Cell Therapy Reporting Levels

Beginning July 2023, new TED and CRF reporting levels for cell therapy were created to reduce the burden of data collection. TED and CRF reporting levels are determined by the center reporting preference and infusion details.

! Cell therapy reporting levels are not a center level attribute like HCT reporting. Each cell therapy infusion will be randomized separately.

TED Level Reporting Forms	CRF Level Reporting Forms
4000	4000
4003	4001
4006	4003
4100	4006
2402	4100
3500	4101
2900	2402 + disease forms (when applicable)
	3500
	3501
	2900

Toxicities on F4100

All toxicities will be present on the F4100; however, they will enable based on TED vs CRF reporting.

TED Level Reporting Forms	CRF Level Reporting Forms
CRS (Y/N) + diagnosis date + symptoms + resolution date	Therapy for CRS
MAS/HLH-like toxicities (Y/N) + diagnosis date + resolution date	Therapy for MAS/HLH-like toxicities, splenomegaly, confirmation by BMBx, lab values
Neurotoxicity (Y/N) + cognitive assessment + neurotoxicity manifestation parent list, details on cerebral edema, depressed level of consciousness, motor neuron disease, movement disorder, seizure, speech impairment	Therapy for neurotoxicity + details on cerebrovascular accident, cognitive impairment, personality change, other
	Hypogammaglobulinemia, tumor lysis syndrome, other toxicity, grade 3/4 organ toxicity, lab values

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