Adverse events reporting and harms {22}
death, birth defect, congenital anomaly, disability
ADVERSE EVENTS, ADVERSE EVENT, EVENT, ADVERSE EVENT, EVENTS
Adverse events (AEs) are defined as any undesirable experience occurring to a subject during the trial, whether considered related to the trial procedure. A serious adverse event (SAE) is any untoward medical occurrence or effect:Results in death.Is life threatening (at the time of the event).Requires hospitalization or prolongation of existing inpatients’ hospitalization.Results in persistent or significant disability or incapacity.A congenital anomaly or birth defect.Any other important medical event that did not result in any of the outcomes listed above due to medical or surgical intervention but could have been based upon appropriate judgment by the investigator. An elective hospital admission will not be considered as a serious adverse event.All (S)AEs reported spontaneously by the subject or observed by the investigator or his staff will be recorded, only if judged to be substantial deviating from expected standard clinical course. The investigator will report all SAEs to the sponsor without undue delay after obtaining knowledge of the events. Subjects will be followed up for AEs and SAEs until the final trial procedures or 7 days after discontinuation of the trial. All reports will be digitally filed in the electronic clinical data capture form.The sponsor will report the SAEs to the accredited Medical Research and Ethics Committee (MREC) Leiden-Den-Haag-Delft, within 7 days of first knowledge for SAEs that result in death or are life threatening followed by a period of maximum of 8 days to complete the initial preliminary report. All other SAEs will be reported within a period of maximum 15 days after the sponsor has first knowledge of the serious adverse events.