Table 1.
Demographic characteristics of Individual Case Safety Reports (ICSRs) involving remdesivir reported in the EudraVigilance spontaneous reporting system from 3 April 2020 to 12 December 2020.
| Individual Case Safety Reports 1375 (%) |
|
|---|---|
| Gender | |
| Male | 863 (62.8) |
| Female | 477 (34.7) |
| Not Specified | 35 (2.5) |
| Age group | |
| Paediatrics (>18 Years) | 12 (0.9) |
| Adult (18–64 Years) | 596 (43.3) |
| Elderly (65–85 Years) | 503 (36.6) |
| Very Elderly (>85 Years) | 93 (6.8) |
| Not Specified | 171 (12.4) |
| Type of reporter | |
| Health Care Professional | 1349 (98.1) |
| Non-Health Care Professional | 26 (1.9) |
| Country | |
| European Economic Area | 509 (37.0) |
| Non-European Economic Area | 866 (63.0) |
| Outcome 1 | |
| Fatal | 416 (30.3) |
| Recovered/Resolved | 338 (24.6) |
| Not Recovered/Not Resolved | 186 (13.5) |
| Recovering/Resolving | 151 (11.0) |
| Recovered/Resolved With Sequelae | 5 (0.4) |
| Unknown | 279 (20.3) |
| Adverse Events | |
| Total Number | 3166 |
| Mean AE per ICSR (±SD) | 2.3 (±2.24) |
1 In case of more than one event/outcome, the worst outcome was considered.