Reporting Deaths Clause Samples
Reporting Deaths. Death must be reported if it occurs during the SAE reporting period, irrespective of any intervening treatment. Any death occurring after the first dose of chemotherapy, for the purpose of pre-conditioning, and within 3 months of KTE-X19 infusion, regardless of attribution to treatment, requires expedited reporting within 24 hours. Any death occurring after the SAE reporting period requires expedited reporting within 24 hours only if it is considered related to treatment. Deaths that occur during the protocol-specified AE reporting period that are attributed by the investigator solely to progression of underlying leukemia should be recorded as SAEs with the preferred term “chronic lymphocytic leukemia” and must be reported immediately to the sponsor. Death is an outcome and not a distinct event. The event or condition that caused or contributed to the fatal outcome should be recorded on the AE form. Every effort should be made to capture the established cause of death, which may become available later on (eg, after autopsy).
Reporting Deaths. Deaths that occur during the protocol-specified adverse event reporting period that are attributed by the investigator solely to progression of underlying lymphoma should be recorded as SAEs with the preferred term “B-cell lymphoma” and must be reported immediately to the sponsor. Death is an outcome and not a distinct event. The event or condition that caused or contributed to the fatal outcome should be recorded on the AE form. The term “unexplained death” should be captured if the cause of death is not known. However, every effort should be made to capture the established cause of death, which may become available later (eg, after autopsy). Deaths during the post-study survival follow-up that are due to underlying cancer should be recorded only on the Survival Status CRF.