Refer to protocol section 7.6 POST-TRANSPLANT GVHD PROPHYLAXIS for administration details.
Post-Transplant Cyclophosphamide Day +3
Was cyclophosphamide administered on Day 3?:
Post-transplant cyclophosphamide will be initiated on Day +3 (between 60 and 72 hours after the start of the PBSC infusion). Report whether cyclophosphamide was administered on Day 3 as Yes or No.
If agent was not administered, a protocol deviation should be logged in the EDC.
Dosing body weight for cyclophosphamide administration:
This field will only appear in the EDC if “Was cyclophosphamide administered” is answered Yes.
Report the subject’s documented body weight used to calculate the cyclophosphamide dose in kilograms or pounds. Enter weight in “XXX.X” format. This format allows for up to three digits prior to the decimal and up to one digit after the decimal. Ideal body weight (IBW) should be used unless subject’s actual body weight (ABW) is below IBW.
Date cyclophosphamide administered:
This field will only appear in the EDC if “Was cyclophosphamide administered” is answered Yes. Report the date Day +3 cyclophosphamide administration began in DD/MMM/YYYY format.
If administered out of window, a protocol deviation should be logged in the EDC.
Total daily dose of cyclophosphamide:
This field will only appear in the EDC if “Was cyclophosphamide administered” is answered Yes. Report the total daily dose of cyclophosphamide in mg in “XXXX.X” format. This format allows for up to four digits prior to the decimal and up to one digit after the decimal.
Was Mesna administered pre- and post-cyclophosphamide?:
This field will only appear in the EDC if “Was cyclophosphamide administered” is answered Yes. Report whether mesna was administered pre- and post-cyclophosphamide as Yes or No. Mesna should be administered per institutional standards.
Total dose of Mesna administered:
This field will only appear in the EDC if “Was Mesna administered pre- and post-cyclophosphamide” is answered Yes. Report the total dose of Mesna in mg in “XXXXX.X” format. This format allows for up to five digits prior to the decimal and up to one digit after the decimal. If given both pre- and post-cyclophosphamide, report the sum of both administrations.
Post-Transplant Cyclophosphamide Day +4
Was cyclophosphamide administered on Day 4?:
Post-transplant cyclophosphamide will be administered on Day +4 (approximately 24 hours after Day +3 cyclophosphamide). Report whether cyclophosphamide was administered on Day 4 as Yes or No.
If agent was not administered, a protocol deviation should be logged in the EDC.
Dosing body weight for cyclophosphamide administration:
This field will only appear in the EDC if “Was cyclophosphamide administered” is answered Yes.
Report the subject’s documented body weight used to calculate the cyclophosphamide dose in kilograms or pounds. Enter weight in “XXX.X” format. This format allows for up to three digits prior to the decimal and up to one digit after the decimal. Ideal body weight (IBW) should be used unless subject’s actual body weight (ABW) is below IBW.
Date cyclophosphamide administered:
This field will only appear in the EDC if “Was cyclophosphamide administered” is answered Yes. Report the date Day +4 cyclophosphamide administration began in DD/MMM/YYYY format.
If administered out of window, a protocol deviation should be logged in the EDC.
Total daily dose of cyclophosphamide:
This field will only appear in the EDC if “Was cyclophosphamide administered” is answered Yes. Report the total daily dose of cyclophosphamide in mg in “XXXX.X” format. This format allows for up to four digits prior to the decimal and up to one digit after the decimal.
Was Mesna administered pre- and post-cyclophosphamide?:
This field will only appear in the EDC if “Was cyclophosphamide administered” is answered Yes. Report whether Mesna was administered pre- and post-cyclophosphamide as Yes or No. Mesna should be administered per institutional standards.
Total dose of Mesna administered:
This field will only appear in the EDC if “Was Mesna administered pre- and post-cyclophosphamide” is answered Yes. Report the total dose of Mesna in mg in “XXXXX.X” format. This format allows for up to five digits prior to the decimal and up to one digit after the decimal. If given both pre- and post-cyclophosphamide, report the sum of both administrations.
Immunosuppressive agents
Were systemic immunosuppressive agents (including corticosteroids) given within 24 hours of completion of post-transplant cyclophosphamide?:
Report whether systemic immunosuppressive agents (including corticosteroids as anti-emetics) were administered within 24 hours of completion of Day +3 and/or Day +4 post-transplant cyclophosphamide (PTCy) as Yes or No. It is crucial that no systemic immunosuppressive agents are given until at least 24 hours after completion of the day +4 dose of PTCy. Steroid use is permitted as pre-medication prior to start of conditioning, but is prohibited from Day 0 through 24 hours post Day 4 PTCy administration.
If Yes, a protocol deviation should be logged in the EDC, and agents reported on Concomitant Medications form.
Specify systemic immunosuppressive agents administered (agent, dose, days):
This field will only appear in EDC if “Were systemic immunosuppressive agents (including corticosteroids) given within 24 hours of completion of post-transplant cyclophosphamide” is answered Yes. Please report the agent, dose, days administered and reason in this free textbox (up to 200 characters).
CCG v1.0 | CRF v1.3
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