Table 7

Treatment-emerging adverse events (AEs) and serious adverse events (SAEs)

	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.