Table 4.
Safety and Tolerability
| Outcome | US316 | US317 | ||
|---|---|---|---|---|
| Placebo (n = 427) |
Favipiravir (n = 428) |
Placebo (n = 283) |
Favipiravir (n = 861) |
|
| Treatment-emergent AE | 131 (30.7) | 111 (25.9) | 71 (25.1) | 241 (28.0) |
| Treatment-related AE | 52 (12.2) | 34 (7.9) | 23 (8.1) | 88 (10.2) |
| SAE | 2 (0.5) | 1 (0.2) | 2 (0.7) | 4 (0.5) |
| AE leading to discontinuation | 8 (1.9) | 8 (1.9) | 1 (0.4) | 10 (1.2) |
Data are presented as No. (%). In US316, 2 subjects received favipiravir despite being randomized to placebo, which accounts for the numerical differences between the safety population and the intention–to–treat population. To prevent inadvertent unblinding of an individual subject’s treatment, uric acid levels were not provided to either the sponsor or the study sites until the safety database was locked. Therefore, elevations in uric acid could not be categorized as AEs.
Abbreviations: AE, adverse event; SAE, serious adverse event.