Table 2.
Characteristics of adverse drug events (N = 1004 ADEs) reported from 439 individuals reported for remdesivir in WHO database
| Parameter | Frequency (%) | |
|---|---|---|
| Age | < 18 Years | 21 (2.1) |
| 18–64 Years | 469 (46.7) | |
| ≥ 65 Years | 417 (41.5) | |
| Not reported | 97 (9.7) | |
| Gender | Female | 399 (39.7) |
| Male | 591 (58.9) | |
| Not reported | 14 (1.4) | |
| Continents | Americas | 680 (67.7) |
| Asia | 7 (0.7) | |
| Europe | 314 (31.3) | |
| Oceania | 3 (0.3) | |
| Report Type | Report from study | 249 (24.8) |
| Spontaneous | 755 (75.2) | |
| Seriousness of Adverse Event | Serious | 828 (82.5) |
| Non-Serious | 176 (17.5) | |
| Route of Administration | Intravenous | 805 (80.2) |
| Iontophoresis | 8 (0.8) | |
| Respiratory (inhalation) | 3 (0.3) | |
| Other | 1 (0.1) | |
| Unknown | 53 (5.3) | |
| Not reported | 134 (13.4) | |
| Indication for use | Covid-19 treatment | 930 (92.6) |
| Acinetobacter infection | 2 (0.2) | |
| ARDS | 1 (0.1) | |
| Drug use for unknown indication | 5 (0.5) | |
| Not reported | 66 (6.5) | |
| Outcome | Fatal | 58 (5.8) |
| Not recovered/not resolved | 122 (12.2) | |
| Recovered/resolved | 101 (10.1) | |
| Recovered/resolved with sequelae | 1 (0.1) | |
| Recovering/resolving | 30 (3.0) | |
| Unknown | 93 (9.7) | |
| Not reported | 599 (59.7) | |
| Dechallenge Action | Dose not changed | 122 (12.2) |
| Drug withdrawn | 221 (22.0) | |
| Not applicable | 25 (2.5) | |
| Unknown | 35 (3.5) | |
| Not reported | 601 (59.9) | |
| Dechallenge Outcome | Fatal | 57 (5.7) |
| No effect observed | 120 (12.0) | |
| Reaction abated | 132 (13.2) | |
| Effect unknown | 93 (9.3) | |
| Not Reported | 602 (60.0) | |
| Rechallenge Action | Rechallenge | 133 (13.2) |
| Not Reported | 871 (86.8) | |
| Rechallenge Outcome | Effect unknown | 106 (10.6) |
| No recurrence | 27 (2.7) | |
| Not Reported | 871 (86.8) | |