Part B
United Kingdom
Serious adverse reactions — imputability levels
| Imputability levels to assess serious adverse reactions. | ||
| Imputability level | Explanation | |
|---|---|---|
| NA | Not assessable | When there is insufficient data for imputability assessment. |
| 0 | Excluded | When there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to alternative causes. |
| Unlikely | When the evidence is clearly in favour of attributing the adverse reaction to causes other than the blood or blood components. | |
| 1 | Possible | When the evidence is indeterminate for attributing adverse reaction either to the blood or blood component or to alternative causes. |
| 2 | Likely, Probable | When the evidence is clearly in favour of attributing the adverse reaction to the blood or blood component. |
| 3 | Certain | When there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to the blood or blood component. |