Table 3.
Adverse Events and Laboratory Abnormalities Reported in ≥4 Patients in a Treatment Group in the Safety Population
| Adverse Event | Presatovir, n = 95 | Placebo, n = 90 |
|---|---|---|
| Any adverse event | 76 (80.0) | 78 (86.7) |
| Serious adverse events | 18 (18.9) | 23 (25.6) |
| Grade ≥3 adverse events | 22 (23.2) | 21 (23.3) |
| Diarrhea | 15 (15.8) | 14 (15.6) |
| Nausea | 13 (13.7) | 10 (11.1) |
| Vomiting | 11 (11.6) | 12 (13.3) |
| Pyrexia | 12 (12.6) | 9 (10.0) |
| Decreased appetite | 7 (7.4) | 6 (6.7) |
| Epistaxis | 9 (9.5) | 3 (3.3) |
| Headache | 5 (5.3) | 7 (7.8) |
| Pneumonia | 4 (4.2) | 7 (7.8) |
| Acute kidney injury | 3 (3.2) | 7 (7.8) |
| Asthenia | 3 (3.2) | 7 (7.8) |
| Cough | 6 (6.3) | 4 (4.4) |
| Dizziness | 7 (7.4) | 3 (3.3) |
| Rash | 4 (4.2) | 5 (5.6) |
| Fatigue | 4 (4.2) | 4 (4.4) |
| Neutropenia | 3 (3.2) | 5 (5.6) |
| Abdominal pain | 3 (3.2) | 4 (4.4) |
| Dyspnea | 3 (3.2) | 4 (4.4) |
| Febrile neutropenia | 2 (2.1) | 5 (5.6) |
| Hypokalemia | 4 (4.2) | 3 (3.3) |
| Anemia | 5 (5.3) | 1 (1.1) |
| Insomnia | 4 (4.2) | 2 (2.2) |
| Edema peripheral | 2 (2.1) | 4 (4.4) |
| Dysgeusia | 1 (1.1) | 4 (4.4) |
| Fall | 1 (1.1) | 4 (4.4) |
| Fluid overload | 4 (4.2) | 1 (1.1) |
| Hypertension | 4 (4.2) | 1 (1.1) |
| Pain in extremity | 4 (4.2) | 1 (1.1) |
| Dysuria | 4 (4.2) | 0 |
| Sinusitis | 4 (4.2) | 0 |
Data are shown as n (%).