CDE Detailed Report
Disease: Sickle Cell Disease
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
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

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

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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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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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

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

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

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

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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

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

24 results.
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