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
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

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

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

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

C60446 Autologous transplant genetically modified hematopoietic stem cell infusion elapsed time category AutlgTPGMHSCInfsElpsTimCat Category of time elapsed since autologous transplant (TP) and genetically modified (GM) hematopoietic stem cell (HSC) infusion. Category of time elapsed since autologous transplant (TP) and genetically modified (GM) hematopoietic stem cell (HSC) infusion. Time since autologous transplant and Genetically Modified HSC Infusion): Day 0;3 months;6 months;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 Day 0;3 months;6 months;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 2021-04-21 16:32:23.0 Genotoxicity Safety Data Adverse Events/Toxicities

Single Pre-Defined Value Selected

C60542 Gene editing off target site confirm other method indicator other text GnEdOfTgtSitCnfrmOthMethIndOTH The free-text field related to "Gene editing off target site confirm other method indicator" specifying other text. The free-text field related to "Gene editing off target site confirm other method indicator" specifying other text. Confirmed by other method: If yes, list: Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-23 11:59:58.0 Genotoxicity Safety Data Adverse Events/Toxicities 4000

Free-Form Entry

C60478 Integrating viral vector for hematopoietic stem progenitor cell therapy transgene component text IntViVeFHSPCTherTrnsgnCompTxt Text field for describing the transgene component(s) of the integrating viral vector(s) used for genetic manipulation of hematopoietic stem and progenitor cells. Text field for describing the transgene component(s) of the integrating viral vector(s) used for genetic manipulation of hematopoietic stem and progenitor cells. Transgene in the vector Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-22 13:06:17.0 Genotoxicity Safety Data Adverse Events/Toxicities 50

Free-Form Entry

C60489 Burst forming unit erythroid cell positive for integrating viral vector percent value BFUEPostvFrIntgrtVrlVctrPctVal Value of the percentage of burst-forming unit - erythroid (BFU-E) cells positive for the integrating viral vector. Value of the percentage of burst-forming unit - erythroid (BFU-E) cells positive for the integrating viral vector. Percentage of Blood Cells Positive for Integrating Vector: BFU-E 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
C60521 Gene editing conversion blood CD15 plus lineage percent value GnEdConvBldCD15PlsLinePctVal Value of the percentage of gene-editing conversions in the blood CD15+ lineage. Value of the percentage of gene-editing conversions in the blood CD15+ lineage. Percent conversion 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

0 100 percent
C60457 Marrow hypoplasia megakaryotic text MrwHypoplsiaMegakaryoticTxt Text describing the megakaryotic component of bone marrow hypoplasia. Text describing the megakaryotic component of bone marrow hypoplasia. Megakaryotic Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-22 09:39:41.0 Genotoxicity Safety Data Adverse Events/Toxicities 100

Free-Form Entry

C60553 Gene editing any associated cell clone minimum 20 percent clone population indicator GnEdAnAsCeClMin20PctClPopInd Indicator of whether any cell clone(s) associated with gene editing comprise >=20 percent of the population of clones. Indicator of whether any cell clone(s) associated with gene editing comprise >=20 percent of the population of clones. Do any cell clone/s associated with an editing event account for >=20% of all clones? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-23 13:38:09.0 Genotoxicity Safety Data Adverse Events/Toxicities

Single Pre-Defined Value Selected

C60564 Malignancy new follow drug product infusion indicator MlgnNwFlwDrgPrdInfsInd Indicator of whether new malignancies were detected following infusion of drug product. Indicator of whether new malignancies were detected following infusion of drug product. Since drug product infusion has there been. New malignancy(ies)? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-23 14:56:07.0 Genotoxicity Safety Data Adverse Events/Toxicities

Single Pre-Defined Value Selected

C60500 Evidence polyclonal gene-modified hematopoiesis specimen type EvidPlyclnlGnModHmtpsSpecTyp Type of specimen in which evidence was found of polyclonal gene-modified hematopoiesis. Type of specimen in which evidence was found of polyclonal gene-modified hematopoiesis. Specimen Type Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-22 14:23:03.0 Genotoxicity Safety Data Adverse Events/Toxicities 25

Free-Form Entry

C60532 Gene editing on target indel bone marrow mononuclear cell count GnEdOnTgtIndelBMMCCt Count of on-target indels in gene editing of bone marrow mononuclear cells (BMMC). Count of on-target indels in gene editing of bone marrow mononuclear cells (BMMC). Bone Marrow: BMMC 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

C60468 Transfusion blood product type TransfusionBloodProductTyp Type(s) of blood product(s) introduced as part of transfusion. Type(s) of blood product(s) introduced as part of transfusion. Blood Product Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-22 10:29:39.0 Genotoxicity Safety Data Adverse Events/Toxicities 100

Free-Form Entry

C60479 Integrating viral vector for hematopoietic stem progenitor cell therapy promoter enhancer component text IntViVeFHSPCTherProEnhCompTxt Text field for describing the promoter and/or enhancer component(s) of the integrating viral vector(s) used for genetic manipulation of hematopoietic stem and progenitor cells. Text field for describing the promoter and/or enhancer component(s) of the integrating viral vector(s) used for genetic manipulation of hematopoietic stem and progenitor cells. Promoter/Enhancers in vector Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-22 13:06:17.0 Genotoxicity Safety Data Adverse Events/Toxicities 50

Free-Form Entry

C60511 Cell clone proportional increase last two analysis identifier text CelClnPrprtnIncrLst2AnlysIdTxt Text field for identifying cell clone(s) that have increased as a proportion of the population of clones over the last two analyses. Text field for identifying cell clone(s) that have increased as a proportion of the population of clones over the last two analyses. Clone Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-22 16:51:48.0 Genotoxicity Safety Data Adverse Events/Toxicities 25

Free-Form Entry

C60447 Hematology since previous report date status HematolSncPrevRptDtStatus Status of subject/participant's hematology since the date of the previous genotoxicity report. Status of subject/participant's hematology since the date of the previous genotoxicity report. Hematological Status since the date of last report: Concerning;Non-concerning Concerning;Non-concerning Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-21 16:43:01.0 Genotoxicity Safety Data Adverse Events/Toxicities

Single Pre-Defined Value Selected

C60543 Gene editing off target site acceptable rate confirm indicator GnEdOfTgtSitAcceptRtCnfrmInd Indicator of whether an acceptable editing rate was confirmed for each off-target gene editing site. Indicator of whether an acceptable editing rate was confirmed for each off-target gene editing site. Acceptable editing rate confirmed for each off-target editing site: No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-23 12:08:45.0 Genotoxicity Safety Data Adverse Events/Toxicities

Single Pre-Defined Value Selected

C60490 Integrating viral vector copy number bone marrow mononuclear cell value IntgrtVrlVCNBMMCVal Value of the integrating viral vector copy number (VCN) in bone marrow for bone marrow mononuclear cells (BMMC). Value of the integrating viral vector copy number (VCN) in bone marrow for bone marrow mononuclear cells (BMMC). Bone Marrow VCN: BMMC Numeric Values Adult;Pediatric Supplemental 1.00 2021-04-22 13:25:18.0 Genotoxicity Safety Data Adverse Events/Toxicities

Free-Form Entry

C60522 Gene editing conversion blood GPA plus lineage percent value GnEdConvBldGPAPlsLinePctVal Value of the percentage of gene-editing conversions in the blood GPA+ lineage. Value of the percentage of gene-editing conversions in the blood GPA+ lineage. Percent conversion 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

Free-Form Entry

0 100 percent
C60458 Bone marrow myeloid erythroid cell ratio text BonMrwMyldErythrdCelRatioTxt Text field for capturing the ratio of maturing myeloid cells to erythroid cells in the bone marrow. Text field for capturing the ratio of maturing myeloid cells to erythroid cells in the bone marrow. What was M:E ratio: Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-22 09:44:38.0 Genotoxicity Safety Data Adverse Events/Toxicities 10

Free-Form Entry

C60554 Gene editing off target cell clone minimum 20 percent clone population gene location GnEdOfTgCeClMn20PcClPopGnLoc Location of the gene containing, or nearest flanking gene to, the site of the off-target gene-editing clone that comprises >=20 percent of the population of all clones. Location of the gene containing, or nearest flanking gene to, the site of the off-target gene-editing clone that comprises >=20 percent of the population of all clones. List the site of off-target gene editing of dominant (=20% representation) clone(s) [e.g. gene location or flanking gene location], if known Alphanumeric Adult;Pediatric Supplemental 1.00 2021-04-23 13:41:43.0 Genotoxicity Safety Data Adverse Events/Toxicities 25

Free-Form Entry

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

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
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

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

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

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

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
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

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

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

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

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
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

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

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

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

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
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

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

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

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

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

Displaying 1 - 50 of 137
CSV