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. 2020 Apr 20;13:1756284820905766. doi: 10.1177/1756284820905766

Table 3.

TEAEs leading to discontinuation in more than one patient.

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).