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The table represents the items from the NSCLC-SAQ V1.0 instrument| 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-240 |
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. Subject 2324-0001 completed all items. Subject 2324-0002 did not fill out the instrument at VISITNUM = 1 Rows 14-26 show the subject was not evaluated on this instrument at visit 1. Since the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred.
| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| columns | key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | QRSSUPP-241 |
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Subtotal and total score calculations are referenced in the copyrighted user manual.| Info |
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| title | Subjects missing visit information abbreviate |
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The second subject's missing VISITNUM - 1 items were abbreviated by representing the first 3 items and then using the "..." approach to indicate that all items up to the last item represented were missing. We would like input regarding whether you (1) agree with this approach or (2) prefer that all items should be listed in the missing-visit use case moving forward. |
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| Dataset wrap |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT |
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| 1 | STUDYX | QS | 2324-P0001 | 1 | NSCLC101 | NSCLC1-Rate Coughing at Worst | NSCLC-SAQ V1.0 | Moderate Coughing | 2 | 2 |
| Y | 1 | | -P7D | | 2 | STUDYX | QS | 2324-P0001 | 2 | NSCLC102 | NSCLC1-Rate Worst Pain in Chest | | Mild Pain | 1 | 1 |
| Y | 1 | 2015-05-15 | -P7D | | 3 | STUDYX | QS | 2324-P0001 | 3 | NSCLC103 | NSCLC1-Rate Worst Pain Other Than Chest | NSCLC-SAQ V1.0 | Mild Pain | 1 | 1 |
| Y | 1 | 2015-05-15 | -P7D | | 4 | STUDYX | QS | 2324-P0001 | 4 | NSCLC104 | NSCLC1-Short of Breath Usual Activities | NSCLC-SAQ V1.0 | Sometimes | 2 | 2 |
| Y | 1 | 2015-05-15 | -P7D | | 5 | STUDYX | QS | 2324-P0001 | 5 | NSCLC105 | NSCLC1-How Often Low Energy | NSCLC-SAQ V1.0 | Sometimes | 2 | 2 |
| Y | 1 | 2015-05-15 | -P7D | | 6 | STUDYX | QS | 2324-P0001 | 6 | NSCLC106 | NSCLC1-How Often Tire Easily | NSCLC-SAQ V1.0 | Sometimes | 2 | 2 |
| Y | 1 | 2015-05-15 | -P7D | | 7 | STUDYX | QS | 2324-P0001 | 7 | NSCLC107 | NSCLC1-How Often Poor Appetite | NSCLC-SAQ V1.0 | Never | 0 | 0 |
| Y | 1 | 2015-05-15 | -P7D | | 8 | STUDYX | QS | 2324-P0001 | 8 | NSCLC108 | NSCLC1-Cough Domain Subscore | NSCLC-SAQ V1.0 | 2 | 2 | 2 |
| Y | 1 | 2015-05-15 | -P7D | | 9 | STUDYX | QS | 2324-P0001 | 9 | NSCLC109 | NSCLC1-Fatigue Domain Subscore | NSCLC-SAQ V1.0 | 2 | 2 | 2 |
| Y | 1 | 2015-05-15 | -P7D | | 10 | STUDYX | QS | 2324-P0001 | 10 | NSCLC110 | NSCLC1-Pain Domain Subscore | NSCLC-SAQ V1.0 | 1 | 1 | 1 |
| Y | 1 | 2015-05-15 | -P7D | | 11 | STUDYX | QS | 2324-P0001 | 11 | NSCLC111 | NSCLC1-Dyspnea Domain Subscore | NSCLC-SAQ V1.0 | 2 | 2 | 2 |
| Y | 1 | 2015-05-15 | -P7D | | 12 | STUDYX | QS | 2324-P0001 | 12 | NSCLC112 | NSCLC1-Appetite Domain Subscore | NSCLC-SAQ V1.0 | 0 | 0 | 0 |
| Y | 1 | 2015-05-15 | -P7D | | 13 | STUDYX | QS | 2324-P0001 | 13 | NSCLC108 | NSCLC1-Total Score | NSCLC-SAQ V1.0 | | 7 | 7 |
| Y | 1 | 2015-05-15 | -P7D | | 14 | STUDYX | QS | 2324-P0002 | 1 | NSCLC101 | NSCLC1-Rate Coughing at Worst | NSCLC-SAQ V1.0 |
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| NOT DONE |
| 1 | |
| | 2015-05-15 | 15 | STUDYX | QS | 2324-P0002 | 2 | NSCLC102 | NSCLC1-Rate Worst Pain in Chest | |
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| NOT DONE |
| 12015-05-15 |
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| | 16 | STUDYX | QS | 2324-P0002 | 3 | NSCLC103 | NSCLC1-Rate Worst Pain Other Than Chest | NSCLC-SAQ V1.0 |
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| NOT DONE |
| 1 | 2015-05-15 |
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| | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | | 26 | STUDYX | QS | 2324-P0002 | 13 | NSCLC108 | NSCLC1-Total Score | NSCLC-SAQ V1.0 | |
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| NOT DONE |
| 12015-05-15 |
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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.
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