Summary of AEs
| AEs | Placebo BID and carbo/paclitaxel (N = 52) | Veliparib BID and carbo/paclitaxel (N = 105) |
|---|---|---|
| Any grade AE, n (%) | 46 (89) | 101 (96) |
| Any grade ≥3 AE, n (%) | 30 (58) | 72 (69) |
| Any SAE | 12 (23) | 28 (27) |
| Alopecia | 22 (42) | 41 (39) |
| Neutropenia | 15 (29) | 38 (36) |
| Anemia | 21 (40) | 33 (31) |
| Nausea | 13 (25) | 29 (28) |
| Peripheral neuropathy | 13 (25) | 25 (24) |
| Fatigue | 13 (25) | 24 (23) |
| Arthralgia | 7 (13) | 20 (19) |
| Dyspnea | 6 (12) | 16 (15) |
| Decreased appetite | 9 (17) | 14 (13) |
| Diarrhea | 8 (15) | 13 (12) |
| Thrombocytopenia | 8 (15) | 13 (12) |
| Myalgia | 4 (8) | 13 (12) |
| Pain | 6 (12) | 12 (11) |
| Constipation | 7 (13) | 9 (9) |
| Cough | 8 (15) | 8 (8) |
| Unbalanced AE, n (%) | ||
| Leukopenia | 0 (0) | 12 (11) |
| Grade ≥3 AEs, n (%) | ||
| Neutropenia | 12 (23) | 20 (19) |
| Anemia | 5 (10) | 11 (10) |
| Alopecia | 3 (6) | 7 (7) |
| Leukopenia | 0 (0) | 6 (6) |
| Thrombocytopenia | 3 (6) | 5 (5) |
| Nausea | 0 (0) | 4 (4) |
| Hyperkalemia | 1 (2) | 4 (4) |
| Arthralgia | 0 (0) | 3 (3) |
| Fatigue | 0 (0) | 3 (3) |
| Hypersensitivity | 0 (0) | 3 (3) |
| Hyponatremia | 1 (2) | 2 (2) |
| Myalgia | 0 (0) | 2 (2) |
| Weight loss | 0 (0) | 2 (2) |
NOTE: Analyses of safety were performed using data from the 157 patients who received at least 1 dose of study drug. Toxicity of any grade occurring in ≥10% of patients and grade ≥3 occurring in >1 patient are reported.
Abbreviations: carbo, carboplatin; SAE, serious adverse event.