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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||
| 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 | Additional Proposed Instruments | Other |
Free-Form Entry |
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| C58729 | Performance status result code | PerformanceStatusResultCode | Code for the result of the subject/participant's performance status using the Karnofsky or Lansky performance status scale. | Code for the result of the subject/participant's performance status using the Karnofsky or Lansky performance status scale. | Record patient's performance status | 02;03;04;05;06;07;08;09;10;01 | 90 (Normal Activity/Minor Restriction in Strenuous Play);80 (Normal Activity with Effort/Restricted in Strenuous Play);70 (Unable to Carry On Normal Activity/Less Time Spent in Play);60 (Requires Occasional Assistance/Minimal Active Play);50 (Requires Considerable Assistance/No Active Play);40 (Disabled/Able to Initiate Quiet Activities);30 (Severely Disabled/Needs Assistance for Quiet Play);20 (Very Sick/Limited to Very Passive Activity);10 (Moribund, Completely Disabled);100 (Normal, No Complaints/Fully Active) | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 11:24:22.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCHCT | |||||||||||||||||||||||||||
| C58789 | Protocol chair officer approve date | ProtocolChairOfficerAproveDate | Date on which the Protocol Chair and/or Protocol Officer approved a variance from study protocol. | Date on which the Protocol Chair and/or Protocol Officer approved a variance from study protocol. | Date of Protocol Chair and/or Protocol Officer approval | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 12:15:49.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
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 | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCRECNE | |||||||||||||||||||||||||||
| C58740 | Hyperbilirubinemia indicate code | HyperbilirubinemiaIndCode | Code indicating whether the subject/participant has hyperbilirubinemia | Code indicating whether the subject/participant has hyperbilirubinemia | Does the patient have hyperbilirubinemia? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 12:14:07.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCHYPER | |||||||||||||||||||||||||||
| C58719 | Pain crisis 1 year prior enrollment start date | PnCris1YrPriorEnrolStartDate | Start date of the severe vaso-occlusive pain crisis or painful episode related to priapism, osteonecrosis, or sickle-related complication one year prior to enrollment. | Start date of the severe vaso-occlusive pain crisis or painful episode related to priapism, osteonecrosis, or sickle-related complication one year prior to enrollment. | Start date of severe pain crisis 1 year prior to enrollment | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 10:12:39.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSC1P1DT | |||||||||||||||||||||||||||||
| C58752 | Liver MRI date | LiverMRIDate | Date on which liver MRI (magnetic resonance imaging) was performed. | Date on which liver MRI (magnetic resonance imaging) was performed. | Record date of liver MRI | Date or Date & Time | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 12:42:35.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCLMRDT | |||||||||||||||||||||||||||||
| C10724 | Echocardiogram performed date and time | EchcrdgrmPerfrmDateTime | Date (and time, if applicable and known) the echocardiography was performed | Date (and time, if applicable and known) the echocardiography was performed | Date echocardiograph was performed | Date or Date & Time | Adult;Pediatric | Proposed | 3.00 | 2013-07-25 08:54:08.2 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
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| C58730 | Cardiac fraction test type code | CardiacFractionTestTypeCode | Code for the type of cardiac fraction test performed. | Code for the type of cardiac fraction test performed. | Record the type of cardiac fraction test performed | 1;2 | Left Ventricular Ejection Fraction (LVEF);Shortening Fraction | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 11:37:18.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCCFT | |||||||||||||||||||||||||||
| C58775 | Transplant solid organ ever receive indicate code | TrpltSldOrgnEverRcvIndCode | Code indicating whether the subject/participant has ever received a solid organ transplant. | Code indicating whether the subject/participant has ever received a solid organ transplant. | Has the patient received a prior solid organ transplant? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 09:45:45.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCORTXP | |||||||||||||||||||||||||||
| C58790 | Donor bone marrow willing indicate code | DonrBoneMarwWillIndCode | Code indicating whether the donor is willing to donate bone marrow. | Code indicating whether the donor is willing to donate bone marrow. | Is the donor willing to donate bone marrow? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-11 13:00:20.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCDWILL | |||||||||||||||||||||||||||
| C58709 | Defer 6 month due clinical radiologic evidence cerebral infarct 30 day prior enrollment indicate code | Df6MoDuClRaEvCeIn30DyPrEnInCod | Code indicating whether the subject/participant's enrollment was deferred for at least 6 months due to clinical or radiological evidence of a recent cerebral infarct by cerebral MRI/MRA within 30 days prior to enrollment. | Code indicating whether the subject/participant's enrollment was deferred for at least 6 months due to clinical or radiological evidence of a recent cerebral infarct by cerebral MRI/MRA within 30 days prior to enrollment. | Was the patient previously deferred for >= 6 months due to clinical or radiologic evidence of a recent cerebral infarct by cerebral MRI/MRA within 30 days prior to enrollment? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-11-21 12:35:08.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCDEFER | |||||||||||||||||||||||||||
| C58741 | Hyperbilirubinemia reason hyperhemolysis post transfusion hemoglobin drop indicate code | HypbilrRsnHyphemPoTrHbDpIndCod | Code indicating whether the subject/participant's hyperbilirubinemia is a result of hyperhemolysis or of a severe drop in hemoglobin following blood transfusion. | Code indicating whether the subject/participant's hyperbilirubinemia is a result of hyperhemolysis or of a severe drop in hemoglobin following blood transfusion. | Is the patient's hyperbilirubinemia a result of hyperhemolysis or a severe drop in hemoglobin post blood transfusion? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 12:16:18.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCHYPHE | |||||||||||||||||||||||||||
| C58720 | Pain crisis information not available specify text | PnCrisInfoNotAvailSpecifyTxt | Text field for specifying why information about the severe vaso-occlusive pain crisis or painful episode related to priapism, osteonecrosis, or sickle-related complication was not available. | Text field for specifying why information about the severe vaso-occlusive pain crisis or painful episode related to priapism, osteonecrosis, or sickle-related complication was not available. | Specify why pain crises information was not available | Alphanumeric | Adult;Pediatric | Proposed | 1.00 | 2018-12-06 10:18:08.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other | 255 |
Free-Form Entry |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCPCSP | ||||||||||||||||||||||||||||
| C58753 | Iron overload significant clinical evidence indicate code | IronOverloadSigClinEvdncIndCod | Code indicating whether the subject/participant has significant clinical evidence of iron overload. | Code indicating whether the subject/participant has significant clinical evidence of iron overload. | Does the patient have significant clinical evidence of iron overload (estimated hepatic iron content >= 10mg Fe/g liver dry weight)? | 1;2;1;2 | Yes;No;Yes;No | Numeric Values | Adult;Pediatric | Proposed | 1.00 | 2018-12-10 12:44:53.0 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
BMTCTN | 1507A Release 5.10 | 1507A (ENR) | HSCFEOV | |||||||||||||||||||||||||||
| C10740 | Echocardiogram left ventricle ejection fraction measurement | EchcrdLftVentEjctnFractnMeasr | Fraction of blood pumped out of the left ventricles with each heart beat measured with echocardiography | Fraction of blood pumped out of the left ventricles with each heart beat measured with echocardiography | Left ventricular ejection fraction | Numeric Values | Adult;Pediatric | Proposed | 3.00 | 2013-07-24 11:38:01.2 | Haplo Sickle Cell Enrollment Form: Segment A | Additional Proposed Instruments | Other |
Free-Form Entry |
percent |