Table 2A.
Treatment-related adverse events ≥ 10% frequency for grade levels and all events for grade 3 or 4
Adverse events | Arm A (n = 30) | Arm B (n = 16) | ||
---|---|---|---|---|
|
|
|||
Any Grade | Grade 3–4 | Any Grade | Grade 3–4 | |
Infections | ||||
Upper respiratory infection | 3 (10.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Shingles | 0 (0.0) | 0 (0.0) | 2 (12.5) | 0 (0.0) |
Nervous system disorders | ||||
Dizziness | 3 (10.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Neuropathy | 0 (0.0) | 0 (0.0) | 2 (12.5) | 0 (0.0) |
General | ||||
Fatigue | 7 (23.3) | 1 (3.3) | 4 (25.0) | 0 (0.0) |
Metabolic disorders | ||||
Hyperglycemia | 4 (13.3) | 1 (3.3) | 2 (12.5) | 0 (0.0) |
Hypokalemia | 4 (13.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Hypomagnesemia | 4 (13.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Hypophosphatemia | 3 (10.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Gastrointestinal disorders | ||||
Constipation | 4 (13.3) | 0 (0.0) | 3 (18.8) | 0 (0.0) |
Diarrhea | 10 (33.3) | 1 (3.3) | 0 (0.0) | 0 (0.0) |
Nausea | 5 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Hematologic toxicities | ||||
Anemia | 6 (20.0) | 2 (6.7) | 4 (25.0) | 1 (6.3) |
Neutropenia | 13 (43.3) | 9 (30.0) | 3 (18.8) | 1 (6.3) |
Thrombocytopenia | 10 (33.3) | 5 (16.7) | 6 (37.5) | 3 (18.8) |
Others | ||||
CPK increased | 0 (0.0) | 0 (0.0) | 2 (12.5) | 0 (0.0) |
Lipase increased | 0 (0.0) | 0 (0.0) | 2 (12.5) | 2 (12.5) |