Table 3.

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 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.