Most commonly reported TEAEs (occurring in >10% [any grade] of the safety population)
| . | Safety population (N = 676) . | |||
|---|---|---|---|---|
| AE, n (%) . | Total . | Grade 3* . | Grade 4* . | Grade 5* . |
| Neutropenia | 383 (56.7) | 200 (29.6) | 136 (20.1) | 0 |
| Anemia | 326 (48.2) | 215 (31.8) | 8 (1.2) | 0 |
| Thrombocytopenia | 234 (34.6) | 82 (12.1) | 81 (12.0) | 0 |
| Fatigue | 194 (28.7) | 38 (5.6) | 2 (0.3) | 0 |
| Pyrexia† | 194 (28.7) | 19 (2.8) | 1 (0.1) | 0 |
| Constipation | 155 (22.9) | 5 (0.7) | 0 | 0 |
| Asthenia | 153 (22.6) | 20 (3.0) | 3 (0.4) | 0 |
| Cough | 133 (19.7) | 2 (0.3) | 0 | 0 |
| Diarrhea | 113 (16.7) | 6 (0.9) | 0 | 0 |
| Dyspnea | 113 (16.7) | 18 (2.7) | 2 (0.3) | 1 (0.1) |
| Pneumonia | 111 (16.4) | 64 (9.5) | 10 (1.5) | 13 (1.9) |
| Peripheral edema | 106 (15.7) | 8 (1.2) | 0 | 0 |
| Back pain | 98 (14.5) | 15 (2.2) | 1 (0.1) | 1 (0.1) |
| Leukopenia | 93 (13.8) | 37 (5.5) | 17 (2.5) | 0 |
| Muscle spasms | 92 (13.6) | 2 (0.3) | 0 | 0 |
| Nausea | 92 (13.6) | 2 (0.3) | 0 | 0 |
| Peripheral sensory neuropathy | 73 (10.8) | 4 (0.6) | 1 (0.1) | 0 |
| Decreased appetite† | 69 (10.2) | 5 (0.7) | 0 | 0 |
| Insomnia | 69 (10.2) | 5 (0.7) | 0 | 0 |
| . | Safety population (N = 676) . | |||
|---|---|---|---|---|
| AE, n (%) . | Total . | Grade 3* . | Grade 4* . | Grade 5* . |
| Neutropenia | 383 (56.7) | 200 (29.6) | 136 (20.1) | 0 |
| Anemia | 326 (48.2) | 215 (31.8) | 8 (1.2) | 0 |
| Thrombocytopenia | 234 (34.6) | 82 (12.1) | 81 (12.0) | 0 |
| Fatigue | 194 (28.7) | 38 (5.6) | 2 (0.3) | 0 |
| Pyrexia† | 194 (28.7) | 19 (2.8) | 1 (0.1) | 0 |
| Constipation | 155 (22.9) | 5 (0.7) | 0 | 0 |
| Asthenia | 153 (22.6) | 20 (3.0) | 3 (0.4) | 0 |
| Cough | 133 (19.7) | 2 (0.3) | 0 | 0 |
| Diarrhea | 113 (16.7) | 6 (0.9) | 0 | 0 |
| Dyspnea | 113 (16.7) | 18 (2.7) | 2 (0.3) | 1 (0.1) |
| Pneumonia | 111 (16.4) | 64 (9.5) | 10 (1.5) | 13 (1.9) |
| Peripheral edema | 106 (15.7) | 8 (1.2) | 0 | 0 |
| Back pain | 98 (14.5) | 15 (2.2) | 1 (0.1) | 1 (0.1) |
| Leukopenia | 93 (13.8) | 37 (5.5) | 17 (2.5) | 0 |
| Muscle spasms | 92 (13.6) | 2 (0.3) | 0 | 0 |
| Nausea | 92 (13.6) | 2 (0.3) | 0 | 0 |
| Peripheral sensory neuropathy | 73 (10.8) | 4 (0.6) | 1 (0.1) | 0 |
| Decreased appetite† | 69 (10.2) | 5 (0.7) | 0 | 0 |
| Insomnia | 69 (10.2) | 5 (0.7) | 0 | 0 |