This form is a Common Form and can be found in the Common Forms section. This form comes due when “Date study ICF signed” is entered on Informed Consent form AND “Is the subject eligible based on Inclusion and Exclusion criteria?” = Yes on Enrollment and Randomization form AND “Is the donor eligible based on Inclusion and Exclusion criteria?” = Yes on Donor Inclusion / Exclusion form.
Overall incidence of CRS of any grade and grade III-IV CRS post-transplant will be reported on all subjects. CRS will be defined and graded using the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria (Appendix G – CRS Guidance and Management).
ASTCT Grade 3-4 CRS should be reported on this form. ASTCT Grade 1-2 CRS does not require reporting unless the event meets serious criteria. If serious, this event should be reported on the adverse event form.
Click +New each new instance of CRS of any grade. This form allows for up to 10 events.
Date diagnosed:
Report the date of diagnosis of Cytokine Release Syndrome in DD/MMM/YYYY format.
Maximum grade of CRS using ASTCT consensus criteria:
Report the maximum grade of CRS using 2019 ASTCT CRS Consensus criteria/guidelines. Refer to CRS grading section is protocol for more details.
Date maximum grade achieved:
Report the date of maximum grade of Cytokine Release Syndrome in DD/MMM/YYYY format.
Were vasopressors required:
Report whether vasopressors were required as Yes or No.
Was oxygen > 6 L/min required:
Report whether oxygen > 6L/min was required as Yes or No. If oxygen is less than or equal to 6L/min, select No.
Was therapy given for CRS:
Report whether therapy was given as Yes or No. Therapy can include but is not limited to vasopressors, tociluzumab, and steroids. If only oxygen was required, select No.
If yes, report therapy(ies) on Concomitant Medications form and add links to this form below.
Date resolved:
Report the date Cytokine Release Syndrome resolved in DD/MMM/YYYY format. If CRS is ongoing, report Intentionally Left Blank and update field when CRS has resolved.
Concomitant Medications form linking:
If the CRS instance is associated with a Concomitant Medication, the appropriate Concomitant Medication form can be linked directly to the Cytokine Release Syndrome form.
To add a link to an Concomitant Medications form, you must first have entered the Concomitant Medications form to report the medication. Next, on the Cytokine Release Syndrome form click +Add Link under the Concomitant Medications heading. In the pop-up window, select the Concomitant Medications to link by clicking on the checkbox to the left of the Reference # then click Save.
CCG v1.0 | CRF v1.3
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