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) |