Adverse event reporting and harms {22}
congenital anomaly, disability
ADVERSE EVENTS, ADVERSE EVENT, EVENT, DISEASE, ADVERSE EVENT, ADVERSE REACTION
Adverse events are defined as any undesirable experience occurring to a subject during the study, whether or not considered related to quilting. All adverse events reported spontaneously by the subject or observed by the investigator or his staff will be recorded.A serious adverse event is any untoward medical occurrence or effect that at any dose:results in death;is life threatening (at the time of the event);requires hospitalisation or prolongation of existing inpatients’ hospitalisation;results in persistent or significant disability or incapacity;is a congenital anomaly or birth defect;is a new event of the trial likely to affect the safety of the subjects, such as an unexpected outcome of an adverse reaction, lack of efficacy of an IMP used for the treatment of a life threatening disease, major safety finding from a newly completed animal study, etc.All SAEs will be reported to the accredited METC.