Table 2.

Overall summary of adverse events (AEs) and treatment-related AEs (TRAEs)

Types of AEs	Safety population (N = 3061) n (%)	95% confidence interval (CI)
Overall AEs	298 (9.7)	8.74, 10.84
Overall TRAEs	168 (5.5)	4.74, 6.35
Serious AEs (SAEs)	37 (1.2)	0.88, 1.66
Serious TRAEs	5 (0.2)	0.07, 0.38
Unexpected AEs	198 (6.5)	5.65, 7.40
Unexpected SAEs	35 (1.1)	0.82, 1.59
Unexpected TRAEs	91 (3.0)	2.43, 3.64
AEs that led to treatment discontinuation	10 (0.3)	0.18, 0.60
AEs that led to death	1 (0.03)	0.01, 0.18

AE adverse event, CI confidence interval, SAE serious adverse event, TRAE treatment-related adverse event