Table 2.
Safety profile of patients in phase Ib and phase II.
| Phase II | |||
|---|---|---|---|
| Samotolisib+enzalutamide | Placebo+enzalutamide | ||
| Phase Ib | n = 65 | n = 64 | |
| Total AEsa | 13 (100.0) | 64 (98.5) | 63 (98.4) |
| Grade ≥3 AEs | 10 (76.9) | 35 (53.8) | 33 (51.6) |
| Discontinuation due to AE | 2 (15.4) | 13 (20.0) | 4 (6.3) |
| Serious AEs | 5 (38.5) | 13 (20.0) | 12 (18.8) |
| Death | 0 (0.0) | 0 (0.0) | 3 (4.7) |
| TEAEs, >15% of all patients, any grade | |||
| Fatigue | 7 (53.8) | 41 (63.1) | 36 (56.3) |
| Nausea | 10 (76.9) | 38 (58.5) | 25 (39.1) |
| Diarrhea | 7 (53.8) | 40 (61.5) | 10 (15.6) |
| Decreased appetite | 5 (38.5) | 20 (30.8) | 14 (21.9) |
| Anemia | 2 (15.4) | 12 (18.5) | 19 (29.7) |
| Constipation | 2 (15.4) | 11 (16.9) | 12 (18.8) |
Note: All values are represented in n (%), unless otherwise specified.
Abbreviation: n, number of patients in each category.
aTotal AEs could be drug-related or non–drug-related.