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| Title | European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Palliative Care Version 1.0 (EORTC QLQ-C15-PAL V1.0)
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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 | Prostate Cancer Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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| Supplement Version | 1.0 |
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| Status | FINALDRAFT |
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| Date | 2022-0410-2811 |
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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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| 2022-0410-2811 | 1.0 FinalDraft |
© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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The table represents the items from the EORTC QLQ-C15-PAL V1.0 instrument instrument. The subject did not fill out the instrument at the scheduled VISITNUM = 2.Rows 16-30 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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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSMETHOD | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT | | 1 | STUDYX | QS | 2324-P0001 | 1 | EOR0201 | EOR02-Trouble Taking Short Walk Outside | EORTC QLQ-C15-PAL V1.0 | Not at All | 1 | 1 |
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| Y | 1 | 2015-11-1 |
| | 2 | STUDYX | QS | 2324-P0001 | 2 | EOR0202 | EOR02-Stay in Bed/Chair During the Day | EORTC QLQ-C15-PAL V1.0 | A Little | 2 | 2 |
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| Y | 1 | 2015-11-1 |
| | 3 | STUDYX | QS | 2324-P0001 | 3 | EOR0203 | EOR02-Need Help Eating/Dressing/Washing | EORTC QLQ-C15-PAL V1.0 | Quite a Bit | 3 | 3 |
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| Y | 1 | 2015-11-1 |
| | 4 | STUDYX | QS | 2324-P0001 | 4 | EOR0204 | EOR02-Were You Short of Breath | EORTC QLQ-C15-PAL V1.0 | Very Much | 4 | 4 |
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| Y | 1 | 2015-11-1 | -P1W | | 5 | STUDYX | QS | 2324-P0001 | 5 | EOR0205 | EOR02-Have You Had Pain | EORTC QLQ-C15-PAL V1.0 | Not at All | 1 | 1 |
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| Y | 1 | 2015-11-1 | -P1W | | 6 | STUDYX | QS | 2324-P0001 | 6 | EOR0206 | EOR02-Have You Had Trouble Sleeping | EORTC QLQ-C15-PAL V1.0 | A Little | 2 | 2 |
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| Y | 1 | 2015-11-1 | -P1W | | 7 | STUDYX | QS | 2324-P0001 | 7 | EOR0207 | EOR02-Have You Felt Weak | EORTC QLQ-C15-PAL V1.0 | Quite a Bit | 3 | 3 |
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| Y | 1 | 2015-11-1 | -P1W | | 8 | STUDYX | QS | 2324-P0001 | 8 | EOR0208 | EOR02-Have You Lacked Appetite | EORTC QLQ-C15-PAL V1.0 | Very Much | 4 | 4 |
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| Y | 1 | 2015-11-1 | -P1W | | 9 | STUDYX | QS | 2324-P0001 | 9 | EOR0209 | EOR02-Have You Felt Nauseated | EORTC QLQ-C15-PAL V1.0 | Not at All | 1 | 1 |
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| Y | 1 | 2015-11-1 | -P1W | | 10 | STUDYX | QS | 2324-P0001 | 10 | EOR0210 | EOR02-Have You Been Constipated | EORTC QLQ-C15-PAL V1.0 | A Little | 2 | 2 |
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| Y | 1 | 2015-11-1 | -P1W | | 11 | STUDYX | QS | 2324-P0001 | 11 | EOR0211 | EOR02-Were You Tired | EORTC QLQ-C15-PAL V1.0 | Quite a Bit | 3 | 3 |
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| Y | 1 | 2015-11-1 | -P1W | | 12 | STUDYX | QS | 2324-P0001 | 12 | EOR0212 | EOR02-Pain Interfere Daily Activities | EORTC QLQ-C15-PAL V1.0 | Very Much | 4 | 4 |
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| Y | 1 | 2015-11-1 | -P1W | | 13 | STUDYX | QS | 2324-P0001 | 13 | EOR0213 | EOR02-Did You Feel Tense | EORTC QLQ-C15-PAL V1.0 | Not at All | 1 | 1 |
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| Y | 1 | 2015-11-1 | -P1W | | 14 | STUDYX | QS | 2324-P0001 | 14 | EOR0214 | EOR02-Did You Feel Depressed | EORTC QLQ-C15-PAL V1.0 | A Little | 2 | 2 |
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| Y | 1 | 2015-11-1 | -P1W | | 15 | STUDYX | QS | 2324-P0001 | 15 | EOR0215 | EOR02-Rate Your Overall Quality of Life | EORTC QLQ-C15-PAL V1.0 | Excellent | 7 | 7 |
| NUMERICAL RATING SCALE 7-POINT | Y | 1 | 2015-11-1 | -P1W | | 16 | STUDYX | QS | 2324-P0001 | 16 | EOR0201 | EOR02-Trouble Taking Short Walk Outside | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 22015-11-8 |
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| | 17 | STUDYX | QS | 2324-P0001 | 17 | EOR0202 | EOR02-Stay in Bed/Chair During the Day | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 |
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| | 18 | STUDYX | QS | 2324-P0001 | 18 | EOR0203 | EOR02-Need Help Eating/Dressing/Washing | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 |
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| | 19 | STUDYX | QS | 2324-P0001 | 19 | EOR0204 | EOR02-Were You Short of Breath | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 22015-11-8 | -P1W |
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| | 20 | STUDYX | QS | 2324-P0001 | 20 | EOR0205 | EOR02-Have You Had Pain | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 | -P1W |
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| | 21 | 21 | STUDYX | QS | 2324-P0001 | 21 | EOR0206 | EOR02-Have You Had Trouble Sleeping | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 | -P1W |
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| | 22 | STUDYX | QS | 2324-P0001 | 22 | EOR0207 | EOR02-Have You Felt Weak | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 | -P1W |
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| | 23 | STUDYX | QS | 2324-P0001 | 23 | EOR0208 | EOR02-Have You Lacked Appetite | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 | -P1W |
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| | 24 | STUDYX | QS | 2324-P0001 | 24 | EOR0209 | EOR02-Have You Felt Nauseated | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 | -P1W |
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| | 25 | STUDYX | QS | 2324-P0001 | 25 | EOR0210 | EOR02-Have You Been Constipated | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 | -P1W |
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| | 26 | STUDYX | QS | 2324-P0001 | 26 | EOR0211 | EOR02-Were You Tired | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 | -P1W |
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| | 27 | STUDYX | QS | 2324-P0001 | 27 | EOR0212 | EOR02-Pain Interfere Daily Activities | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 | -P1W |
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| | 28 | STUDYX | QS | 2324-P0001 | 28 | EOR0213 | EOR02-Did You Feel Tense | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 | -P1W |
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| | 29 | STUDYX | QS | 2324-P0001 | 29 | EOR0214 | EOR02-Did You Feel Depressed | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 | -P1W |
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| | 30 | STUDYX | QS | 2324-P0001 | 30 | EOR0215 | EOR02-Rate Your Overall Quality of Life | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE | NUMERICAL RATING SCALE 7-POINT |
| 2 | 2015-11-8 | -P1W |
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The anchor text and numeric values for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.
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