Table 3. Adverse events.
N, number of participants in dose group.
Number (%) of participants
experiencing an adverse event |
Molnupiravir 200 mg | Molnupiravir 400 mg | Molnupiravir 800 mg | Placebo |
N = 23 | N = 62 | N = 55 | N = 62 | |
Any adverse event | 11 (47.8) | 20 (32.3) | 11 (20.0) | 18 (29.0) |
Adverse events reported by >5% subjects in any group | ||||
Dizziness | 2 (8.7) | 1 (1.6) | 0 | 0 |
Insomnia | 2 (8.7) | 1 (1.6) | 1 (1.8) | 4 (6.5) |
Any adverse event grade 3 or higher |
1 (4.3) | 2 (3.2) | 4 (7.3) | 5 (8.1) |
Any adverse event leading to discontinuation of study drug |
0 | 1 (1.6) | 1 (1.8) | 1 (1.6) |
Any adverse event related to study drug |
4 (17.4) | 13 (21.0) | 1 (1.8) | 8 (12.9) |
Any serious adverse event | 0 | 2 (3.2) | 1 (1.8) | 1 (1.6) |
Any adverse event leading to death |
0 | 0 | 0 | 1 (1.6)* |
*The subject had an adverse event of hypoxia that led to death. This occurred 31 days after discontinuation from the study after completion of study assessments and was not recorded in the study database but was recorded in the safety database.