Table 3.
AE preferred term, n (%) | RCT teduglutide group, n = 109 | RCT/extension teduglutide group, n = 173 | RCT placebo group, n = 59 |
---|---|---|---|
Any TEAE leading to discontinuation | 10 (9.2) | 34 (19.7) | 4 (6.8) |
Abdominal pain | 1 (0.9) | 8 (4.6) | 0 |
Gastrointestinal stoma complication† | 0 | 3 (4.4) | 0 |
Nausea | 1 (0.9) | 3 (1.7) | 0 |
Vomiting | 1 (0.9) | 3 (1.7) | 0 |
Abdominal distension | 2 (1.8) | 2 (1.2) | 0 |
Asthenia | 1 (0.9) | 2 (1.2) | 0 |
Constipation | 2 (1.8) | 2 (1.2) | 0 |
RCT, randomized controlled trial; TEAE, treatment-emergent adverse event.
Percentages calculated based on number of patients with a stoma (n = 68 for the RCT/extension teduglutide group).