Sub-Domain: Protocol Experience
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 |
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C58744 | Bilirubin direct measurement sample date | BlrbnDrctMeasrSamplDate | Date on which sample was taken for direct measurement of bilirubin. | Date on which sample was taken for direct measurement of bilirubin. | Date direct bilirubin sample obtained | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-07 13:22:08.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Study Management |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCBILDT | |||||||||||||||||||||||||||||
C58723 | Red blood cell transfusion therapy information not available specify text | RBCTrfsnThrpyInfoNotAvaiSpTxt | Text specifying why information about packed red blood cell (RBC) transfusion therapy was not available. | Text specifying why information about packed red blood cell (RBC) transfusion therapy was not available. | Specify why RBC transfusion therapy information was not available | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 10:36:51.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Study Management | 255 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | NSCRBCSP | ||||||||||||||||||||||||||||
C58758 | Liver free cirrhosis bridging fibrosis active hepatitis indicate code | LivFreCirBriFibActHepIndCode | Code indicating whether the subject/participant's liver is free from cirrhosis, bridging fibrosis, and active hepatitis. | Code indicating whether the subject/participant's liver is free from cirrhosis, bridging fibrosis, and active hepatitis. | Did the gastroenterology/hepatology consultation and histological examination document the absence of cirrhosis, bridging fibrosis, and active hepatitis? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 12:52:32.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Study Management |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCCIRRH | |||||||||||||||||||||||||||
C57978 | Laboratory procedure alanine aminotransferase value | LabProcedureALTVal | Value of alanine aminotransferase (ALT). | Value of alanine aminotransferase (ALT). | ALT most recent value (units/L) | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-01-22 13:29:51.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Study Management |
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 | Protocol Experience | Study Management |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCDLCDT | |||||||||||||||||||||||||||||
C58779 | Female childbearing potential indicate code | FemalChildbearPotentlIndCode | Code indicating whether the subject/participant is a female of childbearing potential. | Code indicating whether the subject/participant is a female of childbearing potential. | Is the patient a female of childbearing potential (FCBP) (all females > 10 years of age, unless post-menopausal for a minimum of 1 year before the time of consent or surgically sterilized)? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 10:39:18.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Study Management |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCFCBP | |||||||||||||||||||||||||||
C58794 | Patient consent blood sample optional study specific research date | PtCstBldSmplOptStySpfResDate | Date on which the subject/participant gave consent to provide blood samples for optional study-specific research. | Date on which the subject/participant gave consent to provide blood samples for optional study-specific research. | Date patient consented to optional study-specific research samples | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 13:46:09.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Study Management |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCPSMDT | |||||||||||||||||||||||||||||
C58713 | Focal neurological event information not available specify text | FoclNeurEvntInfoNotAvSpcfyTxt | Text field for specifying why information about a focal neurological event was not available. | Text field for specifying why information about a focal neurological event was not available. | Specify why focal neurological event information was not available | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 09:36:32.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Study Management | 255 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCFNESP | ||||||||||||||||||||||||||||
C58745 | Alanine aminotransferase institutional upper limit normal age value | ALTInstUpLimNormAgeVal | Value in units per liter of the institutional upper limit of normal for alanine aminotransferase (ALT) for the subject/participant's age. | Value in units per liter of the institutional upper limit of normal for alanine aminotransferase (ALT) for the subject/participant's age. | Institutional ULN of ALT for age | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 09:06:36.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Study Management |
Free-Form Entry |
0 | 999 | units per liter | BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCALULN | ||||||||||||||||||||||||||
C58724 | Echocardiograph tricuspid valve regurgitant jet velocity equal greater 2.7 meter second indicate code | EchcrdgphTRJVEqGr27MSecIndCod | Code indicating whether the subject/participant has an echocardiographic finding of tricuspid valve regurgitant jet velocity (TRJV) greater than or equal to 2.7 meters per second. | Code indicating whether the subject/participant has an echocardiographic finding of tricuspid valve regurgitant jet velocity (TRJV) greater than or equal to 2.7 meters per second. | Does the patient have an echocardiographic finding of tricuspid valve regurgitant jet velocity (TRJV) >= 2.7m/sec? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 10:39:20.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | 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 | |||||||||||||||||||||||||||
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 |
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 | Protocol Experience | Study Management |
Free-Form Entry |
0 | 9.99 | milligram per deciliter | BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCSC | ||||||||||||||||||||||||||
C58781 | Abstinence contraception 2 form agree practice indicate code | AbstncCntracep2FrmAgrPrxIndCod | Code indicating whether the subject/participant agrees to either practice 2 forms of contraception or true abstinence. | Code indicating whether the subject/participant agrees to either practice 2 forms of contraception or true abstinence. | Does the patient agree either (1) to practice 2 effective methods of contraception at the same time, or (2) to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject, from the time of signing of informed consent through 12 months post-transplant? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 10:42:52.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Study Management |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCCONTR | |||||||||||||||||||||||||||
C58795 | Donor consent blood sample optional study specific research indicate code | DnCstBldSmpOptStySpfResIndCode | Code indicating whether the donor consented to provide blood samples for optional study-specific research. | Code indicating whether the donor consented to provide blood samples for optional study-specific research. | Did the donor give consent to provide blood samples for optional study-specific research? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 13:43:40.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Study Management |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCPSMPL | |||||||||||||||||||||||||||
C58714 | History acute chest syndrome despite care two year before enrollment indicate code | HxACSDsptCr2YrBfrEnrIndCode | Code indicating whether the subject/participant has a history of acute chest syndrome (ACS) during the two years prior to enrollment, despite the institution of supportive care measures. | Code indicating whether the subject/participant has a history of acute chest syndrome (ACS) during the two years prior to enrollment, despite the institution of supportive care measures. | Does the patient have a history of two or more episodes of acute chest syndrome (ACS) in the two-year period preceding enrollment despite the institution of supportive care measures (i.e. asthma therapy and/or hydroxyurea)? | 1;2;3 | Yes;No;Unavailable | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 09:48:32.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | 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 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCALTDT | |||||||||||||||||||||||||||||
C58725 | Tricuspid valve regurgitant jet velocity echocardiograph measurement | TRJVEchcrdgrphMeasr | Measurement in meters per second of the subject/participant's tricuspid valve regurgitant jet velocity (TRJV) by echocardiograph. | Measurement in meters per second of the subject/participant's tricuspid valve regurgitant jet velocity (TRJV) by echocardiograph. | Record tricuspid valve regurgitant jet velocity (TRJV) | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 10:46:12.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Study Management |
Free-Form Entry |
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 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCHLADT | |||||||||||||||||||||||||||||
C58704 | Neurological event result focal deficit last over 24 hour indicate code | NrEvtRstFcDfctLstOv24HrIndCode | Code indicating whether the patient has experienced a neurological event resulting in focal neurological deficits that lasted at least 24 hours. | Code indicating whether the patient has experienced a neurological event resulting in focal neurological deficits that lasted at least 24 hours. | Has the patient experienced a neurological event resulting in focal neurologic deficits that lasted >= 24 hours? | 1;2;3 | Yes;No;Unavailable | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-11-21 09:46:30.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Study Management |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCNEURO | |||||||||||||||||||||||||||
C58736 | Serum creatinine institutional upper limit normal age value | SerCreatInstULNAgeVal | Value of the institutional upper limit of normal (ULN) for the subject/participant's age for serum creatinine | Value of the institutional upper limit of normal (ULN) for the subject/participant's age for serum creatinine | Institutional ULN of serum creatinine for age | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 12:04:28.0 | Haplo Sickle Cell Enrollment Form: Segment A | Protocol Experience | Study Management |
Free-Form Entry |
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 | |||||||||||||||||||||||||||
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 |
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 | Protocol Experience | Study Management |
Free-Form Entry |
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 |
Free-Form Entry |
0 | 999 | units per liter | BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCASULN | ||||||||||||||||||||||||||
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 | |||||||||||||||||||||||||||
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 |
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 | Protocol Experience | Study Management |
Free-Form Entry |
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 | |||||||||||||||||||||||||||
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 |
Free-Form Entry |
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 |