Q4 – 12: Post-Infusion Critical Illness

Questions 4 – 5: Did the recipient experience a complication of infusion requiring a transfer to an intensive care unit?

Report whether the recipient required a transfer to the intensive care unit due to a complication directly related to the infusion. If Yes, report the date of transfer to the intensive care unit. Otherwise, report No.

Question 6: Did the patient develop sepsis requiring pressor support?

Report whether the patient developed sepsis and required pressor support. If Yes, report the date pressor support started. Otherwise, report No.

Question 7: Date pressor support required

Indicate date pressor support was required.

Question 8: Did the recipient die as a result of organ failure?

Indicate if the recipient died as a result of organ failure.

Questions 9 – 10: Did the recipient have steroid-refractory acute graft-versus-host disease (SR acute GVHD)?

Steroid-refractory acute GVHD for this study is defined as “acute GVHD requiring second line treatment beyond corticosteroid-based treatment”.
Systemic steroid therapy (corticosteroid-based) is the first line treatment for acute GVHD. Patients whose GVHD progresses or does not respond, or whose GVHD initially responds but then progresses, require treatment with another agent (second line treatment).

Example 1: A transplant recipient is started on systemic steroid therapy as treatment for acute GVHD (“first line”). The acute GVHD either progresses or shows no response and a non-steroid treatment is initiated (“second line”). This case meets the criteria for steroid-refractory acute GVHD.

Example 2: Acute GVHD may initially respond to systemic steroid therapy but attempts at tapering the dose are unsuccessful, and a second line non-steroid treatment is initiated. In such scenarios another agent, such as Ruxolitinib, may be used as a second-line treatment.

Select Yes if steroid-refractory acute GVHD developed during the reporting period, and report the date that second-line treatment was initiated as the date of diagnosis.

Select No if there is no indication for steroid-refractory acute GVHD.

Unknown must only be selected when GVHD status is not assessed during the reporting period.

Select Previously reported if steroid-refractory acute GVHD was reported in a prior reporting period.

Questions 11 – 12: Did the recipient have steroid refractory chronic GVHD (SR chronic GVHD)?

Steroid-refractory chronic GVHD for this study is defined as “chronic GHVD requiring treatment beyond systemic corticosteroid therapy”. In chronic GVHD, systemic corticosteroid therapy may or may not be the first line of therapy. Any transplant recipient who receives systemic corticosteroid therapy for chronic GVHD (regardless of line of therapy administered) and subsequently requires additional, non-steroid therapy meets the criteria for steroid-refractory chronic GVHD.

Example 1: The first line treatment for chronic GVHD was extracorporeal electrophoresis (ECP) but the GVHD did not respond. Systemic corticosteroids were initiated as second line treatment but the GVHD still did not respond and ibrutinib was initiated. This case meets the criteria for steroid-refractory chronic GVHD.

Select Yes if steroid-refractory chronic GVHD developed during the reporting period and then report the date that subsequent, non-steroidal treatment was initiated as the date of diagnosis.

Select No if there is no indication for steroid-refractory chronic GVHD.

Unknown must only be selected when GVHD status is not assessed during the reporting period.

Select Previously reported if steroid-refractory chronic GVHD has been reported in a prior reporting period.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.