CDE Detailed Report
Disease: general-data-protection-regulation-gdpr
Sub-Domain: Safety Data
CRF:
Sub-Domain: Safety Data
CRF:
137 results.
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| CDE ID | CDE Name | Variable Name | Definition | Short Description | Additional Notes (Question Text) | Permissible Values | Description | Data Type | Disease Specific Instructions | Disease Specific Reference | Population | Classification (e.g., Core) | Version Number | Version Date | CRF Name (CRF Module / Guideline) | Sub Domain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | Source | Form Set | Form | Field | Domain | CDASH Variable | CDASH Definition | CDASH Label | Controlled Terminology | Prompt | Essentiality | Question Text | CDASH imp guidance | SDTM IG target | csDSR | PhenX | Data Type | CRF Completion Inst | SDTMIG Target Var | SDTMIG Target Map | Codelist Name | PVs | Pre Pop Value | Query Display | List Style |
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| 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 |
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| 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 |
Free-Form Entry |
0 | 100 | percent | ||||||||||||||||||||||||||||||
| 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 |
Free-Form Entry |
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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 |
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| 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 |
Free-Form Entry |
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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 |
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| 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 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | Follow Up Status Form - 1507 (F23) | F23DTHDT | |||||||||||||||||||||||||||||
| 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 |
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| 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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| 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 |
Free-Form Entry |
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| 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 |
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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 |
Free-Form Entry |
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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 |
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| 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 |
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| 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 |
Free-Form Entry |
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 |
Free-Form Entry |
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 |
Free-Form Entry |
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| C60474 | Bone marrow aspirate result type | BonMarowAspiratResultTyp | Type(s) of results obtained from bone marrow aspiration. | Type(s) of results obtained from bone marrow aspiration. | Bone Marrow Aspirate Performed? | Abnormal cytogenetics;Normal cytogenetics;Dysplastic morphology;Malignant morphology;Normal morphology | Abnormal cytogenetics;Normal cytogenetics;Dysplastic morphology;Malignant morphology;Normal morphology | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 12:02:30.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Multiple Pre-Defined Values Selected |
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| 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 |
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| 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 |
Free-Form Entry |
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| C60453 | Blast bone marrow type | BlastBoneMarrowTyp | Type of blast(s) present in bone marrow aspirate/biopsy. | Type of blast(s) present in bone marrow aspirate/biopsy. | Blasts type | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 09:28:44.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 255 |
Free-Form Entry |
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| C60549 | Gene editing site translocation on off target droplet digital polymerase chain reaction detection limit text | GnEdStTrOnOfTgDrDgPCRDtLmTxt | Text field for capturing the droplet digital polymerase chain reaction (PCR) detection limit for translocations of on target and off target gene editing sites. | Text field for capturing the droplet digital polymerase chain reaction (PCR) detection limit for translocations of on target and off target gene editing sites. | Translocations between on-target and off-target editing sites detected by: Droplet Digital PCR: If no, what is the limit of detection: | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 13:24:46.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 50 |
Free-Form Entry |
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| C60485 | Integrating viral vector copy number blood CD15 plus lineage value | IntgrtVrlVCNBldCD15PlsLneagVal | Value of the integrating viral vector copy number (VCN) in blood for the CD15+ lineage | Value of the integrating viral vector copy number (VCN) in blood for the CD15+ lineage | VCN in Specific Lineages: CD15+ | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 13:25:18.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60517 | Gene edited hematopoietic stem progenitor cells blood CD3 depleted conversion percent value | GenEdHSPCBldCD3DepltCnvPctVal | Value of the percentage of conversions related to CD3 depletion in gene-edited hematopoietic stem and progenitor cells (HSPC) in blood. | Value of the percentage of conversions related to CD3 depletion in gene-edited hematopoietic stem and progenitor cells (HSPC) in blood. | Percent Conversion | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 11:09:53.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
0 | 100 | percent | ||||||||||||||||||||||||||||||
| C60528 | Gene editing blood CD14 plus lineage on target indel count | GnEdBldCD14PlsLinOnTgtIndelCt | Count of gene-editing on-target indels in the blood CD14+ lineage. | Count of gene-editing on-target indels in the blood CD14+ lineage. | On-target Indels in Specific Blood Lineages: CD14+ | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 11:20:12.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60464 | Abnormal hematopoiesis best descriptor type | AbnormHematopoieBstDscrpTyp | Type of descriptor that best characterizes the abnormal hematopoiesis identified. | Type of descriptor that best characterizes the abnormal hematopoiesis identified. | What best describes the abnormal hematopoiesis? | MDS;Leukemia/lymphoma | Myelodysplastic syndrome;Leukemia/lymphoma | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 10:17:46.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60560 | Post genotoxic event oncogene panel whole exome genome sequencing result text | PstGntxcEvOncPnlWhlExGnSqRsTxt | Text describing the results of oncogene panel, whole exome sequencing, or whole genome sequencing performed following a genotoxic event. | Text describing the results of oncogene panel, whole exome sequencing, or whole genome sequencing performed following a genotoxic event. | State results | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 14:43:36.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 255 |
Free-Form Entry |
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| C60496 | Vector integration site analysis substrate type | VISASubstrateTyp | Type of substrate(s) on which Vector Integration Site Analysis (VISA) was performed. | Type of substrate(s) on which Vector Integration Site Analysis (VISA) was performed. | Vector Integration Site Analysis (VISA) performed in | Blood;Bone marrow;Sorted/fractionated cell populations | Blood;Bone marrow;Sorted/fractionated cell populations | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 14:01:20.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Multiple Pre-Defined Values Selected |
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| C59968 | Platelet count value | PlateletCountVal | Value of the count of platelets in the subject/participant's complete blood cell (CBC) sample. | Value of the count of platelets in the subject/participant's complete blood cell (CBC) sample. | The latest Complete Blood Count Plt | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2020-09-01 13:36:15.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
CIBMTR | n/a | Form 2031 revision 2 | 15: Platelets | |||||||||||||||||||||||||||||
| C60539 | Gene editing off target site confirm GUIDE seq check indicator | GnEdOfTgtSitCnfrmGUIDESeqChInd | Indicator of whether confirmation of off-target gene editing sites involved checking by GUIDE-seq. | Indicator of whether confirmation of off-target gene editing sites involved checking by GUIDE-seq. | Checked by GUIDE-seq? | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 11:59:58.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Single Pre-Defined Value Selected |
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| C60475 | Bone marrow aspirate cytogenetic abnormality describe text | BnMrwAsprtCytgntcAbnormDscrTxt | Text field for describing cytogenetic abnormalities identified in bone marrow aspirate. | Text field for describing cytogenetic abnormalities identified in bone marrow aspirate. | Cytogenetic Abnormalities (describe) | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 12:06:45.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 255 |
Free-Form Entry |
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| C60571 | Hematologic disorder new incidence follow drug product infusion describe text | HmDsNwInFlwDrPrInfDscTxt | Text describing new incidence of hematologic disorder following drug product infusion. | Text describing new incidence of hematologic disorder following drug product infusion. | Since drug product infusion has there been new incidence of a hematologic disorder. If yes, describe: | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 15:02:28.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 255 |
Free-Form Entry |
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| C60507 | Clone integrant minimum 20 percent representation value | ClnIntgrntMin20PctRepVal | Value, as a percentage, of the representation among all clones/integrants of the clones/integrants at the specified gene or flanking gene location, for clones/integrants comprising >=20 percent of all clones/integrants. | Value, as a percentage, of the representation among all clones/integrants of the clones/integrants at the specified gene or flanking gene location, for clones/integrants comprising >=20 percent of all clones/integrants. | Percent Representation/Relative Abundance | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 14:46:13.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
20 | 100 | percent | ||||||||||||||||||||||||||||||
| C60454 | Blast bone marrow percent value | BlastBoneMarrowPctVal | Value of percentage of blast(s) present in bone marrow aspirate/biopsy. | Value of percentage of blast(s) present in bone marrow aspirate/biopsy. | Blasts Percentage | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 09:28:44.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
0 | 100 | percent | ||||||||||||||||||||||||||||||
| C60550 | Gene editing site translocation on off target droplet digital polymerase chain reaction detection frequency text | GnEdStTrOnOfTgDrDgPCRDtFrqTxt | Text field for reporting the frequency of detection of translocation of on target and off target gene editing sites using droplet digital polymerase chain reaction (PCR). | Text field for reporting the frequency of detection of translocation of on target and off target gene editing sites using droplet digital polymerase chain reaction (PCR). | Translocations between on-target and off-target editing sites detected by: Droplet Digital PCR: If yes, what is the frequency of detection: | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 13:29:02.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities | 50 |
Free-Form Entry |
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| C60486 | Integrating viral vector copy number blood GPA plus lineage value | IntgrtVrlVCNBldGPAPlsLneagVal | Value of the integrating viral vector copy number (VCN) in blood for the GPA+ lineage | Value of the integrating viral vector copy number (VCN) in blood for the GPA+ lineage | VCN in Specific Lineages: GPA+ | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-22 13:25:18.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
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| C60518 | Gene edited hematopoietic stem progenitor cells blood CD3 depleted on target indel count | GnEdHSPCBldCD3DpltOnTgtIndCt | Count of on-target indels related to CD3 depletion in gene-edited hematopoietic stem and progenitor cells (HSPC) in blood. | Count of on-target indels related to CD3 depletion in gene-edited hematopoietic stem and progenitor cells (HSPC) in blood. | On-target Indels | Numeric Values | Adult;Pediatric | Supplemental | 1.00 | 2021-04-23 11:12:55.0 | Genotoxicity | Safety Data | Adverse Events/Toxicities |
Free-Form Entry |
137 results.
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