CDE Detailed Report
Disease:
Sub-Domain: Outcomes and End Points
CRF:

55 results.
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
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 Core 1.00 2021-04-23 11:20:12.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

Free-Form Entry

C60633 Hemoglobin analysis current text HgbAnalysCurrentTxt Text field for specifying the current hemoglobin analysis. Text field for specifying the current hemoglobin analysis. Current Hemoglobin analysis Alphanumeric

Use other CRF

Adult;Pediatric Core 1.00 2021-04-29 16:19:24.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr 50

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C60482 Integrating viral vector blood CD3 depleted indicator IntgrtVrlVctrBldCD3DpltInd Indicator of whether the integrating viral vector copy number (VCN) of blood is depleted of CD3. Indicator of whether the integrating viral vector copy number (VCN) of blood is depleted of CD3. CD3 depleted? No;Yes No;Yes Alphanumeric Adult;Pediatric Core 1.00 2021-04-22 13:21:58.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

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 Core 1.00 2021-04-22 13:33:03.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

Free-Form Entry

0 100 percent
C60644 Gene editing blood CD15 plus lineage off target indel count GnEdBldCD15PlsLinOffTgtIndelCt Count of gene-editing off-target indels in the blood CD15+ lineage. Count of gene-editing off-target indels in the blood CD15+ lineage. Off-target Indels in Specific Blood Lineages: CD15+ Numeric Values Adult;Pediatric Core 1.00 2021-04-23 11:20:12.0 Gene Product Follow-Up Outcomes and End Points general-data-protection-regulation-gdpr

Free-Form Entry

55 results.
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