7MDefinition of adverse event

7M Definition of adverse event

For the purposes of the definition of adverse event in subsection 28S(8) of the Act, an adverse event is: (a) for a trial participant or a patient—any of the following in connection with a pregnancy achieved in the trial participant or patient as a result of using a mitochondrial donation technique: (i) a failed embryo development; (ii) a miscarriage; (iii) a premature birth of a child; (iv) the birth of a child with a birth defect, a genetic abnormality or a diagnosis at birth of mitochondrial disease; and (b) for a child of a trial participant—a diagnosis at any time of mitochondrial disease.