Sub-Domain: Treatment/Intervention Data
CRF: Apheresis
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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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 |
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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 |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
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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 |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
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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 |
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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 |
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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 |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
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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 |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
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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 |
Free-Form Entry |
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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 |
Free-Form Entry |
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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 |
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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 |
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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 |
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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 |
Free-Form Entry |
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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 |
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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 |
Free-Form Entry |
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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 |
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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 |