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
 Pyrexia103 (89)9 (8)0 (0)
 Headache44 (38)4 (3)0 (0)
 Neutropenia18 (16)2 (2)16 (14)
 Leukopenia8 (7)5 (4)2 (2)
 Anemia7 (6)4 (3)1 (1)
 ALT increased7 (6)2 (2)4 (3)
 Thrombocytopenia6 (5)2 (2)3 (3)
 AST increased5 (4)1 (1)3 (3)
Any neurologic adverse event*61 (53)12 (10)3 (3)
Neurologic events, worst grade ≥3
 Tremor35 (30)6 (5)0 (0)
 Aphasia15 (13)1 (1)0 (0)
 Dizziness9 (8)1 (1)0 (0)
 Confused state6 (5)1 (1)0 (0)
 Encephalopathy6 (5)3 (3)2 (2)
 Seizure3 (3)1 (1)1 (1)
 Disorientation3 (3)1 (1)0 (0)
 Depressed level of consciousness1 (1)1 (1)0 (0)
 Generalized tonic-clonic seizure1 (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.