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