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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
Free-Form Entry |
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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
Single Pre-Defined Value Selected |
55 results.