Did patient receive infusion:
Report if the patient received the infusion as “Yes” or “No.”
Date of infusion:
This field will only appear in the EDC if “Did patient receive infusion” is answered Yes. Report the date the donor PBSC graft was infused in DD/MMM/YYYY format.
Was the graft manipulated ex-vivo to deplete T-cells?:
Indicate whether the graft was manipulated ex-vivo to deplete T-cells. If “Yes”, a protocol deviation should be logged in the EDC.
Infusion start time:
Report the infusion start time of the PBSC graft. Time should be entered using the 24 hour clock.
Infusion stop time:
Report the infusion stop time of the PBSC graft. Time should be entered using the 24 hour clock.
Was the infused product fresh or cryopreserved:
Report whether the product was fresh or cryopreserved.
The use of fresh over cryopreserved PBSC grafts is recommended if at all possible, given the higher risk of graft failure associated with cryopreserved grafts. If there is a need to cryopreserve the graft, higher PBSC doses may be warranted. If the donor PBSC graft is cryopreserved prior to the start of conditioning, follow institutional practices to ensure a sufficient cell dose is available for infusion after thawing. Refer to protocol section 7.5 HEMATOPOIETIC CELL TRANSPLANTATION (DAY 0) for more information.
Was post-thaw viability assessed:
This field will only appear in the EDC if “Was the infused product fresh or cryopreserved” is answered Cryopreserved. Report whether post-thaw viability was assessed as Yes or No.
% viability:
This field will only appear in the EDC if ““Was post-thaw viability assessed” is answered Yes. This is the viability of total nucleated cells or TNC. Report the % viability, excluding the “%” symbol. This field allows up to 5 characters.
Post-thaw CD34+ Viability:
This field will only appear in the EDC if ““Was post-thaw viability assessed” is answered Yes. Report the post-thaw % CD34+ viability (for cryopreserved PBSC), excluding the “%” symbol. This field allows up to 5 characters.
Infused CD34+ cells:
CD34+ cells are the count of cells with CD34+ markers on the surface. Report CD34+ cells in the unit of x10^6 per kg. Enter the cell count in “XXX.XX” format. This format allows for up to 3 digits before the decimal and up to 2 digits after.
Count should be corrected for viability if product is cryopreserved.
Infused CD3 cells:
CD3 cells are the count of cells with CD3 markers on the surface. Report CD3 cells in the unit of x10^6 per kg. Enter the cell count in “XXX.XX” format. This format allows for up to 3 digits before the decimal and up to 2 digits after.
Count should be corrected for viability if product is cryopreserved.
CCG v1.0 | CRF v1.3
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