CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Safety Data
CRF: Genotoxicity

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
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

C60516 Gene edited hematopoietic stem progenitor cells blood CD3 depleted indicator GenEditHSPCBldCD3DpltInd Indicator of whether the gene-edited hematopoietic stem and progenitor cells (HSPC) blood is depleted of CD3. Indicator of whether the gene-edited hematopoietic stem and progenitor cells (HSPC) 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

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

C60484 Integrating viral vector copy number blood CD19 plus lineage value IntgrtVrlVCNBldCD19PlsLneagVal Value of the integrating viral vector copy number (VCN) in blood for the CD19+ lineage Value of the integrating viral vector copy number (VCN) in blood for the CD19+ lineage VCN in Specific Lineages: CD19+ Numeric Values Adult;Pediatric Supplemental 1.00 2021-04-22 13:25:18.0 Genotoxicity Safety Data Adverse Events/Toxicities

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C60527 Gene editing blood GPA plus lineage on target indel count GnEdBldGPAPlsLinOnTgtIndelCt Count of gene-editing on-target indels in the blood GPA+ lineage. Count of gene-editing on-target indels in the blood GPA+ lineage. On-target Indels in Specific Blood Lineages: GPA+ Numeric Values Adult;Pediatric Supplemental 1.00 2021-04-23 11:20:12.0 Genotoxicity Safety Data Adverse Events/Toxicities

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C60463 Genetic mutational panel indicator GeneticMutationalPanelInd Indicator of whether a genetic mutational panel was performed. Indicator of whether a genetic mutational panel was performed. Was a genetic mutational panel performed? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-22 10:16:11.0 Genotoxicity Safety Data Adverse Events/Toxicities

Single Pre-Defined Value Selected

C60559 Whole genome sequencing follow genotoxic event detection indicator WhlGnmSqncFlwGntxcEvntDtctnInd Indicator of whether whole genome sequencing was performed following detection of a genotoxic event. Indicator of whether whole genome sequencing was performed following detection of a genotoxic event. If genotoxic event detected was whole genome 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

C60495 Bone marrow colony forming cell positive for integrating viral vector percent value BMCFCPstvFrIntVrlVctPctVal Value of the percentage of bone marrow colony forming cells (CFC) positive for the integrating viral vector. Value of the percentage of bone marrow colony forming cells (CFC) positive for the integrating viral vector. Percentage of Bone Marrow Cells Positive for Integrating Vector: CFC 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
C59958 White blood cell count WhiteBloodCellCt Count of white blood cells (WBC) in the subject/participant's complete blood cell (CBC) sample. Count of white blood cells (WBC) in the subject/participant's complete blood cell (CBC) sample. The latest Complete Blood Count WBC Numeric Values Adult;Pediatric Supplemental 1.00 2020-09-01 13:36:15.0 Genotoxicity Safety Data Adverse Events/Toxicities

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CIBMTR n/a Form 2031 revision 2 10. WBC:
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

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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

C60570 Hematologic disorder new incidence follow drug product infusion indicator HmDsNwInFlwDrPrInfInd Indicator of whether there was a new incidence of hematologic disorder following drug product infusion. Indicator of whether there was a new incidence of hematologic disorder following drug product infusion. Since drug product infusion has there been new incidence of a hematologic 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

C60506 Clone integrant minimum 20 percent representation integration site gene location ClnIntgrMn20PctRpIntgrtStGnLoc Location of the integration site (gene or flanking gene) of clone(s) or integrant(s) having >=20 percent representation in the clone population. Location of the integration site (gene or flanking gene) of clone(s) or integrant(s) having >=20 percent representation in the clone population. List the site of integration of dominant (>=20% representation) clone(s) [e.g. gene location or flanking gene location] Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-22 14:42:22.0 Genotoxicity Safety Data Adverse Events/Toxicities 25

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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

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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

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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

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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

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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

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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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