CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Protocol Experience
CRF: Haplo Sickle Cell Enrollment Form: Segment A

Displaying 1 - 50 of 84
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
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

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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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCCFT
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCORTXP
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCHYPHE
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCDWILL
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment 255

Free-Form Entry

BMTCTN 1507A Release 5.10 1507A (ENR) HSCPCSP
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCFEOV
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Free-Form Entry

BMTCTN 1507A Release 5.10 1507A (ENR) HSCLVEDT
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCCLTR
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Free-Form Entry

BMTCTN 1507A Release 5.10 1507A (ENR) HSCMRIDT
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

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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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCDCRIT
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCRBC
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCLIVBX
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Free-Form Entry

BMTCTN 1507A Release 5.10 1507A (ENR) HSCSFDT
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCPREG
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Free-Form Entry

BMTCTN 1507A Release 5.10 1507A (ENR) HSCRMRDT
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

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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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCHEM
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Free-Form Entry

BMTCTN 1507A Release 5.10 1507A (ENR) HSCR1DT
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Free-Form Entry

BMTCTN 1507A Release 5.10 1507A (ENR) HSCLBXDT
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment 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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Free-Form Entry

BMTCTN 1507A Release 5.10 1507A (ENR) HSCO2DT
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCAIMM
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment 255

Free-Form Entry

BMTCTN Release 5.10 1507A (ENR) HSCNEUSP
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Free-Form Entry

BMTCTN 1507A Release 5.10 1507A (ENR) HSCBILDT
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment 255

Free-Form Entry

BMTCTN 1507A Release 5.10 1507A (ENR) NSCRBCSP
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCCIRRH
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

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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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Free-Form Entry

BMTCTN 1507A Release 5.10 1507A (ENR) HSCDLCDT
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCFCBP
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment 255

Free-Form Entry

BMTCTN 1507A Release 5.10 1507A (ENR) HSCFNESP
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Free-Form Entry

0 999 units per liter BMTCTN 1507A Release 5.10 1507A (ENR) HSCALULN
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCTRJV
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCHAPLO
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Free-Form Entry

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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Free-Form Entry

0 9.99 milligram per deciliter BMTCTN 1507A Release 5.10 1507A (ENR) HSCSC
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCCONTR
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCPSMPL
C58714 History acute chest syndrome despite care two year before enrollment indicate code HxACSDsptCr2YrBfrEnrIndCode Code indicating whether the subject/participant has a history of acute chest syndrome (ACS) during the two years prior to enrollment, despite the institution of supportive care measures. Code indicating whether the subject/participant has a history of acute chest syndrome (ACS) during the two years prior to enrollment, despite the institution of supportive care measures. Does the patient have a history of two or more episodes of acute chest syndrome (ACS) in the two-year period preceding enrollment despite the institution of supportive care measures (i.e. asthma therapy and/or hydroxyurea)? 1;2;3 Yes;No;Unavailable Numeric Values Adult;Pediatric Proposed 1.00 2018-12-06 09:48:32.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCACS
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 Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

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BMTCTN 1507A Release 5.10 1507A (ENR) HSCALTDT
C58725 Tricuspid valve regurgitant jet velocity echocardiograph measurement TRJVEchcrdgrphMeasr Measurement in meters per second of the subject/participant's tricuspid valve regurgitant jet velocity (TRJV) by echocardiograph. Measurement in meters per second of the subject/participant's tricuspid valve regurgitant jet velocity (TRJV) by echocardiograph. Record tricuspid valve regurgitant jet velocity (TRJV) Numeric Values Adult;Pediatric Proposed 1.00 2018-12-06 10:46:12.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

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0 99.9 Meter per second BMTCTN 1507A Release 5.10 1507A (ENR) JSCTRJVA
C58762 Human leukocyte antigen typing donor confirmatory date HLATypConfirmatoryDate Date on which confirmatory typing of the donor's human leukocyte antigen (HLA) status was performed. Date on which confirmatory typing of the donor's human leukocyte antigen (HLA) status was performed. Date confirmatory typing completed Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-10 13:03:39.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

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BMTCTN 1507A Release 5.10 1507A (ENR) HSCHLADT
C58704 Neurological event result focal deficit last over 24 hour indicate code NrEvtRstFcDfctLstOv24HrIndCode Code indicating whether the patient has experienced a neurological event resulting in focal neurological deficits that lasted at least 24 hours. Code indicating whether the patient has experienced a neurological event resulting in focal neurological deficits that lasted at least 24 hours. Has the patient experienced a neurological event resulting in focal neurologic deficits that lasted >= 24 hours? 1;2;3 Yes;No;Unavailable Numeric Values Adult;Pediatric Proposed 1.00 2018-11-21 09:46:30.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCNEURO
C58736 Serum creatinine institutional upper limit normal age value SerCreatInstULNAgeVal Value of the institutional upper limit of normal (ULN) for the subject/participant's age for serum creatinine Value of the institutional upper limit of normal (ULN) for the subject/participant's age for serum creatinine Institutional ULN of serum creatinine for age Numeric Values Adult;Pediatric Proposed 1.00 2018-12-06 12:04:28.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Participant/Subject Identification, Eligibility, and Enrollment

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0 9.99 milligram per deciliter BMTCTN 1507A Release 5.10 1507A (ENR) HSCSCULN
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