Safety, efficacy, and pharmacokinetics of gremubamab (MEDI3902), an anti-Pseudomonas aeruginosa bispecific human monoclonal antibody, in P. aeruginosa-colonised, mechanically ventilated intensive care unit patients: a randomised controlled trial

Table 4 Overall summary of TEAEs through 49 days post-dose

Subjects,* n (%) with ≥ 1 event	MEDI3902 500 mg (N = 16)	MEDI3902 1500 mg (N = 85)	Placebo (N = 83)
TEAE	15 (93.8)	84 (98.8)	81 (97.6)
Treatment-related TEAE	0 (0.0)	3 (3.5)	1 (1.2)
TEAE of ≥ grade 3 severity^†	12 (75.0)	60 (70.6)	54 (65.1)
Death (grade 5 severity†)	3 (18.8)	24 (28.2)	19 (22.9)
Serious^‡ TEAE	4 (25.0)	38 (44.7)	35 (42.2)
Serious^‡ and/or ≥ grade 3 severity^† TEAE	12 (75.0)	60 (70.6)	55 (66.3)
Treatment-related serious^‡ TEAE	0 (0.0)	0 (0.0)	1 (1.2)
TEAE leading to discontinuation of treatment	0 (0.0)	0 (0.0)	0 (0.0)
AESI^§	0 (0.0)	2 (2.4)	1 (1.2)
Treatment-related AESI^§	0 (0.0)	2 (2.4)	0 (0.0)
AESI^§ of ≥ grade 3 severity^†	0 (0.0)	1 (1.2)	1 (1.2)

AE adverse event, AESI adverse event of special interest, TEAE treatment-emergent adverse event
^*Subjects are counted once for each category regardless of the number of events; ^†grade 3, severe; grade 4, life-threatening; grade 5, fatal; ^‡serious adverse event criteria: death, life-threatening, required inpatient hospitalisation, prolongation of existing hospitalisation, persistent or significant disability/incapacity, important medical event, congenital anomaly/disorder (in the offspring of the subject); ^§AESI defined as targeted AEs of hepatic function abnormalities, hypersensitivity reactions (including anaphylaxis), infusion-related reactions, and immune complex disease (including vasculitis, endocarditis, neuritis, and glomerulonephritis)

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