Table 2.
Adverse Events.*
| Event | Control Group (N = 371) |
Veliparib-Combination-Only Group (N = 376) |
Veliparib-Throughout Group (N = 377) |
|||
|---|---|---|---|---|---|---|
| Any Grade | Grade 3 or 4 | Any Grade | Grade 3 or 4 | Any Grade | Grade 3 or 4 | |
| number of patients (percent) | ||||||
| Any | 371 (100) | 285 (77) | 376 (100) | 329 (88) | 377 (100) | 332 (88) |
| Nausea | 251 (68) | 10 (3) | 269 (72) | 15 (4) | 302 (80) | 31 (8) |
| Neutropenia | 251 (68) | 183 (49) | 281 (75) | 232 (62) | 284 (75) | 218 (58) |
| Fatigue | 222 (60) | 12 (3) | 235 (62) | 18 (5) | 259 (69) | 31 (8) |
| Peripheral sensory neuropathy | 256 (69) | 9 (2) | 236 (63) | 7 (2) | 242 (64) | 9 (2) |
| Anemia | 195 (53) | 97 (26) | 245 (65) | 153 (41) | 240 (64) | 144 (38) |
| Thrombocytopenia | 122 (33) | 30 (8) | 225 (60) | 115 (31) | 219 (58) | 105 (28) |
| Alopecia | 215 (58) | 2 (1) | 216 (57) | 0 | 197 (52) | 0 |
| Vomiting | 132 (36) | 9 (2) | 133 (35) | 14 (4) | 186 (49) | 15 (4) |
| Diarrhea | 152 (41) | 9 (2) | 140 (37) | 11 (3) | 166 (44) | 8 (2) |
| Constipation | 160 (43) | 2 (1) | 181 (48) | 7 (2) | 165 (44) | 2 (1) |
| Abdominal pain | 118 (32) | 14 (4) | 113 (30) | 13 (3) | 127 (34) | 17 (5) |
| Leukopenia | 89 (24) | 34 (9) | 87 (23) | 44 (12) | 112 (30) | 66 (18) |
| Decreased appetite | 85 (23) | 3 (1) | 81 (22) | 3 (1) | 111 (29) | 7 (2) |
| Insomnia | 87 (23) | 0 | 121 (32) | 1 (<1) | 110 (29) | 3 (1) |
| Arthralgia | 123 (33) | 4 (1) | 106 (28) | 1 (<1) | 106 (28) | 4 (1) |
| Dizziness | 89 (24) | 0 | 81 (22) | 2 (1) | 98 (26) | 4 (1) |
| Headache | 97 (26) | 3 (1) | 91 (24) | 2 (1) | 97 (26) | 1 (<1) |
| Hypomagnesemia | 98 (26) | 10 (3) | 94 (25) | 5 (1) | 84 (22) | 3 (1) |
| Dyspnea | 76 (20) | 3 (1) | 92 (24) | 8 (2) | 84 (22) | 3 (1) |
Data include adverse events of any grade that occurred during treatment (i.e., events reported during trial treatment or within 30 days after the discontinuation of veliparib or placebo) in at least 20% of the safety population of 1124 patients (i.e., those who had received at least one dose of a trial therapy) and corresponding adverse events of grade 3 or 4 that were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. Data are reported according to preferred terms in the Medical Dictionary for Regulatory Activities, version 21.1. Grade 5 adverse events occurring within 30 days of the last dose of a trial drug were reported in 21 patients (<2% overall; 6 patients in the control group, 7 in the veliparib‑combination‑only group, and 8 in the veliparib‑throughout group) and included small‑intestinal obstruction (in 2 patients), intestinal perforation (2), sepsis or septic shock (7), aspiration pneumonia (1), pulmonary embolism (2), and disease progression (7). The events of sepsis or septic shock occurred in 3 patients in the control group, 1 in the veliparib‑combination‑only group, and 3 in the veliparib‑throughout group.