I do have a question relative to AEs recording in interventional clinical trials. Is it allowed NOT to record as AE a condition that is recorded as EFFICACY ENDPOINT? for example: the worsening of disease under study is measured as efficacy endpoint, but it is also associated with a change in the initial patient's condition. are there any rules? are authorities fine to have the "event" only reported among the efficacy results? or maybe have it as AE only if its occurrence, severity or unresponsiveness to treatment is considered by the investigator unusual or abnormal?
thank you!!