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 |