Q74-76: Hematologic Findings Prior to Lymphodepleting Therapy

*Current hematologic findings data collection has been split between TED and CRF level reporting. TED level reporting will capture only LDH values. All other lab values will be captured on the Pre-Cellular Therapy Baseline Data (4001) form if the infusion is selected for CRF level reporting.

Question 74-76: LDH

Testing may be performed multiple times within the pre- infusion work-up time period; report the most recent LDH value obtained within 30 days of the start of lymphodepleting therapy. Laboratory values obtained on the first day of the lymphodepleting therapy may be reported as long as the blood was drawn before any lymphodepleting therapy was administered. If no lymphodepleting therapy is given, report most recent LDH result prior to the cellular infusion.

Indicate whether the LDH result was Known or Unknown prior to the start of lymphodepleting therapy. If Known, report the result, the unit of measure, and specify the upper limit of normal.

Section Updates:

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