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An unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity.
Adverse reaction imputability:
| Definite, certain | Conclusive evidence beyond reasonable doubt for attribution to donation or infusion of the cell product |
| Probably, likely | Evidence in favour of attribution to donation or infusion of the cell product |
| Possible | Evidence is indeterminate |
| Unlikely | Evidence is clearly in favour of attribution to alternative causes |
| Excluded | Conclusive evidence beyond reasonable doubt for attributing adverse reaction to alternative causes |
| Not Assessable | Insufficient data for imputability assessment |
Adverse reaction severity grade
The WMDA follows the Common Terminology Criteria for Adverse Events (CTCAE) guidance for severity assessment.
| Grade 1 | Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. |
| Grade 2 | Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental ADL* |
| Grade 3 | Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL** |
| Grade 4 | Life-threatening consequences; urgent intervention indicated |
| Grade 5 | Death related to AE |
Activities of Daily Living (ADL)
*Instrumental ADL refer to preparing meals,
shopping for groceries or clothes, using the
telephone, managing money, etc.
**Self care ADL refer to bathing, dressing and
undressing, feeding self, using the toilet, taking
medications, and not bedridden.
Adverse reaction imputability:
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Definition serious adverse event (SAE):
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