Sub-Domain: Additional Proposed Instruments
CRF:
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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 |
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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 |
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 |
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