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The table represents the items from the FACT-HEP V4 instrument. The subject was not evaluated on this instrument at visit 2. Since the visit was missed, the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred.

Dataset wrap
Nameqs
Rowcaps
Rows 13-14:Items 11 and 12 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 12 would not appear in the actual dataset and has result values of "XXX".
Rows 15-16:Items 13 and 14 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Item 14 would not appear in the actual dataset and has result values of "XXX".
Row 33:The total score does not have an evaluation interval value represented, since there is a mixture of evaluation interval values with items 13 and 14 that differ from the remaining items on the CRF.
Dataset2
RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNQSSTATQSREASNDQSLOBXFLVISITNUMQSDTCQSEVLINT
1STUDYXQS2324-P00011FAC01501FAC015-I Have a Lack of EnergyFACT-HEP V4A little bit11

Y12015-05-15-P7D
2STUDYXQS2324-P00012FAC01502FAC015-I Have NauseaFACT-HEP V4Not at all00

Y12015-05-15-P7D
3STUDYXQS2324-P00013FAC01503FAC015-Trouble Meeting Needs of FamilyFACT-HEP V4Somewhat22

Y12015-05-15-P7D
4STUDYXQS2324-P00014FAC01504FAC015-I Have PainFACT-HEP V4A little bit11

Y12015-05-15-P7D
5STUDYXQS2324-P00015FAC01505FAC015-Botheredby Treatment Side EffectFACT-HEP V4Not at all00

Y12015-05-15-P7D
6STUDYXQS2324-P00016FAC01506FAC015-I Feel IllFACT-HEP V4A little bit11

Y12015-05-15-P7D
7STUDYXQS2324-P00017FAC01507FAC015-I Am Forced to Spend Time in BedFACT-HEP V4A little bit11

Y12015-05-15-P7D
8STUDYXQS2324-P00018FAC01508FAC015-I Feel Close to My FriendsFACT-HEP V4Quite a bit33

Y12015-05-15-P7D
9STUDYXQS2324-P00019FAC01509FAC015-Get Emotional Support From FamilyFACT-HEP V4Quite a bit33

Y12015-05-15-P7D
10STUDYXQS2324-P000110FAC01510FAC015-I Get Support From FriendsFACT-HEP V4Somewhat22

Y12015-05-15-P7D
11STUDYXQS2324-P000111FAC01511FAC015-My Family Has Accepted My IllnessFACT-HEP V4Quite a bit33

Y12015-05-15-P7D
12STUDYXQS2324-P000112FAC01512FAC015-Satisfied Communication IllnessFACT-HEP V4Very much44

Y12015-05-15-P7D
13STUDYXQS2324-P000113FAC01513FAC015-I Feel close to My PartnerFACT-HEP V4Very much44

Y12015-05-15-P7D
14STUDYXQS2324-P000114FAC01514FAC015-I Am Satisfied With My Sex LifeFACT-HEP V4


NOT DONEPREFER NOT TO ANSWERY12015-05-15-P7D
15STUDYXQS2324-P000115FAC01515FAC015-I Feel SadFACT-HEP V4A little bit11

Y12015-05-15-P7D
16STUDYXQS2324-P000116FAC01516FAC015-Satisfied With How I Am CopingFACT-HEP V4Quite a bit33

Y12015-05-15-P7D
17STUDYXQS2324-P000117FAC01517FAC015-Losing Hope Against IllnessFACT-HEP V4A little bit11

Y12015-05-15-P7D
18STUDYXQS2324-P000118FAC01518FAC015-I Feel NervousFACT-HEP V4A little bit11

Y12015-05-15-P7D
19STUDYXQS2324-P000119FAC01519FAC015-I Worry About DyingFACT-HEP V4A little bit11

Y12015-05-15-P7D
20STUDYXQS2324-P000120FAC01520FAC015-Worry My Condition Will Get WorseFACT-HEP V4Somewhat22

Y12015-05-15-P7D
21STUDYXQS2324-P000121FAC01521FAC015-I Am Able to WorkFACT-HEP V4A little bit11

Y12015-05-15-P7D
22STUDYXQS2324-P000122FAC01522FAC015-My Work Is FulfillingFACT-HEP V4Quite a bit33

Y12015-05-15-P7D
23STUDYXQS2324-P000123FAC01523FAC015-I Am Able to Enjoy LifeFACT-HEP V4Quite a bit33

Y12015-05-15-P7D
24STUDYXQS2324-P000124FAC01524FAC015-I Have Accepted My IllnessFACT-HEP V4Somewhat22

Y12015-05-15-P7D
25STUDYXQS2324-P000125FAC01525FAC015-I Am Sleeping WellFACT-HEP V4Somewhat22

Y12015-05-15-P7D
26STUDYXQS2324-P000126FAC01526FAC015-Enjoy Things I Usually Do for FunFACT-HEP V4Somewhat22

Y12015-05-15-P7D
27STUDYXQS2324-P000127FAC01527FAC015-Content With Quality of My LifeFACT-HEP V4Quite a bit33

Y12015-05-15-P7D
28STUDYXQS2324-P000128FAC01528FAC015-Swelling/Cramps in Stomach AreaFACT-HEP V4Somewhat22

Y12015-05-15-P7D
29STUDYXQS2324-P000129FAC01529FAC015-I Am Losing WeightFACT-HEP V4Not at all00

Y12015-05-15-P7D
30STUDYXQS2324-P000130FAC01530FAC015-I Have Control of My BowelsFACT-HEP V4Quite a bit33

Y12015-05-15-P7D
31STUDYXQS2324-P000131FAC01531FAC015-I Can Digest My Food WellFACT-HEP V4Quite a bit33

Y12015-05-15-P7D
32STUDYXQS2324-P000132FAC01532FAC015-I Have DiarrheaFACT-HEP V4A little bit11

Y12015-05-15-P7D
33STUDYXQS2324-P000133FAC01533FAC015-I Have a Good AppetiteFACT-HEP V4Quite a bit33

Y12015-05-15-P7D
34STUDYXQS2324-P000134FAC01534FAC015-Unhappy About Change in My AppearFACT-HEP V4Not at all00

Y12015-05-15-P7D
35STUDYXQS2324-P000135FAC01535FAC015-I Have Pain in My BackFACT-HEP V4A little bit11

Y12015-05-15-P7D
36STUDYXQS2324-P000136FAC01536FAC015-I Am Bothered by ConstipationFACT-HEP V4A little bit11

Y12015-05-15-P7D
37STUDYXQS2324-P000137FAC01537FAC015-I Feel FatiguedFACT-HEP V4Somewhat22

Y12015-05-15-P7D
38STUDYXQS2324-P000138FAC01538FAC015-Able to Do My Usual ActivitiesFACT-HEP V4A  little bit11

Y12015-05-15-P7D
39STUDYXQS2324-P000139FAC01539FAC015-Bothered by Jaundice/Yellow SkinFACT-HEP V4A little bit11

Y12015-05-15-P7D
40STUDYXQS2324-P000140FAC01540FAC015-I Have Had FeversFACT-HEP V4Not at all00

Y12015-05-15-P7D
41STUDYXQS2324-P000141FAC01541FAC015-I Have Had ItchingFACT-HEP V4A little bit11

Y12015-05-15-P7D
42STUDYXQS2324-P000142FAC01542FAC015-Had Change in the Way Food TastesFACT-HEP V4Not at all00

Y12015-05-15-P7D
43STUDYXQS2324-P000143FAC01543FAC015-I Have Had ChillsFACT-HEP V4Not at all00

Y12015-05-15-P7D
44STUDYXQS2324-P000144FAC01544FAC015-My Mouth Is DryFACT-HEP V4A little bit11

Y12015-05-15-P7D
45STUDYXQS2324-P000145FAC01545FAC015-Discomfort/Pain in Stomach AreaFACT-HEP V4Somewhat22

Y12015-05-15-P7D
46STUDYXQS2324-P000146FAC01546FAC015-Physical Subscale ScoreFACT-HEP V4666

Y12015-05-15-P7D
47STUDYXQS2324-P000147FAC01547FAC015-Social/Family Subscale ScoreFACT-HEP V422.222.222.2

Y12015-05-15-P7D
48STUDYXQS2324-P000148FAC01548FAC015-Emotional Subscale ScoreFACT-HEP V4999

Y12015-05-15-P7D
49STUDYXQS2324-P000149FAC01549FAC015-Functional Subscale ScoreFACT-HEP V4161616

Y12015-05-15-P7D
50STUDYXQS2324-P000150FAC01550FAC015-Additional Concern Subscale ScoreFACT-HEP V4222222

Y12015-05-15-P7D
51STUDYXQS2324-P000151FAC01551FAC015-Trial Outcome Index ScoreFACT-HEP V4




Y12015-05-15-P7D
52STUDYXQS2324-P000152FAC01552FAC015-FACT-G Total ScoreFACT-HEP V4




Y12015-05-15-P7D
53STUDYXQS2324-P000153FAC01553FAC015-Total ScoreFACT-HEP V4




Y12015-05-15-P7D
1STUDYXQS2324-P00011FAC01501FAC015-I Have a Lack of EnergyFACT-HEP V4


1NOT DONE

-P7D2

2STUDYXQS2324-P00012FAC01502FAC015-I Have NauseaFACT-HEP V4


1NOT DONE

-P7D2

3STUDYXQS2324-P00013FAC01503FAC015-Trouble Meeting Needs of FamilyFACT-HEP V4


1NOT DONE

-P7D2

4STUDYXQS2324-P00014FAC01504FAC015-I Have PainFACT-HEP V4


1NOT DONE

-P7D2

5STUDYXQS2324-P00015FAC01505FAC015-Botheredby Treatment Side EffectFACT-HEP V4


1NOT DONE

-P7D2

6STUDYXQS2324-P00016FAC01506FAC015-I Feel IllFACT-HEP V4


1NOT DONE

-P7D2

7STUDYXQS2324-P00017FAC01507FAC015-I Am Forced to Spend Time in BedFACT-HEP V4


1NOT DONE

-P7D2

8STUDYXQS2324-P00018FAC01508FAC015-I Feel Close to My FriendsFACT-HEP V4


1NOT DONE

-P7D2

9STUDYXQS2324-P00019FAC01509FAC015-Get Emotional Support From FamilyFACT-HEP V4


1NOT DONE

-P7D2

10STUDYXQS2324-P000110FAC01510FAC015-I Get Support From FriendsFACT-HEP V4


1NOT DONE

-P7D2

11STUDYXQS2324-P000111FAC01511FAC015-My Family Has Accepted My IllnessFACT-HEP V4


1NOT DONE

-P7D2

12STUDYXQS2324-P000112FAC01512FAC015-Satisfied Communication IllnessFACT-HEP V4


1NOT DONE

-P7D2

13STUDYXQS2324-P000113FAC01513FAC015-I Feel close to My PartnerFACT-HEP V4


1NOT DONE

-P7D2

14STUDYXQS2324-P000114FAC01514FAC015-I Am Satisfied With My Sex LifeFACT-HEP V4


NOT DONE1

-P7D2

15STUDYXQS2324-P000115FAC01515FAC015-I Feel SadFACT-HEP V4


1NOT DONE

-P7D2

16STUDYXQS2324-P000116FAC01516FAC015-Satisfied With How I Am CopingFACT-HEP V4


1NOT DONE

-P7D2

17STUDYXQS2324-P000117FAC01517FAC015-Losing Hope Against IllnessFACT-HEP V4


1NOT DONE

-P7D2

18STUDYXQS2324-P000118FAC01518FAC015-I Feel NervousFACT-HEP V4


1NOT DONE

-P7D2

19STUDYXQS2324-P000119FAC01519FAC015-I Worry About DyingFACT-HEP V4


1NOT DONE

-P7D2

20STUDYXQS2324-P000120FAC01520FAC015-Worry My Condition Will Get WorseFACT-HEP V4


1NOT DONE

-P7D2

21STUDYXQS2324-P000121FAC01521FAC015-I Am Able to WorkFACT-HEP V4


1NOT DONE

-P7D2

22STUDYXQS2324-P000122FAC01522FAC015-My Work Is FulfillingFACT-HEP V4


1NOT DONE

-P7D2

23STUDYXQS2324-P000123FAC01523FAC015-I Am Able to Enjoy LifeFACT-HEP V4


1NOT DONE

-P7D2

24STUDYXQS2324-P000124FAC01524FAC015-I Have Accepted My IllnessFACT-HEP V4


1NOT DONE

-P7D2

25STUDYXQS2324-P000125FAC01525FAC015-I Am Sleeping WellFACT-HEP V4


1NOT DONE

-P7D2

26STUDYXQS2324-P000126FAC01526FAC015-Enjoy Things I Usually Do for FunFACT-HEP V4


1NOT DONE

-P7D2

27STUDYXQS2324-P000127FAC01527FAC015-Content With Quality of My LifeFACT-HEP V4


1NOT DONE

-P7D2

28STUDYXQS2324-P000128FAC01528FAC015-Swelling/Cramps in Stomach AreaFACT-HEP V4


1NOT DONE

-P7D2

29STUDYXQS2324-P000129FAC01529FAC015-I Am Losing WeightFACT-HEP V4


1NOT DONE

-P7D2

30STUDYXQS2324-P000130FAC01530FAC015-I Have Control of My BowelsFACT-HEP V4


1NOT DONE

-P7D2

31STUDYXQS2324-P000131FAC01531FAC015-I Can Digest My Food WellFACT-HEP V4


1NOT DONE

-P7D2

32STUDYXQS2324-P000132FAC01532FAC015-I Have DiarrheaFACT-HEP V4


1NOT DONE

-P7D2

33STUDYXQS2324-P000133FAC01533FAC015-I Have a Good AppetiteFACT-HEP V4


1NOT DONE

-P7D2

34STUDYXQS2324-P000134FAC01534FAC015-Unhappy About Change in My AppearFACT-HEP V4


1NOT DONE

-P7D2

35STUDYXQS2324-P000135FAC01535FAC015-I Have Pain in My BackFACT-HEP V4


1NOT DONE

-P7D2

36STUDYXQS2324-P000136FAC01536FAC015-I Am Bothered by ConstipationFACT-HEP V4


1NOT DONE

-P7D2

37STUDYXQS2324-P000137FAC01537FAC015-I Feel FatiguedFACT-HEP V4


1NOT DONE

-P7D2

38STUDYXQS2324-P000138FAC01538FAC015-Able to Do My Usual ActivitiesFACT-HEP V4


1NOT DONE

-P7D2

39STUDYXQS2324-P000139FAC01539FAC015-Bothered by Jaundice/Yellow SkinFACT-HEP V4


1NOT DONE

-P7D2

40STUDYXQS2324-P000140FAC01540FAC015-I Have Had FeversFACT-HEP V4


1NOT DONE

-P7D2

41STUDYXQS2324-P000141FAC01541FAC015-I Have Had ItchingFACT-HEP V4


1NOT DONE

-P7D2

42STUDYXQS2324-P000142FAC01542FAC015-Had Change in the Way Food TastesFACT-HEP V4


1NOT DONE

-P7D2

43STUDYXQS2324-P000143FAC01543FAC015-I Have Had ChillsFACT-HEP V4


1NOT DONE

-P7D2

44STUDYXQS2324-P000144FAC01544FAC015-My Mouth Is DryFACT-HEP V4


1NOT DONE

-P7D2

45STUDYXQS2324-P000145FAC01545FAC015-Discomfort/Pain in Stomach AreaFACT-HEP V4


1NOT DONE

-P7D2

46STUDYXQS2324-P000146FAC01546FAC015-Physical Subscale ScoreFACT-HEP V4


1NOT DONE

-P7D2

47STUDYXQS2324-P000147FAC01547FAC015-Social/Family Subscale ScoreFACT-HEP V4


1NOT DONE

-P7D2

48STUDYXQS2324-P000148FAC01548FAC015-Emotional Subscale ScoreFACT-HEP V4


1NOT DONE

-P7D2

49STUDYXQS2324-P000149FAC01549FAC015-Functional Subscale ScoreFACT-HEP V4


1NOT DONE

-P7D2

50STUDYXQS2324-P000150FAC01550FAC015-Additional Concern Subscale ScoreFACT-HEP V4


1NOT DONE

-P7D2

51STUDYXQS2324-P000151FAC01551FAC015-Trial Outcome Index ScoreFACT-HEP V4


1NOT DONE

-P7D2

52STUDYXQS2324-P000152FAC01552FAC015-FACT-G Total ScoreFACT-HEP V4


1NOT DONE

-P7D2

53STUDYXQS2324-P000153FAC01553FAC015-Total ScoreFACT-HEP V4


1NOT DONE

-P7D2


4 SDTM Mapping Strategy

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

...

QSSCATQSTESTCD
PHYSICAL WELL-BEINGFAC01501 - FAC01507
SOCIAL/FAMILY WELL-BEINGFAC01508 - FAC01514
EMOTIONAL WELL-BEINGFAC01515 - FAC01520
FUNCTIONAL WELL-BEINGFAC01521 - FAC01527
ADDITIONAL CONCERNSFAC01528 - FAC01545


All QSTESTCDs

QSORRES

QSSTRESC

QSSTRESN

Not at all00
A little bit11
Somewhat22
Quite a bit33
Very much44





End of Document