Safety endpoints
ICH
ADVERSE EVENTS
Safety endpoints include the following:Incidence and severity of adverse events and abnormal laboratory test values; adverse events will be classified according to the ICH International Pharmaceutical Glossary (MedDRA) version 11.0, and their severity will be classified according to the Common Terminology CTCAE version 5.0Incidence of serious adverse events.Percentage of patients who discontinue treatment due to adverse events.