CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Safety Data
CRF: Genotoxicity
Sub-Domain: Safety Data
CRF: Genotoxicity
| 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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| C60538 | Gene editing off target site confirm count | GnEdOffTgtSiteConfirmCt | Count of off-target gene editing sites confirmed. | Count of off-target gene editing sites confirmed. | Number of off-target editing sites confirmed: | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 11:57:22.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60474 | Bone marrow aspirate result type | BonMarowAspiratResultTyp | Type(s) of results obtained from bone marrow aspiration. | Type(s) of results obtained from bone marrow aspiration. | Bone Marrow Aspirate Performed? | Abnormal cytogenetics;Normal cytogenetics;Dysplastic morphology;Malignant morphology;Normal morphology | Abnormal cytogenetics;Normal cytogenetics;Dysplastic morphology;Malignant morphology;Normal morphology | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 12:02:30.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Multiple Pre-Defined Values Selected |
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| 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 | Supplemental | 1.00 | 2021-04-22 13:25:18.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60517 | Gene edited hematopoietic stem progenitor cells blood CD3 depleted conversion percent value | GenEdHSPCBldCD3DepltCnvPctVal | Value of the percentage of conversions related to CD3 depletion in gene-edited hematopoietic stem and progenitor cells (HSPC) in blood. | Value of the percentage of conversions related to CD3 depletion in gene-edited hematopoietic stem and progenitor cells (HSPC) in blood. | Percent Conversion | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 11:09:53.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
0 | 100 | percent | ||||||||||||||||||||||||||||||
| C60453 | Blast bone marrow type | BlastBoneMarrowTyp | Type of blast(s) present in bone marrow aspirate/biopsy. | Type of blast(s) present in bone marrow aspirate/biopsy. | Blasts type | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 09:28:44.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 255 |
Free-Form Entry |
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| C60549 | Gene editing site translocation on off target droplet digital polymerase chain reaction detection limit text | GnEdStTrOnOfTgDrDgPCRDtLmTxt | Text field for capturing the droplet digital polymerase chain reaction (PCR) detection limit for translocations of on target and off target gene editing sites. | Text field for capturing the droplet digital polymerase chain reaction (PCR) detection limit for translocations of on target and off target gene editing sites. | Translocations between on-target and off-target editing sites detected by: Droplet Digital PCR: If no, what is the limit of detection: | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 13:24:46.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 50 |
Free-Form Entry |
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| C60496 | Vector integration site analysis substrate type | VISASubstrateTyp | Type of substrate(s) on which Vector Integration Site Analysis (VISA) was performed. | Type of substrate(s) on which Vector Integration Site Analysis (VISA) was performed. | Vector Integration Site Analysis (VISA) performed in | Blood;Bone marrow;Sorted/fractionated cell populations | Blood;Bone marrow;Sorted/fractionated cell populations | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 14:01:20.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Multiple Pre-Defined Values Selected |
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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 | Supplemental | 1.00 | 2021-04-23 11:20:12.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60464 | Abnormal hematopoiesis best descriptor type | AbnormHematopoieBstDscrpTyp | Type of descriptor that best characterizes the abnormal hematopoiesis identified. | Type of descriptor that best characterizes the abnormal hematopoiesis identified. | What best describes the abnormal hematopoiesis? | MDS;Leukemia/lymphoma | Myelodysplastic syndrome;Leukemia/lymphoma | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 10:17:46.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60560 | Post genotoxic event oncogene panel whole exome genome sequencing result text | PstGntxcEvOncPnlWhlExGnSqRsTxt | Text describing the results of oncogene panel, whole exome sequencing, or whole genome sequencing performed following a genotoxic event. | Text describing the results of oncogene panel, whole exome sequencing, or whole genome sequencing performed following a genotoxic event. | State results | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 14:43:36.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 255 |
Free-Form Entry |
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| C60571 | Hematologic disorder new incidence follow drug product infusion describe text | HmDsNwInFlwDrPrInfDscTxt | Text describing new incidence of hematologic disorder following drug product infusion. | Text describing new incidence of hematologic disorder following drug product infusion. | Since drug product infusion has there been new incidence of a hematologic disorder. If yes, describe: | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 15:02:28.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 255 |
Free-Form Entry |
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| C60507 | Clone integrant minimum 20 percent representation value | ClnIntgrntMin20PctRepVal | Value, as a percentage, of the representation among all clones/integrants of the clones/integrants at the specified gene or flanking gene location, for clones/integrants comprising >=20 percent of all clones/integrants. | Value, as a percentage, of the representation among all clones/integrants of the clones/integrants at the specified gene or flanking gene location, for clones/integrants comprising >=20 percent of all clones/integrants. | Percent Representation/Relative Abundance | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 14:46:13.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
20 | 100 | percent | ||||||||||||||||||||||||||||||
| C59968 | Platelet count value | PlateletCountVal | Value of the count of platelets in the subject/participant's complete blood cell (CBC) sample. | Value of the count of platelets in the subject/participant's complete blood cell (CBC) sample. | The latest Complete Blood Count Plt | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2020-09-01 13:36:15.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
CIBMTR | n/a | Form 2031 revision 2 | 15: Platelets | |||||||||||||||||||||||||||||
| C60539 | Gene editing off target site confirm GUIDE seq check indicator | GnEdOfTgtSitCnfrmGUIDESeqChInd | Indicator of whether confirmation of off-target gene editing sites involved checking by GUIDE-seq. | Indicator of whether confirmation of off-target gene editing sites involved checking by GUIDE-seq. | Checked by GUIDE-seq? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 11:59:58.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60475 | Bone marrow aspirate cytogenetic abnormality describe text | BnMrwAsprtCytgntcAbnormDscrTxt | Text field for describing cytogenetic abnormalities identified in bone marrow aspirate. | Text field for describing cytogenetic abnormalities identified in bone marrow aspirate. | Cytogenetic Abnormalities (describe) | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 12:06:45.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 255 |
Free-Form Entry |
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| C60486 | Integrating viral vector copy number blood GPA plus lineage value | IntgrtVrlVCNBldGPAPlsLneagVal | Value of the integrating viral vector copy number (VCN) in blood for the GPA+ lineage | Value of the integrating viral vector copy number (VCN) in blood for the GPA+ lineage | VCN in Specific Lineages: GPA+ | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 13:25:18.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60518 | Gene edited hematopoietic stem progenitor cells blood CD3 depleted on target indel count | GnEdHSPCBldCD3DpltOnTgtIndCt | Count of on-target indels related to CD3 depletion in gene-edited hematopoietic stem and progenitor cells (HSPC) in blood. | Count of on-target indels related to CD3 depletion in gene-edited hematopoietic stem and progenitor cells (HSPC) in blood. | On-target Indels | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 11:12:55.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60454 | Blast bone marrow percent value | BlastBoneMarrowPctVal | Value of percentage of blast(s) present in bone marrow aspirate/biopsy. | Value of percentage of blast(s) present in bone marrow aspirate/biopsy. | Blasts Percentage | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 09:28:44.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
0 | 100 | percent | ||||||||||||||||||||||||||||||
| C60550 | Gene editing site translocation on off target droplet digital polymerase chain reaction detection frequency text | GnEdStTrOnOfTgDrDgPCRDtFrqTxt | Text field for reporting the frequency of detection of translocation of on target and off target gene editing sites using droplet digital polymerase chain reaction (PCR). | Text field for reporting the frequency of detection of translocation of on target and off target gene editing sites using droplet digital polymerase chain reaction (PCR). | Translocations between on-target and off-target editing sites detected by: Droplet Digital PCR: If yes, what is the frequency of detection: | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 13:29:02.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 50 |
Free-Form Entry |
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| C60497 | Vector integration site analysis sorted fractionated cell population lineage text | VISASortFracCellPopLinTxt | Text field for identifying the sorted/fractionated cell population lineages on which Vector Integration Site Analysis (VISA) was performed. | Text field for identifying the sorted/fractionated cell population lineages on which Vector Integration Site Analysis (VISA) was performed. | Sorted/fractionated Cell Populations (specify lineages) | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 14:04:17.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 100 |
Free-Form Entry |
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| 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). | Bone Marrow: BMMC Percent Conversion | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 11:35:20.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
0 | 100 | percent | ||||||||||||||||||||||||||||||
| C60465 | Abnormal hematopoiesis onset date | AbnormalHematopoiesisOnsetDate | Date of onset of the abnormal hematopoiesis | Date of onset of the abnormal hematopoiesis | Date of onset: | Date or Date & Time | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 10:22:12.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60561 | Genotoxicity pre manipulated cell genetic analysis chromatin immunoprecipitation indicator | GntxcPrMnpCeGenAnlChIPInd | Indicator of whether genetic analysis for chromatin immunoprecipitation (ChIP) was performed on pre-manipulated cells following detection of genotoxicity. | Indicator of whether genetic analysis for chromatin immunoprecipitation (ChIP) was performed on pre-manipulated cells following detection of genotoxicity. | If genotoxicity developed, were pre-manipulated cells genetically analyzed for ChIP? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 14:49:40.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60572 | Infection new incidence potential product relate follow drug product infusion indicator | InfNwInPtPrRlFlwDrPrInfInd | Indicator of whether there was a new incidence of infection that is potentially product-related following drug product infusion. | Indicator of whether there was a new incidence of infection that is potentially product-related following drug product infusion. | Since drug product infusion has there been new incidence of infection (potentially product-related) | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 15:02:28.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60508 | Clone integrant minimum 20 percent representation genetic location | ClnIngrntMin20PctRepGeneLoc | Location, relative to other genes on a DNA strand, of any clone(s) or integrant(s) having >=20 percent representation within the population of clones and integrants. | Location, relative to other genes on a DNA strand, of any clone(s) or integrant(s) having >=20 percent representation within the population of clones and integrants. | Is the location of the dominant integrant(s) | Within or <50Kb of a known oncogene;Within or <50Kb of a Transcriptional Unit of any gene;Within or <50Kb of Cell signaling/proliferation Gene;Within or near the following genes known to be associated with insertional oncogenesis: LMO2, IKZF1, CCND2, HMGA2, MECOM | Within, or fewer than 50 kilobases away from, of a known oncogene;Within, or fewer than 50 kilobases away from, a Transcriptional Unit of any gene;Within, or fewer than 50 kilobases away from, a Cell signaling/proliferation Gene;Within or near the following genes known to be associated with insertional oncogenesis: LMO2, IKZF1, CCND2, HMGA2, MECOM | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 16:30:50.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Multiple Pre-Defined Values Selected |
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| C60093 | Reticulocyte count | ReticulocyteCt | Count of reticulocytes | Count of reticulocytes | The latest Complete Blood Count Retic Count | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-01-14 13:06:05.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60540 | Gene editing off target site confirm next generation sequencing indicator | GnEdOfTgtSitCnfrmNGSInd | Indicator of whether confirmation of off-target gene editing sites was obtained by next-generation sequencing (NGS). | Indicator of whether confirmation of off-target gene editing sites was obtained by next-generation sequencing (NGS). | Confirmed by NGS? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 11:59:58.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60476 | Abnormal hematopoiesis resolve indicator | AbnrmlHmtopoiesisReslvInd | Indicator of whether abnormal hematopoiesis has been resolved. | Indicator of whether abnormal hematopoiesis has been resolved. | Has the abnormal hematopoiesis resolved? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 12:44:34.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| 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 | Supplemental | 1.00 | 2021-04-22 13:25:18.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| 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 | Supplemental | 1.00 | 2021-04-23 11:20:12.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
0 | 100 | percent | ||||||||||||||||||||||||||||||
| C60455 | Marrow hypoplasia indicator | MarrowHypoplasiaInd | Indicator of the presence of bone marrow hypoplasia | Indicator of the presence of bone marrow hypoplasia | Is there marrow hypoplasia? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 09:35:25.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60551 | Gene editing site translocation clonality monitor method type | GnEdTrClonMonMethTyp | Type of method used to monitor clonality in translocation of gene editing sites. | Type of method used to monitor clonality in translocation of gene editing sites. | What method was used to monitor clonality: | On-target indels;Whole exome sequencing;Other | On-target indels;Whole exome sequencing;Other | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 13:32:03.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Multiple Pre-Defined Values Selected |
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| C60498 | Polyclonal population over 999 unique integration minimally fractionated cell specimen demonstrate gene modified hematopoiesis indicator | PPO999UIMFCSDGMHInd | Indicator of whether there is a polyclonal population of >= 1000 unique integrations of minimally fractionated cell specimens demonstrating gene-modified hematopoiesis. | Indicator of whether there is a polyclonal population of >= 1000 unique integrations of minimally fractionated cell specimens demonstrating gene-modified hematopoiesis. | Is there a "Rich" (polyclonal population with =1000 unique integrations) of minimally fractionated cell specimens (whole Bone Marrow, CD34+ cell product, whole blood) | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 14:11:42.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60530 | Gene editing conversion bone marrow CD34 plus percent value | GnEdConvBMCD34PlsPctVal | Value of the percentage of gene editing conversions in bone marrow CD34+ cells. | Value of the percentage of gene editing conversions in bone marrow CD34+ cells. | Bone Marrow: CD34+ Percent Conversion | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 11:35:20.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
0 | 100 | percent | ||||||||||||||||||||||||||||||
| C60466 | Abnormal hematopoiesis treatment indicator | AbnormalHematopoiesisTxInd | Indicator of whether the abnormal hematopoiesis is being treated. | Indicator of whether the abnormal hematopoiesis is being treated. | Is the event being treated? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 10:23:25.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60562 | Genotoxicity pre manipulated cell genetic analysis chromatin immunoprecipitation method text | GntxcPrMnpCeGenAnlChIPMthTxt | Text describing the method used in genetic analysis for chromatin immunoprecipitation (ChIP) performed on pre-manipulated cells following detection of genotoxicity. | Text describing the method used in genetic analysis for chromatin immunoprecipitation (ChIP) performed on pre-manipulated cells following detection of genotoxicity. | If genotoxicity developed, were pre-manipulated cells genetically analyzed for ChIP? How: | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 14:49:40.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 255 |
Free-Form Entry |
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| C60573 | Infection new incidence potential product relate follow drug product infusion describe text | InfNwInPtPrRlFlwDrPrInfDscTxt | Text describing new incidence of infection that is potentially product-related following drug product infusion. | Text describing new incidence of infection that is potentially product-related following drug product infusion. | Since drug product infusion has there been new incidence of infection (potentially product-related)? If yes, describe: | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 15:02:28.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 255 |
Free-Form Entry |
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| C60509 | Insertional oncogene near clone integrant minimum 20 percent representation name | InsOncgnNrClnIntMin20PctRpName | Name(s) of the gene(s) associated with insertional oncogenesis within or near which are located clone(s) or integrant(s) that have >=20 percent representation among the population of all clones and integrants. | Name(s) of the gene(s) associated with insertional oncogenesis within or near which are located clone(s) or integrant(s) that have >=20 percent representation among the population of all clones and integrants. | Is the location of the dominant integrant(s) within or near the following genes known to be associated with insertional oncogenesis | LMO2;MECOM;HMGA2;CCND2;IKZF1 | LMO2;MECOM;HMGA2;CCND2;IKZF1 | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 16:41:29.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Multiple Pre-Defined Values Selected |
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| C60445 | Genetically modified hematopoietic stem cell infusion date | GMHemtpcStemCellInfsnDate | Date of infusion of genetically modified (GM) hematopoietic stem cells (HSC). | Date of infusion of genetically modified (GM) hematopoietic stem cells (HSC). | Date of Genetically Modified HSC Infusion | Date or Date & Time | Adult;Pediatric | Supplemental | 1.00 | 2019-01-14 10:27:55.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60541 | Gene editing off target site confirm other method indicator | GnEdOfTgtSitCnfrmOthMethInd | Indicator of whether confirmation of off-target gene editing sites was obtained by another method. | Indicator of whether confirmation of off-target gene editing sites was obtained by another method. | Confirmed by other method: | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 11:59:58.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60477 | Abnormal hematopoiesis resolve date | AbnrmlHmtopoiesResolvDate | Date on which abnormal hematopoiesis was determined to have been resolved. | Date on which abnormal hematopoiesis was determined to have been resolved. | Date of resolution | Date or Date & Time | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 12:46:18.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| 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 | Supplemental | 1.00 | 2021-04-22 13:33:03.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
0 | 100 | percent | ||||||||||||||||||||||||||||||
| C60520 | Gene editing conversion blood CD19 plus lineage percent value | GnEdConvBldCD19PlsLinePctVal | Value of the percentage of gene-editing conversions in the blood CD19+ lineage. | Value of the percentage of gene-editing conversions in the blood CD19+ lineage. | Percent conversion in Specific Blood Lineages: CD19+ | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 11:20:12.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
0 | 100 | percent | ||||||||||||||||||||||||||||||
| C60456 | Marrow hypoplasia myeloid lineage name | MrwHypoplsiaMyeldLineName | Name of the myeloid lineage present in bone marrow hypoplasia. | Name of the myeloid lineage present in bone marrow hypoplasia. | Myeloid lineage | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 09:39:41.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 100 |
Free-Form Entry |
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| C60552 | Gene editing site translocation clonality monitor method type other text | GnEdTrClonMonMethTypOTH | The free-text field related to "Gene editing site translocation clonality monitor method type", specifying other text. | The free-text field related to "Gene editing site translocation clonality monitor method type", specifying other text. | What method was used to monitor clonality: Other: | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 13:35:25.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 4000 |
Free-Form Entry |
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| C60499 | Evidence polyclonal gene-modified hematopoiesis elapsed time since infusion category | EvPoGeModHmtpsElTmSnInfCat | Category of elapsed time since infusion when evidence was found of polyclonal gene-modified hematopoiesis. | Category of elapsed time since infusion when evidence was found of polyclonal gene-modified hematopoiesis. | Time Point | 0/0.5 yr;1/1.5 yr;2/2.5 yr;3/3.5 yr;4/4.5 yr;5 yr;6 yr;7 yr;8 yr;9 yr;10 yr;11 yr;12 yr;13 yr;14 yr;15 yr | 0/0.5 yr;1/1.5 yr;2/2.5 yr;3/3.5 yr;4/4.5 yr;5 yr;6 yr;7 yr;8 yr;9 yr;10 yr;11 yr;12 yr;13 yr;14 yr;15 yr | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 14:16:52.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| 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 | Supplemental | 1.00 | 2021-04-23 11:35:20.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
0 | 100 | percent | ||||||||||||||||||||||||||||||
| C60467 | Abnormal hematopoiesis treatment type | AbnormalHematopoiesisTxTyp | Type of treatment undertaken for abnormal hematopoiesis. | Type of treatment undertaken for abnormal hematopoiesis. | Treatment | HSC transplant;Chemotherapy;Transfusions | Hematopoietic stem cell (HSC) transplant;Chemotherapy;Transfusions | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 10:25:09.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Multiple Pre-Defined Values Selected |
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| C60563 | Genotoxicity pre manipulated cell genetic analysis chromatin immunoprecipitation result text | GntxcPrMnpCeGenAnlChIPRstTxt | Text describing the result of genetic analysis for chromatin immunoprecipitation (ChIP) performed on pre-manipulated cells following detection of genotoxicity. | Text describing the result of genetic analysis for chromatin immunoprecipitation (ChIP) performed on pre-manipulated cells following detection of genotoxicity. | If genotoxicity developed, were pre-manipulated cells genetically analyzed for ChIP? State results: | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 14:49:40.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 255 |
Free-Form Entry |
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| C60510 | Cell clone proportional increase last two analysis indicator | CelClnProportnIncLst2AnlysInd | Indicator of whether any cell clones have increased in proportion over the last two analyses. | Indicator of whether any cell clones have increased in proportion over the last two analyses. | Is there evidence of clonal expansion/Are any cell clones increasing in proportion over the last two analyses? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 16:49:24.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |