Table 2.

Adverse events by system organ class and preferred term – full analysis set

	FAS n = 21
Patients with at least one drug‐related adverse event, n (%)	1 (4.8)
Gastrointestinal disorders, n (%)	1 (4.8)
Abdominal pain, upper	1 (4.8)
Patients with at least one non–drug‐related adverse event, n (%)	7 (33.3)
General disorders and administration site conditions, n (%)	1 (4.8)
Pyrexia	1 (4.8)
Infections and infestations, n (%)	7 (33.3)
Bronchitis	1 (4.8)
Exanthema subitum	1 (4.8)
Gastroenteritis rotavirus	1 (4.8)
Laryngitis viral	1 (4.8)
Respiratory tract infection	2 (9.5)
Upper respiratory tract infection	2 (9.5)
Urinary tract infection	1 (4.8)
Viral rash	1 (4.8)
Skin and subcutaneous tissue disorders, n (%)	1 (4.8)
Dermatitis allergic	1 (4.8)