CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Additional Proposed Instruments
CRF: Haplo Sickle Cell Enrollment Form: Segment A
Sub-Domain: Additional Proposed Instruments
CRF: Haplo Sickle Cell Enrollment Form: Segment A
| CDE ID | CDE Name | Variable Name | Definition | Short Description | Additional Notes (Question Text) | Permissible Values | Description | Data Type | Disease Specific Instructions | Disease Specific Reference | Population | Classification (e.g., Core) | Version Number | Version Date | CRF Name (CRF Module / Guideline) | Sub Domain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | Source | Form Set | Form | Field | Domain | CDASH Variable | CDASH Definition | CDASH Label | Controlled Terminology | Prompt | Essentiality | Question Text | CDASH imp guidance | SDTM IG target | csDSR | PhenX | Data Type | CRF Completion Inst | SDTMIG Target Var | SDTMIG Target Map | Codelist Name | PVs | Pre Pop Value | Query Display | List Style |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C58744 | Bilirubin direct measurement sample date | BlrbnDrctMeasrSamplDate | Date on which sample was taken for direct measurement of bilirubin. | Date on which sample was taken for direct measurement of bilirubin. | Date direct bilirubin sample obtained | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-07 13:22:08.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCBILDT | |||||||||||||||||||||||||||||
| C58793 | Patient consent blood sample optional study specific research indicate code | PtCstBldSmpOptStySpfResIndCode | Code indicating whether the subject/participant consented to provide blood samples for optional study-specific research. | Code indicating whether the subject/participant consented to provide blood samples for optional study-specific research. | Did the patient give consent to provide blood samples for optional study-specific research? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 13:43:40.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCPSMPL | |||||||||||||||||||||||||||
| C58712 | Neurological event information not available specify text | NeurEvntInfoNotAvailSpcfyTxt | Text field for specifying why information about a neurological event was not available. | Text field for specifying why information about a neurological event was not available. | Specify why neurological event information was not available | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 09:36:32.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other | 255 |
Free-Form Entry |
BMTCTN | Release 5.10 | 1507A (ENR) | HSCNEUSP | ||||||||||||||||||||||||||||
| C58758 | Liver free cirrhosis bridging fibrosis active hepatitis indicate code | LivFreCirBriFibActHepIndCode | Code indicating whether the subject/participant's liver is free from cirrhosis, bridging fibrosis, and active hepatitis. | Code indicating whether the subject/participant's liver is free from cirrhosis, bridging fibrosis, and active hepatitis. | Did the gastroenterology/hepatology consultation and histological examination document the absence of cirrhosis, bridging fibrosis, and active hepatitis? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 12:52:32.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCCIRRH | |||||||||||||||||||||||||||
| C58723 | Red blood cell transfusion therapy information not available specify text | RBCTrfsnThrpyInfoNotAvaiSpTxt | Text specifying why information about packed red blood cell (RBC) transfusion therapy was not available. | Text specifying why information about packed red blood cell (RBC) transfusion therapy was not available. | Specify why RBC transfusion therapy information was not available | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 10:36:51.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other | 255 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | NSCRBCSP | ||||||||||||||||||||||||||||
| C58779 | Female childbearing potential indicate code | FemalChildbearPotentlIndCode | Code indicating whether the subject/participant is a female of childbearing potential. | Code indicating whether the subject/participant is a female of childbearing potential. | Is the patient a female of childbearing potential (FCBP) (all females > 10 years of age, unless post-menopausal for a minimum of 1 year before the time of consent or surgically sterilized)? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 10:39:18.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCFCBP | |||||||||||||||||||||||||||
| C57978 | Laboratory procedure alanine aminotransferase value | LabProcedureALTVal | Value of alanine aminotransferase (ALT). | Value of alanine aminotransferase (ALT). | ALT most recent value (units/L) | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-01-22 13:29:51.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
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| C58734 | Diffusion capacity lung carbon monoxide measurement date | DLCOMeasurementDate | Date on which the subject/participant's diffusion capacity of the lung for carbon monoxide (DLCO) was measured. | Date on which the subject/participant's diffusion capacity of the lung for carbon monoxide (DLCO) was measured. | Date DLCO value obtained | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 11:56:11.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCDLCDT | |||||||||||||||||||||||||||||
| C58745 | Alanine aminotransferase institutional upper limit normal age value | ALTInstUpLimNormAgeVal | Value in units per liter of the institutional upper limit of normal for alanine aminotransferase (ALT) for the subject/participant's age. | Value in units per liter of the institutional upper limit of normal for alanine aminotransferase (ALT) for the subject/participant's age. | Institutional ULN of ALT for age | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 09:06:36.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
0 | 999 | units per liter | BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCALULN | ||||||||||||||||||||||||||
| C58794 | Patient consent blood sample optional study specific research date | PtCstBldSmplOptStySpfResDate | Date on which the subject/participant gave consent to provide blood samples for optional study-specific research. | Date on which the subject/participant gave consent to provide blood samples for optional study-specific research. | Date patient consented to optional study-specific research samples | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 13:46:09.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCPSMDT | |||||||||||||||||||||||||||||
| C58713 | Focal neurological event information not available specify text | FoclNeurEvntInfoNotAvSpcfyTxt | Text field for specifying why information about a focal neurological event was not available. | Text field for specifying why information about a focal neurological event was not available. | Specify why focal neurological event information was not available | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 09:36:32.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other | 255 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCFNESP | ||||||||||||||||||||||||||||
| C58759 | Human leukocyte antigen haploidentical first degree relative bone marrow donate willing able indicate code | HLAHplid1stDgRlBnMrDnWlAbInCod | Code indicating whether the subject/participant has a HLA (human leukocyte antigen)-haploidentical first-degree relative who is willing and able to done bone marrow. | Code indicating whether the subject/participant has a HLA (human leukocyte antigen)-haploidentical first-degree relative who is willing and able to done bone marrow. | Does the patient have a first-degree related HLA-haploidentical donor who is willing and able to donate bone marrow? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 12:57:46.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCHAPLO | |||||||||||||||||||||||||||
| C58724 | Echocardiograph tricuspid valve regurgitant jet velocity equal greater 2.7 meter second indicate code | EchcrdgphTRJVEqGr27MSecIndCod | Code indicating whether the subject/participant has an echocardiographic finding of tricuspid valve regurgitant jet velocity (TRJV) greater than or equal to 2.7 meters per second. | Code indicating whether the subject/participant has an echocardiographic finding of tricuspid valve regurgitant jet velocity (TRJV) greater than or equal to 2.7 meters per second. | Does the patient have an echocardiographic finding of tricuspid valve regurgitant jet velocity (TRJV) >= 2.7m/sec? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 10:39:20.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCTRJV | |||||||||||||||||||||||||||
| C58781 | Abstinence contraception 2 form agree practice indicate code | AbstncCntracep2FrmAgrPrxIndCod | Code indicating whether the subject/participant agrees to either practice 2 forms of contraception or true abstinence. | Code indicating whether the subject/participant agrees to either practice 2 forms of contraception or true abstinence. | Does the patient agree either (1) to practice 2 effective methods of contraception at the same time, or (2) to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject, from the time of signing of informed consent through 12 months post-transplant? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 10:42:52.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCCONTR | |||||||||||||||||||||||||||
| C57979 | Laboratory procedure aspartate aminotransferase value | LabProcedureASTVal | Value of aspartate aminotransferase (AST). | Value of aspartate aminotransferase (AST). | AST most recent value (units/L) | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-01-22 13:29:51.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
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| C58735 | Serum creatinine most recent measurement | SerCreatMostRcntMeasr | Measurement of the most recent serum creatinine evaluation. | Measurement of the most recent serum creatinine evaluation. | Serum creatinine most recent value (mg/dL) | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 11:59:14.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
0 | 9.99 | milligram per deciliter | BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCSC | ||||||||||||||||||||||||||
| C58746 | Alanine aminotransferase sample date | ALTSampleDate | Date on which the alanine aminotransferase (ALT) sample was collected. | Date on which the alanine aminotransferase (ALT) sample was collected. | Date ALT sample obtained | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 09:11:55.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCALTDT | |||||||||||||||||||||||||||||
| C58795 | Donor consent blood sample optional study specific research indicate code | DnCstBldSmpOptStySpfResIndCode | Code indicating whether the donor consented to provide blood samples for optional study-specific research. | Code indicating whether the donor consented to provide blood samples for optional study-specific research. | Did the donor give consent to provide blood samples for optional study-specific research? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 13:43:40.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCPSMPL | |||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCACS | |||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCHLADT | |||||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
Free-Form Entry |
0 | 99.9 | Meter per second | BMTCTN | 1507A Release 5.10 | 1507A (ENR) | JSCTRJVA | ||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
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 | Additional Proposed Instruments | Other |
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 | Additional Proposed Instruments | Other |
Free-Form Entry |
0 | 9.99 | milligram per deciliter | BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCSCULN | ||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
Free-Form Entry |
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 | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCPSMDT | |||||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCAC1DT | |||||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCHLAMS | |||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCHG | |||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
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 | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCNIDT | |||||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCSCDT | |||||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCASTDT | |||||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other | 255 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCACSSP | ||||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCINFEC | |||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCSCTYP | |||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
Free-Form Entry |
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 | Additional Proposed Instruments | Other |
Free-Form Entry |
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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCNEUEV | |||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCBRBC | |||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCVOC | |||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
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 | Additional Proposed Instruments | Other |
Free-Form Entry |
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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCPSS | |||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
Free-Form Entry |
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 | Additional Proposed Instruments | Other |
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 | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCSTRDT | |||||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCLMRI | |||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSC2P1DT | |||||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCHCT |