CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Additional Proposed Instruments
CRF: Haplo Sickle Cell Enrollment Form: Segment A
Sub-Domain: Additional Proposed Instruments
CRF: Haplo Sickle Cell Enrollment Form: Segment A
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C58789 | Protocol chair officer approve date | ProtocolChairOfficerAproveDate | Date on which the Protocol Chair and/or Protocol Officer approved a variance from study protocol. | Date on which the Protocol Chair and/or Protocol Officer approved a variance from study protocol. | Date of Protocol Chair and/or Protocol Officer approval | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 12:15:49.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCAPDT | |||||||||||||||||||||||||||||
| C58708 | Clincal radiologic evidence cerebral infarct 30 day prior enrollment indicate code | ClnRadEvCerInf30DyPrEnrIndCode | Code indicating whether there was clinical or radiological evidence of a recent cerebral infarct by cerebral MRI/MRA within 30 days prior to enrollment. | Code indicating whether there was clinical or radiological evidence of a recent cerebral infarct by cerebral MRI/MRA within 30 days prior to enrollment. | Was there clinical or radiologic evidence of a recent cerebral infarct by cerebral MRI/MRA within 30 days prior to enrollment? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-11-21 12:35:08.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCRECNE | |||||||||||||||||||||||||||
| C58740 | Hyperbilirubinemia indicate code | HyperbilirubinemiaIndCode | Code indicating whether the subject/participant has hyperbilirubinemia | Code indicating whether the subject/participant has hyperbilirubinemia | Does the patient have hyperbilirubinemia? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 12:14:07.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCHYPER | |||||||||||||||||||||||||||
| C58752 | Liver MRI date | LiverMRIDate | Date on which liver MRI (magnetic resonance imaging) was performed. | Date on which liver MRI (magnetic resonance imaging) was performed. | Record date of liver MRI | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 12:42:35.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCLMRDT | |||||||||||||||||||||||||||||
| C58719 | Pain crisis 1 year prior enrollment start date | PnCris1YrPriorEnrolStartDate | Start date of the severe vaso-occlusive pain crisis or painful episode related to priapism, osteonecrosis, or sickle-related complication one year prior to enrollment. | Start date of the severe vaso-occlusive pain crisis or painful episode related to priapism, osteonecrosis, or sickle-related complication one year prior to enrollment. | Start date of severe pain crisis 1 year prior to enrollment | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 10:12:39.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSC1P1DT | |||||||||||||||||||||||||||||
| C58775 | Transplant solid organ ever receive indicate code | TrpltSldOrgnEverRcvIndCode | Code indicating whether the subject/participant has ever received a solid organ transplant. | Code indicating whether the subject/participant has ever received a solid organ transplant. | Has the patient received a prior solid organ transplant? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 09:45:45.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCORTXP | |||||||||||||||||||||||||||
| C10724 | Echocardiogram performed date and time | EchcrdgrmPerfrmDateTime | Date (and time, if applicable and known) the echocardiography was performed | Date (and time, if applicable and known) the echocardiography was performed | Date echocardiograph was performed | Date or Date & Time | Adult;Pediatric | Proposed | 3.00 | 2013-07-25 08:54:08.2 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
|||||||||||||||||||||||||||||||||
| C58730 | Cardiac fraction test type code | CardiacFractionTestTypeCode | Code for the type of cardiac fraction test performed. | Code for the type of cardiac fraction test performed. | Record the type of cardiac fraction test performed | 1;2 | Left Ventricular Ejection Fraction (LVEF);Shortening Fraction | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 11:37:18.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCCFT | |||||||||||||||||||||||||||
| C58790 | Donor bone marrow willing indicate code | DonrBoneMarwWillIndCode | Code indicating whether the donor is willing to donate bone marrow. | Code indicating whether the donor is willing to donate bone marrow. | Is the donor willing to donate bone marrow? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 13:00:20.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCDWILL | |||||||||||||||||||||||||||
| C58709 | Defer 6 month due clinical radiologic evidence cerebral infarct 30 day prior enrollment indicate code | Df6MoDuClRaEvCeIn30DyPrEnInCod | Code indicating whether the subject/participant's enrollment was deferred for at least 6 months due to clinical or radiological evidence of a recent cerebral infarct by cerebral MRI/MRA within 30 days prior to enrollment. | Code indicating whether the subject/participant's enrollment was deferred for at least 6 months due to clinical or radiological evidence of a recent cerebral infarct by cerebral MRI/MRA within 30 days prior to enrollment. | Was the patient previously deferred for >= 6 months due to clinical or radiologic evidence of a recent cerebral infarct by cerebral MRI/MRA within 30 days prior to enrollment? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-11-21 12:35:08.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCDEFER | |||||||||||||||||||||||||||
| C58741 | Hyperbilirubinemia reason hyperhemolysis post transfusion hemoglobin drop indicate code | HypbilrRsnHyphemPoTrHbDpIndCod | Code indicating whether the subject/participant's hyperbilirubinemia is a result of hyperhemolysis or of a severe drop in hemoglobin following blood transfusion. | Code indicating whether the subject/participant's hyperbilirubinemia is a result of hyperhemolysis or of a severe drop in hemoglobin following blood transfusion. | Is the patient's hyperbilirubinemia a result of hyperhemolysis or a severe drop in hemoglobin post blood transfusion? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 12:16:18.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCHYPHE | |||||||||||||||||||||||||||
| C58753 | Iron overload significant clinical evidence indicate code | IronOverloadSigClinEvdncIndCod | Code indicating whether the subject/participant has significant clinical evidence of iron overload. | Code indicating whether the subject/participant has significant clinical evidence of iron overload. | Does the patient have significant clinical evidence of iron overload (estimated hepatic iron content >= 10mg Fe/g liver dry weight)? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 12:44:53.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCFEOV | |||||||||||||||||||||||||||
| C58720 | Pain crisis information not available specify text | PnCrisInfoNotAvailSpecifyTxt | Text field for specifying why information about the severe vaso-occlusive pain crisis or painful episode related to priapism, osteonecrosis, or sickle-related complication was not available. | Text field for specifying why information about the severe vaso-occlusive pain crisis or painful episode related to priapism, osteonecrosis, or sickle-related complication was not available. | Specify why pain crises information was not available | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 10:18:08.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other | 255 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCPCSP | ||||||||||||||||||||||||||||
| C58776 | Other clinical trial drug device investigational off-label past 3 month indicate code | OtClTrDrDvInOfLbPs3MoIndCode | Code indicating whether in the past 3 months the subject/participant participated in another clinical trial of an investigational or off-label use of a drug or device. | Code indicating whether in the past 3 months the subject/participant participated in another clinical trial of an investigational or off-label use of a drug or device. | Has the patient participated in another clinical trial in which the patient received an investigational or off-label use of a drug or device within 3 months of enrollment? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 09:49:49.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCCLTR | |||||||||||||||||||||||||||
| C10740 | Echocardiogram left ventricle ejection fraction measurement | EchcrdLftVentEjctnFractnMeasr | Fraction of blood pumped out of the left ventricles with each heart beat measured with echocardiography | Fraction of blood pumped out of the left ventricles with each heart beat measured with echocardiography | Left ventricular ejection fraction | Numeric Values | Adult;Pediatric | Proposed | 3.00 | 2013-07-24 11:38:01.2 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
percent | ||||||||||||||||||||||||||||||||
| C58731 | Left ventricular ejection fraction perform date | LVEFPerformDate | Date on which the left ventricular ejection fraction (LVEF) test was performed | Date on which the left ventricular ejection fraction (LVEF) test was performed | Date LV ejection fraction performed | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 11:41:18.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCLVEDT | |||||||||||||||||||||||||||||
| C58742 | Bilirubin most recent direct measurement | BlrubinMstRcntDrctMeasr | Measurement in milligrams per deciliter for the most recent direct measurement of bilirubin. | Measurement in milligrams per deciliter for the most recent direct measurement of bilirubin. | Direct bilirubin most recent value (mg/dL) | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-07 13:01:37.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
0 | 9.9 | milligram per deciliter | BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCBILI | ||||||||||||||||||||||||||
| C58791 | Donor meet institution protocol criteria indicate code | DonrMeetInstProtCritIndCode | Code indicating whether the donor meets institutional and protocol criteria for donation | Code indicating whether the donor meets institutional and protocol criteria for donation | Does the donor meet institutional and protocol-specified criteria for donation? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 13:02:29.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCDCRIT | |||||||||||||||||||||||||||
| C58710 | MRI MRA evidence cerebral infarct date | MriMraEvidCerebInfrctDate | Date of cerebral MRI/MRA with evidence of a cerebral infarct. | Date of cerebral MRI/MRA with evidence of a cerebral infarct. | Record the date of the cerebral MRI/MRA with evidence of a cerebral infarct | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-11-21 12:47:10.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCMRIDT | |||||||||||||||||||||||||||||
| C58754 | Liver biopsy performed indicate code | LiverBiopsyPerformIndicateCode | Code indicating whether a liver biopsy was performed. | Code indicating whether a liver biopsy was performed. | Was a liver biopsy performed? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 12:48:47.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCLIVBX | |||||||||||||||||||||||||||
| C58721 | Red blood cell transfusion multiple per year 12 month prior enrollment indicate code | RBCTrfnMltPrYr12MoPriEnrIndCod | Code indicating whether the subject/participant has received multiple packed red blood cell (RBC) transfusions per year for at least one year during the 12 months prior to enrollment. | Code indicating whether the subject/participant has received multiple packed red blood cell (RBC) transfusions per year for at least one year during the 12 months prior to enrollment. | Has the patient received >= 8 packed red blood cell (RBC) transfusions per year for >= 1 year in the 12 months before enrollment to prevent vaso-occlusive clinical complications (i.e. pain, stroke, and acute chest syndrome)? | 1;2;3 | Yes;No;Unavailable | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 10:26:21.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCRBC | |||||||||||||||||||||||||||
| C58777 | Pregnant breastfeed current indicate code | PregBreastfeetCurrentIndCode | Code indicating whether the subject/participant is currently pregnant or breastfeeding. | Code indicating whether the subject/participant is currently pregnant or breastfeeding. | Is the patient pregnant or breastfeeding? | 1;2;3 | Yes;No;Not Applicable | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 09:56:06.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCPREG | |||||||||||||||||||||||||||
| C10744 | Echocardiogram left ventricle fractional shortening measurement | EchcrdgrmLftVentFractShrtMeasr | Measurement of the difference between end-diastolic and end-systolic dimensions of the left ventricle divided by end-diastolic dimension assessed with echocardiography. FS or Fractional Shortening in percentage = EDD minus ESD divided by EDD times 100, where EDD = LV End Diastolic Dimension and ESD = LV End Systolic Dimension. | Measurement of the difference between end-diastolic and end-systolic dimensions of the left ventricle divided by end-diastolic dimension assessed with echocardiography. | LV Shortening fraction | Numeric Values | Adult;Pediatric | Proposed | 3.00 | 2013-07-24 11:38:01.2 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
percent | ||||||||||||||||||||||||||||||||
| C58732 | Left ventricular shortening fraction perform date | LftVentShortFracPerfDate | Date on which the left ventricular shortening fraction test was performed. | Date on which the left ventricular shortening fraction test was performed. | Date LV shortening fraction performed | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 11:43:47.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCSFDT | |||||||||||||||||||||||||||||
| C58743 | Direct bilirubin institutional upper limit normal age value | DirBlrbnInstULNAgeVal | Value of the institutional upper limit of normal (ULN) for the subject/participant's age for bilirubin measured directly. | Value of the institutional upper limit of normal (ULN) for the subject/participant's age for bilirubin measured directly. | Institutional ULN of direct bilirubin for age | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-07 00:00:00.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
0 | 9.9 | milligram per deciliter | BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCBILIU | ||||||||||||||||||||||||||
| C58792 | Donor have clinically significant hemoglobinopathy indicate code | DonrHavClinSigHmglobpthIndCode | Code indicating whether the donor has a clinically significant hemoglobinopathy. | Code indicating whether the donor has a clinically significant hemoglobinopathy. | Does the donor have a clinically significant hemoglobinopathy? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 13:36:00.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCHEM | |||||||||||||||||||||||||||
| C58711 | MRI MRA evidence cerebral infarct stabilization repeat date | MriMraEviCerInfStabRptDate | Date on which a repeat MRI/MRA was performed which provided evidence of stabilization of the cerebral infarct. | Date on which a repeat MRI/MRA was performed which provided evidence of stabilization of the cerebral infarct. | Record the date of the repeat cerebral MRI/MRA with evidence of stabilization of the cerebral infarct | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-11-21 12:49:43.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCRMRDT | |||||||||||||||||||||||||||||
| C58755 | Liver biopsy date | LiverBiopsyDate | Date on which liver biopsy was performed. | Date on which liver biopsy was performed. | Record date of liver biopsy | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 12:51:00.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCLBXDT | |||||||||||||||||||||||||||||
| C58722 | Red blood cell transfusion start date | RBCTransfusionStartDate | Date on which packed red blood cell (RBC) transfusion was begun. | Date on which packed red blood cell (RBC) transfusion was begun. | Start date of RBC transfusion | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 10:34:44.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCR1DT | |||||||||||||||||||||||||||||
| C58778 | Autoimmune disease prevent tolerate transplant indicate code | AutoimDzPrvntTolratTpltIndCode | Code indicating whether the subject/participant has an autoimmune disease that would prevent him or her from tolerating a transplant. | Code indicating whether the subject/participant has an autoimmune disease that would prevent him or her from tolerating a transplant. | Does the patient have a clinically significant, uncontrolled autoimmune disease requiring active medical management (immunosuppressive therapy or chemotherapy), which, in the judgment of the local Principal Investigator, indicates that the patient could not tolerate transplantation? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 10:33:42.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCAIMM | |||||||||||||||||||||||||||
| C18027 | Comment text | CmmntTxt | Provide any additional information that pertains to the question. | Provide any additional information that pertains to the question. | Comments | Alphanumeric | Adult;Pediatric | Proposed | 3.00 | 2013-07-16 14:01:43.01 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other | 4000 |
Free-Form Entry |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C58733 | Oxygen saturation measurement date | OxygenSaturationMeasrDate | Date on which the measurement of the subject/participant's oxygen saturation level was obtained. | Date on which the measurement of the subject/participant's oxygen saturation level was obtained. | Date O2 saturation obtained | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 11:52:29.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCO2DT | |||||||||||||||||||||||||||||
| C58744 | Bilirubin direct measurement sample date | BlrbnDrctMeasrSamplDate | Date on which sample was taken for direct measurement of bilirubin. | Date on which sample was taken for direct measurement of bilirubin. | Date direct bilirubin sample obtained | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-07 13:22:08.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCBILDT | |||||||||||||||||||||||||||||
| C58793 | Patient consent blood sample optional study specific research indicate code | PtCstBldSmpOptStySpfResIndCode | Code indicating whether the subject/participant consented to provide blood samples for optional study-specific research. | Code indicating whether the subject/participant consented to provide blood samples for optional study-specific research. | Did the patient give consent to provide blood samples for optional study-specific research? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 13:43:40.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCPSMPL | |||||||||||||||||||||||||||
| C58712 | Neurological event information not available specify text | NeurEvntInfoNotAvailSpcfyTxt | Text field for specifying why information about a neurological event was not available. | Text field for specifying why information about a neurological event was not available. | Specify why neurological event information was not available | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 09:36:32.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other | 255 |
Free-Form Entry |
BMTCTN | Release 5.10 | 1507A (ENR) | HSCNEUSP | ||||||||||||||||||||||||||||
| C58758 | Liver free cirrhosis bridging fibrosis active hepatitis indicate code | LivFreCirBriFibActHepIndCode | Code indicating whether the subject/participant's liver is free from cirrhosis, bridging fibrosis, and active hepatitis. | Code indicating whether the subject/participant's liver is free from cirrhosis, bridging fibrosis, and active hepatitis. | Did the gastroenterology/hepatology consultation and histological examination document the absence of cirrhosis, bridging fibrosis, and active hepatitis? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 12:52:32.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCCIRRH | |||||||||||||||||||||||||||
| C58723 | Red blood cell transfusion therapy information not available specify text | RBCTrfsnThrpyInfoNotAvaiSpTxt | Text specifying why information about packed red blood cell (RBC) transfusion therapy was not available. | Text specifying why information about packed red blood cell (RBC) transfusion therapy was not available. | Specify why RBC transfusion therapy information was not available | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 10:36:51.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other | 255 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | NSCRBCSP | ||||||||||||||||||||||||||||
| C58779 | Female childbearing potential indicate code | FemalChildbearPotentlIndCode | Code indicating whether the subject/participant is a female of childbearing potential. | Code indicating whether the subject/participant is a female of childbearing potential. | Is the patient a female of childbearing potential (FCBP) (all females > 10 years of age, unless post-menopausal for a minimum of 1 year before the time of consent or surgically sterilized)? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 10:39:18.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCFCBP | |||||||||||||||||||||||||||
| C57978 | Laboratory procedure alanine aminotransferase value | LabProcedureALTVal | Value of alanine aminotransferase (ALT). | Value of alanine aminotransferase (ALT). | ALT most recent value (units/L) | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-01-22 13:29:51.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
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| C58734 | Diffusion capacity lung carbon monoxide measurement date | DLCOMeasurementDate | Date on which the subject/participant's diffusion capacity of the lung for carbon monoxide (DLCO) was measured. | Date on which the subject/participant's diffusion capacity of the lung for carbon monoxide (DLCO) was measured. | Date DLCO value obtained | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 11:56:11.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCDLCDT | |||||||||||||||||||||||||||||
| C58745 | Alanine aminotransferase institutional upper limit normal age value | ALTInstUpLimNormAgeVal | Value in units per liter of the institutional upper limit of normal for alanine aminotransferase (ALT) for the subject/participant's age. | Value in units per liter of the institutional upper limit of normal for alanine aminotransferase (ALT) for the subject/participant's age. | Institutional ULN of ALT for age | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 09:06:36.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
0 | 999 | units per liter | BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCALULN | ||||||||||||||||||||||||||
| C58794 | Patient consent blood sample optional study specific research date | PtCstBldSmplOptStySpfResDate | Date on which the subject/participant gave consent to provide blood samples for optional study-specific research. | Date on which the subject/participant gave consent to provide blood samples for optional study-specific research. | Date patient consented to optional study-specific research samples | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 13:46:09.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCPSMDT | |||||||||||||||||||||||||||||
| C58713 | Focal neurological event information not available specify text | FoclNeurEvntInfoNotAvSpcfyTxt | Text field for specifying why information about a focal neurological event was not available. | Text field for specifying why information about a focal neurological event was not available. | Specify why focal neurological event information was not available | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 09:36:32.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other | 255 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCFNESP | ||||||||||||||||||||||||||||
| C58759 | Human leukocyte antigen haploidentical first degree relative bone marrow donate willing able indicate code | HLAHplid1stDgRlBnMrDnWlAbInCod | Code indicating whether the subject/participant has a HLA (human leukocyte antigen)-haploidentical first-degree relative who is willing and able to done bone marrow. | Code indicating whether the subject/participant has a HLA (human leukocyte antigen)-haploidentical first-degree relative who is willing and able to done bone marrow. | Does the patient have a first-degree related HLA-haploidentical donor who is willing and able to donate bone marrow? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 12:57:46.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCHAPLO | |||||||||||||||||||||||||||
| C58724 | Echocardiograph tricuspid valve regurgitant jet velocity equal greater 2.7 meter second indicate code | EchcrdgphTRJVEqGr27MSecIndCod | Code indicating whether the subject/participant has an echocardiographic finding of tricuspid valve regurgitant jet velocity (TRJV) greater than or equal to 2.7 meters per second. | Code indicating whether the subject/participant has an echocardiographic finding of tricuspid valve regurgitant jet velocity (TRJV) greater than or equal to 2.7 meters per second. | Does the patient have an echocardiographic finding of tricuspid valve regurgitant jet velocity (TRJV) >= 2.7m/sec? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 10:39:20.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCTRJV | |||||||||||||||||||||||||||
| C58781 | Abstinence contraception 2 form agree practice indicate code | AbstncCntracep2FrmAgrPrxIndCod | Code indicating whether the subject/participant agrees to either practice 2 forms of contraception or true abstinence. | Code indicating whether the subject/participant agrees to either practice 2 forms of contraception or true abstinence. | Does the patient agree either (1) to practice 2 effective methods of contraception at the same time, or (2) to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject, from the time of signing of informed consent through 12 months post-transplant? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 10:42:52.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCCONTR | |||||||||||||||||||||||||||
| C57979 | Laboratory procedure aspartate aminotransferase value | LabProcedureASTVal | Value of aspartate aminotransferase (AST). | Value of aspartate aminotransferase (AST). | AST most recent value (units/L) | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-01-22 13:29:51.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
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| C58735 | Serum creatinine most recent measurement | SerCreatMostRcntMeasr | Measurement of the most recent serum creatinine evaluation. | Measurement of the most recent serum creatinine evaluation. | Serum creatinine most recent value (mg/dL) | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 11:59:14.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
0 | 9.99 | milligram per deciliter | BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCSC | ||||||||||||||||||||||||||
| C58746 | Alanine aminotransferase sample date | ALTSampleDate | Date on which the alanine aminotransferase (ALT) sample was collected. | Date on which the alanine aminotransferase (ALT) sample was collected. | Date ALT sample obtained | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 09:11:55.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCALTDT | |||||||||||||||||||||||||||||
| C58795 | Donor consent blood sample optional study specific research indicate code | DnCstBldSmpOptStySpfResIndCode | Code indicating whether the donor consented to provide blood samples for optional study-specific research. | Code indicating whether the donor consented to provide blood samples for optional study-specific research. | Did the donor give consent to provide blood samples for optional study-specific research? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 13:43:40.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCPSMPL |