Table 2.

Summary of treatment-emergent serious adverse events

System organ class preferred term	Arm A (n=24) n (%)	Arm B (n=13) n (%)	Overall (n=37) n (%)
No. (%) of patients with any treatment-emergent SAE	9 (37.5)	6 (46.2)	15 (40.5)
Blood and lymphatic disorders	2 (8.3)	0	2 (5.4)
Haemolytic uremic syndrome	1 (4.2)	0	1 (2.7)
Lymphadenopathy	1 (4.2)	0	1 (2.·7)
Cardiac disorders	0	2 (15.4)	2 (5.4)
Cardiac failure	0	1 (7.7)	1 (2.7)
Supraventricular tachycardia	0	1 (7.7)	1 (2.7)
Gastrointestinal disorders	3 (2.5)	0	3 (8.1)
Ascites	1 (4.2)	0	1 (2.7)
Nausea	1 (4.2)	0	1 (2.7)
Pancreatitis	1 (4.2)	0	1 (2.7)
Vomiting	1 (4.2)	0	1 (2.7)
General disorders and administrative site conditions	2 (8.3)	1 (7.7)	3 (8.1)
Device occlusion	0	1 (7.7)	1 (2.7)
Drug withdrawal syndrome	1 (4.2)	0	1 (2.7)
Fever	1 (4.2)	0	1 (2.7)
Hepatobiliary disorders	0	2 (15.4)	2 (5.4)
Cholangitis	0	2 (15.4)	2 (5.4)
Hyperbilirubinaemia	0	1 (7.7)	1 (2.7)
Infections	1 (4.2)	3 (23.1)	4 (10.8)
Sepsis	0	2 (15.4)	2 (5.4)
Cellulitis	0	1 (7.7)	1 (2.7)
Urinary tract infection	1 (4.2)	0	1 (2.7)
Injury, poisoning and procedural complications	1 (4.2)	0	1 (2.7)
Craniocerebral injury	1 (4.2)	0	1 (2.7)
Respiratory, thoracic and mediastinal disorders	2 (8.3)	1 (7.7)	3 (8.1)
Pneumonitis	1 (4.2)	1 (7.7)	2 (5.4)
Pulmonary embolism	1 (4.2)	0	1 (2.7)
Skin and subcutaneous disorders	1 (4.2)	0	1 (2.7)
Rash	1 (4.2)	0	1 (2.7)

OK as is