Table 1.
Seriousness and Outcome of the Reported Adverse Drug Reactions from the CSL Behring Global Safety Database.
| All ADRs (n = 806) | TEEs (n = 114) | Hypersensitivity reaction events (n = 79) | Transmissions of infectious agents (n = 51) | |
|---|---|---|---|---|
| Seriousness | ||||
| Non-serious | 249 | 0 | 16 | 3 |
| Serious | 557 | 114 | 63 | 48 |
| Outcome | ||||
| Fatal | 76 | 20 | 7 | - |
| Not recovered/Not resolved | 42 | 5 | 2 | 7 |
| Not reported | 124 | 22 | 3 | 3 |
| Recovered/Resolved | 351 | 33 | 57 | 6 |
| Recovering/Resolving | 13 | 4 | 1 | - |
| Recovered/Resolved with sequelae | 7 | 3 | - | 3 |
| Recovered with treatment | 2 | 1 | - | - |
| Unknown | 191 | 26 | 9 | 32 |
N values represent adverse drug reactions.
Abbreviations: ADR, adverse drug reaction; TEE, thromboembolic event.