Table 3.

On-treatment deaths (safety set)

	Everolimus plus octreotide LAR (double-blind phase)	Placebo plus depot octreotide (double-blind phase)	Everolimus plus octreotide LAR (open-label phase)
	n=215 (%)	n=211 (%)	n=170 (%)
On-treatment deaths	19 (9)	11 (5)	22 (13)a
Due to underlying malignancy or disease progression	7 (3)	8 (4)	13 (8)
Due to other cause	12 (6)	3 (1)	9 (5)
Pulmonary embolism	2 (1)	0	0
Sudden death	2 (1)	0	2 (1)
Cardiac arrest	1 (<1)	0	1 (1)
Congestive cardiac failure	1 (<1)	0	0
Cardiopulmonary failure	1 (<1)	0	0
Respiratory failure	1 (<1)	0	1 (1)
Pneumonia	1 (<1)	0	1 (1)
Pulmonary sepsis	1 (<1)	0	0
Small intestinal obstruction	1 (<1)	0	0
Abnormal hepatic function	1 (<1)	0	0
Arrhythmia	0	1 (<1)	0
Cardiorespiratory arrest	0	1 (<1)	0
Hepatic failure	0	1 (<1)	0
Intestinal perforation	0	0	1 (1)
Gastrointestinal hemorrhage	0	0	1 (1)
Renal failure	0	0	1 (1)
Sepsis	0	0	1 (1)

^aAll but one patient were randomized to placebo during the double-blind phase of the study.