Table 3. Summary of Adverse Events in the Safety Analysis Populationa.
| Adverse events | Patients, No. (%) | ||
|---|---|---|---|
| Ensitrelvir, 125 mg (n = 604) | Ensitrelvir, 250 mg (n = 599) | Placebo (n = 605) | |
| Any adverse event | 267 (44.2) | 321 (53.6) | 150 (24.8) |
| Any treatment-related adverse event | 148 (24.5) | 217 (36.2) | 60 (9.9) |
| Any serious adverse eventb | 1 (0.2) | 0 | 1 (0.2) |
| Adverse events leading to death | 0 | 0 | 0 |
| Adverse events leading to treatment discontinuationc | 4 (0.7) | 6 (1.0) | 2 (0.3) |
| Adverse events occurring in ≥2% of patients in either intervention group | |||
| Headache | 13 (2.2) | 20 (3.3) | 14 (2.3) |
| Diarrhea | 6 (1.0) | 9 (1.5) | 12 (2.0) |
| High-density lipoprotein level decreased | 188 (31.1) | 231 (38.6) | 23 (3.8) |
| Blood triglyceride levels increased | 49 (8.1) | 74 (12.4) | 32 (5.3) |
| Blood bilirubin level increased | 36 (6.0) | 56 (9.3) | 6 (1.0) |
| Blood cholesterol level decreased | 20 (3.3) | 28 (4.7) | 3 (0.5) |
| Bilirubin conjugated increased | 15 (2.5) | 20 (3.3) | 3 (0.5) |
| Blood creatine phosphokinase level increased | 14 (2.3) | 8 (1.3) | 11 (1.8) |
| Blood lactate dehydrogenase level increased | 6 (1.0) | 15 (2.5) | 6 (1.0) |
| Aspartate aminotransferase level increased | 4 (0.7) | 9 (1.5) | 12 (2.0) |
| Treatment-related adverse events occurring in ≥2% of patients in either intervention group | |||
| Headache | 4 (0.7) | 13 (2.2) | 2 (0.3) |
| High-density lipoprotein level decreased | 111 (18.4) | 157 (26.2) | 9 (1.5) |
| Blood triglyceride levels increased | 16 (2.6) | 37 (6.2) | 17 (2.8) |
| Blood bilirubin level increased | 17 (2.8) | 35 (5.8) | 3 (0.5) |
| Blood cholesterol level decreased | 8 (1.3) | 12 (2.0) | 1 (0.2) |
a
Data for all patients who received at least 1 ensitrelvir or placebo dose are shown.
b
Both serious adverse events were judged as not treatment related, and patients recovered with appropriate intervention.
c
Among the adverse events leading to treatment discontinuation, mild eczema and mild vomiting in 1 patient each in the ensitrelvir, 125 mg, group; mild rash and moderate rash in 1 patient each in the ensitrelvir, 250 mg, group; and moderate hypoesthesia and mild muscular weakness in 1 patient in the placebo group were judged as treatment related by the investigator. All treatment-related adverse events leading to treatment discontinuation were deemed to be resolving or resolved after study discontinuation.