Table 2. Summary of Adverse Events, Serious Adverse Events, and Adverse Events Leading to Discontinuation through Day 34 (Safety Analysis Population).*.
| Adverse Event Category | Nirmatrelvir plus Ritonavir (N=1109) |
Placebo (N=1115) |
|---|---|---|
| Events that emerged during treatment period | ||
| No. of adverse events | 476 | 525 |
| Patients with adverse events — no. (%) | ||
| Any adverse event | 251 (22.6) | 266 (23.9) |
| Serious adverse event | 18 (1.6) | 74 (6.6) |
| Maximum grade 3 or 4 adverse event | 45 (4.1) | 93 (8.3) |
| Maximum grade 5 adverse event | 0 | 13† (1.2) |
| Discontinued drug or placebo because of adverse event | 23 (2.1) | 47 (4.2) |
| Had dose reduction or temporary discontinuation owing to adverse event | 4 (0.4) | 4 (0.4) |
| Events considered to be related to drug or placebo | ||
| No. of adverse events | 123 | 52 |
| Patients with adverse events — no. (%) | ||
| Any adverse event | 86 (7.8) | 42 (3.8) |
| Serious adverse event | 1 (<0.1) | 0 |
| Maximum grade 3 or 4 adverse event | 5 (0.5) | 5 (0.4) |
| Maximum grade 5 adverse event | 0 | 0 |
| Discontinued drug or placebo because of adverse event | 9 (0.8) | 7 (0.6) |
| Had dose reduction or temporary discontinuation owing to adverse event | 2 (0.2) | 3 (0.3) |
*
Shown are data for all patients who received at least one dose of drug or placebo.
†
All reported deaths were related to Covid-19; causes of death included Covid-19 pneumonia (8 patients), Covid-19 (3 patients), pneumonitis (1 patient), and acute respiratory failure (1 patient).