CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Additional Proposed Instruments
CRF: Miscellaneous Sickle Cell-related CDEs

491 results.
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
C12496 Imaging cerebellum abnormal indicator ImgCrblmAbnrmlInd Indicator as to whether the cerebellum appears normal or abnormal in the image studies Indicator as to whether the cerebellum appears normal or abnormal in the image studies Abnormal;Normal;Abnormal;Normal Abnormal;Normal;Abnormal;Normal Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C13894 Imaging vessel angiography overall assessment type ImgVesselAngioOverallAssmTyp Indicates vessel angiography overall assessment Indicates vessel angiography overall assessment Normal;Small Caliber;Impaired flow Normal;Small Caliber;Impaired flow Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C17972 Medication prior concomitant dose frequency Clinical Data Interchange Standards Consortium Standard Data Tabulation Model code MedPriConDoseFreqCDISCSDTMCode Code that represents the frequency of the dosage of the prior or concomitant medication administered. Clinical Data Interchange Standards Consortium Standard Data Tabulation Model (CDISC SDTM) Code that represents the frequency of the dosage of the prior or concomitant medication administered. Clinical Data Interchange Standards Consortium Standard Data Tabulation Model (CDISC SDTM) Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-24 11:36:20.083 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other 255

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DeBaun Forms
C14029 Vasospasm posterior ratio result VasoPosterRatioReslt Indicates vasospasm posterior ratio result Indicates vasospasm posterior ratio result Numeric Values Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

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0 10
C02310 Adverse event CTCAE low level term name AdvrsEvntCTCAELowLvlTermName Text that represents the Common Terminology Criteria for Adverse Events (CTCAE) low level term name for an adverse event. Text that represents the Common Terminology Criteria for Adverse Events (CTCAE) low level term name for an adverse event. Alphanumeric Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other 255

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3125302 DeBaun Forms
C54688 PROMIS - Global Health quality of life scale PROMISGlbHlthQualOfLfScl Scale related to an individual's rating of his/her quality of life, as part of the PROMIS Global Health Scale related to an individual's rating of his/her quality of life, as part of the PROMIS Global Health 1;2;3;4;5;1;2;3;4;5 Poor;Fair;Good;Very Good;Excellent;Poor;Fair;Good;Very Good;Excellent Alphanumeric Adult;Pediatric Supplemental 1.00 2017-04-07 15:34:25.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C13244 National Institutes of Health Stroke Scale (NIHSS) - Extinction and inattention score NIHSSExtinctInattentScore Extinction and inattention assessed using the NIH Stroke Scale (NIHSS) Extinction and inattention assessed using the NIH Stroke Scale (NIHSS) 0;1;2;UN;0;1;2;UN No abnormality.;Visual, tactile, auditory, spatial, or personal inattention or extinction to bilateral simultaneous stimulation in one of the sensory modalities.;Profound hemi-inattention or extinction to more than one modality. Does not recognize own hand or orients to only one side of space.;Unexaminable (intubated/paralyzed;No abnormality.;Visual, tactile, auditory, spatial, or personal inattention or extinction to bilateral simultaneous stimulation in one of the sensory modalities.;Profound hemi-inattention or extinction to more than one modality. Does not recognize own hand or orients to only one side of space.;Unexaminable (intubated/paralyzed Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C13926 Intima media thickness (IMT) B mode indicator IMTBModeInd Indicates intima media thickness (IMT) B mode Indicates intima media thickness (IMT) B mode Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C18903 Vasomotor response (VMR) vessel anatomic other text VMRVesselAntmicOTH The free-text field related to 'Vasomotor response (VMR) vessel anatomic site' specifying other text. Indicates vasomotor response (VMR) vessel type The free-text field related to 'Vasomotor response (VMR) vessel anatomic site' specifying other text. Indicates vasomotor response (VMR) vessel type Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other 4000

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C15561 Imaging angiography contrast enhanced text ImgAngioContrastEnhancTxt If contrast enhanced in angiography, specify the method If contrast enhanced in angiography, specify the method Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other 255

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C10927 Imaging inversion time ImgInversionTime The time period between the 180° inversion pulse and the 90° excitation pulse in an Inversion Recovery pulse sequence. The time period between the 180° inversion pulse and the 90° excitation pulse in an Inversion Recovery pulse sequence. Numeric Values Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

millisecond
C19805 Medical history endocrine osteoporosis indicator MedHistEndcrnOstprsisInd Indicator of history of osteoporosis Indicator of history of osteoporosis No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2015-02-05 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C17432 EEG focal slowing indicator EEGFocalSlowingInd The yes/no indicator for electroencephalography (EEG) focal slowing. The yes/no indicator for Electroencephalography (EEG) focal slowing. Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C12475 Imaging magnetic resonance imaging T1 T2 sequence name ImgMRIT1T2SeqName The name of the T1 or T2 sequences used for Magnetic Resonance Imaging (MRI) The name of the T1 or T2 sequences used for MRI Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other 4000

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C56417 Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II) - Full Scale 2 T score sum value WASIIIFullScale2TScoreSumVal The sum of two of the subject's T scores (Vocabulary and Matrix Reasoning), as part of the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II). The sum of two of the subject's T scores (Vocabulary and Matrix Reasoning), as part of the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II). Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-12 11:40:41.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

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C14007 Imaging Transcranial Doppler (TCD) findings result type ImgTCDFindResltTyp Indicates Transcranial Doppler (TCD) findings Indicates Transcranial Doppler (TCD) findings Reversed Diastolic Flow;Systolic spike;No signals;Reduced upstroke/Pulsatility Index (PI) Reversed Diastolic Flow;Systolic spike;No signals;Reduced upstroke/Pulsatility Index (PI) Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Multiple Pre-Defined Values Selected

DeBaun Forms
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. Numeric Values Adult;Pediatric Supplemental 3.00 2013-07-22 16:57:17.79 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

0 100 percent DeBaun Forms
C21504 Wechsler Adult Intelligence Scale IV (WAIS IV) - Digit span sequencing subtest item score WAISIVDSSSubtestItemScore Item score, as part of Wechsler Adult Intelligence Scale IV (WAIS IV) Digit Span Sequencing subtest Item score, as part of Wechsler Adult Intelligence Scale IV (WAIS IV) Digit Span Sequencing subtest 0;1;2 0;1;2 Numeric Values Adult;Pediatric Supplemental 1.10 2018-07-30 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C13138 Hague Side Effects Scale (HASES) - chronic side effects sub scale HASESChronSESubscale Hague Side Effects Scale (HASES)- Chronic Side Effects Subscale (6-24) HASES Chronic Side Effects Subscale (6-24) Numeric Values Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

0 24 DeBaun Forms
C13905 Imaging contrast agent method type ImgContrastAgentMethodTyp Indicates imaging contrast agent method of administration Type of imaging contrast agent used for the scan. Bolus;Infusion;Other, specify;Bolus;Infusion;Other, specify Bolus;Infusion;Other, specify;Bolus;Infusion;Other, specify Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C18715 Imaging radio frequency coil other text ImgRFCoilOTH The free-text field related to 'Imaging radio frequency coil type' specifying other text. Type of radio frequency (RF) coil(s) used for the body part scanned The free-text field related to 'Imaging radio frequency coil type' specifying other text. Type of radio frequency (RF) coil(s) used for the body part scanned Alphanumeric Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other 4000

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C14052 Hemoglobin measurement HemoglobMeasr The measurement for hemoglobin. The measurement for hemoglobin. Numeric Values Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

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g/dL DeBaun Forms
C08088 Age value unit of measure AgeValUoM Unit of measure used to initially record the age value Unit of measure used to initially record the age value Days;Weeks;Months;Years;Days;Weeks;Months;Years Days;Weeks;Months;Years;Days;Weeks;Months;Years Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C55776 Imaging ictal headache since onset duration ImagIctHeadSinceOnsetDur The duration of time since the onset of the subject's headache if it was ictal. The duration of time since the onset of the subject's headache if it was ictal. Numeric Values Adult;Pediatric Supplemental 1.00 2017-05-31 12:21:21.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

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C13462 Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003) - cognitive or behavioral deficit scale PSOMSNECogBehavDefScale The scale for cognitive or behavioral deficit based on Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). The scale for cognitive or behavioral deficit based on Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). 0;0.5;1;2;0;0.5;1;2;0;0.5;1;2 None;Mild but no impact on function;Moderate with some impact on function;Severe or profound with missing function;None;Mild but no impact on function;Moderate with some impact on function;Severe or profound with missing function;None;Mild but no impact on function;Moderate with some impact on function;Severe or profound with missing function Numeric values Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C13937 Imaging mean lumen diameter measurement ImgMeanLumenDiameterMeasr Indicates mean lumen diameter measurement (mm) Indicates mean lumen diameter measurement (mm) Numeric Values Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

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millimeter
C13948 Imaging mean blood velocity measurement ImgMeanBloodVelocityMeasr Indicates mean velocity measurement (cm/sec) of blood Indicates mean velocity measurement (cm/sec) of blood Numeric Values Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

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0 999 centimeter per second
C00008 Age value AgeVal Value for participant/subject's age, calculated as elapsed time since the birth of the participant/subject. Value for participant/subject's age, calculated as elapsed time since the birth of the participant/subject. Numeric Values Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

0 1800 month DeBaun Forms
C21483 Wechsler Adult Intelligence Scale IV (WAIS IV) - Digit span forward subtest response text WAISIVDSFRespnsTxt Participant response, as part of Wechsler Adult Intelligence Scale IV (WAIS IV) Digit Span Forward subtest Participant response, as part of Wechsler Adult Intelligence Scale IV (WAIS IV) Digit Span Forward subtest Alphanumeric Adult;Pediatric Supplemental 1.00 2015-07-22 11:32:44.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other 50

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C12486 Imaging other cortical abnormality type ImgOthrCorticalAbnrmlyTyp The type of other cortical abnormality The type of other cortical abnormality Schizencephaly;Porencephaly;Other, specify Schizencephaly;Porencephaly;Other, specify Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Multiple Pre-Defined Values Selected

C13883 Computer tomography (CT) angiography type CTAngioTyp The type of computer tomography angiography being performed. The type of computer tomography angiography being performed. Head;Neck;Computer Tomography Venography (CTV) Head;Neck;Computer Tomography Venography (CTV) Alphanumeric Adult;Pediatric Supplemental 4.00 2017-04-11 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Multiple Pre-Defined Values Selected

C56428 Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II) - Verbal Comprehension confidence interval upper bound value WASIIIVerbCompConfIntrvlUppVal The upper bound of the subject's Verbal Comprehension confidence interval, as part of the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II). The upper bound of the subject's Verbal Comprehension confidence interval, as part of the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II). Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-12 12:55:22.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

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C14019 Sickle cell disease present indicator SickleCellPresInd Indicates presence of sickle cell Indicates presence of sickle cell Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C02016 Medication prior or concomitant start date and time MedctnPriorConcomStrtDateTime The date (and time, if applicable and known) on which the prior/concomitant medication usage began. The date (and time, if applicable and known) on which the prior/concomitant medication usage began. Date or Date & Time Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

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3162752 DeBaun Forms
C54606 Brief Test of Executive Function Second Edition (BRIEF 2) - Inhibit total raw scale score BRIEF2InhbtTtlRwSclScore Total score of the raw scale for the inhibit function, as part of the Brief Test of Executive Function Second Edition (BRIEF 2) Total score of the raw scale for the inhibit function, as part of the Brief Test of Executive Function Second Edition (BRIEF 2) Numeric Values Adult;Pediatric Supplemental 1.00 2017-03-22 09:57:02.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

C13234 National Institutes of Health Stroke Scale (NIHSS) - Level of consciousness tertiary question score NIHSSLvlConscTertryQScore Level of consciousness (LOC) commands assessed using the NIH Stroke Scale (NIHSS) Level of consciousness (LOC) commands assessed using the NIH Stroke Scale (NIHSS) 0;1;2;0;1;2;0;1;2 Performs both tasks correctly.;Performs one task correctly;Performs neither task correctly;Performs both tasks correctly.;Performs one task correctly;Performs neither task correctly;Performs both tasks correctly.;Performs one task correctly;Performs neither task correctly Numeric values Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C13916 Imaging color flow angle measurement ImgColorFlowAngleMeasr Indicates color flow angle (degrees) Indicates color flow angle (degrees) Numeric Values Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

0 360 degree of arc
C18858 Imaging pons abnormality other text ImgPonsAbnrmlyOTH The free-text field related to 'Imaging pons abnormality type' specifying other text. The type of abnormality in the pons on the image The free-text field related to 'Imaging pons abnormality type' specifying other text. The type of abnormality in the pons on the image Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other 4000

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C14680 Pediatric Migraine Disability Assessment (MIDAS) - headache decrease school function day count PedMIDASHeadDecSchFuncDayCt Count days functioning at less than half your ability in school in the last 3 months due to headaches, as part of migraine disability assessment (MIDAS) questionnaire-pediatric form. Count days functioning at less than half your ability in school in the last 3 months due to headaches, as part of migraine disability assessment (MIDAS) questionnaire-pediatric form. Numeric Values Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Free-Form Entry

0 92
C08254 Imaging visual analysis location performed type ImgVisAnlysisLocPerfTyp Location where visual analysis of the imaging data are performed Location where visual analysis of the imaging data are performed Central;Central read;Local - Site;Local read;Local report;Other, specify Central;Central read;Local - Site;Local read;Local report;Other, specify Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

C56384 Conners Continuous Performance Test 3rd Edition (CPT3) - Inattentiveness hit reaction time standard deviation value ConnersCPT3InaHRTStDevVal The standard deviation of the subject's response speed consistency, as part of the Conners Continuous Performance Test 3rd Edition (CPT3). The standard deviation of the subject's response speed consistency, as part of the Conners Continuous Performance Test 3rd Edition (CPT3). Numeric Values Adult;Pediatric Supplemental 1.00 2017-06-09 15:33:41.0 Miscellaneous Sickle Cell-related CDEs Additional Proposed Instruments Other

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491 results.
CSV