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Information for Reviewers

Text in black is part of the template used to create this document and is not under review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

Title

Functional Assessment of Cancer Therapy-Hepatobiliary Version 4 (FACT-HEP V4)

CDISC ReferenceQuestionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

FACT-HEP V4

QRS Permission StatusApproved
TeamPancreatic Cancer Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2023-07-28
Notes
  • This supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.


Revision History

DateVersion
2023-07-281.0 Draft

© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Functional Assessment of Cancer Therapy-Hepatobiliary Version 4 (FACT-HEP V4) QRSSUPP-671 - Getting issue details... STATUS instrument.

CDISC did not modify this questionnaires, ratings, and scales (QRS) instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or implement protocols. CDISC disclaims any liability for your use of this material.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.  

2 Copyright Status

David Cella, PhD, owns the copyright for the FACT-HEP V4 instrument and has granted CDISC permission to include this supplement in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.

These materials discuss and/or include the FACIT Measurement System, which is owned exclusively by Dr. David Cella. No part of the FACIT Measurement System may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of Dr. David Cella and payment of any applicable fees. Copyright Dr. David Cella. All rights reserved.  Copyright 1987, 1997 David Cella, PhD.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values. 

Information for Reviewers

The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.

CDISC acknowledges Dr. David Cella and FACIT.org for the approval to include the FACT-HEP V4 in the CDISC data standards.

Reference for the FACT-HEP V4:

  • FACIT.org for more information as well as the scoring guide.

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the FACT-HEP V4 are listed below.

The FACT-HEP V4 is a multiple-choice health-related quality of life questionnaire about problems associated with hepatobiliary cancer. It consists of 45 items rated on a 5-point scale. The FACT-G is included as the first 27 items in the FACT-HEP V4. 

  1. All items rated on a 5-point scale include a numeric rating (0-4) and a definition of what is represented by the rating (e.g., 0 = "Not at all", 4 = "Very much"). For the FACT-HEP V4, QSORRES is populated with the text description; the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.

    1. FAC01514 may be rated on a 5-point scale or the subject may prefer not to answer. When the checkbox is marked that the subject prefers not to answer the item, this is noted with QSSTAT = "NOT DONE" and QSREASND = "PREFER NOT TO ANSWER". QSORRES, QSSTRESC, and QSSTRESN are all missing.

  2. The time period of evaluation for the FACT-HEP V4 is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the FACT-HEP V4 is the past 7 days (QSEVLINT = "-P7D").

  3. Items are divided into 5 subcategories represented in QSSCAT: "PHYSICAL WELL-BEING", "SOCIAL/FAMILY WELL-BEING", "EMOTIONAL WELL-BEING", "FUNCTIONAL WELL-BEING", and "ADDITIONAL CONCERNS".

  4. Records are created in qs.xpt for every item on the instrument

    1. For items with no data, QSORRES, QSSTRESC, and QSSTRESN are all missing and QSSTAT = "NOT DONE".  If the reason is known then that reason is represented in QSREASND (e.g., QSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.

  5. The FACT-HEP V4 instrument includes subscale scores for each subcategory in addition to trial outcome index, FACT-G, and total scores per FACIT.org's scoring materials and are considered as captured data on the CRF and are not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from FACIT.org.

    1. Subscores and total scores are represented in QSORRES.

    2. If scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible.
  6. Terminology
    1. QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.

3.2 Example for the QRS FACT-HEP V4 QS Domain Model

The FACT-HEP V4 example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline visit for the FACT-HEP V4 instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCATAll original results, matching the CRF item response text, are represented in QSORRES. This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC.


We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.


The following 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, and no date is assumed for when the visit would have occurred.

qs.xpt

qs.xpt

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
222222

Y12015-05-15-P7D
47STUDYXQS2324-P000147FAC01547FAC015-Social/Family Subscale ScoreFACT-HEP V4
222222

Y12015-05-15-P7D
48STUDYXQS2324-P000148FAC01548FAC015-Emotional Subscale ScoreFACT-HEP V4
171717

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

Y12015-05-15-P7D
50STUDYXQS2324-P000150FAC01550FAC015-Additional Concern Subscale ScoreFACT-HEP V4
545454

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
777777

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

Y12015-05-15-P7D
54STUDYXQS2324-P00011FAC01501FAC015-I Have a Lack of EnergyFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

55STUDYXQS2324-P00012FAC01502FAC015-I Have NauseaFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

56STUDYXQS2324-P00013FAC01503FAC015-Trouble Meeting Needs of FamilyFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

57STUDYXQS2324-P00014FAC01504FAC015-I Have PainFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

58STUDYXQS2324-P00015FAC01505FAC015-Botheredby Treatment Side EffectFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

59STUDYXQS2324-P00016FAC01506FAC015-I Feel IllFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

60STUDYXQS2324-P00017FAC01507FAC015-I Am Forced to Spend Time in BedFACT-HEP V4PHYSICAL WELL-BEING


NOT DONE

2

61STUDYXQS2324-P00018FAC01508FAC015-I Feel Close to My FriendsFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

62STUDYXQS2324-P00019FAC01509FAC015-Get Emotional Support From FamilyFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

63STUDYXQS2324-P000110FAC01510FAC015-I Get Support From FriendsFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

64STUDYXQS2324-P000111FAC01511FAC015-My Family Has Accepted My IllnessFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

65STUDYXQS2324-P000112FAC01512FAC015-Satisfied Communication IllnessFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

66STUDYXQS2324-P000113FAC01513FAC015-I Feel close to My PartnerFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

67STUDYXQS2324-P000114FAC01514FAC015-I Am Satisfied With My Sex LifeFACT-HEP V4SOCIAL/FAMILY WELL-BEING


NOT DONE

2

68STUDYXQS2324-P000115FAC01515FAC015-I Feel SadFACT-HEP V4EMOTIONAL WELL-BEING


NOT DONE

2

69STUDYXQS2324-P000116FAC01516FAC015-Satisfied With How I Am CopingFACT-HEP V4EMOTIONAL WELL-BEING


NOT DONE

2

70STUDYXQS2324-P000117FAC01517FAC015-Losing Hope Against IllnessFACT-HEP V4EMOTIONAL WELL-BEING


NOT DONE

2

71STUDYXQS2324-P000118FAC01518FAC015-I Feel NervousFACT-HEP V4EMOTIONAL WELL-BEING


NOT DONE

2

72STUDYXQS2324-P000119FAC01519FAC015-I Worry About DyingFACT-HEP V4EMOTIONAL WELL-BEING


NOT DONE

2

73STUDYXQS2324-P000120FAC01520FAC015-Worry My Condition Will Get WorseFACT-HEP V4EMOTIONAL WELL-BEING


NOT DONE

2

74STUDYXQS2324-P000121FAC01521FAC015-I Am Able to WorkFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

75STUDYXQS2324-P000122FAC01522FAC015-My Work Is FulfillingFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

76STUDYXQS2324-P000123FAC01523FAC015-I Am Able to Enjoy LifeFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

77STUDYXQS2324-P000124FAC01524FAC015-I Have Accepted My IllnessFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

78STUDYXQS2324-P000125FAC01525FAC015-I Am Sleeping WellFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

79STUDYXQS2324-P000126FAC01526FAC015-Enjoy Things I Usually Do for FunFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

80STUDYXQS2324-P000127FAC01527FAC015-Content With Quality of My LifeFACT-HEP V4FUNCTIONAL WELL-BEING


NOT DONE

2

81STUDYXQS2324-P000128FAC01528FAC015-Swelling/Cramps in Stomach AreaFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

82STUDYXQS2324-P000129FAC01529FAC015-I Am Losing WeightFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

83STUDYXQS2324-P000130FAC01530FAC015-I Have Control of My BowelsFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

84STUDYXQS2324-P000131FAC01531FAC015-I Can Digest My Food WellFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

85STUDYXQS2324-P000132FAC01532FAC015-I Have DiarrheaFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

86STUDYXQS2324-P000133FAC01533FAC015-I Have a Good AppetiteFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

87STUDYXQS2324-P000134FAC01534FAC015-Unhappy About Change in My AppearFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

88STUDYXQS2324-P000135FAC01535FAC015-I Have Pain in My BackFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

89STUDYXQS2324-P000136FAC01536FAC015-I Am Bothered by ConstipationFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

90STUDYXQS2324-P000137FAC01537FAC015-I Feel FatiguedFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

91STUDYXQS2324-P000138FAC01538FAC015-Able to Do My Usual ActivitiesFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

92STUDYXQS2324-P000139FAC01539FAC015-Bothered by Jaundice/Yellow SkinFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

93STUDYXQS2324-P000140FAC01540FAC015-I Have Had FeversFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

94STUDYXQS2324-P000141FAC01541FAC015-I Have Had ItchingFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

95STUDYXQS2324-P000142FAC01542FAC015-Had Change in the Way Food TastesFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

96STUDYXQS2324-P000143FAC01543FAC015-I Have Had ChillsFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

97STUDYXQS2324-P000144FAC01544FAC015-My Mouth Is DryFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

98STUDYXQS2324-P000145FAC01545FAC015-Discomfort/Pain in Stomach AreaFACT-HEP V4ADDITIONAL CONCERNS


NOT DONE

2

99STUDYXQS2324-P000146FAC01546FAC015-Physical Subscale ScoreFACT-HEP V4



NOT DONE

2

100STUDYXQS2324-P000147FAC01547FAC015-Social/Family Subscale ScoreFACT-HEP V4



NOT DONE

2

101STUDYXQS2324-P000148FAC01548FAC015-Emotional Subscale ScoreFACT-HEP V4



NOT DONE

2

102STUDYXQS2324-P000149FAC01549FAC015-Functional Subscale ScoreFACT-HEP V4



NOT DONE

2

103STUDYXQS2324-P000150FAC01550FAC015-Additional Concern Subscale ScoreFACT-HEP V4



NOT DONE

2

104STUDYXQS2324-P000151FAC01551FAC015-Trial Outcome Index ScoreFACT-HEP V4



NOT DONE

2

105STUDYXQS2324-P000152FAC01552FAC015-FACT-G Total ScoreFACT-HEP V4



NOT DONE

2

106STUDYXQS2324-P000153FAC01553FAC015-Total ScoreFACT-HEP V4



NOT DONE

2

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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.

QSSCAT alignment with QSTESTCD

As stated in Section 3.1, Assumptions, items on the FACT-HEP V4 are grouped into subcategories. The table below includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.

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

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