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
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 Study Management

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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 Study Management

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 Protocol Experience Study Management

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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 Study Management 255

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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 Study Management

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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 Protocol Experience Study Management

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

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 Study Management

Single Pre-Defined Value Selected

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

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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 Study Management

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 Protocol Experience Study Management

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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 Study Management

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 Study Management

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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 Protocol Experience Study Management

Single Pre-Defined Value Selected

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

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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 Study Management

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

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0 9.99 milligram per deciliter BMTCTN 1507A Release 5.10 1507A (ENR) HSCSCULN
C58783 Abstinence contraception barrier agree practice indicate code AbstncCntracepBarrAgrPrxIndCod Code indicating whether the subject/participant agrees to either practice barrier contraception or true abstinence. Code indicating whether the subject/participant agrees to either practice barrier contraception or true abstinence. Does the patient (even if surgically sterilized) agree to practice effective barrier contraception, or agree to practice true abstinence from the time of signing 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 Study Management

Single Pre-Defined Value Selected

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

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCNEURO
C58715 Acute chest syndrome episode date AcutChestSyndromEpisodDate Date of episode of acute chest syndrome (ACS). Date of episode of acute chest syndrome (ACS). Date of ACS episodes Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-06 09:53:11.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

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BMTCTN 1507A Release 5.10 1507A (ENR) HSCAC1DT
C58747 Aspartate aminotransferase institutional upper limit normal age value ASTInstUpLimNormAgeVal Value in units per liter of the institutional upper limit of normal for aspartate aminotransferase (AST) for the subject/participant's age. Value in units per liter of the institutional upper limit of normal for aspartate aminotransferase (AST) for the subject/participant's age. Institutional ULN of AST 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 Study Management

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0 999 units per liter BMTCTN 1507A Release 5.10 1507A (ENR) HSCASULN
C58796 Donor consent blood sample optional study specific research date DnCstBldSmplOptStySpfResDate Date on which the donor gave consent to provide blood samples for optional study-specific research. Date on which the donor gave consent to provide blood samples for optional study-specific research. Date donor 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 Study Management

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BMTCTN 1507A Release 5.10 1507A (ENR) HSCPSMDT
C58726 Hemoglobin SS beta thalassemia zero indicate code HbSSBetaThalZeroIndCode Code indicating whether the subject/participant has hemoglobin SS (HbSS) disease or hemoglobin sickle beta thalassemia (HbSBeta) zero disease. Code indicating whether the subject/participant has hemoglobin SS (HbSS) disease or hemoglobin sickle beta thalassemia (HbSBeta) zero disease. Does the patient have Hemoglobin SS disease (HbSS) or Hemoglobin S° (HbS°) Thalassemia? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-06 11:09:17.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCHG
C58766 Human leukocyte antigen sibling match bone marrow donate willing able indicate code HLAHplidSibMtchBnMrDnWlAbInCod Code indicating whether the subject/participant has a HLA (human leukocyte antigen)-matched sibling who is willing and able to done bone marrow. Code indicating whether the subject/participant has a HLA (human leukocyte antigen)-matched sibling who is willing and able to done bone marrow. Does the patient have an HLA-matched sibling who is able and willing 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 Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCHLAMS
C58737 Serum creatinine sample date SerumCreatinineSampleDate Date on which the serum creatinine sample was taken from the subject/participant. Date on which the serum creatinine sample was taken from the subject/participant. Date serum creatinine sample obtained Date or Date & Time Adult;Pediatric Proposed 1.00 2018-12-06 12:07:07.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

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BMTCTN 1507A Release 5.10 1507A (ENR) HSCSCDT
C58785 Human leukocyte antigen antibodies anti-donor specific indicate code HLAAntbdyAntDonrSpcfIndCode Code indicating whether the subject/participant exhibits anti-donor specific human leukocyte antigen (HLA) antibodies. Code indicating whether the subject/participant exhibits anti-donor specific human leukocyte antigen (HLA) antibodies. Is there a presence of anti-donor specific HLA antibodies? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-11 10:48:39.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCANTI
C58705 Neurological event result focal deficit last over 24 hour most recent date NeuEvRsFclDfLstOv24HrMsRctDate Date of the most recent neurological event resulting in focal neurologic deficits lasting at least 24 hours. Date of the most recent neurological event resulting in focal neurologic deficits lasting at least 24 hours. Date of most recent neurological event resulting in focal neurologic deficits lasting >= 24 hours Date or Date & Time Adult;Pediatric Proposed 1.00 2018-11-21 09:58:59.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

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BMTCTN 1507A Release 5.10 1507A (ENR) HSCNIDT
C58716 Acute chest syndrome information not available specify text AcutChestSyndromInfoNotAvSpTxt Text field for specifying whether information about acute chest syndrome (ACS) episodes experienced by the subject/participant was not available. Text field for specifying whether information about acute chest syndrome (ACS) episodes experienced by the subject/participant was not available. Specify why ACS information was not available Alphanumeric Adult;Pediatric Proposed 1.00 2018-12-06 09:55:54.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management 255

Free-Form Entry

BMTCTN 1507A Release 5.10 1507A (ENR) HSCACSSP
C58748 Aspartate aminotransferase sample date ASTSampleDate Date on which the aspartate aminotransferase (AST) sample was collected. Date on which the aspartate aminotransferase (AST) sample was collected. Date AST 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 Study Management

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BMTCTN 1507A Release 5.10 1507A (ENR) HSCASTDT
C58727 Sickle cell disease type code SickleCellDiseaseTypeCode Code for the type of sickle cell disease that the subject/participant has. Code for the type of sickle cell disease that the subject/participant has. Record the type of SCD 1;2 Hemoglobin SS disease (HbSS);Hemoglobin S beta zero (HbS beta zero) disease Numeric Values Adult;Pediatric Proposed 1.00 2018-12-06 11:14:08.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCSCTYP
C58770 Infection uncontrolled bacterial viral fungal 6 week prior enrollment indicate code InfUncBacVirFun6WkPriEnrIndCod Code indicating whether the subject/participant had an uncontrolled bacterial, viral, or fungal infection in the 6 weeks prior to his or her enrollment in the study. Code indicating whether the subject/participant had an uncontrolled bacterial, viral, or fungal infection in the 6 weeks prior to his or her enrollment in the study. Has the patient experienced an uncontrolled bacterial, viral, or fungal infection in the 6 weeks before enrollment (currently taking medication with evidence of progression of clinical symptoms or radiologic findings)? 1;2;1;2 Yes;No;Yes;No Numeric Values Adult;Pediatric Proposed 1.00 2018-12-10 16:05:10.0 Haplo Sickle Cell Enrollment Form: Segment A Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCINFEC
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
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
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
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
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

Free-Form Entry

0 100 percent DeBaun Forms
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
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
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
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
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

Free-Form Entry

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
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

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 Protocol Experience Study Management

Single Pre-Defined Value Selected

BMTCTN 1507A Release 5.10 1507A (ENR) HSCRECNE
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