CDE Detailed Report
Disease:
Sub-Domain: Outcomes and End Points
CRF:

Displaying 1 - 50 of 55
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type Source Form Set Form Field Domain CDASH Variable CDASH Definition CDASH Label Controlled Terminology Prompt Essentiality Question Text CDASH imp guidance SDTM IG target csDSR PhenX Data Type CRF Completion Inst SDTMIG Target Var SDTMIG Target Map Codelist Name PVs Pre Pop Value Query Display List Style
C60533 Gene editing on target indel bone marrow CD34 plus cell count GnEdOnTgtIndelBMCD34PlsCellCt Count of on-target indels in gene editing of bone marrow CD34+ cells. Count of on-target indels in gene editing of bone marrow CD34+ cells. Bone marrow: On-target Indels: Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:40:19.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60489 Burst forming unit erythroid cell positive for integrating viral vector percent value BFUEPostvFrIntgrtVrlVctrPctVal Value of the percentage of burst-forming unit - erythroid (BFU-E) cells positive for the integrating viral vector. Value of the percentage of burst-forming unit - erythroid (BFU-E) cells positive for the integrating viral vector. Percentage of Blood Cells Positive for Integrating Vector: BFU-E Numeric Values Adult;Pediatric Core 1.00 2021-04-22 13:33:03.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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0 100 percent
C60640 Gene editing site specific nuclease indel on target percent value GnEdStSpNcleasIndelOnTgtPctVal Value of the percentage of on-target indels in blood for site-specific nuclease gene editing. Value of the percentage of on-target indels in blood for site-specific nuclease gene editing. On-target indels: Numeric Values Adult;Pediatric Core 1.00 2021-04-30 11:24:37.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60523 Gene editing conversion blood CD14 plus lineage percent value GnEdConvBldCD14PlsLinePctVal Value of the percentage of gene-editing conversions in the blood CD14+ lineage. Value of the percentage of gene-editing conversions in the blood CD14+ lineage. Percent conversion in Specific Blood Lineages: CD14+ Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:20:12.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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0 100 percent
C60651 Reporter gene assay method specify text RptrGeneAssayMethdSpcfyTxt Text specifying the type of reporter gene assay used. Text specifying the type of reporter gene assay used. Reporter gene assay: Specify: Alphanumeric Adult;Pediatric Core 1.00 2021-04-30 11:58:46.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr 50

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C60534 Gene editing on target indel bone marrow colony forming cell count GnEdOnTgtIndelBMCFCCt Count of on-target indels in gene editing of bone marrow colony forming cells (CFC). Count of on-target indels in gene editing of bone marrow colony forming cells (CFC). Bone marrow: CFC On-target Indels: Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:40:19.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60490 Integrating viral vector copy number bone marrow mononuclear cell value IntgrtVrlVCNBMMCVal Value of the integrating viral vector copy number (VCN) in bone marrow for bone marrow mononuclear cells (BMMC). Value of the integrating viral vector copy number (VCN) in bone marrow for bone marrow mononuclear cells (BMMC). Bone Marrow VCN: BMMC Numeric Values Adult;Pediatric Core 1.00 2021-04-22 13:25:18.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60641 Gene editing site specific nuclease indel off target percent value GnEdStSpNcleasIndlOffTgtPctVal Value of the percentage of off-target indels in blood for site-specific nuclease gene editing. Value of the percentage of off-target indels in blood for site-specific nuclease gene editing. Off-target indels: Numeric Values Adult;Pediatric Core 1.00 2021-04-30 11:24:37.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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0 100 percent
C60524 Gene editing blood CD3 plus lineage on target indel count GnEdBldCD3PlsLinOnTgtIndelCt Count of gene-editing on-target indels in the blood CD3+ lineage. Count of gene-editing on-target indels in the blood CD3+ lineage. On-target Indels in Specific Blood Lineages: CD3+ Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:20:12.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60652 On target indel frequency associate adverse outcome indicator OnTgtIndlFrqAssocAdvOutcmInd Indicator of whether the on-target indel frequency is associated with an adverse outcome. Indicator of whether the on-target indel frequency is associated with an adverse outcome. Is the on-target indel frequency associated with an adverse outcome? (e.g. thalassemia phenotype) No;Yes No;Yes Alphanumeric Adult;Pediatric Core 1.00 2021-04-30 12:02:06.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

Single Pre-Defined Value Selected

C60392 Sample collect date SamplCollectDate Date on which a sample was collected. Date on which a sample was collected. Date sample drawn Date or Date & Time Adult;Pediatric Core 1.00 2021-01-15 16:40:21.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60631 Elapsed time from infusion at visit category ElapsTimFrmInfusAtVisitCat Category of elapsed time since infusion as of the visit being documented. Category of elapsed time since infusion as of the visit being documented. VISIT [X] CRF (Time since Infusion): Day 0;6 months;1 year;1.5 years;2 years;3 years;4 years;5 years;6 years;7 years;8 years;9 years;10 years;11 years;12 years;13 years;14 years;15 years Day 0;6 months;1 year;1.5 years;2 years;3 years;4 years;5 years;6 years;7 years;8 years;9 years;10 years;11 years;12 years;13 years;14 years;15 years Alphanumeric Adult;Pediatric Core 1.00 2021-04-29 16:11:55.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

Single Pre-Defined Value Selected

C60491 Integrating viral vector copy number bone marrow CD34 plus lineage value IntgrtVrlVCNCD34PlsLneagVal Value of the integrating viral vector copy number (VCN) in bone marrow for the CD34+ lineage. Value of the integrating viral vector copy number (VCN) in bone marrow for the CD34+ lineage. Bone Marrow VCN: CD34+ Numeric Values Adult;Pediatric Core 1.00 2021-04-22 13:25:18.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60642 Gene editing blood CD3 plus lineage off target indel count GnEdBldCD3PlsLinOffTgtIndelCt Count of gene-editing off-target indels in the blood CD3+ lineage. Count of gene-editing off-target indels in the blood CD3+ lineage. Off-target Indels in Specific Blood Lineages: CD3+ Numeric Values Adult Core 1.00 2021-04-23 11:20:12.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60525 Gene editing blood CD19 plus lineage on target indel count GnEdBldCD19PlsLinOnTgtIndelCt Count of gene-editing on-target indels in the blood CD19+ lineage. Count of gene-editing on-target indels in the blood CD19+ lineage. On-target Indels in Specific Blood Lineages: CD19+ Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:20:12.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60653 On target indel frequency associate adverse outcome describe text OnTgtIndlFrqAssAdvOtcmDscrbTxt Text field for describing the adverse outcome (if any) associated with on-target indel frequency. Text field for describing the adverse outcome (if any) associated with on-target indel frequency. If yes, describe Alphanumeric Adult;Pediatric Core 1.00 2021-04-30 12:03:35.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr 100

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C60481 Vector copy number blood value VectrCopyNumBloodVal Value of the vector copy number (VCN) for blood. Value of the vector copy number (VCN) for blood. Blood VCN Numeric Values Adult;Pediatric Core 1.00 2021-04-22 13:20:21.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60632 Complete blood count current text CBCCurrentTxt Text field for specifying the current complete blood count (CBC) Text field for specifying the current complete blood count (CBC) Current CBC Alphanumeric

Use other CRF

Adult;Pediatric Core 1.00 2021-04-29 16:19:24.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr 50

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C60492 Integrating viral vector copy number bone marrow colony forming cell value IntgrtVrlVCNBonMarowCFCVal Value of the integrating viral vector copy number (VCN) in bone marrow for colony forming cells (CFC). Value of the integrating viral vector copy number (VCN) in bone marrow for colony forming cells (CFC). Bone Marrow VCN: CFC Numeric Values Adult;Pediatric Core 1.00 2021-04-22 13:25:18.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60643 Gene editing blood CD19 plus lineage off target indel count GnEdBldCD19PlsLinOffTgtIndelCt Count of gene-editing off-target indels in the blood CD19+ lineage. Count of gene-editing off-target indels in the blood CD19+ lineage. Off-target Indels in Specific Blood Lineages: CD19+ Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:20:12.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60526 Gene editing blood CD15 plus lineage on target indel count GnEdBldCD15PlsLinOnTgtIndelCt Count of gene-editing on-target indels in the blood CD15+ lineage. Count of gene-editing on-target indels in the blood CD15+ lineage. On-target Indels in Specific Blood Lineages: CD15+ Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:20:12.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60482 Integrating viral vector blood CD3 depleted indicator IntgrtVrlVctrBldCD3DpltInd Indicator of whether the integrating viral vector copy number (VCN) of blood is depleted of CD3. Indicator of whether the integrating viral vector copy number (VCN) of blood is depleted of CD3. CD3 depleted? No;Yes No;Yes Alphanumeric Adult;Pediatric Core 1.00 2021-04-22 13:21:58.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

Single Pre-Defined Value Selected

C60633 Hemoglobin analysis current text HgbAnalysCurrentTxt Text field for specifying the current hemoglobin analysis. Text field for specifying the current hemoglobin analysis. Current Hemoglobin analysis Alphanumeric

Use other CRF

Adult;Pediatric Core 1.00 2021-04-29 16:19:24.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr 50

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C60493 Bone marrow mononuclear cell positive for integrating viral vector percent value BMMCPostvFrIntgrtVrlVctrPctVal Value of the percentage of bone marrow mononuclear cells (BMMC) positive for the integrating viral vector. Value of the percentage of bone marrow mononuclear cells (BMMC) positive for the integrating viral vector. Percentage of Bone Marrow Cells Positive for Integrating Vector: BMMC Numeric Values Adult;Pediatric Core 1.00 2021-04-22 13:33:03.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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0 100 percent
C60644 Gene editing blood CD15 plus lineage off target indel count GnEdBldCD15PlsLinOffTgtIndelCt Count of gene-editing off-target indels in the blood CD15+ lineage. Count of gene-editing off-target indels in the blood CD15+ lineage. Off-target Indels in Specific Blood Lineages: CD15+ Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:20:12.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60527 Gene editing blood GPA plus lineage on target indel count GnEdBldGPAPlsLinOnTgtIndelCt Count of gene-editing on-target indels in the blood GPA+ lineage. Count of gene-editing on-target indels in the blood GPA+ lineage. On-target Indels in Specific Blood Lineages: GPA+ Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:20:12.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60483 Integrating viral vector copy number blood CD3 plus lineage value IntgrtVrlVCNBldCD3PlusLneagVal Value of the integrating viral vector copy number (VCN) in blood for the CD3+ lineage Value of the integrating viral vector copy number (VCN) in blood for the CD3+ lineage VCN in Specific Lineages: CD3+ Numeric Values Adult;Pediatric Core 1.00 2021-04-22 13:25:18.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60634 Tissue monitoring anatomic site TissuMonitorAnatSite Anatomic site from which tissue for monitoring was sampled. Anatomic site from which tissue for monitoring was sampled. Tissue monitoring site: Alphanumeric Adult;Pediatric Core 1.00 2021-04-29 16:23:35.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr 50

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C60494 Bone marrow CD34 plus cell positive for integrating viral vector percent value BMCD34PlCPstvFrIntVrlVctPctVal Value of the percentage of bone marrow CD34+ cells positive for the integrating viral vector. Value of the percentage of bone marrow CD34+ cells positive for the integrating viral vector. Percentage of Bone Marrow Cells Positive for Integrating Vector: CD34+ Numeric Values Adult;Pediatric Core 1.00 2021-04-22 13:33:03.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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0 100 percent
C60645 Gene editing blood GPA plus lineage off target indel count GnEdBldGPAPlsLinOffTgtIndelCt Count of gene-editing off-target indels in the blood GPA+ lineage. Count of gene-editing off-target indels in the blood GPA+ lineage. Off-target Indels in Specific Blood Lineages: GPA+ Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:20:12.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60528 Gene editing blood CD14 plus lineage on target indel count GnEdBldCD14PlsLinOnTgtIndelCt Count of gene-editing on-target indels in the blood CD14+ lineage. Count of gene-editing on-target indels in the blood CD14+ lineage. On-target Indels in Specific Blood Lineages: CD14+ Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:20:12.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60484 Integrating viral vector copy number blood CD19 plus lineage value IntgrtVrlVCNBldCD19PlsLneagVal Value of the integrating viral vector copy number (VCN) in blood for the CD19+ lineage Value of the integrating viral vector copy number (VCN) in blood for the CD19+ lineage VCN in Specific Lineages: CD19+ Numeric Values Adult;Pediatric Core 1.00 2021-04-22 13:25:18.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60635 Tissue monitoring type TissueMonitoringTyp Type of tissue sampled for monitoring Type of tissue sampled for monitoring Tissue monitoring site: Peripheral blood;Bone marrow Peripheral blood;Bone marrow Alphanumeric Adult;Pediatric Core 1.00 2021-04-29 16:24:47.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

Multiple Pre-Defined Values Selected

C60495 Bone marrow colony forming cell positive for integrating viral vector percent value BMCFCPstvFrIntVrlVctPctVal Value of the percentage of bone marrow colony forming cells (CFC) positive for the integrating viral vector. Value of the percentage of bone marrow colony forming cells (CFC) positive for the integrating viral vector. Percentage of Bone Marrow Cells Positive for Integrating Vector: CFC Numeric Values Adult;Pediatric Core 1.00 2021-04-22 13:33:03.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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0 100 percent
C60646 Gene editing blood CD14 plus lineage off target indel count GnEdBldCD14PlsLinOffTgtIndelCt Count of gene-editing off-target indels in the blood CD14+ lineage. Count of gene-editing off-target indels in the blood CD14+ lineage. Off-target Indels in Specific Blood Lineages: CD14+ Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:20:12.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60529 Gene editing conversion bone marrow mononuclear cell percent value GnEdConvBMMCPctVal Value of the percentage of gene editing conversions in bone marrow mononuclear cells (BMMC). Value of the percentage of gene editing conversions in bone marrow mononuclear cells (BMMC). BMMC Percent Conversion Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:35:20.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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0 100 percent
C60485 Integrating viral vector copy number blood CD15 plus lineage value IntgrtVrlVCNBldCD15PlsLneagVal Value of the integrating viral vector copy number (VCN) in blood for the CD15+ lineage Value of the integrating viral vector copy number (VCN) in blood for the CD15+ lineage VCN in Specific Lineages: CD15+ Numeric Values Adult;Pediatric Core 1.00 2021-04-22 13:25:18.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60636 Bone marrow cell sort indicator BoneMarrowCellSortInd Indicator of whether bone marrow cells were sorted. Indicator of whether bone marrow cells were sorted. Cells sorted? No;Yes No;Yes Alphanumeric Adult;Pediatric Core 1.00 2021-04-29 16:26:43.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

Single Pre-Defined Value Selected

C60519 Gene editing conversion blood CD3 plus lineage percent value GnEdConvBldCD3PlsLinePctVal Value of the percentage of gene-editing conversions in the blood CD3+ lineage. Value of the percentage of gene-editing conversions in the blood CD3+ lineage. Percent conversion in Specific Blood Lineages: CD3+ Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:20:12.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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0 100 percent
C60647 Gene editing off target indel bone marrow mononuclear cell count GnEdOffTgtIndelBMMCCt Count of off-target indels in gene editing of bone marrow mononuclear cells (BMMC). Count of off-target indels in gene editing of bone marrow mononuclear cells (BMMC). BMMC Off-Target Indels: Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:40:19.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60530 Gene editing conversion bone marrow CD34 plus percent value GnEdConvBMCD34PlsPctVal Value of the percentage of gene editing conversions in bone marrow CD34+ cells. Value of the percentage of gene editing conversions in bone marrow CD34+ cells. Bone marrow: CD34+ Percent Conversion Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:35:20.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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0 100 percent
C60486 Integrating viral vector copy number blood GPA plus lineage value IntgrtVrlVCNBldGPAPlsLneagVal Value of the integrating viral vector copy number (VCN) in blood for the GPA+ lineage Value of the integrating viral vector copy number (VCN) in blood for the GPA+ lineage VCN in Specific Lineages: GPA+ Numeric Values Adult;Pediatric Core 1.00 2021-04-22 13:25:18.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60637 Bone marrow cell sort immunophenotype indicator BoneMarrowCellSortImmnophenInd Indicator of whether bone marrow cells were sorted by immunophenotype. Indicator of whether bone marrow cells were sorted by immunophenotype. Immunophenotype No;Yes No;Yes Alphanumeric Adult;Pediatric Core 1.00 2021-04-29 16:28:12.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

Single Pre-Defined Value Selected

C60520 Gene editing conversion blood CD19 plus lineage percent value GnEdConvBldCD19PlsLinePctVal Value of the percentage of gene-editing conversions in the blood CD19+ lineage. Value of the percentage of gene-editing conversions in the blood CD19+ lineage. Percent conversion in Specific Blood Lineages: CD19+ Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:20:12.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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0 100 percent
C60648 Gene editing off target indel bone marrow CD34 plus cell count GnEdOffTgtIndelBMCD34PlsCellCt Count of off-target indels in gene editing of bone marrow CD34+ cells. Count of off-target indels in gene editing of bone marrow CD34+ cells. Bone marrow: CD34+ Off-target Indels: Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:40:19.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60531 Gene editing conversion bone marrow colony forming cell percent value GnEdConvBMCFCPctVal Value of the percentage of gene editing conversions in bone marrow colony forming cells (CFC). Value of the percentage of gene editing conversions in bone marrow colony forming cells (CFC). Bone marrow: CFC percent conversion: Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:35:20.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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0 100 percent
C60487 Integrating viral vector copy number blood CD14 plus lineage value IntgrtVrlVCNBldCD14PlsLneagVal Value of the integrating viral vector copy number (VCN) in blood for the CD14+ lineage Value of the integrating viral vector copy number (VCN) in blood for the CD14+ lineage VCN in Specific Lineages: CD14+ Numeric Values Adult;Pediatric Core 1.00 2021-04-22 13:25:18.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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C60638 Blood CD3 deplete indicator BloodCD3DepleteInd Indicator of whether blood is depleted of CD3. Indicator of whether blood is depleted of CD3. Blood: CD3 depleted? No;Yes No;Yes Alphanumeric Adult;Pediatric Core 1.00 2021-04-30 11:18:09.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

Single Pre-Defined Value Selected

C60521 Gene editing conversion blood CD15 plus lineage percent value GnEdConvBldCD15PlsLinePctVal Value of the percentage of gene-editing conversions in the blood CD15+ lineage. Value of the percentage of gene-editing conversions in the blood CD15+ lineage. Percent conversion in Specific Blood Lineages: CD15+ Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:20:12.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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0 100 percent
C60649 Gene editing off target indel bone marrow colony forming cell count GnEdOffTgtIndelBMCFCCt Count of off-target indels in gene editing of bone marrow colony forming cells (CFC). Count of off-target indels in gene editing of bone marrow colony forming cells (CFC). Bone marrow: CFC Off-target Indels: Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:40:19.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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