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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C13458 | Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003) - language deficit-production scale | PSOMSNELangDefProdScale | The scale for language deficit - production (including dysarthria) based on Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). | The scale for language deficit - production (including dysarthria) based on Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). | 0;0.5;1;2;0;0.5;1;2;0;0.5;1;2 | None;Mild but no impact on function;Moderate with some impact on function;Severe or profound with missing function;None;Mild but no impact on function;Moderate with some impact on function;Severe or profound with missing function;None;Mild but no impact on function;Moderate with some impact on function;Severe or profound with missing function | Numeric values | Adult;Pediatric | Supplemental | 3.00 | 2013-06-21 00:00:00.0 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C01041 | Alteration consciousness indicator | AOCInd | The indicator of whether the participant/subject experienced any period of alteration of consciousness (AOC). | The indicator of whether the participant/subject experienced any period of alteration of consciousness (AOC). | Yes;No;Suspected;Unknown | Yes;No;Suspected;Unknown | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-07-20 10:21:25.65 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C17503 | Hemoglobin electrophoresis type | HemoglbnElectrophoresisType | Type of hemoglobin that was identified by the electrophoresis test being reported | Type of hemoglobin that was identified by the electrophoresis test being reported | HbSS;HbSA;HBAA;HbFF;HbAF | HbSS;HbSA;HBAA;HbFF;HbAF | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-07-15 16:08:48.687 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C04808 | RETIRED Death cause ICD-9-CM code | DeathCauseICD9CMCode | REDIRECTED to C21665 – Death cause ICD-10-CM code | ICD-9-CM code that describes the cause of participant/subject's death | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Selected Debaun CDEs | Additional Proposed Instruments | Other | 255 |
Free-Form Entry |
3178386 | DeBaun Forms | |||||||||||||||||||||||||||||||
| C13147 | Stroke Specific Quality of Life Scale (SS-QOL) - trouble phone language scale | SSQOLTroubPhonScale | The scale for trouble speaking on phone based on Stroke Specific Quality of Life Scale (SS-QOL). | The scale for trouble speaking on phone based on Stroke Specific Quality of Life Scale (SS-QOL). | 1;2;3;4;5;1;2;3;4;5 | Total help - Couldn't do it at all - Strongly agree;A lot of help - A lot of trouble - Moderately agree;Some help - Some trouble - Neither agree nor disagree;A little help - A little trouble - Moderately disagree;No help needed - No trouble at all - Strongly disagree;Total help - Couldn't do it at all - Strongly agree;A lot of help - A lot of trouble - Moderately agree;Some help - Some trouble - Neither agree nor disagree;A little help - A little trouble - Moderately disagree;No help needed - No trouble at all - Strongly disagree | Numeric values | Adult;Pediatric | Supplemental | 3.00 | 2013-06-21 00:00:00.0 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C14019 | Sickle cell disease present indicator | SickleCellPresInd | Indicates presence of sickle cell | Indicates presence of sickle cell | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-06-21 00:00:00.0 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C01702 | Pregnancy test date and time | PregTestDateTime | The date (and time if applicable and known) when the pregnancy test was performed | The date (and time if applicable and known) when the pregnancy test was performed | Date or Date & Time | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Free-Form Entry |
DeBaun Forms | |||||||||||||||||||||||||||||||||
| C18493 | Screening visit eligibility status | ScreenVisitEligibilityStatus | The status determined from screening criteria that indicates whether a participant/subject may be eligible for a study. | Screening visit eligibility status | Eligible;Eligible but declined;Not eligible;Other, specify;Eligible;Eligible but declined;Not eligible;Other, specify | Eligible;Eligible but declined;Not eligible;Other, specify;Eligible;Eligible but declined;Not eligible;Other, specify | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 16:35:19.49 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C19810 | Medical history abdominal kidney problem indicator | MedHistAbdmnlKdnyProbInd | Indicator of history of kidney problem | Indicator of history of kidney problem | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2015-02-05 00:00:00.0 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C13235 | National Institutes of Health Stroke Scale (NIHSS) - Best gaze score | NIHSSLvlConscBestGazeScore | Best gaze assessed using the NIH Stroke Scale (NIHSS) | Best gaze assessed using the NIH Stroke Scale (NIHSS) | 0;1;2;0;1;2 | Normal;Partial gaze palsy. This score is given when gaze is abnormal in one or both eyes, but where forced deviation or total gaze paresis are not present;Forced deviation, or total gaze paresis not overcome by the oculocephalic maneuver;Normal;Partial gaze palsy. This score is given when gaze is abnormal in one or both eyes, but where forced deviation or total gaze paresis are not present;Forced deviation, or total gaze paresis not overcome by the oculocephalic maneuver | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-06-21 00:00:00.0 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C00023 | Hand preference type | HandPrefTyp | Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusively. | Hand which the participant/subject uses predominantly, not necessarily the hand he/she writes with exclusively. | Left hand;Right hand;Both hands;Unknown;Forced right | Left hand;Right hand;Both hands;Unknown;Forced right | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
2180147 | DeBaun Forms | ||||||||||||||||||||||||||||||
| C14559 | EEG recording start date and time | EEGRecordingStrtDateTime | Date (and time, if applicable and known) the electroencephalogram (EEG) recording began | Date the electroencephalogram (EEG) recording began | Date or Date & Time | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Free-Form Entry |
DeBaun Forms | |||||||||||||||||||||||||||||||||
| C02212 | Informed consent obtained date and time | InformConsntObtnDateTime | Date (and time, if applicable and known) on which the participant/subject (or the legal representative on behalf of the participant/subject) agrees to participate in a protocol, treatment, or other activity by signing an informed consent document. | Date (and time, if applicable and known) on which the participant/subject (or the legal representative on behalf of the participant/subject) agrees to participate in a protocol, treatment, or other activity by signing an informed consent document. | Date or Date & Time | Adult;Pediatric | Supplemental | 3.00 | 2013-07-20 10:21:25.65 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Free-Form Entry |
2435038,656 | DeBaun Forms | ||||||||||||||||||||||||||||||||
| C13459 | Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003) - language deficit-production description text | PSOMSNELangDefProdDescTxt | Description of the language production deficits observed in the participant/subject based on Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). | Description of the language production deficits observed in the participant/subject based on Pediatric Stroke Outcomes Measure-Neuro Exam (PSOM-SNEVOct2003). | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-06-21 00:00:00.0 | Selected Debaun CDEs | Additional Proposed Instruments | Other | 255 |
Free-Form Entry |
DeBaun Forms | ||||||||||||||||||||||||||||||||
| C01052 | Loss of consciousness indicator | LOCInd | The indicator for whether the participant/subject experienced any period of loss of consciousness (LOC). | The indicator for whether the participant/subject experienced any period of loss of consciousness (LOC). | Yes;No;Suspected;Unknown | Yes;No;Suspected;Unknown | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-07-20 10:21:25.65 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C17523 | Friedreich's Ataxia Rating Scale (FARS) - neurological exam peripheral deep tendon reflex ankle jerk left score | FARSPNSNeuExDTenRAnkJLftScore | Score for left-side ankle jerk in the peripheral nervous system section of the neurological exam, as part of the Friedreich's Ataxia Rating Scale (FARS). | Score for left-side ankle jerk in the peripheral nervous system section of the neurological exam, as part of the Friedreich's Ataxia Rating Scale (FARS). | 0;1;2;3;4;0;1;2;3;4;0;1;2;3;4 | 0 - absent;1 - hyporeflexia;2 - normal;3 - hyperreflexia;4 - pathologic hyperreflexia;0 - absent;1 - hyporeflexia;2 - normal;3 - hyperreflexia;4 - pathologic hyperreflexia;0 - absent;1 - hyporeflexia;2 - normal;3 - hyperreflexia;4 - pathologic hyperreflexia | Numeric Values | Adult;Pediatric | Supplemental | 3.00 | 2013-07-15 16:08:48.687 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C05408 | Hospital admission date and time | HospitlAdmissDateTime | Date (and time, if applicable and known) the participant/subject was admitted to the hospital | Date (and time, if applicable and known) the participant/subject was admitted to the hospital | Date or Date & Time | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Free-Form Entry |
DeBaun Forms | |||||||||||||||||||||||||||||||||
| C13192 | Questionnaire for Verifying Stroke Free Status (QVSFS) - stroke status | QVSFSStrokeStatus | Were you ever told by a physician that you had a stroke? | Were you ever told by a physician that you had a stroke? Questionnaire for Verifying Stroke Free Status (QVSFS) - numbness status | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-06-21 00:00:00.0 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C14021 | Sickle cell disease velocity measurement | SickleCellVelMeasr | The velocity measurement of sickle cell. | The velocity measurement of sickle cell. | Numeric Values | Adult;Pediatric | Supplemental | 3.00 | 2013-06-21 00:00:00.0 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Free-Form Entry |
0 | 999 | centimeter per second | DeBaun Forms | ||||||||||||||||||||||||||||||
| C01705 | Lab test name | LabTestName | Name representing the lab test performed on body fluid(s) and tissues. Test names are typically comprised of the analyte name, properties (%, Ratio, etc.), the type of body fluid tested, and any special instructions. | Name representing the lab test performed on body fluid(s) and tissues. Test names are typically comprised of the analyte name, properties (%, Ratio, etc.), the type of body fluid tested, and any special instructions. | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
2003746 | DeBaun Forms | LB | LBTEST |
Lab Test or Examination Name |
Laboratory Test Name |
What was the lab test name? |
LBTEST; LBTESTCD | Char | Record the name of the Lab measurement or finding, if not preprinted on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended. | (LBTEST) |
[Select appropriate values from the LBTEST codelist] |
Prompt | Radio | ||||||||||||||||||||
| C18666 | Body system other text | BodySysOTH | The free-text field related to 'Body system category' specifying other text. Category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured | Free-text category or grouping used in the comprehensive assessment of a participant/subject, which includes a subjective history taking component as well as an objective based structured interview and physical examination of all the body systems. | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2014-05-27 13:34:46.0 | Selected Debaun CDEs | Additional Proposed Instruments | Other | 4000 |
Free-Form Entry |
2002895 | DeBaun Forms | |||||||||||||||||||||||||||||||
| C19811 | Medical history abdominal liver problem indicator | MedHistAbdmnlLiverProbInd | Indicator of history of liver problem | Indicator of history of liver problem | No;Yes | No;Yes | Alphanumeric | Adult;Pediatric | Supplemental | 1.00 | 2015-02-05 00:00:00.0 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C13236 | National Institutes of Health Stroke Scale (NIHSS) - Visual field score | NIHSSLvlConscVisuFldScore | Visual fields assessed using the NIH Stroke Scale (NIHSS) | Visual fields assessed using the NIH Stroke Scale (NIHSS) | 0;1;2;3;UN;0;1;2;3;UN | No visual loss;Partial hemianopia;Complete hemianopia;Bilateral hemianopia (blind including cortical blindness);Unexaminable (intubated/paralyzed);No visual loss;Partial hemianopia;Complete hemianopia;Bilateral hemianopia (blind including cortical blindness);Unexaminable (intubated/paralyzed) | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-06-21 00:00:00.0 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C00035 | Gender Type | GenderTyp | Self-reported gender of the participant/subject. Gender is the socially constructed identity of sex. Gender is equated with phenotypic sex. Gender may differ from the sex of an individual determined genetically. | Self-reported gender of the participant/subject. Gender is the socially constructed identity of sex. | Female;Male;Unknown;Unspecified;Not reported | Female;Male;Unknown;Undifferentiated/Indeterminant/Intersex;Not reported | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-08-28 16:08:00.453 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
2200604 | DeBaun Forms | ||||||||||||||||||||||||||||||
| C16100 | Symptoms new or worsening neurologic indicator | SymptmNewWrseNeuroInd | Indicates whether the participant/subject has new neurologic symptoms or an acute worsening of preexisting neurologic symptoms | Indicates whether the participant/subject has new neurologic symptoms or an acute worsening of preexisting neurologic symptoms | Yes;No;Unknown | Yes;No;Unknown | Alphanumeric | Adult;Pediatric | Supplemental | 3.00 | 2013-06-11 00:00:00.0 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Single Pre-Defined Value Selected |
DeBaun Forms | |||||||||||||||||||||||||||||||
| C02301 | Adverse event end date and time | AdverseEvntEndDateTime | Date (and time, if applicable and known) on which the adverse event discontinued/stopped | Date (and time, if applicable and known) on which the adverse event discontinued/stopped | Date or Date & Time | Adult;Pediatric | Supplemental | 3.00 | 2013-07-18 16:35:19.49 | Selected Debaun CDEs | Additional Proposed Instruments | Other |
Free-Form Entry |
2189843 | DeBaun Forms | ||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||
| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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