Form domain | SDTM domain | In no. of trials | No. of forms | No. of data elements |
---|---|---|---|---|
Medical History | MH | 23 | 85 | 1336 |
Adverse Event | AE | 23 | 78 | 2733 |
Laboratory test results | LB | 10 | 75 | 1643 |
Disposition | DS | 19 | 74 | 653 |
Vital Signs | VS | 23 | 56 | 974 |
Concomitant Medications | CM | 22 | 52 | 1334 |
Questionnaire/Patient reported outcome | QS | 16 | 35 | 1122 |
Demographics | DM | 23 | 34 | 371 |
ECG | EG | 12 | 30 | 436 |
Disease Characteristics | (ZC) | 12 | 25 | 190 |
Substance Use | SU | 14 | 22 | 246 |
Surgery | - | 9 | 20 | 80 |
Physical Examination | PE | 5 | 10 | 33 |
Tumor response | RS | 1 | 7 | 27 |