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| Page properties |
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| Title | Functional Assessment of Anorexia/Cachexia Treatment Version 4 (FAACT V4) |
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| CDISC Reference | Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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| QRS Short Name | |
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| QRS Permission Status | Approved |
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| Team | Pancreatic Cancer Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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| Supplement Version | 1.0 |
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| Status | DRAFT |
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| Date | 2023-0207-1028 |
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| 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.
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Revision History
| Date | Version |
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| 2023-0207-1028 | 1.0 Draft |
© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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This document describes the CDISC implementation of the Functional Assessment of Anorexia/Cachexia Treatment Version 4 (FAACT V4) 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.
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2 Copyright Status
David Cella, PhD. , owns the copyright for the FAACT 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, Ph.DPhD.
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.
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| Info |
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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 FAACT 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.
| Dataset wrap |
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|
| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT |
|---|
| 1 | STUDYX | QS | 2324-P0001 | 1 | FAC06501 | FAC065-I Have a Lack of Energy | FAACT V4 | PHYSICAL WELL-BEING | A little bit | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | | 2 | STUDYX | QS | 2324-P0001 | 2 | FAC06502 | FAC065-I Have Nausea | FAACT V4 | PHYSICAL WELL-BEING | Not at all | 0 | 0 |
|
| Y | 1 | 2015-05-15 | -P7D | | 3 | STUDYX | QS | 2324-P0001 | 3 | FAC06503 | FAC065-Trouble Meeting Needs of Family | FAACT V4 | PHYSICAL WELL-BEING | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | | 4 | STUDYX | QS | 2324-P0001 | 4 | FAC06504 | FAC065-I Have Pain | FAACT V4 | PHYSICAL WELL-BEING | A little bit | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | | 5 | STUDYX | QS | 2324-P0001 | 5 | FAC06505 | FAC065-Bothered by Treatment Side Effect | FAACT V4 | PHYSICAL WELL-BEING | Not at all | 0 | 0 |
|
| Y | 1 | 2015-05-15 | -P7D | | 6 | STUDYX | QS | 2324-P0001 | 6 | FAC06506 | FAC065-I Feel Ill | FAACT V4 | PHYSICAL WELL-BEING | A little bit | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | | 7 | STUDYX | QS | 2324-P0001 | 7 | FAC06507 | FAC065-I Am Forced to Spend Time in Bed | FAACT V4 | PHYSICAL WELL-BEING | A little bit | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | | 8 | STUDYX | QS | 2324-P0001 | 8 | FAC06508 | FAC065-I Feel Close to My Friends | FAACT V4 | SOCIAL/FAMILY WELL-BEING | Quite a bit | 3 | 3 |
|
| Y | 1 | 2015-05-15 | -P7D | | 9 | STUDYX | QS | 2324-P0001 | 9 | FAC06509 | FAC065-Get Emotional Support From Family | FAACT V4 | SOCIAL/FAMILY WELL-BEING | Quite a bit | 3 | 3 |
|
| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC06510 | FAC065-I Get Support From My Friends | FAACT V4 | SOCIAL/FAMILY WELL-BEING | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | | 11 | STUDYX | QS | 2324-P0001 | 11 | FAC06511 | FAC065-My Family Has Accepted My Illness | FAACT V4 | SOCIAL/FAMILY WELL-BEING | Quite a bit | 3 | 3 |
|
| Y | 1 | 2015-05-15 | -P7D | | 12 | STUDYX | QS | 2324-P0001 | 12 | FAC06512 | FAC065-Satisfied Communication Illness | FAACT V4 | SOCIAL/FAMILY WELL-BEING | Very much | 4 | 4 |
|
| Y | 1 | 2015-05-15 | -P7D | | 13 | STUDYX | QS | 2324-P0001 | 13 | FAC06513 | FAC065-I Feel Close to My Partner | FAACT V4 | SOCIAL/FAMILY WELL-BEING | Very much | 4 | 4 |
|
| Y | 1 | 2015-05-15 | -P7D | | 14 | STUDYX | QS | 2324-P0001 | 14 | FAC06514 | FAC065-I Am Satisfied With My Sex Life | FAACT V4 | SOCIAL/FAMILY WELL-BEING |
|
|
| NOT DONE | PREFER NOT TO ANSWER | Y| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | QRSSUPP-693 |
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|
| 1 | 2015-05-15 | -P7D | | 15 | STUDYX | QS | 2324-P0001 | 15 | FAC06515 | FAC065-I Feel Sad | FAACT V4 | EMOTIONAL WELL-BEING | A little bit | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | | 16 | STUDYX | QS | 2324-P0001 | 16 | FAC06516 | FAC065-Satisfied With How I Am Coping | FAACT V4 | EMOTIONAL WELL-BEING | Quite a bit | 3 | 3 |
|
| Y | 1 | 2015-05-15 | -P7D | | 17 | STUDYX | QS | 2324-P0001 | 17 | FAC06517 | FAC065-Losing Hope Against Illness | FAACT V4 | EMOTIONAL WELL-BEING | A little bit | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | | 18 | STUDYX | QS | 2324-P0001 | 18 | FAC06518 | FAC065-I Feel Nervous | FAACT V4 | EMOTIONAL WELL-BEING | A little bit | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | | 19 | STUDYX | QS | 2324-P0001 | 19 | FAC06519 | FAC065-I Worry About Dying | FAACT V4 | EMOTIONAL WELL-BEING | A little bit | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | | 20 | STUDYX | QS | 2324-P0001 | 20 | FAC06520 | FAC065-Worry My Condition Will Get Worse | FAACT V4 | EMOTIONAL WELL-BEING | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | | 21 | STUDYX | QS | 2324-P0001 | 21 | FAC06521 | FAC065-I Am Able to Work | FAACT V4 | FUNCTIONAL WELL-BEING | A little bit | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | | 22 | STUDYX | QS | 2324-P0001 | 22 | FAC06522 | FAC065-My Work Is Fulfilling | FAACT V4 | FUNCTIONAL WELL-BEING | Quite a bit | 3 | 3 |
|
| Y | 1 | 2015-05-15 | -P7D | | 23 | STUDYX | QS | 2324-P0001 | 23 | FAC06523 | FAC065-I Am Able to Enjoy Life | FAACT V4 | FUNCTIONAL WELL-BEING | Quite a bit | 3 | 3 |
|
| Y | 1 | 2015-05-15 | -P7D | | 24 | STUDYX | QS | 2324-P0001 | 24 | FAC06524 | FAC065-I Have Accepted My Illness | FAACT V4 | FUNCTIONAL WELL-BEING | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | | 25 | STUDYX | QS | 2324-P0001 | 25 | FAC06525 | FAC065-I Am Sleeping Well | FAACT V4 | FUNCTIONAL WELL-BEING | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | | 26 | STUDYX | QS | 2324-P0001 | 26 | FAC06526 | FAC065-Enjoy Things I Usually Do for Fun | FAACT V4 | FUNCTIONAL WELL-BEING | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | | 27 | STUDYX | QS | 2324-P0001 | 27 | FAC06527 | FAC065-Content With Quality of My Life | FAACT V4 | FUNCTIONAL WELL-BEING | Quite a bit | 3 | 3 |
|
| Y | 1 | 2015-05-15 | -P7D | | 28 | STUDYX | QS | 2324-P0001 | 28 | FAC06528 | FAC065-I Have a Good Appetite | FAACT V4 | ADDITIONAL CONCERNS | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | | 29 | STUDYX | QS | 2324-P0001 | 29 | FAC06529 | FAC065-Amount I Eat Is Sufficient | FAACT V4 | ADDITIONAL CONCERNS | Not at all | 0 | 0 |
|
| Y | 1 | 2015-05-15 | -P7D | | 30 | STUDYX | QS | 2324-P0001 | 30 | FAC06530 | FAC065-I Am Worried About My Weight | FAACT V4 | ADDITIONAL CONCERNS | Quite a bit | 3 | 3 |
|
| Y | 1 | 2015-05-15 | -P7D | | 31 | STUDYX | QS | 2324-P0001 | 31 | FAC06531 | FAC065-Most Food Tastes Unpleasant to Me | FAACT V4 | ADDITIONAL CONCERNS | Quite a bit | 3 | 3 |
|
| Y | 1 | 2015-05-15 | -P7D | | 32 | STUDYX | QS | 2324-P0001 | 32 | FAC06532 | FAC065-I Am Concerned How Thin I Look | FAACT V4 | ADDITIONAL CONCERNS | A little bit | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | | 33 | STUDYX | QS | 2324-P0001 | 33 | FAC06533 | FAC065-Interest in Food Drops Try to Eat | FAACT V4 | ADDITIONAL CONCERNS | Quite a bit | 3 | 3 |
|
| Y | 1 | 2015-05-15 | -P7D | | 34 | STUDYX | QS | 2324-P0001 | 34 | FAC06534 | FAC065-Have Difficulty Eating Rich Foods | FAACT V4 | ADDITIONAL CONCERNS | Not at all | 0 | 0 |
|
| Y | 1 | 2015-05-15 | -P7D | | 35 | STUDYX | QS | 2324-P0001 | 35 | FAC06535 | FAC065-My Family Pressuring Me to Eat | FAACT V4 | ADDITIONAL CONCERNS | A little bit | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | | 36 | STUDYX | QS | 2324-P0001 | 36 | FAC06536 | FAC065-I Have Been Vomiting | FAACT V4 | ADDITIONAL CONCERNS | A little bit | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | | 37 | STUDYX | QS | 2324-P0001 | 37 | FAC06537 | FAC065-I Seem to Get Full Quickly | FAACT V4 | ADDITIONAL CONCERNS | Somewhat | 2 | 2 |
|
| Y | 1 | 2015-05-15 | -P7D | | 38 | STUDYX | QS | 2324-P0001 | 38 | FAC06538 | FAC065-I Have Pain in My Stomach Area | FAACT V4 | ADDITIONAL CONCERNS | A little bit | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | | 39 | STUDYX | QS | 2324-P0001 | 39 | FAC06539 | FAC065-My General Health Is Improving | FAACT V4 | ADDITIONAL CONCERNS | A little bit | 1 | 1 |
|
| Y | 1 | 2015-05-15 | -P7D | | 40 | STUDYX | QS | 2324-P0001 | 40 | FAC06540 | FAC065-Physical Subscale Score | FAACT V4 |
| 22 | 22 | 22 |
|
| Y | 1 | 2015-05-15 | -P7D | | 41 | STUDYX | QS | 2324-P0001 | 41 | FAC06541 | FAC065-Social/Family Subscale Score | FAACT V4 |
| 22 | 22 | 22 |
|
| Y | 1 | 2015-05-15 | -P7D | | 42 | STUDYX | QS | 2324-P0001 | 42 | FAC06542 | FAC065-Emotional Subscale Score | FAACT V4 |
| 17 | 17 | 17 |
|
| Y | 1 | 2015-05-15 | -P7D | | 43 | STUDYX | QS | 2324-P0001 | 43 | FAC06543 | FAC065-Functional Subscale Score | FAACT V4 |
| 16 | 16 | 16 |
|
| Y | 1 | 2015-05-15 | -P7D | | 44 | STUDYX | QS | 2324-P0001 | 44 | FAC06544 | FAC065-Additional Concern Subscale Score | FAACT V4 |
| 24 | 24 | 24 |
|
| Y | 1 | 2015-05-15 | -P7D | | 45 | STUDYX | QS | 2324-P0001 | 45 | FAC06545 | FAC065-Trial Outcome Index Score | FAACT V4 |
| 62 | 62 | 62 |
|
| Y | 1 | 2015-05-15 | -P7D | | 46 | STUDYX | QS | 2324-P0001 | 46 | FAC06546 | FAC065-FACT-G Total Score | FAACT V4 |
| 77 | 77 | 77 |
|
| Y | 1 | 2015-05-15 | -P7D | | 47 | STUDYX | QS | 2324-P0001 | 47 | FAC06547 | FAC065-Total Score | FAACT V4 |
| 101 | 101 | 101 |
|
| Y | 1 | 2015-05-15 | -P7D | | 48 | STUDYX | QS | 2324-P0001 | 48 | FAC06501 | FAC065-I Have a Lack of Energy | FAACT V4 | PHYSICAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 49 | STUDYX | QS | 2324-P0001 | 49 | FAC06502 | FAC065-I Have Nausea | FAACT V4 | PHYSICAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 50 | STUDYX | QS | 2324-P0001 | 50 | FAC06503 | FAC065-Trouble Meeting Needs of Family | FAACT V4 | PHYSICAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 51 | STUDYX | QS | 2324-P0001 | 51 | FAC06504 | FAC065-I Have Pain | FAACT V4 | PHYSICAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 52 | STUDYX | QS | 2324-P0001 | 52 | FAC06505 | FAC065-Bothered by Treatment Side Effect | FAACT V4 | PHYSICAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 53 | STUDYX | QS | 2324-P0001 | 53 | FAC06506 | FAC065-I Feel Ill | FAACT V4 | PHYSICAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 54 | STUDYX | QS | 2324-P0001 | 54 | FAC06507 | FAC065-I Am Forced to Spend Time in Bed | FAACT V4 | PHYSICAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 55 | STUDYX | QS | 2324-P0001 | 55 | FAC06508 | FAC065-I Feel Close to My Friends | FAACT V4 | SOCIAL/FAMILY WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 56 | STUDYX | QS | 2324-P0001 | 56 | FAC06509 | FAC065-Get Emotional Support From Family | FAACT V4 | SOCIAL/FAMILY WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 57 | STUDYX | QS | 2324-P0001 | 57 | FAC06510 | FAC065-I Get Support From My Friends | FAACT V4 | SOCIAL/FAMILY WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 58 | STUDYX | QS | 2324-P0001 | 58 | FAC06511 | FAC065-My Family Has Accepted My Illness | FAACT V4 | SOCIAL/FAMILY WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 59 | STUDYX | QS | 2324-P0001 | 59 | FAC06512 | FAC065-Satisfied Communication Illness | FAACT V4 | SOCIAL/FAMILY WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 60 | STUDYX | QS | 2324-P0001 | 60 | FAC06513 | FAC065-I Feel Close to My Partner | FAACT V4 | SOCIAL/FAMILY WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 61 | STUDYX | QS | 2324-P0001 | 61 | FAC06514 | FAC065-I Am Satisfied With My Sex Life | FAACT V4 | SOCIAL/FAMILY WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 62 | STUDYX | QS | 2324-P0001 | 62 | FAC06515 | FAC065-I Feel Sad | FAACT V4 | EMOTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 63 | STUDYX | QS | 2324-P0001 | 63 | FAC06516 | FAC065-Satisfied With How I Am Coping | FAACT V4 | EMOTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 64 | STUDYX | QS | 2324-P0001 | 64 | FAC06517 | FAC065-Losing Hope Against Illness | FAACT V4 | EMOTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 65 | STUDYX | QS | 2324-P0001 | 65 | FAC06518 | FAC065-I Feel Nervous | FAACT V4 | EMOTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 66 | STUDYX | QS | 2324-P0001 | 66 | FAC06519 | FAC065-I Worry About Dying | FAACT V4 | EMOTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 67 | STUDYX | QS | 2324-P0001 | 67 | FAC06520 | FAC065-Worry My Condition Will Get Worse | FAACT V4 | EMOTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 68 | STUDYX | QS | 2324-P0001 | 68 | FAC06521 | FAC065-I Am Able to Work | FAACT V4 | FUNCTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 69 | STUDYX | QS | 2324-P0001 | 69 | FAC06522 | FAC065-My Work Is Fulfilling | FAACT V4 | FUNCTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 70 | STUDYX | QS | 2324-P0001 | 70 | FAC06523 | FAC065-I Am Able to Enjoy Life | FAACT V4 | FUNCTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 71 | STUDYX | QS | 2324-P0001 | 71 | FAC06524 | FAC065-I Have Accepted My Illness | FAACT V4 | FUNCTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 72 | STUDYX | QS | 2324-P0001 | 72 | FAC06525 | FAC065-I Am Sleeping Well | FAACT V4 | FUNCTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 73 | STUDYX | QS | 2324-P0001 | 73 | FAC06526 | FAC065-Enjoy Things I Usually Do for Fun | FAACT V4 | FUNCTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 74 | STUDYX | QS | 2324-P0001 | 74 | FAC06527 | FAC065-Content With Quality of My Life | FAACT V4 | FUNCTIONAL WELL-BEING |
|
|
| NOT DONE |
|
| 2 |
|
| | 75 | STUDYX | QS | 2324-P0001 | 75 | FAC06528 | FAC065-I Have a Good Appetite | FAACT V4 | ADDITIONAL CONCERNS |
|
|
| NOT DONE |
|
| 2 |
|
| | 76 | STUDYX | QS | 2324-P0001 | 76 | FAC06529 | FAC065-Amount I Eat Is Sufficient | FAACT V4 | ADDITIONAL CONCERNS |
|
|
| NOT DONE |
|
| 2 |
|
| | 77 | STUDYX | QS | 2324-P0001 | 77 | FAC06530 | FAC065-I Am Worried About My Weight | FAACT V4 | ADDITIONAL CONCERNS |
|
|
| NOT DONE |
|
| 2 |
|
| | 78 | STUDYX | QS | 2324-P0001 | 78 | FAC06531 | FAC065-Most Food Tastes Unpleasant to Me | FAACT V4 | ADDITIONAL CONCERNS |
|
|
| NOT DONE |
|
| 2 |
|
| | 79 | STUDYX | QS | 2324-P0001 | 79 | FAC06532 | FAC065-I Am Concerned How Thin I Look | FAACT V4 | ADDITIONAL CONCERNS |
|
|
| NOT DONE |
|
| 2 |
|
| | 80 | STUDYX | QS | 2324-P0001 | 80 | FAC06533 | FAC065-Interest in Food Drops Try to Eat | FAACT V4 | ADDITIONAL CONCERNS |
|
|
| NOT DONE |
|
| 2 |
|
| | 81 | STUDYX | QS | 2324-P0001 | 81 | FAC06534 | FAC065-Have Difficulty Eating Rich Foods | FAACT V4 | ADDITIONAL CONCERNS |
|
|
| NOT DONE |
|
| 2 |
|
| | 82 | STUDYX | QS | 2324-P0001 | 82 | FAC06535 | FAC065-My Family Pressuring Me to Eat | FAACT V4 | ADDITIONAL CONCERNS |
|
|
| NOT DONE |
|
| 2 |
|
| | 83 | STUDYX | QS | 2324-P0001 | 83 | FAC06536 | FAC065-I Have Been Vomiting | FAACT V4 | ADDITIONAL CONCERNS |
|
|
| NOT DONE |
|
| 2 |
|
| | 84 | STUDYX | QS | 2324-P0001 | 84 | FAC06537 | FAC065-I Seem to Get Full Quickly | FAACT V4 | ADDITIONAL CONCERNS |
|
|
| NOT DONE |
|
| 2 |
|
| | 85 | STUDYX | QS | 2324-P0001 | 85 | FAC06538 | FAC065-I Have Pain in My Stomach Area | FAACT V4 | ADDITIONAL CONCERNS |
|
|
| NOT DONE |
|
| 2 |
|
| | 86 | STUDYX | QS | 2324-P0001 | 86 | FAC06539 | FAC065-My General Health Is Improving | FAACT V4 | ADDITIONAL CONCERNS |
|
|
| NOT DONE |
|
| 2 |
|
| | 87 | STUDYX | QS | 2324-P0001 | 87 | FAC06540 | FAC065-Physical Subscale Score | FAACT V4 |
|
|
|
| NOT DONE |
|
| 2 |
|
| | 88 | STUDYX | QS | 2324-P0001 | 88 | FAC06541 | FAC065-Social/Family Subscale Score | FAACT V4 |
|
|
|
| NOT DONE |
|
| 2 |
|
| | 89 | STUDYX | QS | 2324-P0001 | 89 | FAC06542 | FAC065-Emotional Subscale Score | FAACT V4 |
|
|
|
| NOT DONE |
|
| 2 |
|
| | 90 | STUDYX | QS | 2324-P0001 | 90 | FAC06543 | FAC065-Functional Subscale Score | FAACT V4 |
|
|
|
| NOT DONE |
|
| 2 |
|
| | 91 | STUDYX | QS | 2324-P0001 | 91 | FAC06544 | FAC065-Additional Concern Subscale Score | FAACT V4 |
|
|
|
| NOT DONE |
|
| 2 |
|
| | 92 | STUDYX | QS | 2324-P0001 | 92 | FAC06545 | FAC065-Trial Outcome Index Score | FAACT V4 |
|
|
|
| NOT DONE |
|
| 2 |
|
| | 93 | STUDYX | QS | 2324-P0001 | 93 | FAC06546 | FAC065-FACT-G Total Score | FAACT V4 |
|
|
|
| NOT DONE |
|
| 2 |
|
| | 94 | STUDYX | QS | 2324-P0001 | 94 | FAC06547 | FAC065-Total Score | FAACT V4 |
|
|
|
| NOT DONE |
|
| 2 |
|
|
|
|
...
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, Assumptions, items on the FAACT V4 are grouped into subcategories. The following 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.
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