Table 3. Open in new tab Safety and...

Table 3.

Safety and Tolerability (Safety Set)

Adverse Event	Regdanvimab 40 mg/kg (n = 652)	Placebo (n = 650)	Total (N = 1302)
Any TEAE	198 (30.4)	202 (31.1)	400 (30.7)
Related to study drug	44 (6.7)	46 (7.1)	90 (6.9)
Grade ≥3 TEAEs	61 (9.4)	69 (10.6)	130 (10.0)
Related to study drug	12 (1.8)	15 (2.3)	27 (2.1)
Any TESAE	4 (0.6)	1 (0.2)	5 (0.4)
Deaths^a	0	0	0
Any TEAE leading to discontinuation	0	0	0
TEAEs classified as infusion-related reactions^b	4 (0.6)	7 (1.1)	11 (0.8)

Adverse Event	Regdanvimab 40 mg/kg (n = 652)	Placebo (n = 650)	Total (N = 1302)
Any TEAE	198 (30.4)	202 (31.1)	400 (30.7)
Related to study drug	44 (6.7)	46 (7.1)	90 (6.9)
Grade ≥3 TEAEs	61 (9.4)	69 (10.6)	130 (10.0)
Related to study drug	12 (1.8)	15 (2.3)	27 (2.1)
Any TESAE	4 (0.6)	1 (0.2)	5 (0.4)
Deaths^a	0	0	0
Any TEAE leading to discontinuation	0	0	0
TEAEs classified as infusion-related reactions^b	4 (0.6)	7 (1.1)	11 (0.8)

Data are presented as No. of patients (%).

Abbreviations: TEAE, treatment-emergent adverse event; TESAE, treatment-emergent serious adverse event.

Reported as TESAEs.

TEAEs classified as infusion-related reactions were considered TEAEs of special interest for this study.