CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Treatment/Intervention Data
CRF: Drug Product
Sub-Domain: Treatment/Intervention Data
CRF: Drug Product
24 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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| C60665 | Drug product globin chain interest value type | DrugProdGlobinChainInterValTyp | The positive or negative value of the globin chain of interest in genetic therapy. | The positive or negative value of the globin chain of interest in genetic therapy. | Globin Chain of Interest, Qualitative | Positive;Negative | Positive;Negative | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Single Pre-Defined Value Selected |
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| C60676 | Genetic therapy editing type | GeneticTherapyEditingType | The type related to type of gene editing. | The type related to type of gene editing. | Type of Editing | Other;Zinc Finger Nucleases;Cytosine;Transcription Activator-Like Effector Nucleases;CRISPR-Cas 9 | Other;Zinc Finger Nucleases;Cytosine;Transcription Activator-Like Effector Nucleases;CRISPR-Cas 9 | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Single Pre-Defined Value Selected |
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| C60666 | Drug product globin chain interest value | DrugProdGlobinChainInterestVal | The value of the globin chain of interest in genetic therapy. | The value of the globin chain of interest in genetic therapy. | Globin Chain of Interest, Quantitative | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Free-Form Entry |
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| C60677 | Genetic therapy editing other text | GeneticTherapyEditingOtherTxt | The other specify related to type of gene editing. | The other specify related to type of gene editing. | If Other, specify | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies | 255 |
Free-Form Entry |
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| C60667 | Drug product potency assay indicator | DrugProdPotAssayInd | The indicator related to drug product potency assay. | The indicator related to drug product potency assay. | Additional Drug Product Potency Assays | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Single Pre-Defined Value Selected |
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| C60678 | Nuclease delivery mode type | NucleaseDelivModeType | The type related to mode of nuclease delivery | The type related to mode of nuclease delivery | Mode of Nuclease Delivery | Other;Adeno-associated Virus;mRNA by Electroporation;Ribonucleoprotein by Electroporation | Other;Adeno-associated Virus;mRNA by Electroporation;Ribonucleoprotein by Electroporation | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Single Pre-Defined Value Selected |
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| C60668 | Drug product potency assay text | DrugProdPotAssayText | The free-text field related to drug product potency assay. | The free-text field related to drug product potency assay. | If Yes, Specify | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies | 255 |
Free-Form Entry |
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| C60679 | Nuclease delivery mode other text | NucleaseDelivModeOtherTxt | The free-text field to capture other speicfy for mode of nuclease delivery | The free-text field to capture other speicfy for mode of nuclease delivery | If Other, specify | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies | 255 |
Free-Form Entry |
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| C60669 | Genetic therapy subcategory treatment type | GeneticTherapySubcategoryTxTyp | The type of study treatment subcategory. | The type of study treatment subcategory. | Study Treatment Subcategory | Integrating Vector;Gene Editing Nuclease;Stem Cell Expansion | Integrating Vector;Gene Editing Nuclease;Stem Cell Expansion | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Single Pre-Defined Value Selected |
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| C60680 | Gene editing on-target Indels value | GeneEditOnTargetIndelVal | The value related to on-target Indels | The value related to on-target Indels | On-target Indels | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Free-Form Entry |
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| C60670 | Vector integrate type | VectorIntegratTyp | The type of vector integrating | The type of vector integrating | Type of Integrating Vector | Retrovirus;Lentivirus;Other | Retrovirus;Lentivirus;Other | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Single Pre-Defined Value Selected |
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| C60681 | Gene editing off-target Indels value | GeneEditOffTargetIndelVal | The value related to off-target Indels | The value related to off-target Indels | Off-target Indels | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Free-Form Entry |
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| C60660 | Genetic therapy study category type | GeneticTherapyStudyCatTyp | The type related to genetic therapy study type. | The type related to genetic therapy study type. | Study Treatment Category | Hematopoietic Progenitor Cell, Apheresis (HPC-A);Hematopoietic Progenitor Cell, Cord Blood (HPC-C);Hematopoietic Progenitor Cell, Marrow (HPC-M) | Hematopoietic Progenitor Cell, Apheresis (HPC-A);Hematopoietic Progenitor Cell, Cord Blood (HPC-C);Hematopoietic Progenitor Cell, Marrow (HPC-M) | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Single Pre-Defined Value Selected |
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| C60671 | Vector integrate other text | VectorIntegratOtherTxt | The free-text field related to other vector integrating type. | The free-text field related to other vector integrating type. | Other, Specify | Alphanumeric | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies | 255 |
Free-Form Entry |
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| C60682 | Gene ediing target Indels conversion value | GeneEditTargetIndelConvVal | The value related to conversion. | The value related to conversion. | Conversion | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Free-Form Entry |
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| C60661 | Genetic therapy product manufacture date | GeneticTherapyProductManDat | The date related to study treatment manufacture | The date related to study treatment manufacture | Date of Study Treatment Manufacture | Date or Date & Time | Adult;Pediatric | Supplemental | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Free-Form Entry |
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| C60672 | Vector copy number | VectorCopyNum | The number related to the vector copy. | The number related to the vector copy. | Study Treatment Vector Copy Number | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Free-Form Entry |
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| C60683 | Gene ediing target Indels conversion percentage value | GeneEditTargetIndelConvPercVal | The percentage value related to conversion. | The percentage value related to conversion. | Conversion | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Free-Form Entry |
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| C60662 | Genetic therapy cell count | GeneticTherapyCellCount | The cell count related to biomanufacture in genetic therapy. | The cell count related to biomanufacture in genetic therapy. | Cells | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Free-Form Entry |
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| C60673 | Vector integrating positive count | VectorIntegPositiveCount | The count related to vector integrating positive cells. | The count related to vector integrating positive cells. | Integrating Vector Positive Cells/Cells | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Free-Form Entry |
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| C60663 | Genetic therapy CD34 cell count | GeneticTherapyCDE34CellCount | The CD34 cell count related to biomanufacture in genetic therapy. | The CD34 cell count related to biomanufacture in genetic therapy. | CD34 | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Free-Form Entry |
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| C60674 | Vector integrating positive percentage value | VectorIntegPositivePercVal | The percentage related to vector integrating positive cells. | The percentage related to vector integrating positive cells. | Integrating Vector Positive Cells/Cells (%) | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Free-Form Entry |
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| C60664 | Genetic therapy colonies formed count | GeneticTherapyColoniesFrCount | The count related to colonies formed in genetic therapy biomanufacturing. | The count related to colonies formed in genetic therapy biomanufacturing. | Colonies Formed | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Free-Form Entry |
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| C60675 | Vector copy number to cell value | VectorCopyNumberCellVal | The value related to vector copy number/cells | The value related to vector copy number/cells | Study Treatment Vector Copy Number/Cells | Numeric Values | Adult;Pediatric | Core | 1.00 | 2021-05-10 12:12:04.0 | Drug Product | Treatment/Intervention Data | Therapies |
Free-Form Entry |
24 results.