CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Outcomes and End Points
CRF: Gene Product Follow-Up
Sub-Domain: Outcomes and End Points
CRF: Gene Product Follow-Up
55 results.
| 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 |
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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 | Genetics/Assays |
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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 | Genetics/Assays |
Multiple Pre-Defined Values Selected |
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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 | Genetics/Assays |
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| 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 | Genetics/Assays |
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| 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 | Genetics/Assays |
Free-Form Entry |
55 results.