Table 3.
Summary of adverse events in the modified intention-to-treat population of the DisCoVeRy trial, overall and according to treatment group
| Remdesivir (n=406) | Control (n=418) | Remdesivir vs control, OR (95% CI); p value | ||
|---|---|---|---|---|
| Any adverse events | 241 (59%) | 236 (57%) | 1·14 (0·86–1·50); p=0·37 | |
| Any grade 3 and 4 adverse events | 128 (32%) | 130 (31%) | 1·03 (0·76–1·39); p=0·84 | |
| Any serious adverse events | 135 (33%) | 130 (31%) | 1·11 (0·83–1·50); p=0·48 | |
| Most frequent serious adverse event | ||||
| Acute kidney injury* | 12 (3%) | 15 (4%) | .. | |
| Acute renal failure based on the RIFLE classification | 3 (1%) | 5 (1%) | .. | |
| Acute respiratory distress syndrome | 35 (9%) | 37 (9%) | .. | |
| Acute respiratory failure | 30 (7%) | 47 (11%) | .. | |
| Sepsis | 6 (1%) | 6 (1%) | .. | |
| Arrhythmia | 13 (3%) | 6 (1%) | .. | |
| Transaminases increased | 11 (3%) | 3 (1%) | .. | |
| Pulmonary embolism | 8 (2%) | 11 (3%) | .. | |
| Cholestasis | 0 (0%) | 0 (0%) | .. | |
Some patients had more than a single serious adverse event. Analyses were done in the modified Intention-to-treat population. OR=odds ratio. RIFLE=risk, injury, failure, loss of kidney function, end-stage kidney disease.
*
Excluding acute renal failures defined based on the RIFLE classification.