Adverse event reporting and harms
toxicities, death, incapacity or disability
ADVERSE EVENT, ADVERSE EVENTS, EVENT, ADVERSE EFFECTS, EVENTS
The assessment of acute toxicities (≤ 90 days from the start of RT) and adverse effects of tamoxifen will be scored using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03 [We will record serious adverse events (SAEs), which must fulfill at least one of the following criteria: (1) an unexpected event that immediately results in risk of death; (2) the events require patients to be hospitalized for further care or prolong hospitalization; and (3) the events cause significant or persistent incapacity or disability.