Medications are logged on a common form, which is available at the bottom of the subject’s page in EDC. Click +New to log a new event. Each new medication or dosing change of an ongoing medication should be entered as a new event. The maximum number of new events which can be added is 100.
Do not re-report PTCy, tacrolimus, MMF, Abatacept, and MMF on this CRF if administered per protocol (as this data is captured on the regimen-specific CRFs). If you accidentally record this data on the Concomitant Medications CRF and need to remove it, use the guidance provided below to reset the form.
- Click into the CRF
- Click “Edit Form”
- Once the form is editable, click the ellipses at the right-hand corner
- Choose “Reset Form” from the drop down
- A warning message will appear to confirm “reset”
- Once confirmed, the form will be “reset” and all fields will be blank. Please do not re-save the CRF once it is blank.
Pre-medication and/or treatment for possible AEs related to PTCy are permitted.
Subjects may continue all medications in compliance with local treatment center and local institutional guidelines, except those described in Section 7.9.1.
Prohibited medications should be reported on the Concomitant Medications form, and subject withdrawn from the study. These include:
- Prophylactic anti-viral cellular therapies
- GVHD prophylactic (i.e., enrolled on other GVHD prevention studies)
- Systemic immunosuppressive agents (i.e., corticosteroids and anti-emetics) on from Day 0 through 24 hours post PTCy administration
- Any other investigational medicinal product (i.e., a drug without known FDA-approval)
If GVHD or infection occurs, enrollment on a clinical trial to treat infection or GVHD is permissible. At time of relapse, patients are permitted to enroll on a clinical trial or receive disease targeted therapy. This treatment should be reported on the Concomitant Medications form.
The following medications/therapies must be reported on the Concomitant Medications form:
- Medications taken to treat adverse events that have been reported on the study EDC Adverse Event form.
- Antimicrobial prophylaxis (viral, bacterial, fungal, parasitic).
- Antimicrobial pharmaceutical and cellular therapies used to treat grade II-III infections per BMT CTN grading criteria (Appendix D – BMT CTN Infection Grading).
- Post HCT, primary malignant disease-directed pharmaceutical and cellular therapies.
- Planned maintenance therapy is permitted.
Medication Name:
Report the generic medication name (up to 200 characters).
Start Date:
Enter the date of the first dose of this concomitant medication. This field allows for partial or unknown data elements. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.
End Date:
Enter the date of the last dose of this concomitant medication or the date before the dose changes. This field allows for partial or unknown data elements. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.
Medication Ongoing?:
If medication is ongoing, select this option. If selected, the preceding field (End Date) will disappear. Please ensure this field is updated and that an end date is added, once therapy ends.
Indication:
Indicate the intent of concomitant medications:
- Adverse event
- Antimicrobial prophylaxis
- Antimicrobial treatment of Grade II-III infection per BMT CTN grading criteria
- Post-HCT primary malignant disease-directed treatment
- Maintenance therapy
- GVHD therapy
- Prohibited medications
- CRS Therapy
- Other
Prohibited medications include:
- Prophylactic anti-viral cellular therapies
- GVHD prophylactic (i.e., enrolled on other GVHD prevention studies)
- Systemic immunosuppressive agents (i.e., corticosteroids and anti-emetics) on from Day 0 through 24 hours post PTCy administration
- Any other investigational medicinal product (i.e., a drug without known FDA-approval)
If enrollment on a clinical trial to treat GVHD occurred (which is permissible), report as “GVHD Therapy” (NOT Prohibited medications).
Other indication reason, specify (up to 200 characters):
This field will only appear in the EDC if “Indication” is answered Other. Report the other indication for medication in this textbox (up to 200 characters).
What was the infection status after antimicrobial therapy:
This field will only appear if “Indication” is answered Antimicrobial treatment of Grade II-III infection per BMT CTN grading criteria. Report the infection status as Resolved or Unresolved.
Dose:
Enter the dose of the concomitant medication (up to 20 characters). If the dose has changed, click +New to create a new form for each changed dose with a unique start and stop date for each dose level. Do not enter dose unit. Dose unit will be specified in the following field.
Dose unit:
Select the dose unit in the dropdown list:
- mg
- µg
- µg/kg
- g
- mL
- IU
- %
- Gtt
- mEq
- Other
If there is a dose unit that is not specified, select the “Other” option and specify in the following field.
If Other Dose Unit, Specify:
This field will only appear in the EDC if “Dose unit” is answered Other. Report the other dose unit for medication in this textbox (up to 40 characters).
Dose form:
Select the dose form in the dropdown list:
- Aerosol
- Capsule
- Cream
- Gas
- Gel
- Injection
- Ointment
- Patch
- Powder
- Puff
- Solution
- Spray
- Suppository
- Suspension
- Tablet
- Other
If there is a dose form that is not specified, select the “Other” option and specify in the following field.
If Other Dose Form, Specify:
This field will only appear in the EDC if “Dose form” is answered Other. Report the other dose form for medication in this textbox (up to 100 characters).
Frequency:
Select the dose frequency in the dropdown list:
- Every Hour
- Every Two Hours
- Every Three Hours
- Every Four Hours
- Every Five Hours
- Every Six Hours
- Daily
- Twice Daily
- Three Times Daily
- Four Times Daily
- Every Other Day
- Weekly
- Every 2 Weeks
- Every 3 Weeks
- Every 4 Weeks
- Monthly
- Twice Per Month
- Per Year
- Continuous
- Once
- As Necessary
- Unknown
- Other
If there is a dose frequency that is not specified, select the “Other” option and specify in the following field.
If Other Frequency, Specify:
This field will only appear in the EDC if “Frequency” is answered Other. Report the other dose frequency for medication in this textbox (up to 40 characters).
Route of Administration:
Select the dose route in the dropdown list:
- Auricular (OTIC)
- Intralesional
- Intramuscular
- Intraocular
- Intraperitoneal
- Intravenous
- Intravenous Bolus
- Intravenous Drip
- Nasal
- Ophthalmic
- Oral
- Rectal
- Respiratory (Inhalation)
- Subcutaneous
- Topical
- Transdermal
- Vaginal
- Unknown
- Other
If Other Route of Administration, Specify:
This field will only appear in the EDC if “Route of Administration” is answered Other. Report the other route of administration for medication in this textbox (up to 40 characters).
Adverse Event form linking:
If a medication is given for or related to treatment of a serious adverse event, the appropriate Adverse Event form can be linked directly to the Medication form.
To add a link to an AE form, you must first have entered the AE form to report the event. Next, on the Medication form click +Add Link under the Adverse Event heading. In the pop-up window, select the Adverse Event to link by clicking on the checkbox to the left of the Reference # then click Save.
Medical History form linking:
If a medication is given for a medical history condition related to or associated with a serious adverse event, the appropriate Medical History form can be linked directly to the Medication form.
To add a link to a Medical History form, you must first have entered the Medical History form to report the event. Next, on the Medication form click +Add Link under the Medical History heading. In the pop-up window, select the Medical History 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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