Table 5.

Number of adverse events (AEs) and Grade 3 or 4 AEs reported during the study and assignment of causality to the treatment received. The number of Grade 3 and 4 AEs is shown in parenthesis

	Everolimus	Lanreotide and everolimus	Sunitinib	Lanreotide and sunitinib	Lanreotide
	All AEs (Grade 3–4)	All AEs (Grade 3–4)	All AEs (Grade 3–4)	All AEs (Grade 3–4)	All AEs (Grade 3–4)
AE	129 (21)	9 (2)	70 (17)	15 (5)	6 (1)
Asthenia	15 (5)	0	22 (8)	2 (0)	0
Mucositis	25 (6)	0	6 (0)	0	0
Diarrhoea	17 (2)	1 (0)	5 (1)	5 (1)	1 (0)
Hand-foot skin reaction	8 (0)	0	8 (1)	0	0
Anorexia	9 (1)	0	4 (1)	0	0
Hyperglycaemia	7 (0)	4 (1)	0	1 (0)	1 (0)
Rash	10 (2)	1 (1)	0	0	0
Hypertension	2 (0)	0	6 (1)	0	0
Peripheral oedema	6 (2)	0	1 (0)	0	0
Thrombocytopenia	0	0	4 (0)	3 (3)	0
Anaemia	5 (0)	0	0	2 (1)	0
Pneumonitis	3 (1)	0	1 (0)	0	0
Cardiac toxicity	0	0	3 (2)	0	0
Hypercholesterolemia	4 (0)	0	0	0	0
Hypertriglyceridemia	4 (0)	0	0	0	0
Leucopoenia	1 (0)	0	2 (1)	1 (0)	0
Hepatic alterations	0	2 (0)	0	0	0
Hypothyroidism	0	0	3 (0)	0	0
Nausea	1 (0)	0	0	0	0
Vomiting	1 (0)	0	1 (0)	0	0
Abdominal pain	1 (0)	0	0	0	2 (0)
Weight loss	1 (0)	0	0	1 (0)	0
Headache	0	0	0	0	0
Epistaxis	0	0	1 (0)	0	0
Other	9 (2)	1 (0)	3 (2)	0	2 (1)