Table 3.
System organ class preferred term | OOC (n = 28) n (%) |
Placebo (n = 28) n (%) |
Overall (N = 56) n (%) |
---|---|---|---|
Diarrhea | 8 (28.6) | 6 (21.4) | 14 (25.0) |
Nausea | 6 (21.4) | 3 (10.7) | 9 (16.1) |
Abdominal discomfort | 4 (14.3) | 3 (10.7) | 7 (12.5) |
Vomiting | 4 (14.3) | 0 | 4 (7.1) |
Dyspepsia | 3 (10.7) | 1 (3.6) | 4 (7.1) |
Blood glucose increased | 3 (10.7) | 1 (3.6) | 4 (7.1) |
Sinusitis | 3 (10.7) | 0 | 3 (5.4) |
Osteoarthritis | 3 (10.7) | 0 | 3 (5.4) |
Cholelithiasis | 2 (7.1) | 1 (3.6) | 3 (5.4) |
Urinary tract infection | 2 (7.1) | 1 (3.6) | 3 (5.4) |
Pain | 2 (7.1) | 0 | 2 (3.6) |
Large intestinal polyp | 2 (7.1) | 0 | 2 (3.6) |
Treatment-emergent adverse events were defined as all adverse events (AEs) that occurred after random assignment (ie, date of onset was on or after the date of random assignment) and on or before the end of treatment (last dose of blinded study drug) in the double-blind, placebo-controlled period. A patient could be counted only once within each category. AEs were coded using MedDRA version 18.1.
Abbreviation: OOC, oral octreotide capsules.