Table 4. Grade 3 and 4 adverse events suspected to be study drug related (safety cohort).

	Weekly schedule							Twice-weekly schedule
	2.5 mg (N=3)	5 mg (N=5)	10 mg (N=7)	20 mg (N=6)	30 mg (N=5)	50 mg (N=22)	60 mg (N=5)	25 mg (N=11)	All pts (N=64)
	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)
Constitutional
Asthenia	0	0	0	1 (17)	0	1 (4)	0	0	2 (3)
Insomnia	0	0	0	0	0	0	0	0	0
Gastrointestinal
Diarrhoea	0	0	0	1 (17)	0	2 (9)	2 (40)	3 (27)	8 (13)
Nausea	0	0	0	0	0	0	0	0	0
Anorexia	0	0	0	0	0	0	0	0	0
Abdominal pain	0	0	0	1 (17)	0	0	0	0	1 (2)
Vomiting	0	0	0	1 (17)	0	0	0	0	1 (2)
Weight loss	0	0	0	0	0	0	0	0	0
Dehydration	0	0	0	0	0	0	1 (20)	0	1 (2)
Neurology
Dizziness	0	0	0	0	0	0	0	0	0
Tremor	0	0	0	0	0	0	1 (20)	0	1 (2)
Ataxia	0	0	0	0	0	0	0	0	0
Cerebellar syndrome	0	0	0	0	0	0	0	0	0
Balance disorder	0	0	0	0	0	0	0	0	0
Headache	0	0	0	0	0	0	0	0	0
Muscle spasms	0	0	0	0	0	0	0	0	0
Myoclonus	0	0	0	0	0	1 (4)	0	0	1 (2)
Neurotoxicity	0	0	0	0	0	1 (4)	0	0	1 (2)
Presyncope	0	0	0	0	0	1 (4)	0	0	1 (2)
Syncope	0	0	0	0	0	1 (4)	0	0	1 (2)
Laboratory
ALT increase	0	0	0	0	0	2 (9)	0	0	2 (3)
AST increase	0	0	0	0	0	2 (9)	0	0	2 (3)
Hyponatremia	0	0	0	0	0	0	2 (40)	0	2 (3)
Cardiac
Prolonged QT interval	0	0	0	0	0	2 (9)	0	0	2 (3)

Abbreviations: ALT=alanine transaminase; AST=aspartate aminotransferase; pts=patients.