Adverse events
ADVERSE REACTIONS, ADVERSE EVENT, EVENT, ADVERSE EVENTS
Adverse events (AEs), adverse reactions (ARs), serious adverse events (SAEs), and serious adverse reactions (SARs) were assessed by a medical practitioner for severity and causality. The severity of each was classified as follows: grade 1—minor event not requiring medical intervention, grade 2—an event which is symptomatic and may require medical attention, grade 3—a significant event which requires medical intervention and may require hospitalisation, grade 4—an event that requires urgent medical intervention and is potentially life-threatening, grade 5—death.