Table 3.
Adverse Events.*
| Adverse Event | Adverse Events Reported during Treatment | Treatment-Related Adverse Events | ||||
|---|---|---|---|---|---|---|
| Phase 1 (N = 12) | Phase 2 (N = 26) | Combined Phase 1–2 (N = 38) | Phase 1 (N = 12) | Phase 2 (N = 26) | Combined Phase 1–2 (N = 38) | |
| number of patients (percent) | ||||||
| Any adverse event | 12 (100) | 26 (100) | 38 (100) | 5 (42) | 11 (42) | 16 (42) |
| Grade ≥2 | 12 (100) | 23 (89) | 35 (92) | 3 (25) | 9 (35) | 12 (32) |
| Grade ≥3 | 9 (75) | 15 (58) | 24 (63) | 0 | 6 (23) | 6 (16) |
| Grade ≥4 | 7 (58) | 7 (27) | 14 (37) | 0 | 0 | 0 |
| Serious adverse event | 9 (75) | 15 (58) | 24 (63) | 0 | 3 (12) | 3 (8) |
| Adverse event leading to dose reduction or interruption of therapy | 5 (42) | 9 (35) | 14 (37) | 0 | 5 (19) | 5 (13) |
| Adverse event leading to discontinuation of therapy | 1 (8) | 1 (4) | 2 (5) | 0 | 0 | 0 |
| Fatal adverse event | 7 (58) | 7 (27) | 14 (37) | 0 | 0 | 0 |
*
Shown are adverse events that occurred during treatment and those that occurred within 30 days after the last dose of sotorasib or the end of the trial, whichever occurred earlier. Relatedness to treatment was determined by the investigators. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.