Table 2. Summary of Adverse Events.
Event | Invasive Ventilation (N=34) |
Noninvasive Oxygen Support (N=19) |
Total (N=53) |
---|---|---|---|
number of patients (percent) | |||
Any adverse event | 22 (65) | 10 (53) | 32 (60) |
Adverse events occurring in 2 or more patients | |||
Hepatic enzyme increased* | 8 (24) | 4 (21) | 12 (23) |
Diarrhea | 1 (3) | 4 (21) | 5 (9) |
Rash | 3 (9) | 1 (5) | 4 (8) |
Renal impairment | 4 (12) | 0 | 4 (8) |
Hypotension | 3 (9) | 1 (5) | 4 (8) |
Acute kidney injury | 2 (6) | 1 (5) | 3 (6) |
Atrial fibrillation | 2 (6) | 1 (5) | 3 (6) |
Multiple-organ-dysfunction syndrome | 3 (9) | 0 | 3 (6) |
Hypernatremia | 3 (9) | 0 | 3 (6) |
Deep-vein thrombosis | 3 (9) | 0 | 3 (6) |
Acute respiratory distress syndrome | 1 (3) | 1 (5) | 2 (4) |
Pneumothorax | 2 (6) | 0 | 2 (4) |
Hematuria | 2 (6) | 0 | 2 (4) |
Delirium | 1 (3) | 1 (5) | 2 (4) |
Septic shock | 2 (6) | 0 | 2 (4) |
Pyrexia | 1 (3) | 1 (5) | 2 (4) |
Any serious adverse event | 9 (26) | 3 (16) | 12 (23) |
Serious events occurring in 2 or more patients | |||
Multiple-organ-dysfunction syndrome | 2 (6) | 0 | 2 (4) |
Septic shock | 2 (6) | 0 | 2 (4) |
Acute kidney injury | 2 (6) | 0 | 2 (4) |
Hypotension | 2 (6) | 0 | 2 (4) |
Adverse-event terms are based on the Medical Dictionary for Regulatory Activities, version 22.1. Hepatic enzyme increased includes the following terms: hepatic enzyme increased, alanine aminotransferase increased, aspartate aminotransferase increased, and transaminases increased. Elevated hepatic enzymes resulted in discontinuation of remdesivir therapy in 2 patients.