This form is a Common Form and can be found in the Common Forms section. This form comes due if the study treatment does not equal Abatacept.
Refer to protocol section 7.6 POST-TRANSPLANT GVHD PROPHYLAXIS for administration details.
Was MMF administered in accordance with the protocol:
Report whether Mycophenolate mofetil (MMF) was administered per protocol as Yes or No.
Per protocol, MMF will be given at a dose of 15 mg/kg three times daily (TID) (based upon actual body weight) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and continue until Day +35 post-transplant, at which time it should be discontinued (no taper necessary). Study site investigators may modify dose/taper early if clinically indicated for the study subject. Dose rounding may be done per institutional practice.
Specify reason MMF was not administered in accordance with the protocol:
This field will only appear in EDC if “Was MMF administered in accordance with the protocol” is answered No. Please report the reason MMF was not administered per protocol in this free textbox (up to 200 characters).
Describe how MMF dosing and/or administration differed from the protocol recommended dosing and administration:
This field will only appear in EDC if “Was MMF administered in accordance with the protocol” is answered No.
Please report the agent, dose, and days administered in this free textbox (up to 200 characters).
MMF Dose Administration
Report a new section to capture start and stop dates at each dose level. This section can be repeated up to 50 times.
Start date:
Report the start date of each dose level of MMF administration in DD/MMM/YYYY format. Each dose level MMF was administered will be reported separately (i.e., if there is a change in daily dose level, report the stop date of the previous daily dose and create a new section to capture the start date of the new daily dose (between Day +5 and Day +35), if administered per protocol)).
Stop date:
Report the date this administration ended in DD/MMM/YYYY format.
Total daily dose:
Report the total daily dose of MMF in mg/kg in “XXXX.XX” format. This format allows for up to four digits prior to the decimal and up to two digits after the decimal. If MMF was administered three times daily (per protocol), report the sum of all doses.
CCG v1.0 | CRF v1.3
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