2.7.10. Adverse Events (AEs)
congenital anomaly/birth defect, disability/incapacity
ADVERSE EVENTS, EVENT, ADVERSE EVENT
An adverse event was defined as the appearance or worsening of any undesirable sign, symptom or medical condition occurring in an individual event if the event was not considered to be related to study products. Medical conditions/diseases present before starting administration of the study products were only considered adverse events if they worsened after starting administration of the study products. Abnormal laboratory values or test results were regarded as adverse events only if they induced clinical signs or symptoms and if they were considered clinically significant or required therapy.A severe adverse event (SAE) was defined as an event that was fatal or life-threatening, resulted in persistent or significant disability/incapacity, constituted a congenital anomaly/birth defect, or required inpatient hospitalization or prolongation of existing hospitalization, unless hospitalization was due to one of the following: routine treatment or monitoring of the studied indication, not associated with any deterioration in condition; elective or pre-planned treatment for a pre-existing condition that was unrelated to the indication under study and had not worsened since the start of the administration of the study products; treatment on an emergency outpatient basis for an event not fulfilling any of the definitions of an SAE given above and not resulting in hospital admission; social reasons and respite care in the absence of any deterioration in the patient’s general condition; it was medically significant, i.e., defined as an event that jeopardizes the individual or may require medical or surgical intervention to prevent one of the outcomes listed above.The investigator determined the relationship of the AE and test product consumption using the following scale:Not related: No investigational product was taken, or the AE could be ascribed with reasonable certainty to another cause.Unlikely: There were good reasons to think that there was no relationship.Possible: Equally valid arguments could be considered for or against an implication of the study product.Probable: The relationship was likely.Certain (definitely): There was strong relationship.