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. 2022 Aug 15;5(8):e2225411. doi: 10.1001/jamanetworkopen.2022.25411

Table 2. Adverse Events in the Safety Population in IV and SC Groupsa.

Adverse Event Participants, No. (%)
IV SC
Placebo Casirivimab and imdevimab Placebo Casirivimab and imdevimab
300 mg 600 mg 1200 mg 2400 mg 600 mg 1200 mg
No. 57 115 114 116 115 58 114 114
Patients with
Any TEAE 10 (17.5) 10 (8.7) 16 (14.0) 22 (19.0) 9 (7.8) 6 (10.3) 5 (4.4) 12 (10.5)
Any grade 3 or 4 TEAE 1 (1.8) 0 1 (0.9) 1 (0.9) 0 0 0 0
Any SAE 0 0 0 1 (0.9) 1 (0.9) 0 0 0
Any AESI 1 (1.8) 0 1 (0.9) 2 (1.7) 0 0 0 1 (0.9)
Any serious AESI 0 0 0 0 0 0 0 0
Infusion-related reaction (grade ≥2) through day 4 0 0 0 0 0 0 0 0
Injection-site reactions (grade ≥3) through day 4 0 0 0 0 0 0 0 0
Hypersensitivity reactions (grade ≥2) through day 29 0 0 0 0 0 0 0 0
Any TEAE leading to death 0 0 0 0 0 0 0 0
Any TEAE leading to withdrawal from the study medication 0 0 0 0 1 (0.9) 0 0 0
Any TEAE leading to study infusion interruption 0 0 0 0 0 0 0 0

Abbreviations: AESI, adverse event of special interest; IV, intravenous; SAE, serious adverse event; SC, subcutaneous; TEAE, treatment-emergent adverse event.

a

The safety population includes all randomized patients who received any study drug.