Placebo (n=16) | Teduglutide 0.10 mg/kg/day (n=32) | Teduglutide 0.05 mg/kg/day (n=35) | |
Subjects with AE, n (%) | 15 (94%) | 31 (97%) | 33 (94%) |
Subjects with SAE, n(%) | 5 (31%) | 11 (34%) | 13 (37%) |
Subjects with any AE or SAE leading to study discontinuation, n (%) | 1* (6%) | 2* (6%) | 6 (17%) |
Event description by system organ class | |||
Cardiac disorders | 0 | 0 | 1 |
Cardiac failure congestive | 0 | 0 | 1 |
Gastrointestinal disorders | 0 | 2 | 6 |
Abdominal distension | 0 | 0 | 1 |
Constipation | 0 | 0 | 2 |
Haemorrhoidal haemorrhage | 0 | 0 | 1* |
Nausea | 0 | 0 | 1 |
Pancreatitis | 0 | 1 | 0 |
Small intestinal obstruction | 0 | 1* | 0 |
Vomiting | 0 | 0 | 1 |
General disorders and administration site conditions | 0 | 0 | 1 |
Asthenia | 0 | 0 | 1 |
Infections and infestations | 1* | 1* | 0 |
Catheter sepsis | 1* | 1* | 0 |
Investigations | 0 | 0 | 1 |
Drug level increased | 0 | 0 | 1 |
Nervous system disorders | 0 | 0 | 3* |
Coma | 0 | 0 | 1* |
Dysgeusia | 0 | 0 | 1* |
Hypersomnia | 0 | 0 | 1* |
If a subject experienced more than one adverse event in a category, the subject was counted only once in that category. Each event was counted.
↵* Serious adverse event. Coma, dysguesia and hypersomnia were all found in one patient.