Reporting of SAEs and Non-serious CRS Events Grade Sample Clauses

Reporting of SAEs and Non-serious CRS Events Grade. ≥ 3 The investigator is responsible for reporting all SAEs observed by the investigator or reported by the subject that occur after signing of the consent through 3 months after the anti-CD19 CAR T cell infusion. After 3 months, only serious targeted AEs (eg, neurological, hematological, infections, autoimmune disorders, and secondary malignancies) observed by the investigator or reported by the subject will be reported for 24 months after anti-CD19 CAR T cell infusion or until disease progression, whichever occurs first. For subjects who screen fail or are enrolled but do not receive anti-CD19 CAR T cells, the reporting period for SAEs ends 30 days after the last procedure (eg, screen procedure, leukapheresis, conditioning chemotherapy). Serious events that the investigator assesses as related to axicabtagene ciloleucel or KTE-X19 should be reported regardless of the time period. All SAEs and non-serious CRS events ≥ Grade 3 (Xxx et al, 2014) must be submitted via email to PPD within 24 hours following the investigator’s knowledge of the event using a SAE Report Form. Subsequently, all SAEs will be reported in accordance with EU guidelines, or, if applicable, as per local reporting guidelines. Progression of the malignancy during the study should not be reported as an SAE. SAEs associated with disease progression may be reported as an SAE. If the malignancy has a fatal outcome within 3 months of the last day of the conditioning therapy or anti-CD19 CAR T cell- infusion, then the event leading to death must be recorded as an SAE with CTCAE Grade 5. 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 the anti-CD19 CAR T cell infusion, regardless of attribution to treatment, requires expedited reporting within 24 hours. Any death occurring greater than 3 months after the anti-CD19 CAR T cell infusion requires expedited reporting within 24 hours only if it is considered related to treatment.