Table II.

Summary of adverse events in the safety population (N = 63)

Metric	Total (%)
Adverse events	937
Total number of infusions	746
Patients with ≥ 1AE	59 (93.7%)
Drug-related AEs	300 (32.0%)
Patients with ≥1 drug-related AE	40 (63.5%)
Infusions with ≥1 TAAE	209 (28.0%)
Infusions with ≥1 drug-related TAAE	152 (20.4%)
Patients with ≥1 SAE	7 (11.1%)
Number of SAEs	11
Patients with ≥1 drug-related SAE	1 (1.6%)
Patients with ≥1 AE leading to withdrawal	2 (3.2%)
Severity of drug-related AEs
Mild (No. of patients)	11 (17.5%)
Moderate (No. of patients)	21 (33.3%)
Severe (No. of patients)	8 (12.7%)

TAAE temporally associated adverse event, i.e. occurs within 72 h of an infusion

SAE serious adverse event