Table III.

Adverse Events

A. All Emergent Adverse Events Observed in ≥ 15% of Patients
System	Adverse Event	n%	Grade 1	Grade 2	Grade 3	Grade 4
Gastro- intestinal	Diarrhoea	23 (79)	13	8	2	0
	Nausea	21 (72)	15	5	1	0
	Decreased appetite	7 (24)	6	0	1	0
	Constipation	6 (21)	4	2	0	0
	Vomiting	5 (17)	5	0	0	0
	Flatulence	5 (17)	5	0	0	0
General	Fatigue	15 (52)	8	4	3	0
	Headache	7 (24)	7	0	0	0
	Chills	6 (21)	4	2	0	0
Blood	Neutropenia	8 (28)	0	0	3	5
	Thrombocytopenia	6 (21)	0	1	0	5
Respiratory	Cough	8 (28)	4	4	0	0
	Upper RTI	6 (21)	2	4	0	0
Pain	Back pain	6 (21)	4	0	2	0
Other	Elevated ALT	6 (21)	2	2	2	0
	Hypokalaemia	5 (17)	3	1	1	0

B. Infectious Adverse Events in All Patients
Upper respiratory tract	Upper RTI	6 (21)	2	4	0	0
	Nasopharyngitis	2 (6)	2	0	0	0
	Sinusitis	2 (6)	0	1	1	0
Lower respiratory tract	Lower RTI	2 (6)	0	2	0	0
	Bronchitis	2 (7)	0	2	0	0
	Influenza	1 (3)	1	0	0	0
Ear	Ear infection	1 (3)	0	1	0	0
	Labyrinthitis	1 (3)	0	1	0	0
Urinary	Urinary tract infection	3 (10)	1	2	0	0
	Cystitis	1 (3)	1	0	0	0
Gastro- enterological	Campylobacter enteritis	2 (6)	0	1	1	0
	Gastroenteritis	1 (3)	1	0	0	0
Skin/Mucosa	Oral candidiasis	2 (6)	1	1	0	0
	Zoster	2 (6)	1	1	0	0
	Fungal skin infection	1 (3)	1	0	0	0
	Herpes simplex labialis	1 (3)	1	0	0	0
	Molluscum contagiosum	1 (3)	0	1	0	0
	Gingivitis	1 (3)	1	0	0	0
	Paronychia	1 (3)	1	0	0	0
	Cellulitis	1 (3)	0	1	0	0
Neutropenic	Escherichia coli	1 (3)	0	0	1	0
Sepsis	Pseudomonas	1 (3)	0	0	1	0
General	Viral infection	1 (3)	0	1	0	0

RTI, respiratory tract infection; ALT, alanine aminotransferase.