Table 6.
Frequency of TESAEs occurring in ⩾1.5% of patients in the RCT/extension teduglutide group.
| AE grouping† or AE preferred term, n (%) | RCT teduglutide group, n = 109 | RCT/extension teduglutide group, n = 173 | RCT placebo group, n = 59 |
|---|---|---|---|
| Catheter sepsis events† | 15 (13.8) | 43 (24.9) | 9 (15.3) |
| Gastrointestinal stenosis and obstruction† | 5 (4.6) | 8 (4.6) | 0 |
| Biliary tract disorder† | 3 (2.8) | 8 (4.6) | 0 |
| Gastrointestinal stoma complication‡ | 1 (2.2) | 3 (4.4) | 0 |
| Catheter site–related reaction† | 2 (1.8) | 7 (4.0) | 1 (1.7) |
| Febrile disorders† | 2 (1.8) | 7 (4.0) | 0 |
| Lower respiratory tract infection† | 3 (2.8) | 7 (4.0) | 1 (1.7) |
| Peripheral embolism and thrombosis† | 1 (0.9) | 6 (3.5) | 0 |
| Urinary tract infections† | 3 (2.8) | 6 (3.5) | 1 (1.7) |
| Abdominal pain† | 1 (0.9) | 3 (1.7) | 0 |
| Cognition and attention disorders and disturbances† | 2 (1.8) | 3 (1.7) | 0 |
| Cholestasis and jaundice† | 0 | 3 (1.7) | 1 (1.7) |
| Device dislocation | 2 (1.8) | 3 (1.7) | 2 (3.4) |
| Intestinal haemorrhages† | 1 (0.9) | 3 (1.7) | 0 |
| Pancreatic disorders NEC† | 1 (0.9) | 3 (1.7) | 0 |
AE, adverse event; NEC, not elsewhere classified; RCT, randomized controlled trial; TESAE, treatment-emergent serious AE.
†
The AE preferred terms in the AE groupings represent medically similar terms.
‡
Percentages calculated based on number of patients with a stoma (n = 45 for the RCT teduglutide group; n = 68 for the RCT/extension teduglutide group; n = 22 for the RCT placebo group).