Bone Marrow Assessment
Was a bone marrow aspirate performed?:
Report whether a bone marrow aspirate was performed as “Yes,” “No,” or “N/A – lymphoma with no previous bone marrow involvement.”
If answered Yes complete the questions below regarding the bone marrow aspirate.
Per protocol a bone marrow aspirate is required to be completed at screening for all diseases except Lymphoma. If this field is answered No a protocol deviation should be logged in the EDC.
Date of bone marrow aspirate:
This field will only appear in the EDC if “Was a bone marrow aspirate performed?” is answered Yes. Enter the date the test was completed. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.
Per protocol a bone marrow aspirate is required to be completed within 45 days prior to the anticipated start of the conditioning regimen (for all diseases except Lymphoma). If the bone marrow aspirate date entered is outside of those parameters a protocol deviation should be logged in the EDC.
If the date entered is a future date, a query will appear in the EDC.
Blasts in bone marrow by morphology:
This field will only appear in the EDC if “Was a bone marrow aspirate performed?” is answered Yes. Report the subject’s blasts in bone marrow by morphology in %. Note, this must be the percentage of blasts documented on the bone marrow aspirate report and not the bone marrow biopsy or peripheral blood. This field allows up to five characters.
Was a bone marrow biopsy performed?:
Report whether a bone marrow biopsy was performed as Yes,” “No,” or “N/A – lymphoma with no previous bone marrow involvement.”
If answered Yes complete the questions below regarding the bone marrow biopsy.
Per protocol a bone marrow biopsy is required to be completed if a bone marrow aspirate was performed. If this field is answered No a protocol deviation should be logged in the EDC.
Date of bone marrow biopsy:
This field will only appear in the EDC if “Was a bone marrow biopsy performed?” is answered Yes. Enter the date the test was completed. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.
Per protocol a bone marrow biopsy is required to be completed within 45 days prior to the anticipated start of the conditioning regimen. If the bone marrow biopsy date entered is outside of those parameters a protocol deviation should be logged in the EDC.
If the date entered is a future date, a query will appear in the EDC.
Blasts by morphology:
This field will only appear in the EDC if “Was a bone marrow biopsy performed?” is answered Yes. Report the subject’s blasts by morphology in %. This field allows up to five characters.
Was extramedullary disease present at the time of evaluation pre-transplant:
Report whether extramedullary disease present at the time of evaluation pre-transplant as Yes,” “No,” or “N/A.”
Blasts in Blood
Were blasts detected in blood?:
Report if blasts were detected in blood as “Yes,” “No,” or “N/A.”.
If answered Yes complete the question below regarding the blasts detected. Ensure that blasts detected in blood did not meet the parameters of circulating blasts (as circulating blasts are not permitted).
Blasts in blood:
This field will only appear in the EDC if “Were blasts detected in blood?” is answered Yes. Report the subject’s blasts in blood in %. This field allows up to five characters.
CCG v1.0 | CRF v1.3
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