Table 2 Adverse events (AEs) through day 28
7000 mg dose cohort | 700 mg dose cohort | |||||||
|---|---|---|---|---|---|---|---|---|
Event | Bamlanivimab (n = 48) | Placebo (n = 46) | Risk Ratio (bamlanivimab vs placebo) (95% CI), p-valuea | Risk difference (bamlanivimab vs placebo) (95% CI) | Bamlanivimab (n = 111) | Placebo (n = 112) | Risk Ratio (bamlanivimab vs placebo) (95% CI), p-valuea | Risk difference (bamlanivimab vs placebo) (95% CI) |
Grade 3 or higher TEAEs through day 28 (primary safety outcome), number of participants (%) | 6 (12.5) | 6 (13.0) | 0.96 (0.33, 2.76), p = 0.94 | −0.5 (−14.0, 13.0) % | 12 (10.8) | 7 (6.3) | 1.73 (0.71, 4.23), p = 0.23 | 4.6 (−2.8, 11.9) % |
Grade 2 or higher TEAEs through day 28, number of participants (%) | 20 (41.7) | 16 (34.8) | 1.20 (0.71, 2.01), p = 0.49 | 6.9 (−12.7, 26.5) % | 49 (44.1) | 31 (27.7) | 1.59 (1.11, 2.30), p = 0.01 | 16.5 (4.1, 28.9) % |
AEs leading to premature treatment discontinuation, number of participants (%) | 1 (2.1) | 0 | – | – | 0 | 0 | – | – |
AESIs through day 28, number of participants (%) | 1 (2.1) | 2 (4.3) | – | – | 1 (0.9) | 3 (2.7) | – | – |
Infusion-related reaction | 1 (2.1) | 1 (2.2) | – | – | 1 (0.9) | 1 (0.9) | – | – |
Hypersensitivity reaction | 0 | 1 (2.2) | – | – | 0 | 2 (1.8) | – | – |
Serious adverse events (SAEs) through day 28, number of participants (%) | 2 (4.2) | 4 (8.7) | – | – | 4 (3.6) | 3 (2.7) | – | – |
