Table 2. Incidence of Adverse Events in the Safety Population.
| Adverse Events and Discontinuation | Molnupiravir (N=710) |
Placebo (N=701) |
Estimated Difference (95% CI)* |
|---|---|---|---|
| number (percent) | percentage points | ||
| Participants with adverse events | |||
| ≥1 Adverse event | 216 (30.4) | 231 (33.0) | −2.5 (−7.4 to 2.3) |
| ≥1 Adverse event related to the assigned regimen† | 57 (8.0) | 59 (8.4) | −0.4 (−3.3 to 2.5) |
| ≥1 Serious adverse event | 49 (6.9) | 67 (9.6) | −2.7 (−5.6 to 0.2) |
| ≥1 Serious adverse event related to the assigned regimen† | 0 | 1 (0.1) | −0.1 (−0.8 to 0.4) |
| Death | 2 (0.3) | 12 (1.7) | −1.4 (−2.7 to −0.5) |
| Participants who discontinued the assigned regimen because of an adverse event | |||
| Adverse event | 10 (1.4) | 20 (2.9) | −1.4 (−3.1 to 0.1) |
| Adverse event related to the assigned regimen† | 4 (0.6) | 3 (0.4) | 0.1 (−0.8 to 1.1) |
| Serious adverse event | 5 (0.7) | 13 (1.9) | −1.2 (−2.5 to 0.0) |
| Serious adverse event related to the assigned regimen† | 0 | 0 | 0.0 (−0.5 to 0.5) |
*
Differences shown are for molnupiravir as compared with placebo. Difference estimates were based on the Miettinen and Nurminen method.
†
Related events were those determined by the investigators to be related to the assigned regimen.