Table 3. Summary of Adverse Events According to Remdesivir Treatment Group.*.
| Event or Abnormality | 5-Day Group (N=200) |
10-Day Group (N=197) |
|---|---|---|
| Any adverse event — no. of patients (%) | 141 (70) | 145 (74) |
| Nausea | 20 (10) | 17 (9) |
| Acute respiratory failure | 12 (6) | 21 (11) |
| Alanine aminotransferase increased | 11 (6) | 15 (8) |
| Constipation | 13 (6) | 13 (7) |
| Aspartate aminotransferase increased | 10 (5) | 13 (7) |
| Hypokalemia | 10 (5) | 12 (6) |
| Hypotension | 9 (4) | 12 (6) |
| Respiratory failure | 7 (4) | 14 (7) |
| Insomnia | 10 (5) | 11 (6) |
| Acute kidney injury | 4 (2) | 15 (8) |
| Adverse event leading to discontinuation of treatment — no. of patients (%) | 9 (4) | 20 (10) |
| Any serious adverse event | 42 (21) | 68 (35) |
| Acute respiratory failure | 10 (5) | 18 (9) |
| Respiratory failure | 5 (2) | 10 (5) |
| Septic shock | 2 (1) | 5 (3) |
| Acute respiratory distress syndrome | 1 (<1) | 5 (3) |
| Hypoxia | 2 (1) | 4 (2) |
| Respiratory distress | 3 (2) | 4 (2) |
| Dyspnea | 4 (2) | 1 (1) |
| Pneumothorax | 2 (1) | 3 (2) |
| Viral pneumonia | 3 (2) | 2 (1) |
| Aminotransferase levels increased | 3 (2) | 2 (1) |
| Any grade ≥3 laboratory abnormality — no. of patients/total no. (%) | 53/195 (27) | 64/191 (34) |
| Selected grade ≥3 laboratory abnormalities — no. of patients/total no. (%) | ||
| Creatinine clearance decreased | ||
| Grade 3 | 13/193 (7) | 13/188 (7) |
| Grade 4 | 5/193 (3) | 23/198 (12) |
| ALT elevation | ||
| Grade 3 | 8/194 (4) | 11/191 (6) |
| Grade 4 | 4/194 (2) | 5/191 (3) |
| AST elevation | ||
| Grade 3 | 11/194 (6) | 7/190 (4) |
| Grade 4 | 3/194 (2) | 4/190 (2) |
| Bilirubin increased | ||
| Grade 3 | 1/193 (1) | 3/190 (2) |
| Grade 4 | 0 | 1/190 (1) |
*
Adverse events listed are those that occurred in at least 5% of patients in either treatment group, and serious adverse events listed are those that occurred in 5 or more patients.