ONCO-EX
Two-arm oncology study (RECIST 1.1), 48 weeks: simulated data
By Kenneth Yan, 2026-10-17.
Reporting efforts
- CSR Clinical study report: the ADaM data sets and the standard outputs · reads SDTM snapshot DBR-1
SDTM snapshots
- DBR-1 2026-10-17 · Simulated SDTM data from the oncology template
SDTM data (simulated)
300 subjects randomized, 300 treated, 211 discontinued, 76 screen failures.
| Domain | Records | Variables |
|---|---|---|
| TA | 6 | 10 |
| TE | 4 | 6 |
| TV | 19 | 8 |
| TI | 62 | 6 |
| TS | 38 | 11 |
| DM | 376 | 26 |
| SE | 974 | 11 |
| SV | 3,709 | 10 |
| EX | 3,036 | 17 |
| DS | 1,352 | 12 |
| AE | 1,268 | 37 |
| CM | 891 | 18 |
| MH | 775 | 10 |
| VS | 22,254 | 21 |
| LB | 117,975 | 23 |
| EG | 8,298 | 22 |
| TU | 1,433 | 18 |
| TR | 12,709 | 23 |
| RS | 3,714 | 20 |
| SS | 1,213 | 15 |
| IE | 76 | 12 |