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. Author manuscript; available in PMC: 2021 Jan 1.
Published in final edited form as: Biol Blood Marrow Transplant. 2019 Aug 13;26(1):26–33. doi: 10.1016/j.bbmt.2019.08.003

Table 1:

Definitions of late events and patient population evaluated for each event.

Event Definition Censoring criteria Denominator
Subsequent systemic therapy for underlying disease Subsequent transplant
Late significant cytopenias Cytopenias that required red blood cell or platelet transfusions, or growth factors support.
Occurred and/or persisted beyond 90 days after first CAR-T cell infusion.
Yes Yes N=19
Included patients with ongoing CR without diagnosis of subsequent MDS.
Late hypogammaglobulinemia IgG levels < 400 mg/dL and/or intravenous immunoglobulin (IVIG) replacement.
Occurred and/or persisted beyond 90 days after first CAR-T cell infusion.
Yes Yes N=42
Included patients with available IgG data > 90 days after CAR-T cells
Late infections Any infection documented in medical records (with or without microbiologic or radiologic evidence).
Occurred and/or persisted beyond 90 days after first CAR-T cell infusion.

We considered two different infection events if: (1) occur at different time points (2) different pathogen groups (viral, bacterial, fungal, parasite) were identified (even if documented at the same time point) or (3) different non-adjacent organs were affected (even if documented at the same time point).
Yes Yes N=54
Included patients with available infection data > 90 days after CAR-T cells
Subsequent malignancies All malignancies with pathology confirmation that were diagnosed after CAR-T cell administration. No Yes N=86
Entire cohort
Immune-related events Any possible immune-related condition (except infections), even without a formal diagnostic confirmation.
Occurred and/or persisted beyond 90 days after first CAR-T cell infusion.
No Yes N=86
Entire cohort
Psychiatric and neurologic disorders Occurred and/or persisted beyond 90 days after first CAR-T cell infusion. No No N=86
Entire cohort
GVHD GVHD requiring systemic therapy. No Yes N=15
Patients with history of allogeneic HCT prior to first CAR-T cell infusion.