Summary of adverse events (full analysis set)
| . | All patients (N = 116) . | ||
|---|---|---|---|
| Any grade . | Grade 3 . | Grade 4 . | |
| Any adverse event, n (%) | 116 (100) | 38 (33) | 31 (27) |
| Non-neurologic adverse events, worst grade ≥3 occurring in ≥3% of patients | |||
| Pyrexia | 103 (89) | 9 (8) | 0 (0) |
| Headache | 44 (38) | 4 (3) | 0 (0) |
| Neutropenia | 18 (16) | 2 (2) | 16 (14) |
| Leukopenia | 8 (7) | 5 (4) | 2 (2) |
| Anemia | 7 (6) | 4 (3) | 1 (1) |
| ALT increased | 7 (6) | 2 (2) | 4 (3) |
| Thrombocytopenia | 6 (5) | 2 (2) | 3 (3) |
| AST increased | 5 (4) | 1 (1) | 3 (3) |
| Any neurologic adverse event* | 61 (53) | 12 (10) | 3 (3) |
| Neurologic events, worst grade ≥3 | |||
| Tremor | 35 (30) | 6 (5) | 0 (0) |
| Aphasia | 15 (13) | 1 (1) | 0 (0) |
| Dizziness | 9 (8) | 1 (1) | 0 (0) |
| Confused state | 6 (5) | 1 (1) | 0 (0) |
| Encephalopathy | 6 (5) | 3 (3) | 2 (2) |
| Seizure | 3 (3) | 1 (1) | 1 (1) |
| Disorientation | 3 (3) | 1 (1) | 0 (0) |
| Depressed level of consciousness | 1 (1) | 1 (1) | 0 (0) |
| Generalized tonic-clonic seizure | 1 (1) | 1 (1) | 0 (0) |
| . | All patients (N = 116) . | ||
|---|---|---|---|
| Any grade . | Grade 3 . | Grade 4 . | |
| Any adverse event, n (%) | 116 (100) | 38 (33) | 31 (27) |
| Non-neurologic adverse events, worst grade ≥3 occurring in ≥3% of patients | |||
| Pyrexia | 103 (89) | 9 (8) | 0 (0) |
| Headache | 44 (38) | 4 (3) | 0 (0) |
| Neutropenia | 18 (16) | 2 (2) | 16 (14) |
| Leukopenia | 8 (7) | 5 (4) | 2 (2) |
| Anemia | 7 (6) | 4 (3) | 1 (1) |
| ALT increased | 7 (6) | 2 (2) | 4 (3) |
| Thrombocytopenia | 6 (5) | 2 (2) | 3 (3) |
| AST increased | 5 (4) | 1 (1) | 3 (3) |
| Any neurologic adverse event* | 61 (53) | 12 (10) | 3 (3) |
| Neurologic events, worst grade ≥3 | |||
| Tremor | 35 (30) | 6 (5) | 0 (0) |
| Aphasia | 15 (13) | 1 (1) | 0 (0) |
| Dizziness | 9 (8) | 1 (1) | 0 (0) |
| Confused state | 6 (5) | 1 (1) | 0 (0) |
| Encephalopathy | 6 (5) | 3 (3) | 2 (2) |
| Seizure | 3 (3) | 1 (1) | 1 (1) |
| Disorientation | 3 (3) | 1 (1) | 0 (0) |
| Depressed level of consciousness | 1 (1) | 1 (1) | 0 (0) |
| Generalized tonic-clonic seizure | 1 (1) | 1 (1) | 0 (0) |
All adverse events regardless of causality that occurred during the treatment period plus 30 days. Thirty-six patients (31%) had treatment interruptions because of treatment-emergent adverse events, mainly as a result of neurologic events and flu-like symptoms. Those occurring in ≥2% of patients included pyrexia (8%) and aphasia, encephalopathy, overdose, tremor, ALT increased, AST increased, and chills (3% each).
ALT, alanine aminotransferase; AST, aspartate aminotransferase.
Among all patients. Multiple events may have occurred in some patients.