Example | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSEVAL | VISITNUM | VISIT | RSDTC | RSDY |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
IG33_RS_RS_001 | ABC | RS | 44444 | 1 | TRGRESP | Target Response | RECIST 1.1 | PR | PR | INVESTIGATOR | 40 | WEEK 6 | 2010-02-18 | 46 | |
IG33_RS_RS_001 | ABC | RS | 44444 | 2 | NTRGRESP | Non-target Response | RECIST 1.1 | SD | SD | INVESTIGATOR | 40 | WEEK 6 | 2010-02-18 | 46 | |
IG33_RS_RS_001 | ABC | RS | 44444 | 3 | A2 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | INVESTIGATOR | 40 | WEEK 6 | 2010-02-18 | 46 |
IG33_RS_RS_001 | ABC | RS | 44444 | 4 | TRGRESP | Target Response | RECIST 1.1 | NE | NE | INVESTIGATOR | 60 | WEEK 12 | 2010-04-02 | 88 | |
IG33_RS_RS_001 | ABC | RS | 44444 | 5 | NTRGRESP | Non-target Response | RECIST 1.1 | NE | NE | INVESTIGATOR | 60 | WEEK 12 | 2010-04-02 | 88 | |
IG33_RS_RS_001 | ABC | RS | 44444 | 6 | SYMPTDTR | Symptomatic Deterioration | PROTOCOL DEFINED RESPONSE CRITERIA | Pleural Effusion | PD | INVESTIGATOR | 60 | WEEK 12 | 2010-04-02 | 88 | |
IG33_RS_RS_001 | ABC | RS | 44444 | 7 | A3 | OVRLRESP | Overall Response | PROTOCOL DEFINED RESPONSE CRITERIA | PD | PD | INVESTIGATOR | 60 | WEEK 12 | 2010-04-02 | 88 |
Example | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSNAM | RSEVAL | RSEVALID | RSACPTFL | VISITNUM | VISIT | RSDTC | RSDY |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
IG33_RS_RS_002 | ABC | RS | 55555 | 1 | TRGRESP | Target Response | RECIST 1.1 | PR | PR | ACE IMAGING | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | Y | 40 | WEEK 6 | 2010-02-18 | 46 | |
IG33_RS_RS_002 | ABC | RS | 55555 | 2 | NTRGRESP | Non-target Response | RECIST 1.1 | CR | CR | ACE IMAGING | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | Y | 40 | WEEK 6 | 2010-02-18 | 46 | |
IG33_RS_RS_002 | ABC | RS | 55555 | 3 | NEWLPROG | New Lesion Progression | RECIST 1.1 | EQUIVOCAL | EQUIVOCAL | ACE IMAGING | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | Y | 40 | WEEK 6 | 2010-02-18 | 46 | |
IG33_RS_RS_002 | ABC | RS | 55555 | 4 | A2 | OVRLRESP | Overall Response | RECIST 1.1 | PR | PR | ACE IMAGING | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | Y | 40 | WEEK 6 | 2010-02-18 | 46 |
IG33_RS_RS_002 | ABC | RS | 55555 | 5 | TRGRESP | Target Response | RECIST 1.1 | PD | PD | ACE IMAGING | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | Y | 60 | WEEK 12 | 2010-04-02 | 88 | |
IG33_RS_RS_002 | ABC | RS | 55555 | 6 | NTRGRESP | Non-target Response | RECIST 1.1 | CR | CR | ACE IMAGING | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | Y | 60 | WEEK 12 | 2010-04-02 | 88 | |
IG33_RS_RS_002 | ABC | RS | 55555 | 7 | NEWLPROG | New Lesion Progression | RECIST 1.1 | UNEQUIVOCAL | UNEQUIVOCAL | ACE IMAGING | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | Y | 60 | WEEK 12 | 2010-04-02 | 88 | |
IG33_RS_RS_002 | ABC | RS | 55555 | 8 | A3 | OVRLRESP | Overall Response | RECIST 1.1 | PD | PD | ACE IMAGING | INDEPENDENT ASSESSOR | RADIOLOGIST 1 | Y | 60 | WEEK 12 | 2010-04-02 | 88 |
Example | STUDYID | DOMAIN | USUBJID | RSSEQ | RSLNKGRP | RSTESTCD | RSTEST | RSCAT | RSSTTPT | RSSTRTPT | RSENRTPT | RSENTPT | RSORRES | RSORRESU | RSSTRESC | RSSTRESN | RSSTRESU | RSEVAL | VISITNUM | VISIT | RSDTC | RSDY |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
IG33_RS_RS_003 | ABC | RS | 55555 | 1 | CM1 | OVRLRESP | Overall Response | UNSPECIFIED | BEFORE | SCREEN | PD | PD | INVESTIGATOR | 10 | SCREEN | 2010-02-18 | -32 | |||||
IG33_RS_RS_003 | ABC | RS | 66666 | 2 | CM2 | BESTRESP | Best Response | UNSPECIFIED | BEFORE | SCREEN | SD | SD | INVESTIGATOR | 10 | SCREEN | 2010-02-18 | -32 | |||||
IG33_RS_RS_003 | ABC | RS | 66666 | 3 | PR2 | BESTRESP | Best Response | UNSPECIFIED | BEFORE | SCREEN | MINIMAL RESPONSE | MINIMAL REPSONSE | INVESTIGATOR | 10 | SCREEN | 2010-02-18 | -32 | |||||
IG33_RS_RS_003 | ABC | RS | 77777 | 4 | CM3 | BESTRESP | Best Response | UNSPECIFIED | AFTER | STUDY TREATMENT DISCONTINUATION | SD | SD | INVESTIGATOR | 240 | FOLLOW-UP MONTH 4 | 2010-04-02 | 520 | |||||
IG33_RS_RS_003 | ABC | RS | 77777 | 5 | CM3 | OVRLRESP | Overall Response | UNSPECIFIED | AFTER | STUDY TREATMENT DISCONTINUATION | PD | PD | INVESTIGATOR | 260 | FOLLOW-UP MONTH 6 | 2010-04-02 | 581 |
Example | STUDYID | DOMAIN | USUBJID | RSSEQ | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSSTRESN | RSLOBXFL | RSEVAL | VISITNUM | RSDTC |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
IG33_RS_RS_004 | STUDYX | RS | P0001 | 1 | SSS01001 | SSS01-Snoring Volume | SMITH SNORING SCALE | loud | 3 | 3 | Y | SPOUSE | 1 | 2012-11-16 |
IG33_RS_RS_004 | STUDYX | RS | P0001 | 2 | SSS01002 | SSS01-Snoring Extent | SMITH SNORING SCALE | 25-50% of sleep time | 2 | 2 | Y | SPOUSE | 1 | 2012-11-16 |
IG33_RS_RS_004 | STUDYX | RS | P0001 | 3 | SSS01003 | SSS01-Snoring Pattern | SMITH SNORING SCALE | very regular | 1 | 1 | Y | SPOUSE | 1 | 2012-11-16 |
IG33_RS_RS_004 | STUDYX | RS | P0001 | 4 | SSS01004 | SSS01-Total Score | SMITH SNORING SCALE | 6 | 6 | 6 | Y | SPOUSE | 1 | 2012-11-16 |