSL.TRT01AN</div></td></tr><tr id="MT.MT.ADTTE.TRTDUR" class="tablerowodd"><td>Algorithm to derive ADTTE.TRTDUR</td><td>Computation</td><td><div class="method-code">ADSL.TRTDUR</div></td></tr><tr id="MT.MT.ADTTE.TRTEDT" class="tableroweven"><td>Algorithm to derive ADTTE.TRTEDT</td><td>Computation</td><td><div class="method-code">ADSL.TRTEDT</div></td></tr><tr id="MT.MT.ADTTE.TRTP" class="tablerowodd"><td>Algorithm to derive ADTTE.TRTP</td><td>Computation</td><td><div class="method-code">ADSL.TRT01P</div></td></tr><tr id="MT.MT.ADTTE.TRTSDT" class="tableroweven"><td>Algorithm to derive ADTTE.TRTSDT</td><td>Computation</td><td><div class="method-code">ADSL.TRTSDT</div></td></tr><tr id="MT.MT.ADTTE.USUBJID" class="tablerowodd"><td>Algorithm to derive ADTTE.USUBJID</td><td>Computation</td><td><div class="method-code">ADSL.USUBJID</div></td></tr><tr id="MT.MT.ADVS.ABLFL" class="tableroweven"><td>Algorithm to derive ADVS.ABLFL</td><td>Computation</td><td><div class="method-code">VS.VSBLFL</div></td></tr><tr id="MT.MT.ADVS.ADT" class="tablerowodd"><td>Algorithm to derive ADVS.ADT</td><td>Computation</td><td><div class="method-code">the date part of VS.VSDTC converted to a SAS date</div></td></tr><tr id="MT.MT.ADVS.ADY" class="tableroweven"><td>Algorithm to derive ADVS.ADY</td><td>Computation</td><td><div class="method-code">VS.VSDY</div></td></tr><tr id="MT.MT.ADVS.AGE" class="tablerowodd"><td>Algorithm to derive ADVS.AGE</td><td>Computation</td><td><div class="method-code">ADSL.AGE</div></td></tr><tr id="MT.MT.ADVS.AGEGR1" class="tableroweven"><td>Algorithm to derive ADVS.AGEGR1</td><td>Computation</td><td><div class="method-code">ADSL.AGEGR1</div></td></tr><tr id="MT.MT.ADVS.AGEGR1N" class="tablerowodd"><td>Algorithm to derive ADVS.AGEGR1N</td><td>Computation</td><td><div class="method-code">ADSL.AGEGR1N</div></td></tr><tr id="MT.MT.ADVS.ANL01FL" class="tableroweven"><td>Algorithm to derive ADVS.ANL01FL</td><td>Computation</td><td><div class="method-code">ANL01FL="Y" if the value is to be included in a per visit analysis. ANL01FL is missing for values from SDTM screening visits, unscheduled visits, and event related visits, e.g. "AMBUL ECG REMOVAL"</div></td></tr><tr id="MT.MT.ADVS.ATPT" class="tablerowodd"><td>Algorithm to derive ADVS.ATPT</td><td>Computation</td><td><div class="method-code">VS.VSTPT</div></td></tr><tr id="MT.MT.ADVS.ATPTN" class="tableroweven"><td>Algorithm to derive ADVS.ATPTN</td><td>Computation</td><td><div class="method-code">Numeric code for ATPT</div></td></tr><tr id="MT.MT.ADVS.AVAL" class="tablerowodd"><td>Algorithm to derive ADVS.AVAL</td><td>Computation</td><td><div class="method-code">VS.VSSTRESN</div></td></tr><tr id="MT.MT.ADVS.AVISIT" class="tableroweven"><td>Algorithm to derive ADVS.AVISIT</td><td>Computation</td><td><div class="method-code">Derived from VS.VISIT for values to be included in a per visit analysis. AVISIT is missing for values from SDTM screening visits, unscheduled visits, and event related visits, e.g. "AMBUL ECG REMOVAL", which are not included in a per visit analysis.</div></td></tr><tr id="MT.MT.ADVS.AVISITN" class="tablerowodd"><td>Algorithm to derive ADVS.AVISITN</td><td>Computation</td><td><div class="method-code">Numeric code for AVISIT</div></td></tr><tr id="MT.MT.ADVS.BASE" class="tableroweven"><td>Algorithm to derive ADVS.BASE</td><td>Computation</td><td><div class="method-code">VS.VSSTRESN where VSBLFL="Y"</div></td></tr><tr id="MT.MT.ADVS.BASETYPE" class="tablerowodd"><td>Algorithm to derive ADVS.BASETYPE</td><td>Computation</td><td><div class="method-code">VS.VSTPT</div></td></tr><tr id="MT.MT.ADVS.CHG" class="tableroweven"><td>Algorithm to derive ADVS.CHG</td><td>Computation</td><td><div class="method-code">AVAL-BASE</div></td></tr><tr id="MT.MT.ADVS.PARAM" class="tablerowodd"><td>Algorithm to derive ADVS.PARAM</td><td>Computation</td><td><div class="method-code">VS.VSBLFL</div></td></tr><tr id="MT.MT.ADVS.PARAMCD" class="tableroweven"><td>Algorithm to derive ADVS.PARAMCD</td><td>Computation</td><td><div class="method-code">VS.VSTESTCD</div></td></tr><tr id="MT.MT.ADVS.PARAMN" class="tablerowodd"><td>Algorithm to derive ADVS.PARAMN</td><td>Computation</td><td><div class="method-code">Numeric code for Parameter</div></td></tr><tr id="MT.MT.ADVS.PCHG" class="tableroweven"><td>Algorithm to derive ADVS.PCHG</td><td>Computation</td><td><div class="method-code">100* (CHG/BASE)</div></td></tr><tr id="MT.MT.ADVS.RACE" class="tablerowodd"><td>Algorithm to derive ADVS.RACE</td><td>Computation</td><td><div class="method-code">ADSL.RACE</div></td></tr><tr id="MT.MT.ADVS.RACEN" class="tableroweven"><td>Algorithm to derive ADVS.RACEN</td><td>Computation</td><td><div class="method-code">ADSL.RACEN</div></td></tr><tr id="MT.MT.ADVS.SAFFL" class="tablerowodd"><td>Algorithm to derive ADVS.SAFFL</td><td>Computation</td><td><div class="method-code">ADSL.SAFFL</div></td></tr><tr id="MT.MT.ADVS.SEX" class="tableroweven"><td>Algorithm to derive ADVS.SEX</td><td>Computation</td><td><div class="method-code">ADSL.SEX</div></td></tr><tr id="MT.MT.ADVS.SITEID" class="tablerowodd"><td>Algorithm to derive ADVS.SITEID</td><td>Computation</td><td><div class="method-code">ADSL.SITEID</div></td></tr><tr id="MT.MT.ADVS.STUDYID" class="tableroweven"><td>Algorithm to derive ADVS.STUDYID</td><td>Computation</td><td><div class="method-code">ADSL.STUDYID</div></td></tr><tr id="MT.MT.ADVS.TRTA" class="tablerowodd"><td>Algorithm to derive ADVS.TRTA</td><td>Computation</td><td><div class="method-code">ADSL.TRT01AN</div></td></tr><tr id="MT.MT.ADVS.TRTAN" class="tableroweven"><td>Algorithm to derive ADVS.TRTAN</td><td>Computation</td><td><div class="method-code">ADSL.TRT01AN</div></td></tr><tr id="MT.MT.ADVS.TRTEDT" class="tablerowodd"><td>Algorithm to derive ADVS.TRTEDT</td><td>Computation</td><td><div class="method-code">ADSL.TRTEDT</div></td></tr><tr id="MT.MT.ADVS.TRTP" class="tableroweven"><td>Algorithm to derive ADVS.TRTP</td><td>Computation</td><td><div class="method-code">ADSL.TRT01P</div></td></tr><tr id="MT.MT.ADVS.TRTPN" class="tablerowodd"><td>Algorithm to derive ADVS.TRTPN</td><td>Computation</td><td><div class="method-code">ADSL.TRT01PN</div></td></tr><tr id="MT.MT.ADVS.TRTSDT" class="tableroweven"><td>Algorithm to derive ADVS.TRTSDT</td><td>Computation</td><td><div class="method-code">ADSL.TRTSDT</div></td></tr><tr id="MT.MT.ADVS.USUBJID" class="tablerowodd"><td>Algorithm to derive ADVS.USUBJID</td><td>Computation</td><td><div class="method-code">ADSL.USUBJID</div></td></tr><tr id="MT.MT.ADVS.VISIT" class="tableroweven"><td>Algorithm to derive ADVS.VISIT</td><td>Computation</td><td><div class="method-code">VS.VISIT</div></td></tr><tr id="MT.MT.ADVS.VISITNUM" class="tablerowodd"><td>Algorithm to derive ADVS.VISITNUM</td><td>Computation</td><td><div class="method-code">VS.VISITNUM</div></td></tr><tr id="MT.MT.ADVS.VSSEQ" class="tableroweven"><td>Algorithm to derive ADVS.VSSEQ</td><td>Computation</td><td><div class="method-code">VS.VSSEQ</div></td></tr><tr id="MT.MT.ADADAS.AVISIT" class="tablerowodd"><td>Algorithm to derive ADADAS.AVISIT</td><td>Computation</td><td><div class="method-code">Derived based on windowing algorithm described in SAP, Section 8.2</div></td></tr><tr id="MT.MT.ADADAS.AVISITN" class="tableroweven"><td>Algorithm to derive ADADAS.AVISITN</td><td>Computation</td><td><div class="method-code">Numeric code for AVISIT</div></td></tr><tr id="MT.MT.ADADAS.ADY" class="tablerowodd"><td>Algorithm to derive ADADAS.ADY</td><td>Computation</td><td><div class="method-code">ADY = ADT - TRTSDT + 1, if ADT>=TRTSDT. ADY =
ADT - TRTSDT, if ADT<TRTSDT.</div></td></tr><tr id="MT.MT.ADADAS.ADT" class="tableroweven"><td>Algorithm to derive ADADAS.ADT</td><td>Computation</td><td><div class="method-code">SAS date from QS.QSDTC</div></td></tr><tr id="MT.MT.ADADAS.BASE" class="tablerowodd"><td>Algorithm to derive ADADAS.BASE</td><td>Computation</td><td><div class="method-code">QS.QSSTRESN when QS.QSBLFL=Y (QS.VISITNUM=3)</div></td></tr><tr id="MT.MT.ADADAS.CHG" class="tableroweven"><td>Algorithm to derive ADADAS.CHG</td><td>Computation</td><td><div class="method-code">AVAL - BASE</div></td></tr><tr id="MT.MT.ADADAS.PCHG" class="tablerowodd"><td>Algorithm to derive ADADAS.PCHG</td><td>Computation</td><td><div class="method-code">100* (CHG/BASE)</div></td></tr><tr id="MT.MT.ADADAS.ANL01FL" class="tableroweven"><td>Algorithm to derive ADADAS.ANL01FL</td><td>Computation</td><td><div class="method-code">If multiple visits fall into the same visit window, then the one closest to the target date is chosen for analysis. These are flagged with ANL01FL="Y".</div></td></tr><tr id="MT.MT.ADADAS.DTYPE" class="tablerowodd"><td>Algorithm to derive ADADAS.DTYPE</td><td>Computation</td><td><div class="method-code">Set to "LOCF" if a record is imputated when PARAMCD="ACTOT"; otherwise, set to missing</div></td></tr></tbody></table></div><p class="linktop">Go to the <a href="#main">top</a> of the Define-XML document</p><br></div></body></html><html>
<head>
<title>Title</title>
</head>
<body>
<p>This is an R HTML document. When you click the <b>Knit HTML</b> button a web page will be generated that includes both content as well as the output of any embedded R code chunks within the document. You can embed an R code chunk like this:</p>
<!--begin.rcode
summary(cars)
end.rcode-->
<p>You can also embed plots, for example:</p>
<!--begin.rcode fig.width=7, fig.height=6
plot(cars)
end.rcode-->
</body>
</html>