Assessment of severity/intensity of adverse events
death, congenital anomaly/birth defect, disability, SADR, Cancer
ADVERSE EVENT, ADVERSE EVENTS, ADVERSE DRUG REACTION, EVENT, ADVERSE EVENT, SYNDROME, EVENTS, CANCER
The severity of any (S)AE's occurring will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0.Personnel of the trial center that is involved with the study must have access to a copy of the NCI-CTCAE version 5.0.AE's are to be documented with the following details:
Indication of the diagnosis or syndrome, duration of the AE, severity, assessment of whether an AE is serious or not (if an AE is to be classified as a SAE, additional reporting as SAE is required), assessment of the causal relationship with the study medication and the outcome of the AE's.In this study, all adverse events occurring from the time of signed informed consent by the patient until 30 days after the last administration of the study medication are to be documented as adverse events.A serious adverse event (SAE) or serious adverse drug reaction (SADR) is any AE that fulfils at least one of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, is a congenital anomaly/birth defect or constitutes an important medical event.Important medical events are defined as those occurrences that may not be immediately life threatening or result in death, hospitalization, or disability, but may jeopardize the subject or require medical or surgical intervention to prevent one of the other outcomes listed above. Medical and scientific judgment should be exercised in deciding whether such an AE should be considered serious. SAE’s must be reported immediately within 24 h knowledge of the event.