Table 3.
Summary of adverse events
| Placebo + WBRT (N = 101)a | Veliparib 50 mg + WBRT (N = 103) | Veliparib 200 mg + WBRT (N = 102) | |
|---|---|---|---|
| Any AE, n (%) | 91 (90) | 90 (87) | 90 (98) |
| Any grade 3/4, n (%) | 43 (43) | 29 (28)b | 26 (25)b |
| Any SAE, n (%) | 39 (39) | 31 (30) | 36 (35) |
| Any fatal AE, n (%) | 13 (13) | 11 (11) | 18 (18) |
| Any AE (≥10 % patients), n (%) | |||
| Nausea | 30 (30) | 23 (22) | 32 (31) |
| Fatigue | 22 (22) | 27 (26) | 21 (21) |
| Alopecia | 19 (19) | 15 (15) | 15 (15) |
| Headache | 15 (15) | 18 (17) | 21 (21) |
| Decreased appetite | 14 (14) | 11 (11) | 15 (15) |
| Dyspnea | 14 (14) | 8 (8) | 11 (11) |
| Constipation | 12 (12) | 10 (10) | 11 (11) |
| Insomnia | 11 (11) | 10 (10) | 6 (6) |
| Asthenia | 11 (11) | 9 (9) | 13 (13) |
| Dizziness | 11 (11) | 8 (8) | 10 (10) |
| Malignant neoplasm progression | 8 (8) | 11 (11) | 18 (18) |
| Any Grade 3/4 AE (≥3 % patients), n (%) | |||
| Pneumonia | 6 (8) | 3 (3) | 2 (2) |
| Fatigue | 4 (4) | 2 (2) | 2 (2) |
| Pain | 4 (4) | 1 (1) | 0 (0) |
| Anemia | 3 (3) | 1 (1) | 2 (2) |
| Dehydration | 3 (3) | 0 (0) | 1 (1) |
| Brain edema | 3 (3) | 0 (0) | 0 (0) |
| Convulsion | 3 (3) | 0 (0) | 0 (0) |
| Malignant neoplasm progression | 2 (2) | 2 (2) | 4 (4) |
| Pulmonary embolism | 1 (1) | 4 (4) | 2 (2) |
| Thrombocytopenia | 1 (1) | 3 (3) | 2 (2) |
| Hyperglycemia | 1 (1) | 2 (2) | 3 (3) |
| Statistically significant AEs, n (%) | |||
| Vomiting | 15 (15) | 5 (5)b | 11 (11) |
| Brain edema | 6 (6) | 1 (1) | 0 (0)b |
| Dehydration | 5 (5) | 0 (0)b | 1 (1) |
AE adverse event, SAE serious adverse event, WBRT whole-brain radiation therapy
aSafety analysis population = 101
b p < 0.05