Conditioning Regimen Details
Classify the conditioning regimen intensity:
Select the conditioning regimen intensity as MAC or RIC/NMA.
Was irradiation performed as part of the pre-HCT preparative regimen:
Indicate if irradiation was performed as part of the pre-HCT preparative regimen as “Yes” or “No”. If Yes, report dose, date started, and confirm radiation fractions in the following fields.
If yes, total dose:
Report the total dose of irradiation, including units, in XXXX.X format. This field only accepts 4 digit(s) before the decimal and 1 digit(s) after the decimal.
This field will only appear in the EDC if “Was irradiation performed as part of the pre-HCT preparative regimen” is answered Yes.
If yes, date started:
Report the date irradiation started. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.
This field will only appear in the EDC if “Was irradiation performed as part of the pre-HCT preparative regimen” is answered Yes.
If yes, was the radiation fractionated:
Report if radiation was fractionated as “Yes” or “No.” This is a process where the radiation dose is divided into several “fractions”, or several smaller doses.
This field will only appear in the EDC if “Was irradiation performed as part of the pre-HCT preparative regimen” is answered Yes.
Total # of fractions:
Report the total number of fractions (several smaller doses) of radiation in XX format of radiation.
This field will only appear in the EDC if “Was irradiation performed as part of the pre-HCT preparative regimen” is answered Yes.
Conditioning Drugs
Click on “New Section” to separately report each conditioning drug administered on each day. This section can be repeated up to 50 times.
Drug name:
Select the conditioning agent’s name from the list below:
• Bendamustine
• Busulfan
• Carboplatin
• Carmustine (BCNU)
• CCNU (Lomustine)
• Clofarabine (Clolar)
• Cyclophosphamide (Cytoxan)
• Cytarabine (Ara-C)
• Etoposide (VP-16, VePesid)
• Fludarabine
• Gemcitabine
• Ibritumomab tiuxetan (Zevalin)
• Ifosfamide
• Melphalan (L-Pam)
• Methylprednisolone (Solu-Medrol)
• Pentostatin
• Propylene glycol-free melphalan (Evomela)
• Rituximab (Rituxan)
• Thiotepa
• Tositumomab (Bexxar)
• Treosulfan
• Other drug, specify
Specify other drug:
This field will only appear in the EDC if “Drug name” is answered “Other drug, specify”. Report the agent’s name in this free textbox (up to 200 characters).
Total daily dose:
Report the total daily dose of this agent administered on this date only in mg in XXXX.X format. Format allows for up to 4 digits before decimal and up to 1 digit after decimal. If agent was not administered per conditioning regimen plan, mark this field as “Intentionally left blank” and report reason.
Date administered:
Report the date this agent was administered. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used. If agent was not administered per conditioning regimen plan, mark this field as “Intentionally left blank” and report reason.
Route:
Report the route in which this agent was administered – Oral or Intravenous. If agent was not administered per conditioning regimen plan, mark this field as “Intentionally left blank” and report reason.
Busulfan PK Monitoring
If busulfan was given, was daily busulfan PK monitoring done:
Indicate if daily busulfan PK monitoring was done “Yes”, “No” OR “N/A – Busulfan not given.”
If answered Yes complete the questions below regarding the PK monitoring.
Was an average daily busulfan AUC target of 4800-5300 uM*Min achieved:
This field will only appear in the EDC if “If busulfan was given, was daily busulfan PK monitoring done” is answered Yes. Indicate if an average daily busulfan Area Under Curve (AUC) reached the target of 4800-5300 μM*min as “Yes” or “No”.
If no, what target was achieved:
This field will only appear in the EDC if “Was an average daily busulfan AUC target of 4800-5300 μM*min achieved?” is answered No. Report average daily busulfan AUC (up to 200 characters). Please ensure unit of measurement is included.
CCG v1.0 | CRF v1.3
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