Table 4.

Incidence of select adverse events of special interest during the double-blind placebo-controlled period

	OOC (n = 28) n (%)	Placebo (n = 28) n (%)	Overall (N = 56) n (%)
Patients with ≥ 1 AESI	15 (53.6)	26 (92.9)	41 (73.2)
Arthralgia	7 (25.0)	15 (53.6)	22 (39.3)
Hyperhidrosis	5 (17.9)	7 (25.0)	12 (21.4)
Headache	0 (0)	9 (32.1)	9 (16.1)
Fatigue	1 (3.6)	7 (25.0)	8 (14.3)
Carpal tunnel syndrome	4 (14.3)	4 (14.3)	8 (14.3)
Peripheral swelling	3 (10.7)	4 (14.3)	7 (12.5)
Arthritis	1 (3.6)	2 (7.1)	3 (5.4)

Additional adverse events (AEs) identified by the investigator may also be included as AEs of special interest (AESIs). An individual could be counted only once within each category. AEs were coded using MedDRA version 18.1.

Abbreviation: OOC, oral octreotide capsules.