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
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

DeBaun Forms
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

Free-Form Entry

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

Free-Form Entry

DeBaun Forms
C13196 Questionnaire for Verifying Stroke Free Status (QVSFS) - painless vision loss status QVSFSPainlsVisnLossStatus Have you ever had sudden painless loss of vision in one or both eyes? Have you ever had sudden painless loss of vision in one or both eyes? 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
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 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

g/dL DeBaun Forms
C16679 Cambridge Brain Repair Center Sleep Questionnaire (BRC-Sleep) - intentionally nap day indicator BRCIntentNapDayInd The yes/no indicator for napping intentionally during the day from Cambridge Brain Repair Center Sleep Questionnaire (BRC-Sleep). The yes/no indicator for napping intentionally during the day from Cambridge Brain Repair Center Sleep Questionnaire (BRC-Sleep). No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-14 19:48:50.273 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C02308 Adverse event during study indicator AdvrsEvntDuringStudyInd Indicator of whether the participant/subject experienced any adverse events during the study Indicator of whether the participant/subject experienced any adverse events during the 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

2188132;3177812 DeBaun Forms
C20415 Serious adverse event report completed date SerAdvrsEvntRprtCompDt Date when the report on the adverse event was completed. Date when the report on the adverse event was completed. Alphanumeric Adult;Pediatric Supplemental 1.00 2015-03-24 11:55:24.0 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

DeBaun Forms
C13241 National Institutes of Health Stroke Scale (NIHSS) - Sensory score NIHSSSensoryScore Sensory abilities assessed using the NIH Stroke Scale (NIHSS) Sensory abilities assessed using the NIH Stroke Scale (NIHSS) 0;1;2;UN;0;1;2;UN Normal: no sensory loss.;Mild to moderate sensory loss: patient feels pinprick is less sharp or is dull on the affected side, or there is a loss of superficial pain with pinprick but patient is aware he/she is being touched.;Severe to total sensory loss: patient is not aware of being touched in the face, arm, and leg.;Unexaminable (intubated/paralyzed);Normal: no sensory loss.;Mild to moderate sensory loss: patient feels pinprick is less sharp or is dull on the affected side, or there is a loss of superficial pain with pinprick but patient is aware he/she is being touched.;Severe to total sensory loss: patient is not aware of being touched in the face, arm, and leg.;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
C00321 Medical history for body system indicator MedclHistBodySysInd Indicator of whether the participant/subject has a history of medical problems/conditions for the specific body system. Indicator of whether the participant/subject has a history of medical problems/conditions for the specific body system. Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-22 16:57:17.79 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C01535 Respiratory rate RespRate Rate of the participant/subject's breathing (inhalation and exhalation). Rate of the participant/subject's breathing (inhalation and exhalation). Numeric Values Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Selected Debaun CDEs Additional Proposed Instruments Other

Free-Form Entry

0 120 breaths per minute 2644399 DeBaun Forms
C17527 Friedreich's Ataxia Rating Scale (FARS) - neurological exam peripheral deep tendon reflex brachioradialis jerk left score FARSPNSNeuExDTenRefBrJLftScore Score for left-side brachioradialis 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 brachioradialis 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
C08177 Hemorrhage indicator HemrrhgInd Indicator of the presence of cerebral hemorrhages, regardless of size in any region of the brain Indicator of the presence of cerebral hemorrhages, regardless of size in any region of the brain 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
C13463 Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003) - cognitive or behavioral deficit description text PSOMSNECogBehavDeficitDescTxt Description of the cognitive or behavioral deficits observed in the participant/subject based on Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). Description of the cognitive or behavioral 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
C02008 Medication prior or concomitant end date and time MedctnPriorConcomEndDateTime The date (and time, if applicable and known) the administration of the prior/concomitant medication ended. The date (and time, if applicable and known) the administration of the prior/concomitant medication ended. 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

3162753 DeBaun Forms
C19166 Special care unit admittance indicator SCUAddmittanceInd Indicator for the admittance of participant to special care unit, including any Intensive Care or Step-Down Unit Indicator for the admittance of participant to special care unit, including any Intensive Care or Step-Down Unit No;Yes No;Yes Alphanumeric Adult;Pediatric Supplemental 1.00 2014-05-29 13:03:57.0 Selected Debaun CDEs Additional Proposed Instruments Other

Single Pre-Defined Value Selected

DeBaun Forms
C13197 Questionnaire for Verifying Stroke Free Status (QVSFS) - sudden vision loss status QVSFSSussVisnLossStatus Have you ever suddenly lost one half of your vision? Have you ever suddenly lost one half of your vision? 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
C14127 Seizure generalized classification type SeizGenClassTyp The type of generalized epileptic seizures, considered to originate at some point within, and rapidly engage, bilaterally distributed networks and may include such bilateral networks as ortical and subcortical structures, but do not necessarily include the entire cortex, experienced by the participant/subject. The type of generalized epileptic seizures, considered to originate at some point within, and rapidly engage, bilaterally distributed networks, experienced by the participant/subject. Tonic clonic;Absence;Typical;Atypical;Myoclonic absence;Eyelid myoclonia;Myoclonic;Myoclonic atonic;Myoclonic tonic;Clonic;Tonic;Atonic;Epileptic spasms, focal or generalized Tonic clonic (in any combination);Absence;Absence-Typical;Absence-Atypical;Absence-Myoclonic absence;Absence-Eyelid myoclonia;Myoclonic;Myoclonic-Myoclonic atonic;Myoclonic-Myoclonic tonic;Clonic;Tonic;Atonic;Epileptic spasms, focal or generalized 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

DeBaun Forms
C17397 Visit number VisitNum The numeric value associated with a particular assessment/examination of a participant/subject on a study The numeric value associated with a particular assessment/examination of a participant/subject on a study Numeric Values Adult;Pediatric Supplemental 1.00 2012-12-20 00:00:00.0 Selected Debaun CDEs Additional Proposed Instruments Other

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DeBaun Forms
C02309 Serious adverse event indicator SeriousAdvrsEvntInd The indicator of whether the adverse event is serious. The indicator of whether the adverse event is serious. Yes;No;Unknown Yes;No;Unknown Alphanumeric Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Selected Debaun CDEs Additional Proposed Instruments Other

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2199908 DeBaun Forms
C20416 National Institutes of Health Stroke Scale (NIHSS) - Motor arm amputation text NIHSSMotArmAmpTxt The text field for explaining the amputation or joint fusion for question related to motor ability of the arm (both left and right) assessed using the NIH Stroke Scale (NIHSS). The text field for explaining the amputation or joint fusion for question related to motor ability of the arm (both left and right) assessed using the NIH Stroke Scale (NIHSS). Alphanumeric Adult;Pediatric Supplemental 3.00 2013-06-21 00:00:00.0 Selected Debaun CDEs Additional Proposed Instruments Other 4000

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