Table 4.

Most common (≥ 10%) treatment-related adverse events of any grade

Event, n (%)	Group A1 (n = 11) 250 mg BID		Group A2 (n =1 5) 200 mg BID		Group B (n =2 0) 250 mg BID		Group C1 (n = 10) 250 mg QD		Group C2 (n = 16) 200 mg BID		Group D (n = 16) 250 mg QD		Total (N = 88)
	Any grade	Grade 3 or 4	Any grade	Grade 3 or 4	Any grade	Grade 3 or 4	Any grade	Grade 3 or 4	Any grade	Grade 3 or 4	Any grade	Grade 3 or 4	Any grade	Grade 3 or 4
Any event	9 (82)	3 (27)	14 (93)	3 (20)	15 (75)	3 (15)	6 (60)	1 (10)	11 (69)	7 (44)	11 (69)	5 (31)	66 (75)	22 (25)
Blood and lymph disorders
Anemia	1 (9)	1 (9)	2 (13)	0	0	0	1 (10)	0	1 (6)	1 (6)	0	0	5 (6)	2 (2)
Neutropenia	0	0	0	0	00	0	0	0	1 (6)	1 (6)	1 (6)	1 (6)	2 (2)	2 (2)
Thrombocytopenia	0	0	0	0	1 (5)	1 (5)	0	0	0	0	0	0	1 (1)	1 (1)
Eye disorders
Vision blurred	3 (27)	0	1 (7)	0	2 (10)	0	2 (20)	0	2 (13)	0	0	0	10 (11)	0
Vitreous floaters	2 (18)	0	0	0	1 (5)	0	3 (30)	0	2 (13)	0	1 (6)	0	9 (10)	0
Photophobia	0	0	2 (13)	0	0	0	0	0	0	0	0	0	2 (2)	0
Gastrointestinal disorders
Diarrhea	6 (55)	0	3 (20)	1 (7)	3 (15)	0	1 (10)	0	1 (6)	0	1 (6)	0	15 (17)	1 (1)
Nausea	5 (45)	0	7 (47)	0	11 (55)	0	1 (10)	0	6 (38)	0	4 (25)	0	34 (39)	0
Constipation	2 (18)	0	1 (7)	0	2 (10)	1 (5)	1 (10)	0	1 (6)	0	0	0	7 (8)	1 (1)
Vomiting	2 (18)	0	7 (47)	1 (7)	6 (30)	0	1 (10)	0	6 (38)	1 (6)	3 (19)	0	25 (28)	2 (2)
Dry mouth	1 (9)	0	0	0	1 (5)	0	0	0	2 (13)	0	0	0	4 (5)	0
Dyspepsia	1 (9)	0	2 (13)	0	0	0	0	0	1 (6)	0	1 (6)	0	5 (6)	0
GERD	1 (9)	0	2 (13)	0	0	0	0	0	0	0	0	0	3 (3)	0
General disorders and administration-site conditions
Edema peripheral	3 (27)	0	2 (13)	0	2 (10)	0	0	0	0	0	0	0	7 (8)	0
Fatigue	2 (18)	0	4 (27)	0	2 (10)	0	2 (20)	1 (10)	5 (31)	3 (19)	4 (25)	1 (6)	19 (22)	5 (6)
Face edema	0	0	0	0	0	0	1 (10)	0	0	0	0	0	1 (1)	0
Pyrexia	0	0	2 (13)	0	0	0	0	0	1 (6)	0	0	0	3 (3)	0
Hepatobiliary disorders
Hyperbilirubinemia	0	0	0	0	0	0	0	0	3 (19)	3 (19)	0	0	3 (3)	3 (3)
Investigations
ALT increased	2 (18)	0	0	0	4 (20)	0	0	0	2 (13)	0	1 (6)	0	9 (10)	0
AST increased	3 (27)	0	0	0	4 (20)	1 (5)	0	0	1 (6)	0	1 (6)	1 (6)	9 (10)	2 (2)
Blood creatinine increased	1 (9)	0	1 (7)	0	2 (10)	0	1 (10)	0	0	0	0	0	5 (6)	0
Activated PTT prolonged	1 (9)	1 (9)	0	0	0	0	0	0	0	0	0	0	1 (1)	1 (1)
Neutrophil count decreased	0	0	0	0	0	0	0	0	0	0	3 (19)	2 (13)	3 (3)	2 (2)
Weight increased	0	0	1 (7)	0	0	0	1 (10)	0	0	0	0	0	1 (1)	0
White blood cell count decreased	0	0	0	0	0	0	0	0	0	0	2 (13)	2 (13)	2 (2)	2 (2)
Metabolic and nutritional disorders
Decreased appetite	1 (9)	0	3 (20)	0	2 (10)	0	1 (10)	0	3 (19)	0	0	0	10 (11)	0
Hyponatremia	0	0	3 (20)	2 (13)	0	0	0	0	1 (6)	1 (6)	1 (6)	1 (6)	5 (6)	4 (5)
Hypophosphatemia	1 (9)	1 (9)	0	0	0	0	3 (30)	0	1 (6)	0	0	0	5 (6)	1 (1)
Hyperglycemia	0	0	0	0	0	0	1 (10)	0	0	0	0	0	1 (1)	0
Musculoskeletal and connective tissue disorders
Arthralgia	2 (18)	0	0	0	0	0	0	0	0	0	0	0	2 (2)	0
Pain in extremity	2 (18)	1 (9)	0	0	0	0	0	0	0	0	0	0	2 (2)	1 (1)
Nervous system disorders
Dysgeusia	2 (18)	0	1 (7)	0	3 (15)	0	1 (10)	0	1 (6)	0	1 (6)	0	9 (10)	0
Headache	2 (18)	0	0	0	0	0	0	0	0	0	1 (6)	0	3 (3)	0
Respiratory disorders
Respiratory failure	0	0	1 (7)	1 (7)	0	0	0	0	0	0	0	0	1 (1)	1 (1)
Skin disorders
Dry skin	0	0	0	0	0	0	1 (10)	0	0	0	1 (6)	0	2 (2)	0
Vascular disorders
Flushing	0	0	0	0	0	0	2 (20)	0	0	0	0	0	2 (2)	0

ALT alanine aminotransferase, AST aspartate aminotransferase, BID twice daily, GERD gastroesophageal reflux disease, PTT partial thromboplastin time, QD once daily