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. Author manuscript; available in PMC: 2019 Jan 5.
Published in final edited form as: N Engl J Med. 2018 Jul 5;379(1):44–53. doi: 10.1056/NEJMoa1705688

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.