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
C58787 Solid phase immunoassay determine HLA antibody presence specificity perform date SolPhImsDtHLAAbdyPrsSpfPfDate Date on which solid phase immunoassay was performed to determine HLA (human leukocyte antigen) presence and specificity. Date on which solid phase immunoassay was performed to determine HLA (human leukocyte antigen) presence and specificity. Date solid phase immunoassay performed to determine HLA antibody presence and specificity Date or Date & Time

HLA antibody presence and specificity will be determined by solid phase immunoassays. An anti-donor specific HLA antibody will be considered positive when the mean fluorescence intensity (MFI) is higher than the cut-off defined by each institution. Recommended cut-off values are MFI >1000 for donor specific antibody to HLA-A, -B, and DRB1 and MFI >2000 for HLA-C, DQB1 and DPB1.

Adult;Pediatric Proposed 1.00 2018-12-11 12:05:15.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

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BMTCTN 1507A Release 5.10 1507A (ENR) HSCIMMDT
C58706 Focal neurological event abnormal T2 FLAIR acute infarct indicate code FocNeuEvAbnT2FLRActIfctIndCode Code indicating whether the subject/participant has had a focal neurological event with abnormalities indicative of an acute infarct on T2-weighted or FLAIR images. Code indicating whether the subject/participant has had a focal neurological event with abnormalities indicative of an acute infarct on T2-weighted or FLAIR images. Has the patient experienced a focal neurological event resulting in abnormalities on T2-weighted or FLAIR images using an MRI scan, indicative of an acute infarct, with no other reasonable medical explanation? 1;2;3 Yes;No;Unavailable Numeric Values Adult;Pediatric Proposed 1.00 2018-11-21 10:11:57.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCNEUEV
C58738 Creatinine clearance most recent measurement CreatininClearMostRecntMeasr Measurement of creatinine clearance from the most recent sample taken from the subject/participant Measurement of creatinine clearance from the most recent sample taken from the subject/participant Creatinine clearance most recent value (mL/min/1.73m^2) Numeric Values Adult;Pediatric Proposed 1.00 2018-12-06 12:09:07.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

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0 999.99 milliliter per minute per 1.73 square meters BMTCTN 1507A Release 5.10 1507A (ENR) HSCCRCL
C58717 History pain crisis sickle related complication over two per year prior enrollment indicate code HxPnCrScReCoOv2PrYrPriEnrInCod Code indicating whether the subject/participant has a history of three or more vaso-occlusive pain crises per year prior to enrollment despite supportive care; or painful episodes related to priapism, osteonecrosis, or any sickle-related complication. Code indicating whether the subject/participant has a history of three or more vaso-occlusive pain crises per year prior to enrollment despite supportive care; or painful episodes related to priapism, osteonecrosis, or any sickle-related complication. Does the patient have a history of three or more severe vaso-occlusive pain crises per year in the two-year period preceding enrollment despite the institution of supportive care measures (i.e. a pain management plan and/or treatment with hydroxyurea); painful episodes related to priapism, osteonecrosis or any sickle-related complication? 1;2;3 Yes;No;Unavailable Numeric Values Adult;Pediatric Proposed 1.00 2018-12-06 10:06:28.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCVOC
C58750 Red blood cell transfusion 8 times year 20 times ever indicate code RBCTrsfn8xYr20xEvrIndCode Code indicating whether the subject/participant has received packed red blood cell (RBC) transfusions totalling either 8 or more times per year for at least one year, or at least 20 times over his or her lifetime. Code indicating whether the subject/participant has received packed red blood cell (RBC) transfusions totalling either 8 or more times per year for at least one year, or at least 20 times over his or her lifetime. Is the patient currently receiving >= 8 packed red blood cell transfusions per year for >= 1 year or has the patient received >= 20 packed red blood cell transfusions (lifetime cumulative)? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-10 12:29:15.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCBRBC
C01554 Oxygen saturation measurement O2SatMeasr Value, as a percent, of baseline O2 saturation (SPO2) in nocturnal oximetry, as part of Nocturnal Oximetry. Value, as a percent, of baseline O2 saturation (SPO2) in nocturnal oximetry, as part of Nocturnal Oximetry. Record patient's O2 saturation Numeric Values Adult;Pediatric Proposed 3.00 2013-07-22 16:57:17.79 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

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0 100 percent DeBaun Forms
C58728 Performance status scale code PerformanceStatusScaleCode Code for the scale used to evaluate the subject/participant's performance status. Code for the scale used to evaluate the subject/participant's performance status. Performance status scale used to evaluate patient (Lansky for patients < 16 years old; Karnofsky for patients >= 16) 2;1 Lansky;Karnofsky Numeric Values Adult;Pediatric Proposed 1.00 2018-12-06 11:18:08.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCPSS
C58771 HIV positive serology infection indicate code HIVPosSerolInfectIndCode Code indicating whether the subject/participant has evidence of either HIV (Human Immunodeficiency Virus) infection or HIV positive serology. Code indicating whether the subject/participant has evidence of either HIV (Human Immunodeficiency Virus) infection or HIV positive serology. Does the patient have evidence of human immunodeficiency virus (HIV) infection or known HIV positive serology? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-10 16:10:18.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCHIV
C58788 Mean fluorescence intensity donor specific antibody exceed limit indicate code MnFluoIntDonSpfAbdExcLtIndCode Code indicating whether the MFI (mean fluorescence intensity) for donor specific antibodies exceeds allowable limit. Code indicating whether the MFI (mean fluorescence intensity) for donor specific antibodies exceeds allowable limit. Was MFI >1000 for donor specific antibody to HLA-A, -B, DRB1 and/or MFI >2000 for HLA-C, DQB1 and DPB1? 1;3;2 Yes;No;Yes, approved by Protocol Char and/or Protocol Officer Numeric Values

HLA antibody presence and specificity will be determined by solid phase immunoassays. An anti-donor specific HLA antibody will be considered positive when the mean fluorescence intensity (MFI) is higher than the cut-off defined by each institution. Recommended cut-off values are MFI >1000 for donor specific antibody to HLA-A, -B, and DRB1 and MFI >2000 for HLA-C, DQB1 and DPB1.

Adult;Pediatric Proposed 1.00 2018-12-11 12:10:33.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCMFI
C58707 Focal neurological event abnormal T2 FLAIR acute infarct most recent date FocNeuevAbnT2FLRAcInMsRcDate Date of the subject/participant's most recent focal neurological event with abnormalities indicative of acute infarct on T2-weighted or FLAIR images. Date of the subject/participant's most recent focal neurological event with abnormalities indicative of acute infarct on T2-weighted or FLAIR images. Date of most recent focal neurological event resulting in abnormalities on T2-weighted or FLAIR images using an MRI scan Date or Date & Time Adult;Pediatric Proposed 1.00 2018-11-21 10:18:17.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

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BMTCTN 1507A Release 5.10 1507A (ENR) HSCSTRDT
C58739 Creatinine clearance sample date CreatininClearanceSampleDate Date on which the sample for creatinine clearance measurement was taken from the subject/participant. Date on which the sample for creatinine clearance measurement was taken from the subject/participant. Date creatinine clearance sample obtained Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-06 12:12:19.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

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BMTCTN 1507A Release 5.10 1507A (ENR) HSCCRDT
C58718 Pain crisis 2 year prior enrollment start date PnCris2YrPriorEnrolStartDate Start date of the severe vaso-occlusive pain crisis or painful episode related to priapism, osteonecrosis, or sickle-related complication two years prior to enrollment. Start date of the severe vaso-occlusive pain crisis or painful episode related to priapism, osteonecrosis, or sickle-related complication two years prior to enrollment. Start date of severe pain crisis 2 years 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 Protocol Experience Study Management

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BMTCTN 1507A Release 5.10 1507A (ENR) HSC2P1DT
C58751 Liver MRI hepatic iron content valid methodology indicate code LivrMRIHepatcIrnCntntIndCode Code indicating whether a liver MRI (magnetic resonance imaging) was performed using a validated methodology for estimation of hepatic iron content. Code indicating whether a liver MRI (magnetic resonance imaging) was performed using a validated methodology for estimation of hepatic iron content. Was a liver MRI performed using a validated methodology per institutional preference (T2* or R2* or by ferriscan [R2 MRI]) for estimation of hepatic iron content? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-10 12:35:20.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCLMRI
C10179 Diffusion Capacity Corrected measurement DiffusionCapacityCorrectdMeasr Diffusion Capacity Corrected (DLCO CORR) = A correction for predicted value is made using patients Hemoglobin Diffusion Capacity Corrected (DLCO CORR) = A correction for predicted value is made using patients Hemoglobin Record patient's DLCO value (corrected for hemoglobin) Numeric Values Adult;Pediatric Proposed 3.00 2013-07-22 09:34:41.527 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

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C58729 Performance status result code PerformanceStatusResultCode Code for the result of the subject/participant's performance status using the Karnofsky or Lansky performance status scale. Code for the result of the subject/participant's performance status using the Karnofsky or Lansky performance status scale. Record patient's performance status 02;03;04;05;06;07;08;09;10;01 90 (Normal Activity/Minor Restriction in Strenuous Play);80 (Normal Activity with Effort/Restricted in Strenuous Play);70 (Unable to Carry On Normal Activity/Less Time Spent in Play);60 (Requires Occasional Assistance/Minimal Active Play);50 (Requires Considerable Assistance/No Active Play);40 (Disabled/Able to Initiate Quiet Activities);30 (Severely Disabled/Needs Assistance for Quiet Play);20 (Very Sick/Limited to Very Passive Activity);10 (Moribund, Completely Disabled);100 (Normal, No Complaints/Fully Active) Numeric Values Adult;Pediatric Proposed 1.00 2018-12-06 11:24:22.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCPSR
C58772 Hematopoietic stem cell transplant previous indicate code HTCPrevIndCode Code indicating whether the subject/participant has received a previous hematopoietic stem cell transplant (HCT). Code indicating whether the subject/participant has received a previous hematopoietic stem cell transplant (HCT). Has the patient received a previous hematopoietic stem cell transplant (HCT)? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-10 16:13:44.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCHCT
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 Protocol Experience Study Management

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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 Protocol Experience Study Management

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 Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCHYPER
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 Protocol Experience Study Management

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BMTCTN 1507A Release 5.10 1507A (ENR) HSC1P1DT
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 Protocol Experience Study Management

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BMTCTN 1507A Release 5.10 1507A (ENR) HSCLMRDT
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 Study Management

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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 Study Management

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 Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCORTXP
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 Study Management

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 Protocol Experience Study Management

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 Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCHYPHE
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 Study Management 255

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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 Study Management

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 Study Management

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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 Study Management

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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 Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCCLTR
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 Study Management

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 Protocol Experience Study Management

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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 Study Management

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0 9.9 milligram per deciliter BMTCTN 1507A Release 5.10 1507A (ENR) HSCBILI
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 Study Management

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 Study Management

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 Study Management

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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 Study Management

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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 Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCPREG
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 Study Management

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 Protocol Experience Study Management

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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 Study Management

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0 9.9 milligram per deciliter BMTCTN 1507A Release 5.10 1507A (ENR) HSCBILIU
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 Study Management

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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 Study Management

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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 Study Management 4000

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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 Study Management

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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 Study Management

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 Study Management

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 Study Management 255

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BMTCTN Release 5.10 1507A (ENR) HSCNEUSP
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