Table 4.

Comparison of secondary outcome measures from patients in the study population versus those that received placebo. Only events of grade 3 or higher (those requiring procedural intervention) were considered meaningful, except where indicated. C.I., confidence interval.

Secondary Outcome	Pasireotide Group (n=652)	95% C.I.	Placebo Group (n=148)	95% C.I.	p-value
Secondary Outcomes
Biliary leak/fistula	4 (0.6%)	[0.2 - 1.6]	5 (3.4%)	[1.1 – 7.7]	0.014
Delayed gastric emptying	30 (4.6%)	[3.1 - 6.5]	6 (4.1%)	[1.5 – 8.6]	>0.95
Enteric leak/fistula	3 (0.5%)	[0.1 - 1.3]	2 (1.4%)	[0.2 – 4.8]	0.23
Other morbidity ≥ grade 3	45 (6.9%)	[5.1 - 9.1]	18 (12.2%)	[7.4 – 18.5]	0.041
Hemorrhage (≥ grade 2)	30 (4.6%)	[3.1 - 6.5]	13 (8.8%)	[4.8 – 14.6]	0.07
Mortality (90 day, any cause)	8 (1.2%)	[0.5 - 2.4]	1 (0.7%)	[0.0 – 3.7]	>0.95