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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C04807 | Vital status | VitStatus | Status of participant/subject as alive or dead | Status of participant/subject as alive or dead | Survival Status | Alive;Dead | Alive;Dead | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-07-20 10:21:25.65 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| 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: CD34+ On-target Indels | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 11:40:19.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60469 | Transfusion frequency text | TransfusionFrequencyTxt | Text field for capturing frequency of blood transfusions | Text field for capturing frequency of blood transfusions | Transfusion frequency | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 10:31:04.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 50 |
Free-Form Entry |
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| C60565 | Malignancy new follow drug product infusion describe text | MlgnNwFlwDrgPrdInfsDscTxt | Text describing new malignancies detected following infusion of drug product. | Text describing new malignancies detected following infusion of drug product. | Since drug product infusion has there been. New malignancy(ies)? If yes, describe: | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 14:56:07.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 100 |
Free-Form Entry |
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| C60501 | Evidence polyclonal gene-modified hematopoiesis unique integrand count | EvPlyclnlGnMdHmtpsUniqIngrndCt | Count of unique integrands of the selected specimen type displaying evidence of gene-modified hematopoiesis. | Count of unique integrands of the selected specimen type displaying evidence of gene-modified hematopoiesis. | Number of unique integrands | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 14:24:48.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
0 | ||||||||||||||||||||||||||||||||
| C60448 | Bone marrow aspirate biopsy prior genetically modified hematopoietic stem cell infusion indicator | BoMwAspBpsPrGMHSCInfsInd | Indicator of whether bone marrow aspirate or biopsy was performed prior to infusion of genetically modified (GM) hematopoietic stem cells (HSC). | Indicator of whether bone marrow aspirate or biopsy was performed prior to infusion of genetically modified (GM) hematopoietic stem cells (HSC). | Was bone marrow aspirate/biopsy done prior to infusion? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-21 16:53:07.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60544 | Gene editing off target site dominant location | GnEdOffTgtSiteDominantLoc | Location(s) of the dominant off-target gene editing site(s). | Location(s) of the dominant off-target gene editing site(s). | What is the location of the dominant off-target site(s): | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 13:04:33.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 100 |
Free-Form Entry |
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| C60480 | Integrating viral vector copy number assessment type | IntgrtVrlVctrCpyNumAssessTyp | Type of assessment(s) of vector copy number (VCN) performed for the integrating viral vector products. | Type of assessment(s) of vector copy number (VCN) performed for the integrating viral vector products. | Vector Copy Number (VCN) performed in | Blood VCN;Bone marrow VCN;VCN in specific lineages;Percentage of Blood Cells Positive for Integrating Vector;Percentage of Bone Marrow Cells Positive for Integrating Vector | Blood vector copy number (VCN);Bone marrow vector copy number (VCN);Vector copy number (VCN) in specific lineages;Percentage of Blood Cells Positive for Integrating Vector;Percentage of Bone Marrow Cells Positive for Integrating Vector | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 13:12:48.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Multiple Pre-Defined Values Selected |
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| C60512 | Cell clone proportional increase last two analysis previous proportion percent value | ClClnPrpIncLst2AnlPrvPrpPctVal | Value as a percent of the proportion of all cell clones, that the specified cell clone showing proportional increase over the last two analyses presented during the previous analysis. | Value as a percent of the proportion of all cell clones, that the specified cell clone showing proportional increase over the last two analyses presented during the previous analysis. | Last % representation/abundance | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 16:53:58.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
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 | Supplemental | 1.00 | 2021-04-23 11:20:12.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
0 | 100 | percent | ||||||||||||||||||||||||||||||
| C60459 | Cytogenetic test indicator | CytogeneticTestInd | Indicator of whether cytogenetics was tested | Indicator of whether cytogenetics was tested | Was cytogenetics tested? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 09:47:52.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60555 | Gene editing off target cell clone minimum 20 percent clone population proportion value | GnEdOfTgCeClMn20PctClPoPrVal | Value, as a percentage, of the proportion of the population of clones that is comprised by off-target gene-editing clones with a proportion >= 20 percent. | Value, as a percentage, of the proportion of the population of clones that is comprised by off-target gene-editing clones with a proportion >= 20 percent. | Percent Representation/Relative Abundance | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 13:45:16.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
20 | 100 | percent | ||||||||||||||||||||||||||||||
| 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 | Supplemental | 1.00 | 2021-04-22 13:25:18.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C14052 | Hemoglobin measurement | HemoglobMeasr | The measurement for hemoglobin. | The measurement for hemoglobin. | The latest Complete Blood Count Hb | Numeric Values | Adult;Pediatric | Supplemental | 3.00 | 2013-06-21 00:00:00.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
g/dL | DeBaun Forms | |||||||||||||||||||||||||||||||
| 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 | Supplemental | 1.00 | 2021-04-23 11:40:19.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60470 | Hematological toxicity probable cause analysis perform indicator | HematToxProbCausAnlPrfmInd | Indicator of whether an analysis has been performed to identify the probable cause of hematological toxicity. | Indicator of whether an analysis has been performed to identify the probable cause of hematological toxicity. | Has analysis been performed to determine probable cause of hematological toxicity? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 10:33:16.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60566 | Neurologic disorder preexist new incidence exacerbation follow drug product infusion indicator | NrDsPrxNwInExFlwDrPrInfInd | Indicator of whether a pre-existing neurological disorder presented exacerbation or a new incidence following drug product infusion. | Indicator of whether a pre-existing neurological disorder presented exacerbation or a new incidence following drug product infusion. | Since drug product infusion has there been new incidence or exacerbation of a pre-existing neurologic disorder? | 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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| C60502 | Polyclonal gene-modified hematopoiesis over 999 unique integration indicator | PlyclnGnMdHmtpsOv999UnqIntgInd | Indicator of whether >=1000 unique integrations providing evidence of polyclonal gene-modified hematopoiesis were identified in the selected specimen type. | Indicator of whether >=1000 unique integrations providing evidence of polyclonal gene-modified hematopoiesis were identified in the selected specimen type. | "Rich" (polyclonal population with >=1000 unique integrations) | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 14:27:42.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60449 | Bone marrow aspirate biopsy prior genetically modified hematopoietic stem cell infusion date | BoMwAspBpsPrGMHSCInfsDate | Indicator of whether bone marrow aspirate or biopsy was performed prior to infusion of genetically modified (GM) hematopoietic stem cells (HSC). | Indicator of whether bone marrow aspirate or biopsy was performed prior to infusion of genetically modified (GM) hematopoietic stem cells (HSC). | Was bone marrow aspirate/biopsy done prior to infusion? Date | Date or Date & Time | Adult;Pediatric | Supplemental | 1.00 | 2021-04-21 16:53:07.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60545 | Gene editing off target site dominant location type | GnEdOffTgtSiteDomLocTyp | Type of location of dominant off-target gene editing site | Type of location of dominant off-target gene editing site | Is the editing site location: | Inter-genic;Intra-genic | Inter-genic;Intra-genic | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 13:06:18.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| 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 | Supplemental | 1.00 | 2021-04-22 13:20:21.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60513 | Cell clone proportional increase last two analysis current proportion percent value | ClClnPrpIncLst2AnlCurPrpPctVal | Value as a percent of the proportion of all cell clones, that the specified cell clone showing proportional increase over the last two analyses presented during the current (i.e., most recent) analysis. | Value as a percent of the proportion of all cell clones, that the specified cell clone showing proportional increase over the last two analyses presented during the current (i.e., most recent) analysis. | Current % Abundance | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 16:53:58.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
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 | Supplemental | 1.00 | 2021-04-23 11:20:12.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60460 | Cytogenetic abnormality indicator | CytogeneticAbnormalityInd | Indicator of whether abnormalities were identified in cytogenetics testing. | Indicator of whether abnormalities were identified in cytogenetics testing. | Abnormalities | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 09:49:40.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60556 | Gene editing off-site target clone minimum 20 percent representation genetic location | GnEdOfStTgClMn20PctRpGntcLoc | Location, relative to other genes on a DNA strand, of any clone(s) having >=20 percent representation within the population of clones. | Location, relative to other genes on a DNA strand, of any clone(s) having >=20 percent representation within the population of clones. | Is the location of the dominant gene editing site | 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 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 | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 13:53:51.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Multiple Pre-Defined Values Selected |
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| 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 | Supplemental | 1.00 | 2021-04-22 13:25:18.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C57964 | Laboratory procedure percent neutrophils value | LabProcedurePrctNeutrophilsVal | Value of percent neutrophils. | Value of percent neutrophils. | The latest Complete Blood Count Neutrophils % | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2018-01-22 11:03:02.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60535 | Gene editing off target interrogation bioinformatic type | GnEdOffTgtInterrgntBioinfoTyp | Type of bioinformatic method employed in interrogating off-target gene-editing results. | Type of bioinformatic method employed in interrogating off-target gene-editing results. | Off Target Interrogation: Bioinformatic | CRISPOR;CRISTA;Other (list) | CRISPOR;CRISTA;Other (list) | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 11:50:01.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Multiple Pre-Defined Values Selected |
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| C60471 | Abnormal hematopoeisis related to caused by genetic manipulation indicator | AbHmtpsRltToCsByGenManipInd | Indicator of whether abnormal hematopoeisis is related to or probably caused by genetic manipulation | Indicator of whether abnormal hematopoeisis is related to or probably caused by genetic manipulation | Is it related or likely due to the genetic manipulation? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 11:47:42.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60567 | Neurologic disorder preexist new incidence exacerbation follow drug product infusion describe text | NrDsPrxNwInExFlwDrPrInfDscTxt | Text describing exacerbation or new incidence of a pre-existing neurological disorder following drug product infusion. | Text describing exacerbation or new incidence of a pre-existing neurological disorder following drug product infusion. | Since drug product infusion has there been new incidence or exacerbation of a pre-existing neurologic 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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| C60503 | Vector copy number specimen type evidence gene modified hematopoiesis value | VCNSpcmnTypGnModHmtpsVal | Value of the vector copy number (VCN) for the selected specimen type displaying evidence of polyclonal gene-modified hematopoiesis | Value of the vector copy number (VCN) for the selected specimen type displaying evidence of polyclonal gene-modified hematopoiesis | VCN | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 14:32:32.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60450 | Premalignant malignant hematopoiesis evidence dysplastic cell indicator | PreMlgnHmtpsEvdDysCelInd | Indicator of the presence of dysplastic cells evidencing premalignant or malignant hematopoiesis. | Indicator of the presence of dysplastic cells evidencing premalignant or malignant hematopoiesis. | Is there evidence of Premalignant/Malignant Hematopoiesis? Dysplastic Cells | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 09:19:39.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60546 | Gene editing site translocation on off target cytogenetic detection indicator | GnEdStTrnslocOnOfTgtCytoDetINd | Indicator of whether gene editing translocations between on-target and off-target sites were detected by cytogenetics. | Indicator of whether gene editing translocations between on-target and off-target sites were detected by cytogenetics. | Translocations between on-target and off-target editing sites detected by: Cytogenetics | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 13:10:07.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| 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 | Supplemental | 1.00 | 2021-04-22 13:21:58.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60514 | Gene modified hematopoiesis best characterize type | GenModHemtopoisBstCharTyp | Type of condition that best characterizes the observed gene-modified hematopoiesis. | Type of condition that best characterizes the observed gene-modified hematopoiesis. | Based on VCN and VISA, what best describes the gene-modified hematopoiesis? | Clonal dominance;Oligoclonal hematopoiesis;MDS;Leukemia/lymphoma | Clonal dominance;Oligoclonal hematopoiesis;Myelodysplastic syndrome (MDS);Leukemia/lymphoma | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 10:54:46.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| 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 | Supplemental | 1.00 | 2021-04-23 11:20:12.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60461 | Cytogenetic abnormality type | CytogeneticAbnormalityTyp | Type(s) of cytogenic abnormalities identified in cytogenetics testing. | Type(s) of cytogenic abnormalities identified in cytogenetics testing. | Mark all that apply | Monosomy-13;Monosomy-20;Monosomy-5;Monosomy-7;Monosomy-Y;Trisomy+19;Trisomy+8;Translocation t(1:3);Translocation t(11,16);Translocation t(2,11);Translocation t(3,21);Translocation t(3,3);Translocation t(6,9);Deletion: del(12p)/12p-;Deletion: del(13q)/13q-;Deletion: del(20q)/20q-;Deletion: del(9q)/9q-;Deletion: del(11q)/11q-;Deletion: del(3q)/3q-;Deletion: del(5q)/5q-;Deletion: del(7q)/7q-;Inversion (3);Other i17q;Other abnormality (specify) | Monosomy-13;Monosomy-20;Monosomy-5;Monosomy-7;Monosomy-Y;Trisomy+19;Trisomy+8;Translocation t(1:3);Translocation t(11,16);Translocation t(2,11);Translocation t(3,21);Translocation t(3,3);Translocation t(6,9);Deletion: del(12p)/12p-;Deletion: del(13q)/13q-;Deletion: del(20q)/20q-;Deletion: del(9q)/9q-;Deletion: del(11q)/11q-;Deletion: del(3q)/3q-;Deletion: del(5q)/5q-;Deletion: del(7q)/7q-;Inversion (3);Other i17q;Other abnormality (specify) | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 09:51:37.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Multiple Pre-Defined Values Selected |
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| C60557 | Oncogene panel follow genotoxic event detection indicator | OncgnPnlFlwGntxcEvntDtctnInd | Indicator of whether an oncogene panel was performed following detection of a genotoxic event. | Indicator of whether an oncogene panel was performed following detection of a genotoxic event. | If genotoxic event detected was an Oncogene panel used? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 14:35:44.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| 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 | Supplemental | 1.00 | 2021-04-22 13:33:03.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
0 | 100 | percent | ||||||||||||||||||||||||||||||
| C57965 | Laboratory procedure percent lymphocytes value | LabProcedurePrctLymphocytesVal | Value of percent lymphocytes. | Value of percent lymphocytes. | The latest Complete Blood Count Lymphocytes % | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2018-01-22 11:03:02.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60536 | Gene editing off target interrogation bioinformatic type other text | GnEdOffTgtInterrtBioinfoTypOTH | The free-text field related to "Gene editing off target interrogation bioinformatic type", specifying other text. | The free-text field related to "Gene editing off target interrogation bioinformatic type", specifying other text. | Off Target Interrogation: Bioinformatic: Other (list) | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 11:50:01.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 4000 |
Free-Form Entry |
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| C60472 | Abnormal hematopoeisis relationship genetic manipulation type | AbnmlHmtpsRltnshpGntcMnipTyp | Type of relationship believed to exist between observed abnormal hematopoiesis and performance of genetic manipulation. | Type of relationship believed to exist between observed abnormal hematopoiesis and performance of genetic manipulation. | Specify relationship | Unrelated;Definitely related;Probably related;Possibly related | Unrelated;Definitely related;Probably related;Possibly related | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 11:50:16.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60568 | Rheumatologic autoimmune prior disorder new instance exacerbation follow drug product infusion indicator | RhAiPrDsNwInExFlwDrPrInfInd | Indicator of whether a prior rheumatologic or other autoimmune disorder presented exacerbation or a new instance following drug product infusion. | Indicator of whether a prior rheumatologic or other autoimmune disorder presented exacerbation or a new instance following drug product infusion. | Since drug product infusion has there been new incidence or exacerbation of a prior rheumatologic or other autoimmune disorder | 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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| C60504 | Oligoclonal gene modified hematopoiesis evidence indicator | OligoclnlGnModHmtpsEvdncInd | Indicator of whether there is evidence of oligoclonal gene modified hematopoiesis. | Indicator of whether there is evidence of oligoclonal gene modified hematopoiesis. | Is there evidence of oligoclonal gene modified hematopoiesis? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 14:34:33.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60451 | Dysplastic cell lineage name | DysplasticCellLineName | Name of the dysplastic cell lineage | Name of the dysplastic cell lineage | Lineages affected | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 09:23:14.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 100 |
Free-Form Entry |
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| C60547 | Gene editing site translocation on off target cytogenetic detection other text | GnEdStTnslcOnOfTgtCytDetOTH | The free-text field related to "Gene editing site translocation on off target cytogenetic detection indicator" specifying other text. | The free-text field related to "Gene editing site translocation on off target cytogenetic detection indicator" specifying other text. | Translocations between on-target and off-target editing sites detected by: Cytogenetics: Summarize | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 13:15:40.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 4000 |
Free-Form Entry |
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| 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 | Supplemental | 1.00 | 2021-04-22 13:25:18.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60515 | Gene edit frequency text | GeneEditFrequencyTxt | Text field for capturing the frequency with which gene editing was performed. | Text field for capturing the frequency with which gene editing was performed. | Gene editing frequency performed: | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 11:03:20.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 25 |
Free-Form Entry |
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| 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 | Supplemental | 1.00 | 2021-04-23 11:20:12.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60462 | Cytogenetic abnormality type other text | CytogeneticAbnormalityTypOTH | The free-text field related to "Cytogenetic abnormality type", specifying other text. | The free-text field related to "Cytogenetic abnormality type", specifying other text. | Other abnormality (specify) | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 10:13:49.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 4000 |
Free-Form Entry |