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| Title | Functional Assessment of Cancer Therapy-Hepatobiliary Version 4 (FACT-HEP 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 | Approve |
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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 | 2002-11-0116 |
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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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| 2022-11-0116 | 1.0 Draft |
© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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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 QSCAT. All 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.
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Update the data in the table below to the current instrument. Include row descriptions as needed to highlight idiosyncrasies or items otherwise of note in this particular instrument. If only 1 or 2 row descriptions are needed, then the information should be included as a paragraph instead.
For the not done visit that is now being included in all QRS supplements, when no reason is collected, information should be included, either in the paragraph before, or as a row description as follows:
| Rows 49-60: | Show 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. |
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When the reason is collected for a not done visit, information or a row description should be added as follows:
| Rows 49-60: | 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 --DTC for when the visit was planned. |
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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. |
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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 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.
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| 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. | |
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| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT |
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| 1 | STUDYX | QS | 2324-P0001 | 1 | FAC01501 | FAC015-I Have a Lack of Energy | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 2 | STUDYX | QS | 2324-P0001 | 2 | FAC01502 | FAC015-I Have Nausea | FACT-HEP V4 | Not at all | 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | | 3 | STUDYX | QS | 2324-P0001 | 3 | FAC01503 | FAC015-Trouble Meeting Needs of Family | FACT-HEP V4 | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 4 | STUDYX | QS | 2324-P0001 | 4 | FAC01504 | FAC015-I Have Pain | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 5 | STUDYX | QS | 2324-P0001 | 5 | FAC01505 | FAC015-Botheredby Treatment Side Effect | FACT-HEP V4 | Not at all | 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | | 6 | STUDYX | QS | 2324-P0001 | 6 | FAC01506 | FAC015-I Feel Ill | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 7 | STUDYX | QS | 2324-P0001 | 7 | FAC01507 | FAC015-I Am Forced to Spend Time in Bed | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 8 | STUDYX | QS | 2324-P0001 | 8 | FAC01508 | FAC015-I Feel Close to My Friends | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 9 | STUDYX | QS | 2324-P0001 | 9 | FAC01509 | FAC015-Get Emotional Support From Family | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01510 | FAC015-I Get Support From Friends | FACT-HEP V4 | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 11 | STUDYX | QS | 2324-P0001 | 11 | FAC01511 | FAC015-My Family Has Accepted My Illness | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 12 | STUDYX | QS | 2324-P0001 | 12 | FAC01512 | FAC015-Satisfied Communication Illness | FACT-HEP V4 | Very much | 4 | 4 |
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| Y | 1 | 2015-05-15 | -P7D | | 13 | STUDYX | QS | 2324-P0001 | 13 | FAC01513 | FAC015-I Feel close to My Partner | FACT-HEP V4 | Very much | 4 | 4 |
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| Y | 1 | 2015-05-15 | -P7D | | 14 | STUDYX | QS | 2324-P0001 | 14 | FAC01514 | FAC015-I Am Satisfied With My Sex Life | FACT-HEP V4 |
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| NOT DONE | PREFER NOT TO ANSWER | Y | 1 | 2015-05-15 | -P7D | | 15 | STUDYX | QS | 2324-P0001 | 15 | FAC01515 | FAC015-I Feel Sad | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 16 | STUDYX | QS | 2324-P0001 | 16 | FAC01516 | FAC015-Satisfied With How I Am Coping | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 17 | STUDYX | QS | 2324-P0001 | 17 | FAC01517 | FAC015-Losing Hope Against Illness | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 18 | STUDYX | QS | 2324-P0001 | 18 | FAC01518 | FAC015-I Feel Nervous | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 19 | STUDYX | QS | 2324-P0001 | 19 | FAC01519 | FAC015-I Worry About Dying | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 20 | STUDYX | QS | 2324-P0001 | 20 | FAC01520 | FAC015-Worry My Condition Will Get Worse | FACT-HEP V4 | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 21 | STUDYX | QS | 2324-P0001 | 21 | FAC01521 | FAC015-I Am Able to Work | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 22 | STUDYX | QS | 2324-P0001 | 22 | FAC01522 | FAC015-My Work Is Fulfilling | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 23 | STUDYX | QS | 2324-P0001 | 23 | FAC01523 | FAC015-I Am Able to Enjoy Life | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 24 | STUDYX | QS | 2324-P0001 | 24 | FAC01524 | FAC015-I Have Accepted My Illness | FACT-HEP V4 | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 25 | STUDYX | QS | 2324-P0001 | 25 | FAC01525 | FAC015-I Am Sleeping Well | FACT-HEP V4 | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 26 | STUDYX | QS | 2324-P0001 | 26 | FAC01526 | FAC015-Enjoy Things I Usually Do for Fun | FACT-HEP V4 | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 27 | STUDYX | QS | 2324-P0001 | 27 | FAC01527 | FAC015-Content With Quality of My Life | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 28 | STUDYX | QS | 2324-P0001 | 28 | FAC01528 | FAC015-Swelling/Cramps in Stomach Area | FACT-HEP V4 | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 29 | STUDYX | QS | 2324-P0001 | 29 | FAC01529 | FAC015-I Am Losing Weight | FACT-HEP V4 | Not at all | 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | | 30 | STUDYX | QS | 2324-P0001 | 30 | FAC01530 | FAC015-I Have Control of My Bowels | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 31 | STUDYX | QS | 2324-P0001 | 31 | FAC01531 | FAC015-I Can Digest My Food Well | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 32 | STUDYX | QS | 2324-P0001 | 32 | FAC01532 | FAC015-I Have Diarrhea | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 33 | STUDYX | QS | 2324-P0001 | 33 | FAC01533 | FAC015-I Have a Good Appetite | FACT-HEP V4 | Quite a bit | 3 | 3 |
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| Y | 1 | 2015-05-15 | -P7D | | 34 | STUDYX | QS | 2324-P0001 | 34 | FAC01534 | FAC015-Unhappy About Change in My Appear | FACT-HEP V4 | Not at all | 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | | 35 | STUDYX | QS | 2324-P0001 | 35 | FAC01535 | FAC015-I Have Pain in My Back | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 36 | STUDYX | QS | 2324-P0001 | 36 | FAC01536 | FAC015-I Am Bothered by Constipation | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 37 | STUDYX | QS | 2324-P0001 | 37 | FAC01537 | FAC015-I Feel Fatigued | FACT-HEP V4 | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 38 | STUDYX | QS | 2324-P0001 | 38 | FAC01538 | FAC015-Able to Do My Usual Activities | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 39 | STUDYX | QS | 2324-P0001 | 39 | FAC01539 | FAC015-Bothered by Jaundice/Yellow Skin | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 40 | STUDYX | QS | 2324-P0001 | 40 | FAC01540 | FAC015-I Have Had Fevers | FACT-HEP V4 | Not at all | 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | | 41 | STUDYX | QS | 2324-P0001 | 41 | FAC01541 | FAC015-I Have Had Itching | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 42 | STUDYX | QS | 2324-P0001 | 42 | FAC01542 | FAC015-Had Change in the Way Food Tastes | FACT-HEP V4 | Not at all | 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | | 43 | STUDYX | QS | 2324-P0001 | 43 | FAC01543 | FAC015-I Have Had Chills | FACT-HEP V4 | Not at all | 0 | 0 |
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| Y | 1 | 2015-05-15 | -P7D | | 44 | STUDYX | QS | 2324-P0001 | 44 | FAC01544 | FAC015-My Mouth Is Dry | FACT-HEP V4 | A little bit | 1 | 1 |
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| Y | 1 | 2015-05-15 | -P7D | | 45 | STUDYX | QS | 2324-P0001 | 45 | FAC01545 | FAC015-Discomfort/Pain in Stomach Area | FACT-HEP V4 | Somewhat | 2 | 2 |
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| Y | 1 | 2015-05-15 | -P7D | | 46 | STUDYX | QS | 2324-P0001 | 46 | FAC01546 | FAC015-Physical Subscale Score | FACT-HEP V4 | 6 | 6 | 6 |
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| Y | 1 | 2015-05-15 | -P7D | | 47 | STUDYX | QS | 2324-P0001 | 47 | FAC01547 | FAC015-Social/Family Subscale Score | FACT-HEP V4 | 22.2 | 22.2 | 22.2 |
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| Y | 1 | 2015-05-15 | -P7D | | 48 | STUDYX | QS | 2324-P0001 | 48 | FAC01548 | FAC015-Emotional Subscale Score | FACT-HEP V4 | 9 | 9 | 9 |
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| Y | 1 | 2015-05-15 | -P7D | | 49 | STUDYX | QS | 2324-P0001 | 49 | FAC01549 | FAC015-Functional Subscale Score | FACT-HEP V4 | 16 | 16 | 16 |
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| Y | 1 | 2015-05-15 | -P7D | | 50 | STUDYX | QS | 2324-P0001 | 50 | FAC01550 | FAC015-Additional Concern Subscale Score | FACT-HEP V4 | 22 | 22 | 22 |
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| Y | 1 | 2015-05-15 | -P7D | | 51 | STUDYX | QS | 2324-P0001 | 51 | FAC01551 | FAC015-Trial Outcome Index Score | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 52 | STUDYX | QS | 2324-P0001 | 52 | FAC01552 | FAC015-FACT-G Total Score | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D | | 53 | STUDYX | QS | 2324-P0001 | 53 | FAC01553 | FAC015-Total Score | FACT-HEP V4 |
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| Y | 1 | 2015-05-15 | -P7D |
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| Dataset wrap |
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| Rowcaps |
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| 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 |
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| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT | | 1 | STUDYX | QS | 2324-P0001 | 1 | FAC01501 | FAC015-I Have a Lack of Energy | FACT-HEP V4 |
A little bit | 1Y | 1 | 2015-05-15 |
| -P7D | | 2 | STUDYX | QS | 2324-P0001 | 2 | FAC01502 | FAC015-I Have Nausea | FACT-HEP V4 |
Not at all | 0 | 0 | Y | 201505-15-| P7D | | 3 | STUDYX | QS | 2324-P0001 | 3 | FAC01503 | FAC015-Trouble Meeting Needs of |
FamilyFACT-HEP V4 | Somewhat | 2 | 2 | Y201505-15-| P7D | | 4 | STUDYX | QS | 2324-P0001 | 4 | FAC01504 | FAC015-I Have Pain | FACT-HEP V4 |
A little bit | 1 | Y | 1 | 2015-05-15 |
| -P7D | | 5 | STUDYX | QS | 2324-P0001 | 5 | FAC01505 | FAC015-Botheredby Treatment Side Effect | FACT-HEP V4 |
Not at all | 0 | 0 | Y2015-05-15 |
| -P7D | | 6 | STUDYX | QS | 2324-P0001 | 6 | FAC01506 | FAC015-I Feel Ill | FACT-HEP V4 |
A little bit | 20151 | Y | 1 | 05-15-| P7D | | 7 | STUDYX | QS | 2324-P0001 | 7 | FAC01507 | FAC015-I Am Forced to Spend Time |
in BedFACT-HEP V4 | A little bit | 1 | 1 | Y | 1 | 2015-05-15 | -| P7D | | 8 | STUDYX | QS | 2324-P0001 | 8 | FAC01508 | FAC015-I Feel Close to My Friends | FACT-HEP V4 |
Quite a bit | 3 | 3 | Y | 2015-05-15 |
| -P7D | | 9 | STUDYX | QS | 2324-P0001 | 9 | FAC01509 | FAC015-Get Emotional Support From Family | FACT-HEP V4 |
Quite a bit | 3 | 3Y | 2015-05-15 |
| -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | FAC01510 | FAC015-I Get Support From Friends | FACT-HEP V4 |
Somewhat | 2 | 2 | Y | 201505-15-| P7D | | 11 | STUDYX | QS | 2324-P0001 | 11 | FAC01511 | FAC015-My Family Has Accepted |
My IllnessFACT-HEP V4 | Quite a bit | 3 | 3 | Y | 1 | 2015-05-15 | -| P7D | | 12 | STUDYX | QS | 2324-P0001 | 12 | FAC01512 | FAC015-Satisfied Communication Illness | FACT-HEP V4 |
Very much | 4 | 4 | Y | 2015-05-15 |
| -P7D | | 13 | STUDYX | QS | 2324-P0001 | 13 | FAC01513 | FAC015-I Feel close to My Partner | FACT-HEP V4 |
Very much | 4 | 4 | Y2015-05-15 |
| -P7D | | 14 | STUDYX | QS | 2324-P0001 | 14 | FAC01514 | FAC015-I Am Satisfied With My Sex Life | FACT-HEP V4 |
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| NOT DONE |
PREFER NOT TO ANSWER | Y | 2015-0515-| P7D | | 15 | STUDYX | QS | 2324-P0001 | 15 | FAC01515 | FAC015-I Feel Sad | FACT-HEP V4 |
A little bit | 1 | 1Y | 2015-05-15 |
| -P7D | | 16 | STUDYX | QS | 2324-P0001 | 16 | FAC01516 | FAC015-Satisfied With How I Am Coping | FACT-HEP V4 |
Quite a bit | 33 | Y | 201505-15-| P7D | | 17 | STUDYX | QS | 2324-P0001 | 17 | FAC01517 | FAC015-Losing Hope Against Illness | FACT-HEP V4 |
A little bit | 1 | Y | 1 | 2015-05-15 |
| -P7D | | 18 | STUDYX | QS | 2324-P0001 | 18 | FAC01518 | FAC015-I Feel Nervous | FACT-HEP V4 |
A little bit | 1 | 1 | Y201505-15-| P7D | | 19 | STUDYX | QS | 2324-P0001 | 19 | FAC01519 | FAC015-I Worry About Dying | FACT-HEP V4 |
A little bit | 20151 | Y | 1 | 05-15-| P7D | | 20 | STUDYX | QS | 2324-P0001 | 20 | FAC01520 | FAC015-Worry My Condition Will Get Worse |
FACT-HEP V4 | Somewhat | 2 | 2 | Y201505-15-| P7D | | 21 | STUDYX | QS | 2324-P0001 | 21 | FAC01521 | FAC015-I Am Able to Work | FACT-HEP V4 |
A little bit | 1 | Y | 1 | 2015-05-15 |
| -P7D | | 22 | STUDYX | QS | 2324-P0001 | 22 | FAC01522 | FAC015-My Work Is Fulfilling | FACT-HEP V4 |
Quite a bit | 3 | 3 | Y2015-05-15 |
| -P7D | | 23 | STUDYX | QS | 2324-P0001 | 23 | FAC01523 | FAC015-I Am Able to Enjoy Life | FACT-HEP V4 |
Quite a bit | 3 | 3 | Y | 201505-15-| P7D | | 24 | STUDYX | QS | 2324-P0001 | 24 | FAC01524 | FAC015-I Have Accepted My Illness | FACT-HEP V4 |
Somewhat | 2 | 2 | Y | 1 | 2015-05-15 |
| -P7D | | 25 | STUDYX | QS | 2324-P0001 | 25 | FAC01525 | FAC015-I Am Sleeping Well | FACT-HEP V4 |
Somewhat2 | 2 | Y | 201505-15-| P7D | | 26 | STUDYX | QS | 2324-P0001 | 26 | FAC01526 | FAC015-Enjoy Things I Usually Do for Fun | FACT-HEP V4 |
Somewhat | 2 | 2 | Y | 2015-05-15 |
| -P7D | | 27 | STUDYX | QS | 2324-P0001 | 27 | FAC01527 | FAC015-Content With Quality of My Life | FACT-HEP V4 |
Quite a bit | 3 | 3 | Y201505-15-| P7D | | 28 | STUDYX | QS | 2324-P0001 | 28 | FAC01528 | FAC015-Swelling/Cramps in Stomach Area | FACT-HEP V4 |
Somewhat | 2 | 2 | Y | 201505-15-| P7D | | 29 | STUDYX | QS | 2324-P0001 | 29 | FAC01529 | FAC015-I Am Losing Weight | FACT |
-HEP V4Not at all | 0 | 0 | Y | 1 | 2015-05-15 |
| -P7D | | 30 | STUDYX | QS | 2324-P0001 | 30 | FAC01530 | FAC015-I Have Control of My Bowels | FACT-HEP V4 |
Quite a bit | 3 | 3 | Y | 201505-15-| P7D | | 31 | STUDYX | QS | 2324-P0001 | 31 | FAC01531 | FAC015-I Can Digest My Food Well | FACT-HEP V4 |
Quite a bit3 | 3 | Y | 2015-05-15 |
| -P7D | | 32 | STUDYX | QS | 2324-P0001 | 32 | FAC01532 | FAC015-I Have Diarrhea | FACT-HEP V4 |
A little bit | 2015-051 | Y | 1 | 15-| P7D | | 33 | STUDYX | QS | 2324-P0001 | 33 | FAC01533 | FAC015-I Have a Good Appetite | FACT-HEP V4 |
Quite a bit | 3 | 3Y | 2015-05-15 |
| -P7D | | 34 | STUDYX | QS | 2324-P0001 | 34 | FAC01534 | FAC015-Unhappy About Change in My Appear | FACT-HEP V4 |
Not at all | 00 | Y | 201505-15-| P7D | | 35 | STUDYX | QS | 2324-P0001 | 35 | FAC01535 | FAC015-I Have Pain in My Back | FACT-HEP V4 |
A little bit | 1 | Y | 1 | 2015-05-15 |
| -P7D | | 36 | STUDYX | QS | 2324-P0001 | 36 | FAC01536 | FAC015-I Am Bothered by Constipation | FACT-HEP V4 |
A little bit | 1 | 1 | Y201505-15-| P7D | | 37 | STUDYX | QS | 2324-P0001 | 37 | FAC01537 | FAC015-I Feel Fatigued | FACT-HEP V4 |
Somewhat | 2 | 2 | Y | 201505-15-| P7D | | 38 | STUDYX | QS | 2324-P0001 | 38 | FAC01538 | FAC015-Able to Do My Usual Activities | FACT |
-HEP V4A little bit | 1 | 1 | Y | 1 | 2015-05-15 |
| -P7D | | 39 | STUDYX | QS | 2324-P0001 | 39 | FAC01539 | FAC015-Bothered by Jaundice/Yellow Skin | FACT-HEP V4 |
A little bit | 20151 | Y | 1 | 05-15-| P7D | | 40 | STUDYX | QS | 2324-P0001 | 40 | FAC01540 | FAC015-I Have Had Fevers | FACT-HEP V4 |
Not at all0 | 0 | Y | 2015-05-15 |
| -P7D | | 41 | STUDYX | QS | 2324-P0001 | 41 | FAC01541 | FAC015-I Have Had Itching | FACT-HEP V4 |
A little bit | 2015-051 | Y | 1 | 15-| P7D | | 42 | STUDYX | QS | 2324-P0001 | 42 | FAC01542 | FAC015-Had Change in the Way Food Tastes | FACT-HEP V4 |
Not at all | 0 | 0Y | 2015-05-15 |
| -P7D | | 43 | STUDYX | QS | 2324-P0001 | 43 | FAC01543 | FAC015-I Have Had Chills | FACT-HEP V4 |
Not at all | 00 | Y | 201505-15-| P7D | | 44 | STUDYX | QS | 2324-P0001 | 44 | FAC01544 | FAC015-My Mouth Is Dry | FACT-HEP V4 |
A little bit | 1 | Y | 1 | 2015-05-15 |
| -P7D | | 45 | STUDYX | QS | 2324-P0001 | 45 | FAC01545 | FAC015-Discomfort/Pain in Stomach Area | FACT-HEP V4 |
Somewhat | 2 | 2Y | 2015-05-15 |
| -P7D | | 46 | STUDYX | QS | 2324-P0001 | 46 | FAC01546 | FAC015-Physical Subscale Score | FACT-HEP V4 |
6 | 6 | 6 | Y | 201505-15-| P7D | | 47 | STUDYX | QS | 2324-P0001 | 47 | FAC01547 | FAC015-Social/Family Subscale Score | FACT-HEP |
V422.2 | 22.2 | 22.2 | Y | 1 | 2015-05-15 |
| -P7D | | 48 | STUDYX | QS | 2324-P0001 | 48 | FAC01548 | FAC015-Emotional Subscale Score | FACT-HEP V4 |
9 | 9 | 9 | Y | 2015-0515-| P7D | | 49 | STUDYX | QS | 2324-P0001 | 49 | FAC01549 | FAC015-Functional Subscale Score | FACT-HEP V4 |
16 | 16 | 16 | Y201505-15-| P7D | | 50 | STUDYX | QS | 2324-P0001 | 50 | FAC01550 | FAC015-Additional Concern Subscale Score | FACT-HEP V4 |
22 | 22 | 22 | Y201505-15-| P7D | | 51 | STUDYX | QS | 2324-P0001 | 51 | FAC01551 | FAC015-Trial Outcome Index Score | FACT-HEP V4 |
Y | 2015-0515-| P7D | | 52 | STUDYX | QS | 2324-P0001 | 52 | FAC01552 | FAC015-FACT-G Total Score | FACT-HEP V4 |
Y | 2015-05-15 |
| -P7D | | 53 | STUDYX | QS | 2324-P0001 | 53 | FAC01553 | FAC015-Total Score | FACT-HEP V4 |
Y | 2015-05-15 |
|
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.
...
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.
| QSSCAT | QSTESTCD |
|---|
| PHYSICAL WELL-BEING | FAC01501 - FAC01507 |
| SOCIAL/FAMILY WELL-BEING | FAC01508 - FAC01514 |
| EMOTIONAL WELL-BEING | FAC01515 - FAC01520 |
| FUNCTIONAL WELL-BEING | FAC01521 - FAC01527 |
| ADDITIONAL CONCERNS | FAC01528 - FAC01545 |
All QSTESTCDs
QSORRES | QSSTRESC | QSSTRESN |
|---|
| Not at all | 0 | 0 |
| A little bit | 1 | 1 |
| Somewhat | 2 | 2 |
| Quite a bit | 3 | 3 |
| Very much | 4 | 4 |
End of Document