TABLE 3.
Adverse Events Occurring in ≥10% of Patients Treated with Obatoclax and Docetaxel in Phase 1 and Phase 2
Treatment-Emergent Adverse Events, n (%) | Phase 1 N = 18 |
Phase 2 N = 32 |
||
---|---|---|---|---|
All Grades | Grade 3 or 4 | All Grades | Grade 3 or 4 | |
≥1 Event | 18 (100.0) | 15 (83.3) | 32 (100.0) | 20 (62.5) |
Hematologic | ||||
Anemia | 10 (55.6) | — | 15 (46.9) | 2 (6.3) |
Neutropenia | 10 (55.6) | 10 (55.6) | 12 (37.5) | 10 (31.3) |
Febrile neutropenia | 3 (16.7) | 3 (16.7) | 5 (15.6) | 5 (15.7) |
Nonhematologic | ||||
Fatigue | 9 (50) | — | 19 (59) | 2 (6) |
Nausea | 7 (38.9) | — | 17 (53) | — |
Dyspnea | 3 (16.7) | 2 (11.1) | 16 (50) | 6 (19) |
Alopecia | 11 (61.1) | — | 14 (44) | — |
Anorexia | 5 (27.8) | — | 13 (41) | — |
Dizziness | 2 (11.1) | — | 11 (34) | — |
Cough | 2 (11.1) | — | 9 (28) | 1 (3) |
Constipation | 3 (16.7) | — | 8 (25) | — |
Insomnia | — | — | 8 (25) | — |
Diarrhea | 3 (16.7) | — | 7 (22) | — |
Vomiting | 3 (16.7) | 1 (5.6) | 7 (22) | 1 (3) |
Mucosal inflammation | — | — | 7 (22) | 1 (3) |
Flushing | 2 (11.1) | — | 7 (22) | — |
Ataxia | 3 (16.7) | — | 6 (19) | — |
Pharyngolaryngeal pain | 7 (38.9) | — | 6 (19) | — |
Dehydration | 5 (27.8) | — | 6 (19) | — |
Peripheral edema | — | — | 5 (16) | — |
Dysgeusia | 2 (11.1) | — | 5 (16) | — |
Headache | 2 (11.1) | — | 5 (16) | — |
Peripheral neuropathy | — | — | 5 (16) | — |
Somnolence | — | — | 5 (16) | — |
Confusional state | 4 (22.2) | — | 5 (16) | — |
Euphoric mood | 4 (22.2) | — | 5 (16) | — |
Back pain | 3 (16.7) | 1 (5.6) | 5 (16) | 2 (6) |
Chills | 2 (11.1) | — | 4 (13) | — |
Pyrexia | 3 (16.7) | — | 4 (13) | — |
Anxiety | — | — | 4 (13) | — |
Hallucinations | — | — | 4 (13) | 2 (6) |