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
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Genetics/Assays |
Free-Form Entry |
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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
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 | Genetics/Assays |
Free-Form Entry |
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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| C60532 | Gene editing on target indel bone marrow mononuclear cell count | GnEdOnTgtIndelBMMCCt | Count of on-target indels in gene editing of bone marrow mononuclear cells (BMMC). | Count of on-target indels in gene editing of bone marrow mononuclear cells (BMMC). | BMMC 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 |
|||||||||||||||||||||||||||||||||
| C60488 | Peripheral blood mononuclear cell positive for integrating viral vector percent value | PBMCPostvFrIntgrtVrlVctrPctVal | Value of the percentage of peripheral blood mononuclear cells (PBMC) positive for the integrating viral vector. | Value of the percentage of peripheral blood mononuclear cells (PBMC) positive for the integrating viral vector. | Percentage of Blood Cells Positive for Integrating Vector: PBMC | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-04-22 13:33:03.0 | Gene Product Follow-Up | Outcomes and End Points | Genetics/Assays |
Free-Form Entry |
0 | 100 | percent | ||||||||||||||||||||||||||||||
| C60639 | Blood CD3 depleted conversion percent value | BloodCD3DepleteConversnPctVal | Value of the percentage of conversions related to CD3 depletion in blood. | Value of the percentage of conversions related to CD3 depletion in blood. | Percent conversion | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-04-30 11:22:27.0 | Gene Product Follow-Up | Outcomes and End Points | Genetics/Assays |
Free-Form Entry |
0 | 100 | percent | ||||||||||||||||||||||||||||||
| C60522 | Gene editing conversion blood GPA plus lineage percent value | GnEdConvBldGPAPlsLinePctVal | Value of the percentage of gene-editing conversions in the blood GPA+ lineage. | Value of the percentage of gene-editing conversions in the blood GPA+ lineage. | Percent conversion 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 | Genetics/Assays |
Free-Form Entry |
0 | 100 | percent | ||||||||||||||||||||||||||||||
| C60650 | Site specific nuclease gene edit on target frequency method type | SitSpcNcleasGnEdOnTgtFqMthdTyp | Type of method used for determining on-target frequency of gene editing for site-specific nucleases. | Type of method used for determining on-target frequency of gene editing for site-specific nucleases. | Method | RFLP;Sanger sequencing;Western Blot;NGS;TIDE3;Reporter gene assay;Other | Restriction fragment length polymorphism;Sanger sequencing;Western Blot;Next-generation sequencing;Tracking of Indels by Decomposition - 3;Reporter gene assay;Other | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-04-30 11:52:35.0 | Gene Product Follow-Up | Outcomes and End Points | Genetics/Assays |
Single Pre-Defined Value Selected |
|||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
Free-Form Entry |
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 | Genetics/Assays |
Free-Form Entry |
0 | 100 | percent | ||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
Free-Form Entry |
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 | Genetics/Assays | 50 |
Free-Form Entry |
||||||||||||||||||||||||||||||||
| 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 |
|||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays | 100 |
Free-Form Entry |
||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays | 50 |
Free-Form Entry |
|||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
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 | Genetics/Assays | 50 |
Free-Form Entry |
|||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
Free-Form Entry |
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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays | 50 |
Free-Form Entry |
||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
Free-Form Entry |
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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 |
|||||||||||||||||||||||||||||||
| 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 |
Free-Form Entry |
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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
Free-Form Entry |
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 | Genetics/Assays |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| 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 | Genetics/Assays |
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 | Genetics/Assays |
Free-Form Entry |
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 | Genetics/Assays |
Free-Form Entry |