Table 2.
Treatment-Emergent AEs in the Single and Multiple Ascending Dose Groups
| Lufotrelvir | Placebo | |||
|---|---|---|---|---|
| 250 mg | 500 mg | 250 mga | 500 mgb | |
| A: Single Ascending Dose | ||||
| All causality | ||||
| Evaluable participants | 2 | 2 | 2 | 2 |
| No. of AEs | 2 | 3 | 5 | 9 |
| AEs | 1 (50.0) | 1 (50.0) | 2 (100.0) | 2 (100.0) |
| SAEs | 0 | 1 (50.0) | 1 (50.0) | 1 (50.0) |
| Severe AEs | 1 (50.0) | 1 (50.0) | 1 (50.0) | 1 (50.0) |
| Discontinued from study due to AEs | 0 | 0 | 0 | 0 |
| Treatment relatedc | ||||
| Evaluable participants | 2 | 2 | 2 | 2 |
| No. of AEs | 0 | 0 | 1 | 0 |
| AEs | 0 | 0 | 1 (50.0)d | 0 |
| SAEs | 0 | 0 | 0 | 0 |
| Severe AEs | 0 | 0 | 0 | 0 |
| B: Multiple Ascending Dose | … | |||
| All causality | ||||
| Evaluable participants | 7 | 6 | 4 | … |
| No. of AEs | 13 | 4 | 9 | … |
| AEs | 4 (57.1) | 2 (33.3) | 3 (75.0) | … |
| SAEs | 2 (28.6) | 1 (16.7) | 1 (25.0) | … |
| Severe AEs | 2 (28.6) | 0 | 1 (25.0) | … |
| Discontinued from study due to AEs | 0 | 0 | 1 (25.0)e | … |
| Discontinued drug due to AE and continued study | 0 | 0 | 0 | … |
| Dose reduction or temporary discontinuation due to AE | 0 | 1 (16.7) | 0 | … |
| Treatment relatedc | ||||
| Evaluable participants | 7 | 6 | 4 | … |
| No. of AEs | 0 | 0 | 1 | … |
| AEs | 0 | 0 | 1 (25.0)a | … |
| SAEs | 0 | 0 | 0 | … |
| Severe AEs | 0 | 0 | 0 | … |
All data are presented as No. (%) unless stated otherwise. Results are for the safety analysis set. Except for the number of AEs, participants were counted only once per treatment in each row.
Abbreviations: AE, adverse event; SAE, serious AE.
a
Placebo group for lufotrelvir, 250 mg.
b
Placebo group for lufotrelvir, 500 mg.
c
As determined by the investigator.
d
Mild hematuria.
e
Increased liver function test.