Table 3.
Adverse Events That Occurred or Worsened during Receipt of Tecovirimat or Placebo in the Overall Summary Safety Population.
| Type of Event* | Placebo (N = 90) | Tecovirimat (N = 359) | Total (N = 449) | |||
|---|---|---|---|---|---|---|
| No. of Participants (%) | No. of Events | No. of Participants (%) | No. of Events | No. of Participants (%) | No. of Events | |
| Any event | 30 (33.3) | 68 | 134 (37.3) | 318 | 164 (36.5) | 386 |
|
| ||||||
| Event related to the trial agent | 15 (16.7) | 32 | 71 (19.8) | 176 | 86 (19.2) | 208 |
|
| ||||||
| Event leading to discontinuation of trial agent | 2 (2.2) | 3 | 6 (1.7) | 16 | 8 (1.8) | 19 |
|
| ||||||
| Serious events and events leading to death | 0 | 0 | 1 (0.3)† | 1 | 1 (0.2) | 1 |
The adverse events considered here included any newly occurring event or previous condition that increased in severity or frequency since administration of the first dose of tecovirimat or placebo.
The death was due to a pulmonary embolus that was judged by the investigators not to be related to tecovirimat.