This form is a Common Form and can be found in the Common Forms section.
Refer to protocol section 7.6 POST-TRANSPLANT GVHD PROPHYLAXIS for administration details.
Tacrolimus or Alternate Immunosuppressant Administration
Was tacrolimus administered in accordance with the protocol:
Report whether tacrolimus was administered per protocol as Yes or No.
Per protocol, tacrolimus will be given per institutional practices, at a dose of 0.05 mg/kg per os (PO) or an IV dose of 0.03 mg/kg of IBW starting on Day +5. The dose of tacrolimus may be rounded to the nearest 0.5mg for oral formulations. See protocol for further details.
Specify reason tacrolimus was not administered per protocol:
This field will only appear in EDC if “Was tacrolimus administered in accordance with the protocol” is answered No. Please report the reason tacrolimus was not administered per protocol in this free textbox (up to 200 characters).
Describe how tacrolimus dosing and/or administration differed from the protocol recommended dosing and administration:
This field will only appear in EDC if “Was tacrolimus 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).
Was tacrolimus interrupted for >3 days:
Report if tacrolimus dosing was held for more than 3 days as Yes or No.
Reason for interruption:
This field will only appear in EDC if “Was tacrolimus interrupted for >3 days” is answered Yes. Please report the reason for interruption in this free textbox (up to 200 characters).
Alternate Immunosuppressant Administration
Was the patient given an alternate post-transplant immunosuppressive agent in place of tacrolimus?:
Report if the patient was given an alternate post-transplant immunosuppressive agent in place of tacrolimus as Yes or No (i.e., if subject received cyclosporine or sirolimus due to a severe intolerance of tacrolimus). This therapy will be reported below (and does not need to be reported on the Concomitant Medications CRF).
Which agent was administered?:
This field will only appear in EDC if “Was the patient given an alternate post-transplant immunosuppressive agent in place of tacrolimus” is answered Yes. Report the agent administered as Sirolimus or Cyclosporine.
Per protocol, subjects with severe intolerance of tacrolimus may be placed on Cyclosporine (trough level of 200-400 ng/mL) or Sirolimus (trough level of 5-10 ng/mL).
Why was an alternate immunosuppressant used?:
This field will only appear in EDC if “Was the patient given an alternate post-transplant immunosuppressive agent in place of tacrolimus” is answered Yes. Please report the reason the alternate immunosuppressant was used in this free textbox (up to 200 characters).
Tacrolimus (or substitute) Dose Administration
Report a new section to capture start and stop dates at each daily dose level. This section can be repeated up to 50 times.
Dose Holds
If dose was held, report a stop date (date of last dose prior to hold), then add a new section to report when dosing resumed.
Example: Subject initiates tacrolimus at Day 5 (05-JAN). On Day 16 (16-JAN), their whole blood levels are 16 ng/mL, which is above the recommended range per site’s institutional standard. Site issues a dose hold that day to allow levels to drop to the acceptable range. On Day 19 (19-JAN), the subject’s whole blood levels are within the acceptable range. Dosing resumes.
This would be reported in Veeva, as follows:
| Medication Name | Start Date | Stop Date | Total Daily Dose |
|---|---|---|---|
| Tacrolimus | 05-JAN-24 | 15-JAN-24 | 0.03 mg/kg |
| Tacrolimus | 19-JAN-24 | 0.03 mg/kg |
Medication name:
Report the agent administered as tacrolimus, sirolimus or cyclosporine. Each daily dose level an immunosuppressive agent was administered will be reported separately (i.e., there should be one administration recorded for each daily dose level between Day +5 and ~ Day +180 if administered per protocol).
Start date:
Report the start date of administration at each daily dose level in DD/MMM/YYYY format.
Stop date:
Report the end date this administration in DD/MMM/YYYY format.
Total daily dose:
Report the total daily dose of this agent in mg/kg in “XXXX.XX” format. This is not the sum of dosing across all dates at this dosing level. This format allows for up to four digits prior to the decimal and up to two digits after the decimal.
CCG v1.0 | CRF v1.3
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