Adverse event | AE | Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment |
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Adverse drug reaction | ADR | All untoward and unintended responses to an investigational medicinal product related to any dose administered |
Serious adverse event | SAE | A serious adverse event/reaction is any untoward medical occurrence or effect that at any dose: • Results in death • Is life-threatening • Requires hospitalization or extension of existing hospitalization • Results in persistent or significant disability or incapacity • Is a congenital anomaly or birth defect |
Serious adverse reaction | SADR | |
Unexpected adverse reaction | UADR | Adverse reaction, the nature, severity or outcome of which is not consistent with the product information (SmPC) |
Suspected unexpected serious adverse reaction | SUSAR | Any suspected adverse reaction related to the study treatment that is both serious and unexpected |