Table 4.
Frequency of TEAEs reported in at least 5.0% 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 |
|---|---|---|---|
| Gastrointestinal stoma complications‡ | 17 (37.8) | 31 (45.6) | 3 (13.6) |
| Abdominal pain† | 42 (38.5) | 72 (41.6) | 16 (27.1) |
| Upper respiratory tract infection† | 30 (27.5) | 50 (28.9) | 8 (13.6) |
| Catheter sepsis events† | 17 (15.6) | 47 (27.2) | 10 (16.9) |
| Nausea† | 29 (26.6) | 46 (26.6) | 12 (20.3) |
| Headaches† | 18 (16.5) | 35 (20.2) | 9 (15.3) |
| Asthenic conditions† | 14 (12.8) | 35 (20.2) | 7 (11.9) |
| Injection site reactions† | 22 (20.2) | 33 (19.1) | 7 (11.9) |
| Abdominal distension | 18 (16.5) | 32 (18.5) | 1 (1.7) |
| Urinary tract infections† | 17 (15.6) | 32 (18.5) | 10 (16.9) |
| Catheter site–related reactions† | 9 (8.3) | 29 (16.8) | 8 (13.6) |
| Febrile disorders† | 10 (9.2) | 29 (16.8) | 7 (11.9) |
| Vomiting | 15 (13.8) | 26 (15.0) | 6 (10.2) |
| Weight decreased† | 2 (1.8) | 26 (15.0) | 6 (10.2) |
| Musculoskeletal pain† | 8 (7.3) | 25 (14.5) | 6 (10.2) |
| Diarrhoea† | 7 (6.4) | 24 (13.9) | 7 (11.9) |
| Fluid overload† | 11 (10.1) | 23 (13.3) | 4 (6.8) |
| Hypersensitivity† | 9 (8.3) | 21 (12.1) | 3 (5.1) |
| Flatulence | 9 (8.3) | 19 (11.0) | 4 (6.8) |
| Cognition and attention disorders and disturbances† | 5 (4.6) | 17 (9.8) | 4 (6.8) |
| Dehydration | 4 (3.7) | 17 (9.8) | 5 (8.5) |
| Arthralgia | 7 (6.4) | 15 (8.7) | 3 (5.1) |
| Muscle spasms | 4 (3.7) | 15 (8.7) | 4 (6.8) |
| Appetite disorders† | 8 (7.3) | 14 (8.1) | 2 (3.4) |
| Biliary tract disorders† | 4 (3.7) | 14 (8.1) | 1 (1.7) |
| Lower respiratory tract infection† | 6 (5.5) | 13 (7.5) | 3 (5.1) |
| Skin haemorrhage† | 5 (4.6) | 13 (7.5) | 1 (1.7) |
| Gastrointestinal stenosis and obstruction† | 6 (5.5) | 12 (6.9) | 0 |
| Sleep disturbances† | 6 (5.5) | 10 (5.8) | 0 |
| Depressive disorders† | 2 (1.8) | 10 (5.8) | 1 (1.7) |
| Coughing and associated symptoms† | 5 (4.6) | 9 (5.2) | 0 |
| Hepatic enzyme increased† | 4 (3.7) | 9 (5.2) | 2 (3.4) |
| Pancreatic disorders NEC† | 3 (2.8) | 9 (5.2) | 1 (1.7) |
| Contusion | 2 (1.8) | 9 (5.2) | 0 |
| Peripheral embolism and thrombosis† | 1 (0.9) | 9 (5.2) | 2 (3.4) |
| Hot flush | 1 (0.9) | 9 (5.2) | 0 |
| Blood bicarbonate decreased | 0 | 9 (5.2) | 0 |
AE, adverse event; NEC, not elsewhere classified; RCT, randomized controlled trial; TEAE, treatment-emergent AE.
†
The 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).