CDE Detailed Report
Disease: Sickle Cell Disease
Sub-Domain: Additional Proposed Instruments
CRF: Selected Debaun CDEs
Sub-Domain: Additional Proposed Instruments
CRF: Selected Debaun CDEs
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||
| C00322 | Medical history condition text | MedclHistCondTxt | Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history | Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Selected Debaun CDEs | Additional Proposed Instruments | Other | 4000 |
Free-Form Entry |
2003874 | 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 |
Free-Form Entry |
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 |
Single Pre-Defined Value Selected |
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 |
Free-Form Entry |
DeBaun Forms | ||||||||||||||||||||||||||||||||
| C13242 | National Institutes of Health Stroke Scale (NIHSS) - Best language score | NIHSSBestLangScore | Language ability assessed using the NIH Stroke Scale (NIHSS) | Language ability assessed using the NIH Stroke Scale (NIHSS) | 0;1;2;3;UN;0;1;2;3;UN | No aphasia, normal;Mild to moderate aphasia: some obvious loss of fluency or facility of comprehension, without significant limitation on ideas expressed or form of expression. Reduction of speech and/or comprehension, however, makes conversation about provided material difficult or impossible. For example in conversation about provided materials examiner can identify picture or naming card from patient's response.;Severe aphasia: all communication is through fragmentary expression, great need for inference, questioning, and guessing by the listener. Range of information that can be exchanged is limited: listener carries burden of communication. Examiner cannot identify materials provided from patient response.;Mute, global aphasia: no usable speech or auditory comprehension.;Unexaminable (intubated/paralyzed);No aphasia, normal;Mild to moderate aphasia: some obvious loss of fluency or facility of comprehension, without significant limitation on ideas expressed or form of expression. Reduction of speech and/or comprehension, however, makes conversation about provided material difficult or impossible. For example in conversation about provided materials examiner can identify picture or naming card from patient's response.;Severe aphasia: all communication is through fragmentary expression, great need for inference, questioning, and guessing by the listener. Range of information that can be exchanged is limited: listener carries burden of communication. Examiner cannot identify materials provided from patient response.;Mute, global aphasia: no usable speech or auditory comprehension.;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 | |||||||||||||||||||||||||||||||
| C13464 | Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003) - total score | PSOMSNETotalScore | The total score on the Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). | The total score on the Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). | 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 | 10 | DeBaun Forms | |||||||||||||||||||||||||||||||
| C01539 | Temperature measurement | TempMeasr | Measurement of the participant's/subject's body temperature. | Measurement of the participant's/subject's body temperature. | 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 | 50 | degree Celsius | 2644401 | DeBaun Forms | |||||||||||||||||||||||||||||
| C17528 | Friedreich's Ataxia Rating Scale (FARS) - neurological exam peripheral deep tendon reflex brachioradialis jerk right score | FARSPNSNeuExDTenRefBrJRtScore | Score for right-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 right-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 | |||||||||||||||||||||||||||||||
| C10609 | Hospitalization reason | HospitRsn | Reason why the participant/subject was hospitalized, excluding all surgeries | Reason why the participant/subject was hospitalized, excluding all surgeries | Pneumonia or Respiratory;Dehydration;Trauma;Fracture;Cardiomyopathy/Arrhythmia;Failure to Thrive;Other, specify;Infection other than pneumonia;Seizures;Cardiovascular | Pneumonia or Respiratory;Dehydration;Trauma;Fracture;Cardiomyopathy/Arrhythmia;Failure to Thrive;Other, specify;Infection other than pneumonia;Seizures;Cardiovascular | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Multiple Pre-Defined Values Selected |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C14424 | Epilepsy etiology specific classification type | EpilepsyEtioSpecClassTyp | The specific etiologies preceeding the development of epilepsy in the participant/subject, as described by the International League Against Epilepsy (ILAE). | The specific etiologies preceding the development of epilepsy in the participant/subject. | Viral, bacterial and parasitic infections;Traumatic brain injury;Stroke;Intraventricular hemorrhage;Hypoxic-ischemic encephalopathy;Other metabolic or toxic insults;Neurocutaneous syndromes;Inborn errors of metabolism;Genetic and chromosomal development encephalopathies;Malformations of cortical or other brain development with or without known genetic determinants;Neoplasia;Dementia;Other degenerative neurologic diseases;Genetic or presumed genetic;Epilepsy of unknown cause, without relevant abnormalities on examination, cognition, history, or imaging;Other, specify;Developmental encephalopathy of unknown cause;Mesial Temporal Sclerosis | Viral, bacterial and parasitic infections;Traumatic brain injury;Stroke;Intraventricular hemorrhage;Hypoxic-ischemic encephalopathy;Other metabolic or toxic insults;Neurocutaneous syndromes;Inborn errors of metabolism;Genetic and chromosomal development encephalopathies;Malformations of cortical or other brain development with or without known genetic determinants;Neoplasia;Dementia;Other degenerative neurologic diseases;Genetic or presumed genetic;Epilepsy of unknown cause, without relevant abnormalities on examination, cognition, history, or imaging;Other, specify;Developmental encephalopathy of unknown cause as evidenced by the presence of mental retardation, cerebral palsy, or autism with no evidence of a specific insult or disorder to which cause can be attributed preceding the onset of epilepsy;Mesial Temporal Sclerosis | 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 | |||||||||||||||||||||||||||||||
| C02014 | Medication prior or concomitant name | MedctnPriorConcomName | Name of the prior/concomitant agent or drug administered. | Name of the prior/concomitant agent or drug administered. | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Selected Debaun CDEs | Additional Proposed Instruments | Other | 4000 |
Free-Form Entry |
3162728 | DeBaun Forms | |||||||||||||||||||||||||||||||
| C19167 | Special care unit type | SCUTyp | Type of special care unit | Type of special care unit | Intensive Care Unit;Step-Down Unit | Intensive Care Unit (ICU);Step-Down Unit (SDU) | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2014-05-29 14:04:21.0 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C13198 | Questionnaire for Verifying Stroke Free Status (QVSFS) - understanding status | QVSFSUndstandStatus | Have you ever suddenly lost the ability to understand what people were saying? | Have you ever suddenly lost the ability to understand what people were saying? 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 | |||||||||||||||||||||||||||||||
| C00720 | Family history medical condition type | FamHistMedclCondTyp | Type of medical condition or health related event for which the family history is taken | Type of medical condition or health related event for which the family history is taken | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-07-24 11:38:01.2 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Multiple Pre-Defined Values Selected |
3165585 | DeBaun Forms | ||||||||||||||||||||||||||||||||
| C17409 | Visit date | VisitDate | Date of interview or visit (actually the date when data in the form were captured) | Date of interview or visit | Date or Date & Time | Adult;Pediatric | Supplemental | 3.00 | 2013-06-21 00:00:00.0 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Free-Form Entry |
DeBaun Forms | LB | VISDAT |
Visit Date |
Visit Date |
What [is/was] the date of the visit? |
N/A | Char | Record the [date/start date] of the visit using DD-MON-YYYY format. | Prompt | ||||||||||||||||||||||||
| C02310 | Adverse event CTCAE low level term name | AdvrsEvntCTCAELowLvlTermName | Text that represents the Common Terminology Criteria for Adverse Events (CTCAE) low level term name for an adverse event. | Text that represents the Common Terminology Criteria for Adverse Events (CTCAE) low level term name for an adverse event. | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Selected Debaun CDEs | Additional Proposed Instruments | Other | 255 |
Free-Form Entry |
3125302 | DeBaun Forms | |||||||||||||||||||||||||||||||
| C20419 | National Institutes of Health Stroke Scale (NIHSS) - Limb ataxia amputation text | NIHSSLimbAtaxiaAmputTxt | The text field for explaining the amputation or joint fusion for question related to Limb ataxia assessed using the NIH Stroke Scale (NIHSS). | The text field for explaining the amputation or joint fusion for question related to Limb ataxia assessed using the NIH Stroke Scale (NIHSS). | Alphanumeric | Adult;Pediatric | Supplemental | 4.00 | 2015-04-27 00:00:00.0 | Selected Debaun CDEs | Additional Proposed Instruments | Other | 4000 |
Free-Form Entry |
DeBaun Forms | ||||||||||||||||||||||||||||||||
| C13243 | National Institutes of Health Stroke Scale (NIHSS) - Dysarthria score | NIHSSDysarthriaScore | Dysarthria assessed using the NIH Stroke Scale (NIHSS) | Dysarthria assessed using the NIH Stroke Scale (NIHSS) | 0;1;2;UN;0;1;2;UN | Normal;Mild to moderate: patient slurs at least some words and, at worst, can be understood with some difficulty.;Severe: patient's speech is so slurred as to be unintelligible in the absence of or out of proportion to any dysphasia, or is mute/anarthric.;Intubated or other physical barrier, explain;Normal;Mild to moderate: patient slurs at least some words and, at worst, can be understood with some difficulty.;Severe: patient's speech is so slurred as to be unintelligible in the absence of or out of proportion to any dysphasia, or is mute/anarthric.;Intubated or other physical barrier, 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 | |||||||||||||||||||||||||||||||
| C13468 | Stroke Adjudication Worksheet - symptom duration | StrokeAdjudWksSymDur | How long the symptom(s) experienced around the time of the stroke event lasted | How long the symptom(s) experienced around the time of the stroke event lasted | Confirmed to be greater than or equal to 24 hours;Confirmed to be less than 24 hours;Duration of symptoms could not be confirmed;Confirmed to be greater than or equal to 24 hours;Confirmed to be less than 24 hours;Duration of symptoms could not be confirmed | Confirmed to be greater than or equal to 24 hours;Confirmed to be less than 24 hours;Duration of symptoms could not be confirmed;Confirmed to be greater than or equal to 24 hours;Confirmed to be less than 24 hours;Duration of symptoms could not be confirmed | 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 |
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| C01541 | Weight measurement | WgtMeasr | Measurement of participant's/subject's weight | Measurement of participant's/subject's weight | 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 | 500 | kilogram | 2179689 | DeBaun Forms | |||||||||||||||||||||||||||||
| C17529 | Friedreich's Ataxia Rating Scale (FARS) - neurological exam peripheral deep tendon reflex knee jerk left score | FARSPNSNeuExDTenRKneeJLtScore | Score for left-side knee 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 knee 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 |
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| C11026 | Neuromuscular Exam Muscle weakness indicator | NeuromuExmCranlMuscleWeaknInd | Indicator whether there is muscle weakness in the muscle or muscle group examined | Whether there is muscle weakness in the muscle or muscle group examined | Yes;No;Not assessed;Unknown | Yes;No;Not assessed;Unknown | 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 |
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| C14443 | Muscle tone assessment anatomic site | MuscToneAssmtAntmicSite | Anatomic location of the muscle tone as part of the motor examination. | Anatomic location of the muscle tone as part of the motor examination. | Right upper extremity;Left upper extremity;Right lower extremity;Left lower extremity;Truncal tone | Right upper extremity (RUE);Left upper extremity (LUE);Right lower extremity (RLE);Left lower extremity (LLE);Truncal tone | 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 |
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| C02016 | Medication prior or concomitant start date and time | MedctnPriorConcomStrtDateTime | The date (and time, if applicable and known) on which the prior/concomitant medication usage began. | The date (and time, if applicable and known) on which the prior/concomitant medication usage began. | Date or Date & Time | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Free-Form Entry |
3162752 | DeBaun Forms | ||||||||||||||||||||||||||||||||
| C19358 | Lab test type | LabTstTyp | Type of 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. | Type of 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 | ||||||||||||||||||||||||||||||||
| C13199 | Questionnaire for Verifying Stroke Free Status (QVSFS) - verbal status | QVSFSVerbalStatus | Have you ever suddenly lost the ability to express yourself verbally or in writing? | Have you ever suddenly lost the ability to express yourself verbally or in writing? 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 |
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| C00721 | Family history medical condition indicator | FamHistMedclCondInd | Indicator of whether a family member or first and second degree blood relatives of the participant/subject has had a history of the particular medical condition or health related event | Indicator of whether a family member or first and second degree blood relatives of the participant/subject has had a history of the particular medical condition or health related event | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-07-24 11:38:01.2 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
3165788 | DeBaun Forms | ||||||||||||||||||||||||||||||
| C17432 | EEG focal slowing indicator | EEGFocalSlowingInd | The yes/no indicator for electroencephalography (EEG) focal slowing. | The yes/no indicator for Electroencephalography (EEG) focal slowing. | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
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| C02311 | Adverse event MedDRA lower level term code | AdvsEvntMedDRALowerLvlTermCode | Code that corresponds to the Medical Dictionary for Regulatory Activities (MedDRA) Lower Level Term (LLT) for an adverse event | Code that corresponds to the Medical Dictionary for Regulatory Activities (MedDRA) Lower Level Term (LLT) for an adverse event | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 16:35:19.49 | Selected Debaun CDEs | Additional Proposed Instruments | Other | 255 |
Free-Form Entry |
3133353 | DeBaun Forms |