Table 2.
Frequency of events
| Event | Number of patients | Number of events (%) | Hazard model | Exposure covariatea |
|---|---|---|---|---|
| Efficacy | ||||
| Tumor progression, locally assessed | 416 | 321 (77.2) | Not done | Not done |
| Tumor progression, centrally assessed | 401 | 261 (65.1) | Weibull | AUC12AV |
| Safety | ||||
| Grade ≥ 3 AEs | 413 | 259 (62.7) | Constant + Gompertz | Average dose |
| Grade ≥ 4 AEs | 413 | 47 (11.4) | Gompertz | None |
| Grade ≥ 2 diarrhea | 413 | 59 (14.3) | Weibull | Dose rate |
| Grade 3 HFSRs | 413 | 47 (11.4) | Constant + Gompertz | Average dose |
| Grade ≥ 3 hypertension | 413 | 24 (5.8) | Constant | AUC12AV |
AE, adverse event; AUC12AV, average area under the curve during the dosing interval of 12 hours (exposure); HFSRs, hand‐foot skin reactions.
a
Selected exposure covariate that influences the hazard significantly (P < 0.01).