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Dataset wrap
Namers
Rowcaps
Rows 1-16:Show the symptom and area responses for the baseline visit.
Rows 17-29:Show the subscores and total scores for the baseline visit.
Rows 30-59:Show the subject was not evaluated on this instrument at visit 2. Since the reason for not completing the visit was collected, the date is included in RSDTC for when the visit was planned.
Dataset2
RowSTUDYIDDOMAINUSUBJIDRSSEQRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSSTRESNRSSTATRSREASNDRSLOBXFLVISITNUMRSDTC
1STUDYXRS2324-P00011PASI0201PASI0401PASI02PASI04-Head: Erythema/Redness
PASI V2EMASlight11

Y12015-05-15
2STUDYXRS2324-P00012PASI0202PASI0402PASI02PASI04-Head: Thickness/Induration
PASI V2EMANoneNo symptoms00

Y12015-05-15
3STUDYXRS2324-P00013PASI0203PASI0403PASI02PASI04-Head: Desquamation/Scaling
PASI V2EMANoneNo symptoms00

Y12015-05-15
4STUDYXRS2324-P00014PASI0204PASI0404PASI02PASI04-Head: Area Score
PASI V2EMA<10%11

Y12015-05-15
5STUDYXRS2324-P00015PASI0205PASI0405PASI02PASI04-Up Extrem: Erythema/Redness
PASI V2EMAMildModerate22

Y12015-05-15
6STUDYXRS2324-P00016PASI0206PASI0406PASI02PASI04-Up Extrem: Thickness/Induration
PASI V2EMASlight11

Y12015-05-15
7STUDYXRS2324-P00017PASI0207PASI0407PASI02PASI04-Up Extrem: Desquamation/Scaling
PASI V2EMAMildModerate22

Y12015-05-15
8STUDYXRS2324-P00018PASI0208PASI0408PASI02PASI04-Up Extrem: Area Score
PASI V2EMA30 - <50%49%33

Y12015-05-15
9STUDYXRS2324-P00019PASI0209PASI0409PASI02PASI04-Trunk: Erythema/Redness
PASI V2EMANoneNo symptoms00

Y12015-05-15
10STUDYXRS2324-P000110PASI0210PASI0410PASI02PASI04-Trunk: Thickness/Induration
PASI V2EMANoneNo symptoms00

Y12015-05-15
11STUDYXRS2324-P000111PASI0211PASI0411PASI02PASI04-Trunk: Desquamation/Scaling
PASI V2EMANoneNo symptoms00

Y12015-05-15
12STUDYXRS2324-P000112PASI0212PASI0412PASI02PASI04-Trunk: Area Score
PASI V20 (clear)0EMA< 10%110

Y12015-05-15
13STUDYXRS2324-P000113PASI0213PASI0413PASI02PASI04-Low Extrem: Erythema/Redness
PASI V2EMASlight11

Y12015-05-15
14STUDYXRS2324-P000114PASI0214PASI0414PASI02PASI04-Low Extrem: Thickness/Induration
PASI V2EMASlight11

Y12015-05-15
15STUDYXRS2324-P000115PASI0215PASI0415PASI02PASI04-Low Extrem: Desquamation/Scaling
PASI V2EMASlight11

Y12015-05-15
16STUDYXRS2324-P000116PASI0216PASI0416PASI02PASI04-Low Extrem: Area Score
PASI V2EMA10 - <30%29%22

Y12015-05-15
17STUDYXRS2324-P000117PASI0217PASI0417PASI02PASI04-Head: Sum of Symptom Scores
PASI V2EMA111

Y12015-05-15
18STUDYXRS2324-P000118PASI0218PASI0418PASI02PASI04-Head: Sum X Area
PASI V2EMA111

Y12015-05-15
19STUDYXRS2324-P000119PASI0219PASI0419PASI02PASI04-Head: Sum X Area X 0.1
PASI V2EMA0.10.10.1

Y12015-05-15
20STUDYXRS2324-P000120PASI0220PASI0420PASI02PASI04-Up Extrem: Sum of Symptom Scores
PASI V2EMA555

Y12015-05-15
21STUDYXRS2324-P000121PASI0221PASI0421PASI02PASI04-Up Extrem: Sum X Area
PASI V2EMA151515

Y12015-05-15
22STUDYXRS2324-P000122PASI0222PASI0422PASI02PASI04-Up Extrem: Sum X Area X 0.2
PASI V2EMA333

Y12015-05-15
23STUDYXRS2324-P000123PASI0223PASI0423PASI02PASI04-Trunk: Sum of Symptom Scores
PASI V2EMA000

Y12015-05-15
24STUDYXRS2324-P000124PASI0224PASI0424PASI02PASI04-Trunk: Sum X Area
PASI V2EMA000

Y12015-05-15
25STUDYXRS2324-P000125PASI0225PASI0425PASI02PASI04-Trunk: Sum X Area X 0.3
PASI V2EMA000

Y12015-05-15
26STUDYXRS2324-P000126PASI0226PASI0426PASI02PASI04-Low Extrem: Sum of Symptom Scores
PASI V2EMA333

Y12015-05-15
27STUDYXRS2324-P000127PASI0227PASI0427PASI02PASI04-Low Extrem: Sum X Area
PASI V2EMA666

Y12015-05-15
28STUDYXRS2324-P000128PASI0228PASI0428PASI02PASI04-Low Extrem: Sum X Area X 0.4
PASI V2EMA2.42.42.4

Y12015-05-15
29STUDYXRS2324-P000129PASI0229PASI0429PASI02PASI04-Total Sum
PASI V2EMA5.55.55.5

Y12015-05-15
30STUDYXRS2324-P000130PASI0201PASI0401PASI02PASI04-Head: Erythema/Redness
PASI V2EMA


NOT DONEREFUSED
22015-06-14
31STUDYXRS2324-P000131PASI0202PASI0402PASI02PASI04-Head: Thickness/Induration
PASI V2EMA


NOT DONEREFUSED
22015-06-14
32STUDYXRS2324-P000132PASI0203PASI0403PASI02PASI04-Head: Desquamation/Scaling
PASI V2EMA


NOT DONEREFUSED
22015-06-14
...














59STUDYXRS2324-P000159PASI0229PASI0429PASI02PASI04-Total Sum
PASI V2EMA


NOT DONEREFUSED
22015-06-14

...

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, and RSSTRESN) should be populated.


RSTESTCD = "PASI0201PASI0401" RSTEST = "PASI02PASI04-Head: Erythema/Redness"

RSTESTCD = "PASI0202PASI0402" RSTEST = "PASI02PASI04-Head: Thickness/Induration"

RSTESTCD = "PASI0203PASI0403" RSTEST = "PASI02PASI04-Head: Desquamation/Scaling"

RSTESTCD = "PASI0205PASI0405" RSTEST = "PASI02PASI04-Up Extrem: Erythema/Redness"

RSTESTCD = "PASI0206PASI0406" RSTEST = "PASI02PASI04-Up Extrem: Thickness/Induration"

RSTESTCD = "PASI0207PASI0407" RSTEST = "PASI02PASI04-Up Extrem: Desquamation/Scaling"

RSTESTCD = "PASI0209PASI0409" RSTEST = "PASI02PASI04-Trunk: Erythema/Redness"

RSTESTCD = "PASI0210PASI0410" RSTEST = "PASI02PASI04-Trunk: Thickness/Induration"

RSTESTCD = "PASI0211PASI0411" RSTEST = "PASI02PASI04-Trunk: Desquamation/Scaling"

RSTESTCD = "PASI0213PASI0413" RSTEST = "PASI02PASI04-Low Extrem: Erythema/Redness"

RSTESTCD = "PASI0214PASI0414" RSTEST = "PASI02PASI04-Low Extrem: Thickness/Induration"

RSTESTCD = "PASI0215PASI0415" RSTEST = "PASI02PASI04-Low Extrem: Desquamation/Scaling"


RSORRESRSSTRESCRSSTRESN
NoneNo symptoms00
Slight11
MildModerate22
ModerateMarked33Severe
Very marked44


RSTESTCD = "PASI0204PASI0404" RSTEST = "PASI02PASI04-Head: Area Score"

RSTESTCD = "PASI0208PASI0408" RSTEST = "PASI02PASI04-Up Extrem: Area Score"

RSTESTCD = "PASI0212PASI0412" RSTEST = "PASI02PASI04-Trunk: Area Score"

RSTESTCD = "PASI0216PASI0416" RSTEST = "PASI02PASI04-Low Extrem: Area Score"

0
RSORRESRSSTRESCRSSTRESN0 (clear)0
<10%11
10% - <30%29%22
30% - <50%49%33
50% - <70%69%44
70% - <90%89%55
90% - 100%66


End of Document