CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Treatment/Intervention Data
CRF: Apheresis

43 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
C60685 Hemoglobin S prior red blood exchange percentage value HgSPriorRBEPerVal The percentage value of hemoglobin S prior to red blood exchange. The percentage value of hemoglobin S prior to red blood exchange. What was the pre-procedure HbS? Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60717 Apheresis product differential value ApheresisProdDiffVal The value related to differential cells in apheresis product The value related to differential cells in apheresis product Product Differential Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60696 Stem cell CD34 interval before apheresis time value StemCellCD34Interval The time drawn prior to apheresis of CD34. The time drawn prior to apheresis of CD34. Time drawn prior to apheresis Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60707 Anticoagulant agent additional administered indicator AnticoagAgntAddAdminInd The indicator related to additional anticoagulant agent being administered The indicator related to additional anticoagulant agent being administered Was additional anti-coagulant added after collection No;Yes No;Yes Alphanumeric Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

Single Pre-Defined Value Selected

C60686 Hemoglobin S post red blood exchange percentage value HgSPostRBEPerVal The percentage value of hemoglobin S post red blood exchange. The percentage value of hemoglobin S post red blood exchange. What was the post procedure HbS? Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60718 Transfusion plan indicator TransPlanInd The indicator related to transfusion plan The indicator related to transfusion plan Any transfusions planned No;Yes No;Yes Alphanumeric Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

Single Pre-Defined Value Selected

C60697 Apheresis device manufacturer model text ApherDevManModTxt The free-text field related to apheresis device manufacturer and model. The free-text field related to apheresis device manufacturer and model. Apheresis device manufacturer and model Alphanumeric Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60708 Anticoagulant agent additional administered type AnticoagAgntAddAdminTyp The type related to additional anticoagulant agent being administered. The type related to additional anticoagulant agent being administered. Type of anticoagulant Alphanumeric Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60687 Chronic red cell exchange program past year indicator ChronicRBEProgPastYrInd The indicator related to participant being part of an chronic red cell exchange program in the past year. The indicator related to participant being part of an chronic red cell exchange program in the past year. Is the participant part of a chronic Red Cell Exchange program in the past year? No;Yes No;Yes Alphanumeric Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

Single Pre-Defined Value Selected

C60719 Post apheresis peripheral red blood cell unit value PostApheresPRBCUnitVal The value related to peripheral red blood cell transfusion post apheresis. The value related to peripheral red blood cell transfusion post apheresis. Units PRBC Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60698 Apheresis device program used text ApherDevProgUsedTxt The free-text field related to apheresis device manufacturer and model. The free-text field related to apheresis device manufacturer and model. Apheresis program used Alphanumeric Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60709 Anticoagulant agent apheresis collection total value AnticoagAgntApheresisTotalVal The total anticoagulant during the apheresis collection. The total anticoagulant during the apheresis collection. Total anticoagulant in the HPC-A Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60688 Red blood exchange collection interval day count RBECollIntervalDayCt The number of days between last exchange and collection of red blood cells. The number of days between last exchange and collection of red blood cells. Number of Days Between Last Exchange and Collection Date Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

Free-Form Entry

C60720 Post apheresis platelet unit value PostApheresPlateletUnitVal The value related to platelets post apheresis. The value related to platelets post apheresis. Units platelets Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

Free-Form Entry

C60699 Anticoagulant agent administered text AnticoagAgntAdminTxt The free-text field related to anticoagulant agent administered. The free-text field related to anticoagulant agent administered. Anticoagulation Alphanumeric Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

Free-Form Entry

C60710 Apheresis product volume value ApheresisProdVolVal The total volume of apheresis product. The total volume of apheresis product. Product Volume (mL) Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60689 Red blood exchange vascular access type RBEVascularAccessTyp The type as related to vascular access used in collection of red blood cells. The type as related to vascular access used in collection of red blood cells. Vascular Access used for collection Other;Implanted Vascular Access Device (i.e. Port);Peripheral Access;Central Venous Catheter Other;Implanted Vascular Access Device (i.e. Port);Peripheral Access;Central Venous Catheter Alphanumeric Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

Single Pre-Defined Value Selected

C60721 Apheresis collection next day indicator ApheresisCollNextDayInd The indicator related to having collection for apheresis the next day. The indicator related to having collection for apheresis the next day. Collecting again tomorrow No;Yes No;Yes Alphanumeric Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

Single Pre-Defined Value Selected

C60700 Apheresis average flow rate value ApheresisAveFlowRateVal The value related to average flow rate in apheresis The value related to average flow rate in apheresis Average flow rate Alphanumeric Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60711 Apheresis product total nucleated cell count ApheresisProdTotalNucCellCt The total nucleated cell count of apheresis product The total nucleated cell count of apheresis product Product Total Nucleated Cell Number (cells/mL) Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60690 Apheresis mobilization agent plerixafor dose value ApheresisMobAgenPlerDoseVal The dose related plerixafor for mobilization agent in apheresis. The dose related plerixafor for mobilization agent in apheresis. Plerixafor dose Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

Free-Form Entry

C60701 Apheresis kit venus access failure indicator ApheresisVenAccFailInd The indicator related to kit failure or venous access failure in apheresis. The indicator related to kit failure or venous access failure in apheresis. Kit failure or venous access failure No;Yes No;Yes Alphanumeric Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

Single Pre-Defined Value Selected

C60712 Apheresis product CD34 value ApheresisProdCD34Val The total value of CD34 in apheresis product The value of CD34 in apheresis product CD34+ Cell Dose(cells/kg) Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60691 Apheresis mobilization agent plerixafor prior collection time value ApheresisMobAgenPlerPrCTVal The value related to time prior to collection for administration of plerixafor for mobilization agent in apheresis. The value related to time prior to collection for administration of plerixafor for mobilization agent in apheresis. Time given prior to apheresis collection Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60702 Apheresis instrument duration value ApheresisInstrDurVal The time in hours and minutes of being on instrument for apheresis. The time in hours and minutes of being on instrument for apheresis. Time on Instrument (hours/minutes) Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60713 Apheresis product CD34 total value ApheresisProdCD34Val The total value of CD34 in apheresis product The total value of CD34 in apheresis product Total CD34+ Cell Yield(cells/uL) Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60692 Apheresis mobilization other agent type ApheresisMobOtherAgenTyp The other type of mobilization agent used in apheresis. The other type of mobilization agent used in apheresis. Other mobilization agent(s) used Alphanumeric Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60703 Apheresis instrument interface color preference percentage hematocrit text ApheresisInstrColorPrefHCTTxt The free-text field related to apheresis instrument preference for interface color preference as it represents percentage hematocrit. The free-text field related to apheresis instrument preference for interface color preference as it represents percentage hematocrit. Interface Color preference/Percent Hct Alphanumeric Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60714 Apheresis product hematocrit percentage value ApheresisProdHCTPercVal The percentage value of hematocrit in apheresis product The percentage value of hematocrit in apheresis product Product Hematocrit (Hct %) Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60693 Apheresis mobilization other agent dose value ApheresisMobOtherAgenDoseVal The dose related other agent for mobilization in apheresis. The dose related other agent for mobilization in apheresis. Dose Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60704 Apheresis total blood volume value ApheresisTotalBloodVolVal The value of total blood volume processed in apheresis. The value of total blood volume processed in apheresis. Total Blood Volume Processed (TBV) Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60715 Apheresis product white blood cell count value ApheresisProdWBCVal The value related to white blood cells in apheresis product The value related to white blood cells in apheresis product Product WBC (k/uL) Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60694 Apheresis mobilization other agent prior collection time value ApheresisMobOtherAgenPrCTVal The value related to time prior to collection for administration of other agent for mobilization in apheresis. The value related to time prior to collection for administration of other agent for mobilization in apheresis. Time given prior to apheresis Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60705 Apheresis plerixafor mobilization time interval value ApheresisPlerMobTimeInterVal The time from plerixafor or mobilization agent to start of apheresis in minutes The time from plerixafor or mobilization agent to start of apheresis in minutes Time from Plerixafor to start of apheresis Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

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C60684 Red blood cell exchange performed most recent date RBCExchangePerfLanDt The date related to last red blood cell exchange for treatment of sickle cell disease. The date related to last red blood cell exchange for treatment of sickle cell disease. If Yes, when was the latest? Date Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

Free-Form Entry

C60716 Apheresis product platelet count value ApheresisProdPlateletVal The value related to platetet cells in apheresis product The value related to platetet cells in apheresis product Product Platelet Count (k/uL) Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

Free-Form Entry

C60695 Stem cell CD34 before apheresis value StemCellCD34Before The CD34 value pre-apheresis. The CD34 value pre-apheresis. CD34 Numeric Values Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

Free-Form Entry

C60706 Adverse event relate apheresis indicator AERelApheresisInd The indicator related to adverse event from apheresis. The indicator related to adverse event from apheresis. Any AE's related to collection No;Yes No;Yes Alphanumeric Adult;Pediatric Exploratory 1.00 2021-05-10 12:12:04.0 Apheresis Treatment/Intervention Data Therapies

Single Pre-Defined Value Selected

C60127 Surgical splenectomy indicator SurgicalSplenectomyInd Indicator of whether the subject/participant's spleen was surgically removed. Indicator of whether the subject/participant's spleen was surgically removed. Has the participant had a splenectomy? No;Yes No;Yes Alphanumeric Adult;Pediatric Exploratory 1.00 2021-01-15 10:47:24.0 Apheresis Treatment/Intervention Data Therapies

Single Pre-Defined Value Selected

PR SPLENECT_PROCCUR

Procedure Occurrence

Splenectomy Performed

Has the subject had a splenectomy?

Char Indicate if a splenectomy was performed by checking Yes or No. PROCCUR

PROCCUR where PRTRT = "SPLENECTOMY"

(NY)

Yes; No

Prompt Radio
C60423 Transfusion sickle cell disease treatment recent receive indicator TransfSCDTxRecentRecInd Whether the participant/subject received recent transfusion for treatment of sickle cell disease. Whether the participant/subject received recent transfusion for treatment of sickle cell disease. Has the participant received recent blood transfusions? No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2017-01-23 15:46:25.0 Apheresis Treatment/Intervention Data Therapies

Single Pre-Defined Value Selected

C60424 Transfusion sickle cell disease treatment past year count TransfSCDTxPastYrCt The count as related to number of transfusions in the past 12 months for treatment of sickle cell disease. The count as related to number of transfusions in the past 12 months for treatment of sickle cell disease. How many transfusions have been received in the past 12 months Numeric Values Adult;Pediatric Exploratory 1.00 2017-01-23 15:46:25.0 Apheresis Treatment/Intervention Data Therapies

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C60425 Hemoglobin sickle less than 30 percent past year indicator HgSLess30PercPastYrInd The indicator of whether hemoglobin S percentage value was less than 30 in the past 12 months. The indicator of whether hemoglobin S percentage value was less than 30 in the past 12 months. Has the HbS percentage been <30% for the past three months No;Yes No;Yes Alphanumeric Adult;Pediatric Exploratory 1.00 2017-01-23 15:46:25.0 Apheresis Treatment/Intervention Data Therapies

Single Pre-Defined Value Selected

C60426 Red blood cell exchange indicator RBCExchangeInd The indicator related to red blood cell exchange for treatment of sickle cell disease. The indicator related to red blood cell exchange for treatment of sickle cell disease. Has the participant undergone a Red Cell Exchange in the past year? No;Yes No;Yes Alphanumeric Adult;Pediatric Exploratory 1.00 2017-01-23 15:46:25.0 Apheresis Treatment/Intervention Data Therapies

Single Pre-Defined Value Selected

43 results.
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