CDE Detailed Report
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Sub-Domain: Safety Data
CRF:

Displaying 1 - 50 of 137
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
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

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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

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

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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

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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

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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

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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

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

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

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

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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

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

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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

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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

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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

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

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

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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

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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

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

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

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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

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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

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

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

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

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

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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

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

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

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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

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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

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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

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

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

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

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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

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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

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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

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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

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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

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C60558 Whole exome sequencing follow genotoxic event detection indicator WhlExmSqncFlwGntxcEvntDtctnInd Indicator of whether whole exome sequencing was performed following detection of a genotoxic event. Indicator of whether whole exome sequencing was performed following detection of a genotoxic event. If genotoxic event detected was whole exome sequencing used? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-23 14:37:50.0 Genotoxicity Safety Data Adverse Events/Toxicities

Single Pre-Defined Value Selected

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 Supplemental 1.00 2021-04-22 13:33:03.0 Genotoxicity Safety Data Adverse Events/Toxicities

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0 100 percent
C58800 Death date DeathDate Date on which the subject/participant died Date on which the subject/participant died Date expired: Date or Date & Time Adult;Pediatric Supplemental 1.00 2018-12-12 12:24:18.0 Genotoxicity Safety Data Adverse Events/Toxicities

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BMTCTN 1507A Release 5.10 Follow Up Status Form - 1507 (F23) F23DTHDT
C60537 Gene editing off target site screen count GnEdOffTgtSiteScreenCt Count of off-target gene editing sites screened. Count of off-target gene editing sites screened. Number of off-target editing sites screened Numeric Values Adult;Pediatric Supplemental 1.00 2021-04-23 11:57:22.0 Genotoxicity Safety Data Adverse Events/Toxicities

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C60473 Bone marrow aspirate perform indicator BonMarowAspiratPerfrmInd Indicator of whether any bone marrow aspiration was performed. Indicator of whether any bone marrow aspiration was performed. Bone Marrow Aspirate Performed? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-22 12:00:51.0 Genotoxicity Safety Data Adverse Events/Toxicities

Single Pre-Defined Value Selected

C60569 Rheumatologic autoimmune prior disorder new incidence exacerbation follow drug product infusion describe text RhAiPrDsNwInExFlwDrPrInfDscTxt Text describing exacerbation or a new incidence of a prior rheumatologic or other autoimmune disorder following drug product infusion. Text describing exacerbation or a new incidence of a prior rheumatologic or other autoimmune disorder following drug product infusion. Since drug product infusion has there been new incidence or exacerbation of a prior rheumatologic or other autoimmune disorder? If yes, describe: Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-23 15:02:28.0 Genotoxicity Safety Data Adverse Events/Toxicities 255

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C60505 Cell clone integrant comprise 20 percent clone population indicator CelClnIntgCmpr20PctClnPopInd Indicator of whether any cell clone(s) or integrant(s) comprise >=20 percent of all clones. Indicator of whether any cell clone(s) or integrant(s) comprise >=20 percent of all clones. Is there evidence of Clonal Dominance? i.e., Do any cell clone(s) or integrant(s) account for >=20% of all clones? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-22 14:36:37.0 Genotoxicity Safety Data Adverse Events/Toxicities

Single Pre-Defined Value Selected

C60452 Premalignant malignant hematopoiesis evidence blast indicator PreMlgnHmtpsEvdBlastInd Indicator of the presence of blasts evidencing premalignant or malignant hematopoiesis. Indicator of the presence of blasts evidencing premalignant or malignant hematopoiesis. Is there evidence of Premalignant/Malignant Hematopoiesis? Blasts 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

C60548 Gene editing site translocation on off target droplet digital polymerase chain reaction detection indicator GnEdStTrOnOfTgDpDgPCRDtInd Indicator of whether gene editing translocations between on-target and off-target sites were detected by droplet digital polymerase chain reaction (PCR). Indicator of whether gene editing translocations between on-target and off-target sites were detected by droplet digital polymerase chain reaction (PCR). Translocations between on-target and off-target editing sites detected by: Droplet Digital PCR No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-23 13:18:53.0 Genotoxicity Safety Data Adverse Events/Toxicities

Single Pre-Defined Value Selected

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