Table 4.

Overview of ADRs (safety analysis set, N = 821)

Preferred term	n (%)
Any ADR	93 (11.33)
Any serious ADR	25 (3.05)
ADRs in ≥ 0.5% of patients
Nausea	13 (1.58)
Renal impairment	12 (1.46)
Acute graft versus host disease	5 (0.61)
Cytomegalovirus test positive	5 (0.61)
Hepatic function abnormal	5 (0.61)
Serious ADRs in ≥ 0.2% of patients
Ascites	2 (0.24)
Acute kidney injury	2 (0.24)
Engraft failure	2 (0.24)
Hepatic function abnormal	2 (0.24)
Hepatic vein occlusion	2 (0.24)

ADRs adverse drug reactions, IV intravenous