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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C13460 | Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003) - language deficit-comprehension scale | PSOMSNELangDefCompScale | The scale for language deficit - comprehension based on Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). | The scale for language deficit - comprehension based on Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). | 0;0.5;1;2;0;0.5;1;2;0;0.5;1;2 | None;Mild but no impact on function;Moderate with some impact on function;Severe or profound with missing function;None;Mild but no impact on function;Moderate with some impact on function;Severe or profound with missing function;None;Mild but no impact on function;Moderate with some impact on function;Severe or profound with missing function | Numeric values | Adult;Pediatric | Supplemental | 3.00 | 2013-06-21 00:00:00.0 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C01507 | Blood pressure diastolic measurement | BldPressrDiastlMeasr | Measurement of pressure of the participant's/subject's blood against the artery walls during diastole (the relaxation phase) in millimeters of mercury (mmHg) | Measurement of pressure of the participant's/subject's blood against the artery walls during diastole (the relaxation phase) in millimeters of mercury (mmHg) | Numeric Values | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Free-Form Entry |
0 | 300 | millimeter of mercury | 2004291 | DeBaun Forms | |||||||||||||||||||||||||||||
| C17524 | Friedreich's Ataxia Rating Scale (FARS) - neurological exam peripheral deep tendon reflex ankle jerk right score | FARSPNSNeuExDTenRAnkJRtScore | Score for right-side ankle jerk in the peripheral nervous system section of the neurological exam, as part of the Friedreich's Ataxia Rating Scale (FARS). | Score for right-side ankle jerk in the peripheral nervous system section of the neurological exam, as part of the Friedreich's Ataxia Rating Scale (FARS). | 0;1;2;3;4;0;1;2;3;4;0;1;2;3;4 | 0 - absent;1 - hyporeflexia;2 - normal;3 - hyperreflexia;4 - pathologic hyperreflexia;0 - absent;1 - hyporeflexia;2 - normal;3 - hyperreflexia;4 - pathologic hyperreflexia;0 - absent;1 - hyporeflexia;2 - normal;3 - hyperreflexia;4 - pathologic hyperreflexia | Numeric Values | Adult;Pediatric | Supplemental | 3.00 | 2013-07-15 16:08:48.687 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C06421 | SCI Classification light touch single side score | SCIClssLghtTchSnglSdScore | Score of sensation of light touch for the specific side of the body. | Score of sensation of light touch for the specific side of the body. | Numeric Values | Adult;Pediatric | Supplemental | 3.00 | 2013-07-17 09:26:36.973 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Free-Form Entry |
DeBaun Forms | |||||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||
| 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 |
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| 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 |
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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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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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