Adverse event reporting and harms {22}
deaths
EVENTS
As previously mentioned, medically treated falls, safety events, and deaths are trial outcomes and therefore not reportable to the IRB. The one exception is for safety events related to an ADWE. The study team will monitor the 6-month period following the last intervention mailing for ADWE through chart review; those events determined to be “definite” will be reported to the IRB.