Table 6.

Most common adverse events (>10% in any group) regardless of study drug relationship. Data are presented as n (%).

Adverse events	Long-acting pasireotide 40 mg*, n = 63		Long-acting pasireotide 60 mg*, n = 62		Crossover to pasireotide†, n = 62
	All grades	Grade 3/4	All grades	Grade 3/4	All grades	Grade 3/4
Total	61 (96.8)	32 (50.8)	60 (96.8)	33 (53.2)	61 (98.4)	31 (50.0)
Hyperglycaemia	25 (39.7)	7 (11.1)	25 (40.3)	6 (9.7)	16 (25.8)	2 (3.2)
Cholelithiasis	22 (34.9)	3 (4.8)	21 (33.9)	1 (1.6)	19 (30.6)	3 (4.8)
Diabetes mellitus	20 (31.7)	1 (1.6)	25 (40.3)	6 (9.7)	18 (29.0)	2 (3.2)
Headache	18 (28.6)	0	6 (9.7)	3 (4.8)	8 (12.9)	0
Diarrhoea	14 (22.2)	0	17 (27.4)	1 (1.6)	11 (17.7)	1 (1.6)
Back pain	13 (20.6)	1 (1.6)	7 (11.3)	1 (1.6)	3 (4.8)	1 (1.6)
Abdominal pain	10 (15.9)	1 (1.6)	10 (16.1)	0	6 (9.7)	0
Anaemia	10 (15.9)	1 (1.6)	10 (16.1)	2 (3.2)	16 (25.8)	0
Hypoglycaemia	7 (11.1)	0	7 (11.3)	2 (3.2)	4 (6.5)	0
Dizziness	8 (12.7)	0	3 (4.8)	0	3 (4.8)	1 (1.6)
Pyrexia	8 (12.7)	0	1 (1.6)	0	2 (3.2)	0
Influenza	9 (14.3)	0	9 (14.5)	0	5 (8.1)	0
Viral upper RTI	7 (11.1)	0	9 (14.5)	0	5 (8.1)	0
Hypertension	7 (11.1)	1 (1.6)	4 (6.5)	1 (1.6)	5 (8.1)	2 (3.2)
Haematuria	7 (11.1)	0	2 (3.2)	0	0	0
Vomiting	8 (12.7)	0	1 (1.6)	0	0	0
Nausea	7 (11.1)	0	7 (11.3)	0	3 (4.8)	1 (1.6)
Arthralgia	7 (11.1)	0	9 (14.5)	3 (4.8)	3 (4.8)	0
Urinary tract infection	6 (9.5)	0	5 (8.1)	0	9 (14.5)	0
Hypercholesterolaemia	5 (7.9)	0	6 (9.7)	0	8 (12.9)	0
Alopecia	3 (4.8)	0	8 (12.9)	0	0	0

Hyperglycaemia was defined as a post-baseline FPG measurement of ≥126 mg/dL; RTI, respiratory tract infection.

*From start of study drug to study end; ^†from time of crossover to study end.