Q99-102: 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.

Questions 99-102: LDH

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

Testing may be performed multiple times within the pre- infusion work-up time period; report the most recent LDH value obtained immediately prior to the start of lymphodepleting therapy (ideally the value from the day prior to the start). 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.

If LD therapy was started, then stopped for any reason, and restarted, report the LDH value immediately prior to the second start date.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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