Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

Dataset wrap
Nameqs
Dataset2
RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSSCATQSORRESQSSTRESCQSSTRESNQSSTATQSREASNDQSLOBXFLVISITNUMQSDTCQSEVLINT
1STUDYXQS2324-P00011FAC01501FAC015-I Have a Lack of EnergyFACT-HEP V4PHYSICAL WELL-BEINGA little bit11

Y12015-05-15-P7D
2STUDYXQS2324-P00012FAC01502FAC015-I Have NauseaFACT-HEP V4PHYSICAL WELL-BEINGNot at all00

Y12015-05-15-P7D
3STUDYXQS2324-P00013FAC01503FAC015-Trouble Meeting Needs of FamilyFACT-HEP V4PHYSICAL WELL-BEINGSomewhat22

Y12015-05-15-P7D
4STUDYXQS2324-P00014FAC01504FAC015-I Have PainFACT-HEP V4PHYSICAL WELL-BEINGA little bit11

Y12015-05-15-P7D
5STUDYXQS2324-P00015FAC01505FAC015-Botheredby Treatment Side EffectFACT-HEP V4PHYSICAL WELL-BEINGNot at all00

Y12015-05-15-P7D
6STUDYXQS2324-P00016FAC01506FAC015-I Feel IllFACT-HEP V4PHYSICAL WELL-BEINGA little bit11

Y12015-05-15-P7D
7STUDYXQS2324-P00017FAC01507FAC015-I Am Forced to Spend Time in BedFACT-HEP V4PHYSICAL WELL-BEINGA little bit11

Y12015-05-15-P7D
8STUDYXQS2324-P00018FAC01508FAC015-I Feel Close to My FriendsFACT-HEP V4SOCIAL/FAMILY WELL-BEINGQuite a bit33

Y12015-05-15-P7D
9STUDYXQS2324-P00019FAC01509FAC015-Get Emotional Support From FamilyFACT-HEP V4SOCIAL/FAMILY WELL-BEINGQuite a bit33

Y12015-05-15-P7D
10STUDYXQS2324-P000110FAC01510FAC015-I Get Support From FriendsFACT-HEP V4SOCIAL/FAMILY WELL-BEINGSomewhat22

Y12015-05-15-P7D
11STUDYXQS2324-P000111FAC01511FAC015-My Family Has Accepted My IllnessFACT-HEP V4SOCIAL/FAMILY WELL-BEINGQuite a bit33

Y12015-05-15-P7D
12STUDYXQS2324-P000112FAC01512FAC015-Satisfied Communication IllnessFACT-HEP V4SOCIAL/FAMILY WELL-BEINGVery much44

Y12015-05-15-P7D
13STUDYXQS2324-P000113FAC01513FAC015-I Feel close to My PartnerFACT-HEP V4SOCIAL/FAMILY WELL-BEINGVery much44

Y12015-05-15-P7D
14STUDYXQS2324-P000114FAC01514FAC015-I Am Satisfied With My Sex LifeFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONEPREFER NOT TO ANSWERY12015-05-15-P7D
15STUDYXQS2324-P000115FAC01515FAC015-I Feel SadFACT-HEP V4EMOTIONAL WELL-BEINGA little bit11

Y12015-05-15-P7D
16STUDYXQS2324-P000116FAC01516FAC015-Satisfied With How I Am CopingFACT-HEP V4EMOTIONAL WELL-BEINGQuite a bit33

Y12015-05-15-P7D
17STUDYXQS2324-P000117FAC01517FAC015-Losing Hope Against IllnessFACT-HEP V4EMOTIONAL WELL-BEINGA little bit11

Y12015-05-15-P7D
18STUDYXQS2324-P000118FAC01518FAC015-I Feel NervousFACT-HEP V4EMOTIONAL WELL-BEINGA little bit11

Y12015-05-15-P7D
19STUDYXQS2324-P000119FAC01519FAC015-I Worry About DyingFACT-HEP V4EMOTIONAL WELL-BEINGA little bit11

Y12015-05-15-P7D
20STUDYXQS2324-P000120FAC01520FAC015-Worry My Condition Will Get WorseFACT-HEP V4EMOTIONAL WELL-BEINGSomewhat22

Y12015-05-15-P7D
21STUDYXQS2324-P000121FAC01521FAC015-I Am Able to WorkFACT-HEP V4FUNCTIONAL WELL-BEINGA little bit11

Y12015-05-15-P7D
22STUDYXQS2324-P000122FAC01522FAC015-My Work Is FulfillingFACT-HEP V4FUNCTIONAL WELL-BEINGQuite a bit33

Y12015-05-15-P7D
23STUDYXQS2324-P000123FAC01523FAC015-I Am Able to Enjoy LifeFACT-HEP V4FUNCTIONAL WELL-BEINGQuite a bit33

Y12015-05-15-P7D
24STUDYXQS2324-P000124FAC01524FAC015-I Have Accepted My IllnessFACT-HEP V4FUNCTIONAL WELL-BEINGSomewhat22

Y12015-05-15-P7D
25STUDYXQS2324-P000125FAC01525FAC015-I Am Sleeping WellFACT-HEP V4FUNCTIONAL WELL-BEINGSomewhat22

Y12015-05-15-P7D
26STUDYXQS2324-P000126FAC01526FAC015-Enjoy Things I Usually Do for FunFACT-HEP V4FUNCTIONAL WELL-BEINGSomewhat22

Y12015-05-15-P7D
27STUDYXQS2324-P000127FAC01527FAC015-Content With Quality of My LifeFACT-HEP V4FUNCTIONAL WELL-BEINGQuite a bit33

Y12015-05-15-P7D
28STUDYXQS2324-P000128FAC01528FAC015-Swelling/Cramps in Stomach AreaFACT-HEP V4ADDITIONAL CONCERNSSomewhat22

Y12015-05-15-P7D
29STUDYXQS2324-P000129FAC01529FAC015-I Am Losing WeightFACT-HEP V4ADDITIONAL CONCERNSNot at all00

Y12015-05-15-P7D
30STUDYXQS2324-P000130FAC01530FAC015-I Have Control of My BowelsFACT-HEP V4ADDITIONAL CONCERNSQuite a bit33

Y12015-05-15-P7D
31STUDYXQS2324-P000131FAC01531FAC015-I Can Digest My Food WellFACT-HEP V4ADDITIONAL CONCERNSQuite a bit33

Y12015-05-15-P7D
32STUDYXQS2324-P000132FAC01532FAC015-I Have DiarrheaFACT-HEP V4ADDITIONAL CONCERNSA little bit11

Y12015-05-15-P7D
33STUDYXQS2324-P000133FAC01533FAC015-I Have a Good AppetiteFACT-HEP V4ADDITIONAL CONCERNSQuite a bit33

Y12015-05-15-P7D
34STUDYXQS2324-P000134FAC01534FAC015-Unhappy About Change in My AppearFACT-HEP V4ADDITIONAL CONCERNSNot at all00

Y12015-05-15-P7D
35STUDYXQS2324-P000135FAC01535FAC015-I Have Pain in My BackFACT-HEP V4ADDITIONAL CONCERNSA little bit11

Y12015-05-15-P7D
36STUDYXQS2324-P000136FAC01536FAC015-I Am Bothered by ConstipationFACT-HEP V4ADDITIONAL CONCERNSA little bit11

Y12015-05-15-P7D
37STUDYXQS2324-P000137FAC01537FAC015-I Feel FatiguedFACT-HEP V4ADDITIONAL CONCERNSSomewhat22

Y12015-05-15-P7D
38STUDYXQS2324-P000138FAC01538FAC015-Able to Do My Usual ActivitiesFACT-HEP V4ADDITIONAL CONCERNSA  little bit11

Y12015-05-15-P7D
39STUDYXQS2324-P000139FAC01539FAC015-Bothered by Jaundice/Yellow SkinFACT-HEP V4ADDITIONAL CONCERNSA little bit11

Y12015-05-15-P7D
40STUDYXQS2324-P000140FAC01540FAC015-I Have Had FeversFACT-HEP V4ADDITIONAL CONCERNSNot at all00

Y12015-05-15-P7D
41STUDYXQS2324-P000141FAC01541FAC015-I Have Had ItchingFACT-HEP V4ADDITIONAL CONCERNSA little bit11

Y12015-05-15-P7D
42STUDYXQS2324-P000142FAC01542FAC015-Had Change in the Way Food TastesFACT-HEP V4ADDITIONAL CONCERNSNot at all00

Y12015-05-15-P7D
43STUDYXQS2324-P000143FAC01543FAC015-I Have Had ChillsFACT-HEP V4ADDITIONAL CONCERNSNot at all00

Y12015-05-15-P7D
44STUDYXQS2324-P000144FAC01544FAC015-My Mouth Is DryFACT-HEP V4ADDITIONAL CONCERNSA little bit11

Y12015-05-15-P7D
45STUDYXQS2324-P000145FAC01545FAC015-Discomfort/Pain in Stomach AreaFACT-HEP V4ADDITIONAL CONCERNSSomewhat22

Y12015-05-15-P7D
46STUDYXQS2324-P000146FAC01546FAC015-Physical Subscale ScoreFACT-HEP V4
6

22
6
22
6
22

Y12015-05-15-P7D
47STUDYXQS2324-P000147FAC01547FAC015-Social/Family Subscale ScoreFACT-HEP V4
22
.2
22
.2
22
.2


Y12015-05-15-P7D
48STUDYXQS2324-P000148FAC01548FAC015-Emotional Subscale ScoreFACT-HEP V4
9

17
9
17
9
17

Y12015-05-15-P7D
49STUDYXQS2324-P000149FAC01549FAC015-Functional Subscale ScoreFACT-HEP V4
161616

Y12015-05-15-P7D
50STUDYXQS2324-P000150FAC01550FAC015-Additional Concern Subscale ScoreFACT-HEP V4
22

54
22
54
22
54

Y12015-05-15-P7D
51STUDYXQS2324-P000151FAC01551FAC015-Trial Outcome Index ScoreFACT-HEP V4
929292

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

777777

Y12015-05-15-P7D
53STUDYXQS2324-P000153FAC01553FAC015-Total ScoreFACT-HEP V4
131131131

Y12015-05-15-P7D
1STUDYXQS2324-P00011FAC01501FAC015-I Have a Lack of EnergyFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

2STUDYXQS2324-P00012FAC01502FAC015-I Have NauseaFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

3STUDYXQS2324-P00013FAC01503FAC015-Trouble Meeting Needs of FamilyFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

4STUDYXQS2324-P00014FAC01504FAC015-I Have PainFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

5STUDYXQS2324-P00015FAC01505FAC015-Botheredby Treatment Side EffectFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

6STUDYXQS2324-P00016FAC01506FAC015-I Feel IllFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

7STUDYXQS2324-P00017FAC01507FAC015-I Am Forced to Spend Time in BedFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

8STUDYXQS2324-P00018FAC01508FAC015-I Feel Close to My FriendsFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

9STUDYXQS2324-P00019FAC01509FAC015-Get Emotional Support From FamilyFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

10STUDYXQS2324-P000110FAC01510FAC015-I Get Support From FriendsFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

11STUDYXQS2324-P000111FAC01511FAC015-My Family Has Accepted My IllnessFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

12STUDYXQS2324-P000112FAC01512FAC015-Satisfied Communication IllnessFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

13STUDYXQS2324-P000113FAC01513FAC015-I Feel close to My PartnerFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

14STUDYXQS2324-P000114FAC01514FAC015-I Am Satisfied With My Sex LifeFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

15STUDYXQS2324-P000115FAC01515FAC015-I Feel SadFACT-HEP V4EMOTIONAL WELL-BEING


NOT DONE

2

16STUDYXQS2324-P000116FAC01516FAC015-Satisfied With How I Am CopingFACT-HEP V4EMOTIONAL WELL-BEING


NOT DONE

2

17STUDYXQS2324-P000117FAC01517FAC015-Losing Hope Against IllnessFACT-HEP V4EMOTIONAL WELL-BEING


NOT DONE

2

18STUDYXQS2324-P000118FAC01518FAC015-I Feel NervousFACT-HEP V4EMOTIONAL WELL-BEING


NOT DONE

2

19STUDYXQS2324-P000119FAC01519FAC015-I Worry About DyingFACT-HEP V4EMOTIONAL WELL-BEING


NOT DONE

2

20STUDYXQS2324-P000120FAC01520FAC015-Worry My Condition Will Get WorseFACT-HEP V4EMOTIONAL WELL-BEING


NOT DONE

2

21STUDYXQS2324-P000121FAC01521FAC015-I Am Able to WorkFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

22STUDYXQS2324-P000122FAC01522FAC015-My Work Is FulfillingFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

23STUDYXQS2324-P000123FAC01523FAC015-I Am Able to Enjoy LifeFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

24STUDYXQS2324-P000124FAC01524FAC015-I Have Accepted My IllnessFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

25STUDYXQS2324-P000125FAC01525FAC015-I Am Sleeping WellFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

26STUDYXQS2324-P000126FAC01526FAC015-Enjoy Things I Usually Do for FunFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

27STUDYXQS2324-P000127FAC01527FAC015-Content With Quality of My LifeFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

28STUDYXQS2324-P000128FAC01528FAC015-Swelling/Cramps in Stomach AreaFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

29STUDYXQS2324-P000129FAC01529FAC015-I Am Losing WeightFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

30STUDYXQS2324-P000130FAC01530FAC015-I Have Control of My BowelsFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

31STUDYXQS2324-P000131FAC01531FAC015-I Can Digest My Food WellFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

32STUDYXQS2324-P000132FAC01532FAC015-I Have DiarrheaFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

33STUDYXQS2324-P000133FAC01533FAC015-I Have a Good AppetiteFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

34STUDYXQS2324-P000134FAC01534FAC015-Unhappy About Change in My AppearFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

35STUDYXQS2324-P000135FAC01535FAC015-I Have Pain in My BackFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

36STUDYXQS2324-P000136FAC01536FAC015-I Am Bothered by ConstipationFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

37STUDYXQS2324-P000137FAC01537FAC015-I Feel FatiguedFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

38STUDYXQS2324-P000138FAC01538FAC015-Able to Do My Usual ActivitiesFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

39STUDYXQS2324-P000139FAC01539FAC015-Bothered by Jaundice/Yellow SkinFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

40STUDYXQS2324-P000140FAC01540FAC015-I Have Had FeversFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

41STUDYXQS2324-P000141FAC01541FAC015-I Have Had ItchingFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

42STUDYXQS2324-P000142FAC01542FAC015-Had Change in the Way Food TastesFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

43STUDYXQS2324-P000143FAC01543FAC015-I Have Had ChillsFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

44STUDYXQS2324-P000144FAC01544FAC015-My Mouth Is DryFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

45STUDYXQS2324-P000145FAC01545FAC015-Discomfort/Pain in Stomach AreaFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

46STUDYXQS2324-P000146FAC01546FAC015-Physical Subscale ScoreFACT-HEP V4



NOT DONE

2

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



NOT DONE

2

48STUDYXQS2324-P000148FAC01548FAC015-Emotional Subscale ScoreFACT-HEP V4



NOT DONE

2

49STUDYXQS2324-P000149FAC01549FAC015-Functional Subscale ScoreFACT-HEP V4



NOT DONE

2

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



NOT DONE

2

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



NOT DONE

2

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



NOT DONE

2

53STUDYXQS2324-P000153FAC01553FAC015-Total ScoreFACT-HEP V4



NOT DONE

2


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.

...