Table 3.
Percentage of trial participants with any AEs or SAEs of remdesivir, BNT162b2 mRNA (BioNTech/Pfizer) and Ad26.COV2-S (Janssen)
| Women | Men | P value | |
| remdesivir (study 5774)* | |||
| Any AEs | |||
| RDV 5 days | 59.7 | 44.7 | 0.042 |
| RDV 10 days | 56.0 | 54.2 | 0.810 |
| SOC | 49.3 | 42.4 | 0.340 |
| Any SAEs | |||
| RDV 5 days | 2.6 | 5.3 | 0.367 |
| RDV 10 days | 2.7 | 4.2 | 0.569 |
| SOC | 5.3 | 11.2 | 0.160 |
| BioNTech/Pfizer | |||
| Any AEs | |||
| Vaccine | 29.5 | 24.5 | <0.001 |
| Placebo | 13.2 | 11.9 | 0.011 |
| Any SAEs | |||
| Vaccine | 0.5 | 0.6 | 0.385 |
| Placebo | 0.4 | 0.5 | 0.582 |
| Janssen | |||
| Any SAEs | |||
| ≥1 SAE vaccine | 0.4 | 0.4 | 0.353 |
| ≥1 SAE placebo | 0.6 | 0.7 | 0.492 |
*Data from the confidential marketing authorisation application dossier.
AE, adverse event; RDV, remdesivir; SAE, serious adverse event; SOC, standard of care.