CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Additional Proposed Instruments
CRF: Selected Debaun CDEs

Displaying 51 - 100 of 137
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
C00007 Birth date BirthDate Date (and time, if applicable and known) the participant/subject was born Date (and time, if applicable and known) the participant/subject was born Date or Date & Time Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

793 DeBaun Forms
C14462 Reflex plantar right response result RflxPlntrRtRespnsReslt The results from reflex plantar response on the right side The results from reflex plantar response on the right side Flexor;Extensor;Equivocal;Cannot Assess;Other, specify Flexor;Extensor;Equivocal;Cannot Assess;Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2012-10-05 00:00:00.0 Selected Debaun CDEs Additional Proposed Instruments Other

Multiple Pre-Defined Values Selected

DeBaun Forms
C02203 Off study reason OffStdyRsn Primary reason participant/ subject is no longer participating in study (i.e., is not being followed and will not receive intervention/treatment). Primary reason participant/ subject is no longer participating in study (i.e., is not being followed and will not receive intervention/treatment). Completed study;Refused further participation (or withdrew consent);Lost to follow-up (or cannot be located);Died;Completed study;Refused further participation (or withdrew consent);Lost to follow-up (or cannot be located);Died Completed study;Refused further participation (or withdrew consent);Lost to follow-up (or cannot be located);Died;Completed study;Refused further participation (or withdrew consent);Lost to follow-up (or cannot be located);Died Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

2979313 DeBaun Forms
C19779 Medical history asthma pulmonary assessment indicator MedHistAsthmaPulAssesInd Indicator of history of asthma Indicator of history of asthma No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2015-02-05 00:00:00.0 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C13233 National Institutes of Health Stroke Scale (NIHSS) - Level of consciousness secondary question score NIHSSLvlConscSecdryQScore Level of consciousness (LOC) questions assessed using the NIH Stroke Scale (NIHSS) Level of consciousness (LOC) questions assessed using the NIH Stroke Scale (NIHSS) 0;1;2;0;1;2;0;1;2 Answers both questions correctly;Answers one question correctly;Answers neither question correctly;Answers both questions correctly;Answers one question correctly;Answers neither question correctly;Answers both questions correctly;Answers one question correctly;Answers neither question correctly Numeric values Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C13457 Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003) - sensorimotor deficit type PSOMSNESensDefTyp The type of sensorimotor deficits observed in the participant/subject based on Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). The type of sensorimotor deficits observed in the participant/subject based on Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). Global developmental delay;Global hypotonia or hypertonia;Hemiparesis;Hemifacial weakness;Dysarthria;Hemitaxia;Other motor deficit;Hemisensory deficit;Other sensory deficit;Difficulty with vision;Difficulty with drinking, chewing, or swallowing;Other describe Global developmental delay;Global hypotonia or hypertonia;Hemiparesis;Hemifacial weakness;Dysarthria;Hemitaxia;Other motor deficit;Hemisensory deficit;Other sensory deficit;Difficulty with vision;Difficulty with drinking, chewing, or swallowing;Other describe Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Selected Debaun CDEs Additional Proposed Instruments Other

Multiple Pre-Defined Values Selected

DeBaun Forms
C01013 Physical exam description text PhysExamDescripTxt Free text field to describe the abnormality in a specific body system or an explanation of why the body system was not examined Free text field to describe the abnormality in a specific body system or an explanation of why the body system was not examined Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Selected Debaun CDEs Additional Proposed Instruments Other 255

Free-Form Entry

2201880 DeBaun Forms
C17495 Delay motor milestone indicator DelayMotorMilestoneInd Indicator as to whether the participant/subject has or had delayed motor milestones, as diagnosed by a pediatrician or neurologist Indicator as to whether the participant/subject has or had delayed motor milestones, as diagnosed by a pediatrician or neurologist Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C04804 Hospital discharge date and time HospitDischgDateTime Date (and time, if applicable and known) the participant/subject was discharged from the hospital Date (and time, if applicable and known) the participant/subject was discharged from the hospital Date or Date & Time Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

DeBaun Forms
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 Selected Debaun CDEs Additional Proposed Instruments Other

Multiple Pre-Defined Values Selected

DeBaun Forms
C01701 Lab specimen collection date and time LabSpecmnCollDateTime Date (and time if applicable and known) when the specimen was collected Date (and time if applicable and known) when the specimen was collected Date or Date & Time Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

2004004 DeBaun Forms LB LBDTC

Specimen Collection Date

Collection Date

What was the date of the lab specimen collection?

LBDTC Char Record the date when specimen collection was done using this format (DD-MON-YYYY). Prompt
C18492 Screening visit date and time ScreenVisitDateTime Date (and time, if applicable and known) the participant/subject was interviewed and screened for potential enrollment into the study Subject screened date and time Date or Date & Time Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

DeBaun Forms
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 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

0 24 DeBaun Forms
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 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

0 1800 month DeBaun Forms
C14463 Reflex plantar left response result RflxPlntrLftRespnsReslt The results from reflex plantar response on the left side The results from reflex plantar response on the left side Flexor;Extensor;Equivocal;Cannot Assess;Other, specify Flexor;Extensor;Equivocal;Cannot Assess;Other, specify Alphanumeric Adult;Pediatric Supplemental 1.00 2012-10-05 00:00:00.0 Selected Debaun CDEs Additional Proposed Instruments Other

Multiple Pre-Defined Values Selected

DeBaun Forms
C02209 Informed consent obtained indicator InfConsntObtInd Indicator of whether informed consent was obtained for the participant/subject to participate in the clinical research study. Indicator of whether informed consent was obtained for the participant/subject to participate in the clinical research study Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

2186028 DeBaun Forms
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 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
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 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C13458 Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003) - language deficit-production scale PSOMSNELangDefProdScale The scale for language deficit - production (including dysarthria) based on Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). The scale for language deficit - production (including dysarthria) 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 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C01041 Alteration consciousness indicator AOCInd The indicator of whether the participant/subject experienced any period of alteration of consciousness (AOC). The indicator of whether the participant/subject experienced any period of alteration of consciousness (AOC). Yes;No;Suspected;Unknown Yes;No;Suspected;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C17503 Hemoglobin electrophoresis type HemoglbnElectrophoresisType Type of hemoglobin that was identified by the electrophoresis test being reported Type of hemoglobin that was identified by the electrophoresis test being reported HbSS;HbSA;HBAA;HbFF;HbAF HbSS;HbSA;HBAA;HbFF;HbAF Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C04808 RETIRED Death cause ICD-9-CM code DeathCauseICD9CMCode REDIRECTED to C21665 – Death cause ICD-10-CM code ICD-9-CM code that describes the cause of participant/subject's death Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Selected Debaun CDEs Additional Proposed Instruments Other 255

Free-Form Entry

3178386 DeBaun Forms
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 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C01702 Pregnancy test date and time PregTestDateTime The date (and time if applicable and known) when the pregnancy test was performed The date (and time if applicable and known) when the pregnancy test was performed Date or Date & Time Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

DeBaun Forms
C18493 Screening visit eligibility status ScreenVisitEligibilityStatus The status determined from screening criteria that indicates whether a participant/subject may be eligible for a study. Screening visit eligibility status Eligible;Eligible but declined;Not eligible;Other, specify;Eligible;Eligible but declined;Not eligible;Other, specify Eligible;Eligible but declined;Not eligible;Other, specify;Eligible;Eligible but declined;Not eligible;Other, specify Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C13147 Stroke Specific Quality of Life Scale (SS-QOL) - trouble phone language scale SSQOLTroubPhonScale The scale for trouble speaking on phone based on Stroke Specific Quality of Life Scale (SS-QOL). The scale for trouble speaking on phone based on Stroke Specific Quality of Life Scale (SS-QOL). 1;2;3;4;5;1;2;3;4;5 Total help - Couldn't do it at all - Strongly agree;A lot of help - A lot of trouble - Moderately agree;Some help - Some trouble - Neither agree nor disagree;A little help - A little trouble - Moderately disagree;No help needed - No trouble at all - Strongly disagree;Total help - Couldn't do it at all - Strongly agree;A lot of help - A lot of trouble - Moderately agree;Some help - Some trouble - Neither agree nor disagree;A little help - A little trouble - Moderately disagree;No help needed - No trouble at all - Strongly disagree Numeric values Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C00023 Hand preference type HandPrefTyp Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusively. Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusively. Left hand;Right hand;Both hands;Unknown;Forced right Left hand;Right hand;Both hands;Unknown;Forced right Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

2180147 DeBaun Forms
C14559 EEG recording start date and time EEGRecordingStrtDateTime Date (and time, if applicable and known) the electroencephalogram (EEG) recording began Date the electroencephalogram (EEG) recording began Date or Date & Time Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

DeBaun Forms
C02212 Informed consent obtained date and time InformConsntObtnDateTime Date (and time, if applicable and known) on which the participant/subject (or the legal representative on behalf of the participant/subject) agrees to participate in a protocol, treatment, or other activity by signing an informed consent document. Date (and time, if applicable and known) on which the participant/subject (or the legal representative on behalf of the participant/subject) agrees to participate in a protocol, treatment, or other activity by signing an informed consent document. Date or Date & Time Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

2435038,656 DeBaun Forms
C19810 Medical history abdominal kidney problem indicator MedHistAbdmnlKdnyProbInd Indicator of history of kidney problem Indicator of history of kidney problem No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2015-02-05 00:00:00.0 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C13235 National Institutes of Health Stroke Scale (NIHSS) - Best gaze score NIHSSLvlConscBestGazeScore Best gaze assessed using the NIH Stroke Scale (NIHSS) Best gaze assessed using the NIH Stroke Scale (NIHSS) 0;1;2;0;1;2 Normal;Partial gaze palsy. This score is given when gaze is abnormal in one or both eyes, but where forced deviation or total gaze paresis are not present;Forced deviation, or total gaze paresis not overcome by the oculocephalic maneuver;Normal;Partial gaze palsy. This score is given when gaze is abnormal in one or both eyes, but where forced deviation or total gaze paresis are not present;Forced deviation, or total gaze paresis not overcome by the oculocephalic maneuver Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C13459 Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003) - language deficit-production description text PSOMSNELangDefProdDescTxt Description of the language production deficits observed in the participant/subject based on Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). Description of the language production deficits observed in the participant/subject based on Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Selected Debaun CDEs Additional Proposed Instruments Other 255

Free-Form Entry

DeBaun Forms
C01052 Loss of consciousness indicator LOCInd The indicator for whether the participant/subject experienced any period of loss of consciousness (LOC). The indicator for whether the participant/subject experienced any period of loss of consciousness (LOC). Yes;No;Suspected;Unknown Yes;No;Suspected;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C17523 Friedreich's Ataxia Rating Scale (FARS) - neurological exam peripheral deep tendon reflex ankle jerk left score FARSPNSNeuExDTenRAnkJLftScore Score for left-side ankle jerk in the peripheral nervous system section of the neurological exam, as part of the Friedreich's Ataxia Rating Scale (FARS). Score for left-side ankle jerk in the peripheral nervous system section of the neurological exam, as part of the Friedreich's Ataxia Rating Scale (FARS). 0;1;2;3;4;0;1;2;3;4;0;1;2;3;4 0 - absent;1 - hyporeflexia;2 - normal;3 - hyperreflexia;4 - pathologic hyperreflexia;0 - absent;1 - hyporeflexia;2 - normal;3 - hyperreflexia;4 - pathologic hyperreflexia;0 - absent;1 - hyporeflexia;2 - normal;3 - hyperreflexia;4 - pathologic hyperreflexia Numeric Values Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C05408 Hospital admission date and time HospitlAdmissDateTime Date (and time, if applicable and known) the participant/subject was admitted to the hospital Date (and time, if applicable and known) the participant/subject was admitted to the hospital Date or Date & Time Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

DeBaun Forms
C14021 Sickle cell disease velocity measurement SickleCellVelMeasr The velocity measurement of sickle cell. The velocity measurement of sickle cell. Numeric Values Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

0 999 centimeter per second DeBaun Forms
C01705 Lab test name LabTestName Name representing the lab test performed on body fluid(s) and tissues. Test names are typically comprised of the analyte name, properties (%, Ratio, etc.), the type of body fluid tested, and any special instructions. Name representing the lab test performed on body fluid(s) and tissues. Test names are typically comprised of the analyte name, properties (%, Ratio, etc.), the type of body fluid tested, and any special instructions. Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

2003746 DeBaun Forms LB LBTEST

Lab Test or Examination Name

Laboratory Test Name

What was the lab test name?

LBTEST; LBTESTCD Char Record the name of the Lab measurement or finding, if not preprinted on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended. (LBTEST)

[Select appropriate values from the LBTEST codelist]

Prompt Radio
C18666 Body system other text BodySysOTH The free-text field related to 'Body system category' specifying other text. Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured Free-text category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems. Alphanumeric Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Selected Debaun CDEs Additional Proposed Instruments Other 4000

Free-Form Entry

2002895 DeBaun Forms
C13192 Questionnaire for Verifying Stroke Free Status (QVSFS) - stroke status QVSFSStrokeStatus Were you ever told by a physician that you had a stroke? Were you ever told by a physician that you had a stroke? Questionnaire for Verifying Stroke Free Status (QVSFS) - numbness status No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C00035 Gender Type GenderTyp Self-reported gender of the participant/subject. Gender is the socially constructed identity of sex. Gender is equated with phenotypic sex. Gender may differ from the sex of an individual determined genetically. Self-reported gender of the participant/subject. Gender is the socially constructed identity of sex. Female;Male;Unknown;Unspecified;Not reported Female;Male;Unknown;Undifferentiated/Indeterminant/Intersex;Not reported Alphanumeric Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

2200604 DeBaun Forms
C16100 Symptoms new or worsening neurologic indicator SymptmNewWrseNeuroInd Indicates whether the participant/subject has new neurologic symptoms or an acute worsening of preexisting neurologic symptoms Indicates whether the participant/subject has new neurologic symptoms or an acute worsening of preexisting neurologic symptoms Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C02301 Adverse event end date and time AdverseEvntEndDateTime Date (and time, if applicable and known) on which the adverse event discontinued/stopped Date (and time, if applicable and known) on which the adverse event discontinued/stopped Date or Date & Time Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

2189843 DeBaun Forms
C19811 Medical history abdominal liver problem indicator MedHistAbdmnlLiverProbInd Indicator of history of liver problem Indicator of history of liver problem No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2015-02-05 00:00:00.0 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C13236 National Institutes of Health Stroke Scale (NIHSS) - Visual field score NIHSSLvlConscVisuFldScore Visual fields assessed using the NIH Stroke Scale (NIHSS) Visual fields assessed using the NIH Stroke Scale (NIHSS) 0;1;2;3;UN;0;1;2;3;UN No visual loss;Partial hemianopia;Complete hemianopia;Bilateral hemianopia (blind including cortical blindness);Unexaminable (intubated/paralyzed);No visual loss;Partial hemianopia;Complete hemianopia;Bilateral hemianopia (blind including cortical blindness);Unexaminable (intubated/paralyzed) Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C13460 Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003) - language deficit-comprehension scale PSOMSNELangDefCompScale The scale for language deficit - comprehension based on Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). The scale for language deficit - comprehension 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 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C01507 Blood pressure diastolic measurement BldPressrDiastlMeasr Measurement of pressure of the participant's/subject's blood against the artery walls during diastole (the relaxation phase) in millimeters of mercury (mmHg) Measurement of pressure of the participant's/subject's blood against the artery walls during diastole (the relaxation phase) in millimeters of mercury (mmHg) Numeric Values Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

0 300 millimeter of mercury 2004291 DeBaun Forms
C17524 Friedreich's Ataxia Rating Scale (FARS) - neurological exam peripheral deep tendon reflex ankle jerk right score FARSPNSNeuExDTenRAnkJRtScore Score for right-side ankle jerk in the peripheral nervous system section of the neurological exam, as part of the Friedreich's Ataxia Rating Scale (FARS). Score for right-side ankle jerk in the peripheral nervous system section of the neurological exam, as part of the Friedreich's Ataxia Rating Scale (FARS). 0;1;2;3;4;0;1;2;3;4;0;1;2;3;4 0 - absent;1 - hyporeflexia;2 - normal;3 - hyperreflexia;4 - pathologic hyperreflexia;0 - absent;1 - hyporeflexia;2 - normal;3 - hyperreflexia;4 - pathologic hyperreflexia;0 - absent;1 - hyporeflexia;2 - normal;3 - hyperreflexia;4 - pathologic hyperreflexia Numeric Values Adult;Pediatric Supplemental 3.00 2013-07-15 16:08:48.687 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C06421 SCI Classification light touch single side score SCIClssLghtTchSnglSdScore Score of sensation of light touch for the specific side of the body. Score of sensation of light touch for the specific side of the body. Numeric Values Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

DeBaun Forms
C14022 Sickle cell disease criterion result text SickleCellCriterResltTxt Indicates sickle cell criterion result Indicates sickle cell criterion result Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Selected Debaun CDEs Additional Proposed Instruments Other 255

Free-Form Entry

DeBaun Forms
C02004 Study drug dispensed date and time StdyDrugDispnsdDateTime Date (and time, if applicable and known) on which a participant/subject was given or applied a therapeutic agent (drug, intervention therapy) used in a clinical trial protocol Date (and time, if applicable and known) on which a participant/subject was given or applied a therapeutic agent (drug, intervention therapy) used in a clinical trial protocol Date or Date & Time Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

3163963 DeBaun Forms
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