Table 3.

AEs Through Week 12: As-treated Population

	Sotrovimab, No. (%)
	500 mg IV (n = 393)	500 mg IM (n = 385)	250 mg IM (n = 195)
Any AE	39 (10)	41 (11)	26 (13)
Related to study treatmenta	7 (2)	4 (1)	3 (2)
Leading to permanent discontinuation of study treatment	0 (0)	0 (0)	0 (0)
Leading to dose interruption/delay	1 (<1)	0 (0)	0 (0)
Any grade 3 or 4 AE	8 (2)	8 (2)	4 (2)
Related to study treatmenta	0 (0)	0 (0)	0 (0)
Any serious AEb	3 (<1)	7 (2)	3 (2)
Related to study treatmenta	0 (0)	0 (0)	0 (0)
Fatal	0 (0)	0 (0)	0 (0)
Any injection/infusion-related reaction	2 (<1)	1 (<1)	1 (<1)
Chills	1 (<1)	0 (0)	0 (0)
Hypersensitivity	1 (<1)	0 (0)	0 (0)
Pyrexia	1 (<1)	0 (0)	0 (0)
Pruritus	0 (0)	1 (<1)	0 (0)
Asthma	0 (0)	0 (0)	1 (<1)
Any DRE	18 (5)	16 (4)	20 (10)
Leading to study discontinuation	0 (0)	2 (<1)	2 (1)
Any grade 3 or 4 DRE	4 (1)	4 (1)	6 (3)
Leading to study discontinuation	0 (0)	0 (0)	0 (0)
Any serious DRE	3 (<1)	6 (2)	10 (5)
Leading to study discontinuation	0 (0)	2 (<1)	2 (1)
Fatal	0 (0)	2 (<1)	2 (1)
DREs in ≥2 patients across treatment groups
COVID-19 pneumonia	2 (<1)	4 (1)	4 (2)
Pneumonia	1 (<1)	2 (<1)	5 (3)
Increased lipase level	1 (<1)	4 (1)	2 (1)
Cough	3 (<1)	0 (0)	2 (1)
Acidosis	2 (<1)	2 (<1)	0 (0)
Dyspnea	1 (<1)	2 (<1)	1 (<1)
Pharyngeal erythema	1 (<1)	2 (<1)	1 (<1)
Bronchitis	1 (<1)	0 (0)	2 (1)
Back pain	0 (0)	1 (<1)	1 (<1)
COVID-19	0 (0)	2 (<1)	0 (0)
Dehydration	1 (<1)	0 (0)	1 (<1)
Headache	1 (<1)	1 (<1)	0 (0)
Pyrexia	0 (0)	0 (0)	2 (1)
Thrombocytopenia	1 (<1)	0 (0)	1 (<1)
Thrombocytosis	1 (<1)	1 (<1)	0 (0)

The as-treated population includes all patients who received the study intervention and are analyzed according to the treatment received.

Abbreviations: AE, adverse event; DRE, disease-related event; IM, intramuscular; IV, intravenous.

^aRelatedness was determined by individual study investigators.

^bSerious AEs were collected through week 36; no serious AEs occurred after week 12.