- Serious infections (including tuberculosis)
- lymphoma
- Aplastic anemia/ pancytopenia
- Demyelinating diseases
- Decompensated heart failure
- Gastrointestinal ulceration/ perforation
- malignancy
- myocardial infarction
- Stroke
- Severe Hepatitis/Liver Failure
- severe hypersensitivity reaction/infusion incident
- Pregnancy, birth
- Death
Possible causal relationship
In any case, a SUE demand occurs when the causal relationship between SUE and therapy has been documented by the physician as “clear”, “possible”, “probable”, “unknown” or not at all.
Any conceivable causal relationship entails SUE demand
