Table 3.

Summary of adverse events (full analysis set)

All patients (N = 116)
Any gradeGrade 3Grade 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 gradeGrade 3Grade 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.

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