Rowcaps |
---|
Row 1: | Shows that the subject has at least one target tumor (TUTESTCD = "TIND"), i.e., the subject has measurable disease. Prior to SDTMIG 3.4, this row would not be included. However, in SDTMIG 3.4., it is now allowed to include indicator test records in TU. | Row 2: | Shows that the subject does not have any non-target tumors (TUTESTCD = "NTIND"). Prior to SDTMIG 3.4, this row would not be included. However, in SDTMIG 3.4., it is now allowed to include indicator test records in TU. | Row 3: | Shows the single target lesion in the breast. The subject only has one target lesion and no non-targets. | Row 4: | Shows new bone lesion identified at week 24. |
|
Dataset2 |
---|
Row | STUDYID | DOMAIN | USUBJID | TUSEQ | TULNKID | TUTESTCD | TUTEST | TUORRES | TUSTRESC | TULOC | TULAT | TUMETHOD | TUEVAL | EPOCH | VISITNUM | VISIT | TUDTC | TUDY |
---|
1 | EX55555 | TU | 90005 | 1 |
| TIND | Target Indicator | Y | Y |
|
|
| INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 2 | EX55555 | TU | 90005 | 2 |
| NTIND | Non-Target Indicator | N | N |
|
|
| INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 3 | EX55555 | TU | 90005 | 3 | T01 | TUMIDENT | Tumor Identification | TARGET | TARGET | BREAST | RIGHT | CT SCAN | INVESTIGATOR | SCREEN | 1 | SCREENING | 2007-01-01 | 1 | 4 | EX55555 | TU | 90005 | 4 | NEW01 | TUMIDENT | Tumor Identification | NEW | NEW | BONE |
| CT SCAN | INVESTIGATOR | TREATMENT | 7 | WEEK 24 | 2009-06-19 | 168 | |
|