Safety assessments
disability or incapacity, death, birth defect, congenital anomaly
ADVERSE EVENTS, ADVERSE EVENT, DISEASE, EVENT, ADVERSE REACTION, ADVERSE EVENT
Adverse events (AEs) were recorded and monitored throughout the study from the signing of informed consent form through to the post-study follow-up visit. AEs were defined as any untoward medical occurrence in a participant to whom a product has been administered, including occurrences which are not necessarily caused by or related to that product. An AE could be any unfavorable and unintended sign, including abnormal laboratory findings considered to be clinically significant, symptom, or disease temporarily associated with the use of a study product, whether or not considered related to the product. An unexpected adverse reaction was defined as an adverse reaction where the nature or severity was not consistent with the applicable product information (e.g., documented in the Investigator’s brochure). A product-emergent adverse event (PEAE) was defined as an AE not present prior to the use of a study product or an AE already present that worsened in intensity or frequency following the use of a study product.Serious adverse events (SAEs) were defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability or incapacity, was a congenital anomaly or birth defect, or was a medically significant event that required treatment/intervention to prevent one of the listed outcomes. All serious adverse events (SAEs) and AEs that had not resolved by the end of the study would be followed up by the Investigator until resolution or until the Investigator believed there would be no further change, whichever was earlier.