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

Displaying 1 - 50 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
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

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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
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
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
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
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
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
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
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
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
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
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
C18805 Hospitalization other text HospitOTH The free-text field related to 'Hospitalization reason' specifying other text. Reason why the participant/subject was hospitalized, excluding all surgeries The free-text field related to 'Hospitalization reason' specifying other text. Reason why the participant/subject was hospitalized, excluding all surgeries Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Selected Debaun CDEs Additional Proposed Instruments Other 4000

Free-Form Entry

DeBaun Forms
C13194 Questionnaire for Verifying Stroke Free Status (QVSFS) - painless weakness status QVSFSPainlsWeaknsStatus Have you ever had sudden painless weakness on one side of your body? Have you ever had sudden painless weakness on one side of your body? Questionnaire for Verifying Stroke Free Status (QVSFS) 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
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
C16187 Vaccine type VaccTyp Vaccination received by pediatric patient Vaccination received by pediatric patient Routine: measles, mumps, rubella;Routine: tetanus, pertussis, diptheria, polio;Hepatitis B;Hemophilus Influenza Type B;Chicken pox vaccine Routine: measles, mumps, rubella;Routine: tetanus, pertussis, diptheria, polio;Hepatitis B;Hemophilus Influenza Type B;Chicken pox vaccine 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
C02306 Adverse event start date and time AdvrsEvntStartDateTime Date (and time, if applicable and known) on which the adverse event was first evident Date (and time, if applicable and known) on which the adverse event was first evident 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

2744993 DeBaun Forms
C19840 Medical history medication change since last visit indicator MedHistMedctnChngeSLVInd Indicator of medication changes since last study visit Indicator of medication changes since last study visit No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2015-02-06 00:00:00.0 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C13238 National Institutes of Health Stroke Scale (NIHSS) - Motor arm score NIHSSLvlConscMotArmScore Motor ability of the arm (both left and right) assessed using the NIH Stroke Scale (NIHSS) Motor ability of the arm (both left and right) assessed using the NIH Stroke Scale (NIHSS) 0;1;2;3;4;UN;0;1;2;3;4;UN No drift: limb holds 90 (or 45) degrees for full 10 seconds;Drift: limb holds 90 (or 45) degrees, but drifts down before full 10 seconds, does not hit bed or other support;Some effort against gravity: limb cannot get to or maintain (if cued) 90 (or 45) degrees, drifts down to bed, but has some effort against gravity.;No effort against gravity: limb falls;No movement;Amputation or joint fusion, explain;No drift: limb holds 90 (or 45) degrees for full 10 seconds;Drift: limb holds 90 (or 45) degrees, but drifts down before full 10 seconds, does not hit bed or other support;Some effort against gravity: limb cannot get to or maintain (if cued) 90 (or 45) degrees, drifts down to bed, but has some effort against gravity.;No effort against gravity: limb falls;No movement;Amputation or joint fusion, explain 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
C00312 Body system category BodySysCat 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. 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. Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;Other, specify:;Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;Other, specify: Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;Other, specify:;Allergic/Immunologic;Cardiovascular;Constitutional symptoms (e.g., fever, weight loss);Dermatological;Ears, Nose, Mouth, Throat;Endocrine;Eyes;Gastrointestinal;Gastrointestinal/Abdominal;Genitourinary;Gynecologic/Urologic/ Renal;Hematologic/Lymphatic;Hepatobiliary;Integumentary (skin and/or breast);Musculoskeletal;Musculoskeletal (separate from ALS exam);Neurological;Neurologic/CNS;Neurological (separate from ALS exam);Oncologic;Psychiatric;Pulmonary;Respiratory;Other, specify: 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

2002895 DeBaun Forms
C01521 Heart rate HeartRate The participant/subject's pulse or number of contractions (heart beats) per minute The participant/subject's pulse or number of contractions (heart beats) per minute Numeric Values Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

0 300 beats per minute 2767073 DeBaun Forms
C17525 Friedreich's Ataxia Rating Scale (FARS) - neurological exam peripheral deep tendon reflex biceps jerk left score FARSPNSNeuExDTenRefBicJLftScr Score for left-side biceps 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 biceps 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
C08147 Data source DataSource Source of the data provided on the case report form Source of the data provided on the case report form Participant/subject;Mother;Father;Sister;Brother;Son;Daughter;Family, specify relation;Friend;Physician;Chart/Medical record;Other, specify;Unknown;Spouse Participant/subject;Mother;Father;Sister;Brother;Son;Daughter;Family, specify relation;Friend;Physician;Chart/Medical record;Other, specify;Unknown;Spouse Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-20 10:46:24.96 Selected Debaun CDEs Additional Proposed Instruments Other

Multiple Pre-Defined Values Selected

DeBaun Forms
C13461 Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003) - language deficit-comprehension description text PSOMSNELangDefCompDescTxt Description of the language comprehension deficits observed in the participant/subject based on Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). Description of the language comprehension 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
C02005 Study drug returned date and time StdyDrugRetrnDateTime Date (and time, if applicable and known) on which the study drug was returned Date (and time, if applicable and known) on which the study drug was returned 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

3164209 DeBaun Forms
C18942 Cerebellar or coordination assessment abnormality present other text CerbllCoordAssmtAbnrmlyPrsOTH The free-text field related to 'Cerebellar or coordination assessment abnormality present status' specifying other text. Whether the cerebellar/coordination assessment found abnormalities The free-text field related to 'Cerebellar or coordination assessment abnormality present status' specifying other text. Whether the cerebellar/coordination assessment found abnormalities Alphanumeric Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Selected Debaun CDEs Additional Proposed Instruments Other 4000

Free-Form Entry

DeBaun Forms
C13195 Questionnaire for Verifying Stroke Free Status (QVSFS) - numbness status QVSFSNumbStatus Have you ever had sudden numbness or a dead feeling on one side of your body? Have you ever had sudden numbness or a dead feeling on one side of your body? Questionnaire for Verifying Stroke Free Status (QVSFS) 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
C14023 Sickle cell disease diagnosis result SickleCellDiagnosReslt Indicates sickle cell diagnosis result Indicates sickle cell diagnosis result Abnormal;Normal;Conditional;Abnormal;Normal;Conditional Abnormal;Normal;Conditional;Abnormal;Normal;Conditional 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
C16188 Vaccine received indicator VaccRcvdInd Indicates whether participant/subject received the vaccine Indicates whether participant/subject received the vaccine Yes;No;Unknown;Not Asked Yes;No;Unknown;Not Asked 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
C02307 Adverse event verbatim term text AdvrsEvntVerbatimTermText Text that describes the adverse event word for word as described by the participant/subject Adverse event verbatim term text Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-18 16:35:19.49 Selected Debaun CDEs Additional Proposed Instruments Other 4000

Free-Form Entry

2188132 DeBaun Forms
C19904 Symptom disease lab data known disease other text SymptSignDisLabDataOTH Text of other symptoms, signs, known diseases, and lab data Text of other symptoms, signs, known diseases, and lab data Alphanumeric Adult;Pediatric Supplemental 1.00 2015-02-09 00:00:00.0 Selected Debaun CDEs Additional Proposed Instruments Other 4000

Free-Form Entry

DeBaun Forms
C13239 National Institutes of Health Stroke Scale (NIHSS) - Motor leg score NIHSSLvlConscMotLegScore Motor ability of the leg (both left and right) assessed using the NIH Stroke Scale (NIHSS) Motor ability of the leg (both left and right) assessed using the NIH Stroke Scale (NIHSS) 0;1;2;3;4;UN;0;1;2;3;4;UN No drift: leg holds 30 degrees position for full 5 seconds.;Drift: leg falls by the end of the 5 second period but does not hit bed.;Some effort against gravity: leg falls to bed by 5 seconds, but has some effort against gravity.;No effort against gravity, leg falls to bed immediately.;No movement;Amputation or joint fusion, explain;No drift: leg holds 30 degrees position for full 5 seconds.;Drift: leg falls by the end of the 5 second period but does not hit bed.;Some effort against gravity: leg falls to bed by 5 seconds, but has some effort against gravity.;No effort against gravity, leg falls to bed immediately.;No movement;Amputation or joint fusion, explain 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
C00313 Medical history condition SNOMED CT code MedclHistCondSNOMEDCTCode Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Selected Debaun CDEs Additional Proposed Instruments Other 255

Free-Form Entry

DeBaun Forms
C01522 Height measurement HgtMeasr Measurement of participant's/subject's height. Measurement of participant's/subject's height. Numeric Values Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

0 400 centimeter 649 DeBaun Forms
C17526 Friedreich's Ataxia Rating Scale (FARS) - neurological exam peripheral deep tendon reflex biceps jerk right score FARSPNSNeuExDTenRefBicJRtScore Score for right-side biceps 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 biceps 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
C08173 Ischemic hemorrhagic or vascular pathology indicator IschHemVasclPathInd Indicator of the presence of ischemic, hemorrhagic, or vascular pathology Indicator of the presence of ischemic, hemorrhagic, or vascular pathology Yes;No;Unknown;Not assessed Yes;No;Unknown;Not assessed Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-22 09:34:41.527 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
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 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

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C02006 Medication prior or concomitant dose MedctnPriorConcomDose Dose of prior/concomitant medication taken per administration. Dose of prior/concomitant medication taken per administration. Numeric Values Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Selected Debaun CDEs Additional Proposed Instruments Other

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3162729 DeBaun Forms
C19151 Discontinuation date DiscontinuationDate The date of discontinuation The date of discontinuation Date or Date & Time Adult;Pediatric Supplemental 1.00 2014-05-29 11:10:46.0 Selected Debaun CDEs Additional Proposed Instruments Other

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