CDE Detailed Report

Disease: content
Sub-Domain: History of Disease/Injury Event
CRF: welcome

Displaying 1 - 14 of 14
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 External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C05404 Symptom onset date and time SymptmOnsetDateTime Date (and time, if applicable and known) reported for onset of participant's/subject's symptoms Date (and time, if applicable and known) reported for onset of participant's/subject's symptoms Approximate date of onset Date or Date & Time

Provide approximate date for all Motor Symptoms Developing Over the Course of Illness. If date is unknown, leave date blank and check Unknown on the form. In the study database a convention should be developed for entering unknown or partial dates.

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events

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C19529 Ambulatory axial difficulty abnormal posture gait other text AmbAsDiffAbnormPostGaitOth The free-text field related to ambulatory/axial difficulties-other abnormality of posture or gait specifying other text. The free-text field related to ambulatory/axial difficulties-other abnormality of posture or gait specifying other text. Ambulatory/Axial Difficulties-Other abnormality of posture or gait (other, specify) Alphanumeric

Choose all that apply

No references available Adult Supplemental 3.00 2013-07-22 09:34:41.527 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events 255

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C08006 Symptoms first appeared date and time SymptmFirstAppearDateTime Date (and time if applicable and known) the symptoms for the disease or disorder first appeared as confirmed by the participant's/subject's medical history obtained by a physician Date (and time if applicable and known) the symptoms for the disease or disorder first appeared as confirmed by the participant's/subject's medical history obtained by a physician Year of First Symptoms as confirmed by history obtained by the physician? Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 21:00:23.88 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events

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C08007 Diagnosis first given date and time DiagnosFirstGivnDateTime Date (and time if applicable and known) the participant/subject was initially diagnosed with the disease or disorder Date (and time if applicable and known) the participant/subject was initially diagnosed with the disease or disorder Year of Initial Diagnosis? Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

No references available Adult;Pediatric Supplemental 3.00 2013-07-24 11:38:01.2 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events

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C08008 Diagnostic feature criterion type DiagnosFeatureCriterionTyp Type of diagnostic feature or criterion assessed in the participant/subject. Type of diagnostic feature or criterion assessed in the participant/subject. Diagnostic Features Criteria as evident on clinical assessment of the patient 4-6 Hz Rest Tremor;Bradykinesia;Rigidity;Asymmetric Onset;Substantial Response to Dopaminergic Therapy 4-6 Hz Rest Tremor;Bradykinesia;Rigidity;Asymmetric Onset;Substantial Response to Dopaminergic Therapy Alphanumeric

For each PD diagnostic feature or criterion, indicate whether it is Present/ Absent/ Unknown

No references available Adult Supplemental 3.00 2013-07-22 09:34:41.527 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C08009 Diagnostic feature criterion presence indicator DiagnosFtrCriterionPresenceTyp Indicator of whether the diagnostic feature or criterion is observed during clinical assessment of the participant/subject Indicator of whether the diagnostic feature or criterion is observed during clinical assessment of the participant/subject Diagnostic Features/Criteria (as evident on clinical assessment of the patient) Present;Absent;Unknown Present;Absent;Unknown Alphanumeric

Should be answered for each PD diagnostic feature or criterion

No references available Adult Supplemental 3.00 2013-07-22 09:34:41.527 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C08010 Diagnosis certainty percentage range DiagnosCertaintyPercentgRange Range of the clinician's certainty of the medical diagnosis of the disease or disorder. Range of the clinician's certainty of the medical diagnosis of the disease or disorder. Degree of Certainty of Diagnosis of PD 90-100% certain;50-89% certain;10-49% certain;0-9% certain 90-100% certain;50-89% certain;10-49% certain;0-9% certain Alphanumeric

Choose one

No references available Adult Supplemental 3.00 2013-07-22 09:34:41.527 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C08011 Diagnostic alternative reason DiagnosAltrntiveRsn Reason for other important diagnostic alternative(s) to Parkinson's disease. Reason for other important diagnostic alternative(s) to Parkinson's disease. Other important diagnostic alternatives give reason Alphanumeric

Answer only if applicable. Not a required field

No references available Adult Supplemental 3.00 2013-07-22 09:34:41.527 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events 255

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C08012 Motor symptom Parkinsonian initial type MtrSymptmParkinsonianInitlTyp Type(s) of initial motor symptoms of Parkinson's disease described by the participant/subject. Type(s) of initial motor symptoms of Parkinson's disease described by the participant/subject. Initial Motor Symptoms, i.e., as described by the patient (please check all that apply) Tremor;Stiffness;Change in facial expression;Disturbances of dexterity;Micrographia;Weakness;Dystonia;Ambulatory/Axial Difficulties-Freezing;Ambulatory/Axial Difficulties-Lack of arm swing;Ambulatory/Axial Difficulties-Leg dragging;Ambulatory/Axial Difficulties-Shuffling of gait;Ambulatory/Axial Difficulties-Postural imbalance;Ambulatory/Axial Difficulties-Falls;Ambulatory/Axial Difficulties-Slowness of gait;Ambulatory/Axial Difficulties-Other abnormality of posture or gait Tremor (including internal tremor);Stiffness;Change in facial expression;Disturbances of dexterity;Micrographia;Weakness;Dystonia (specify symptoms);Ambulatory/Axial Difficulties-Freezing;Ambulatory/Axial Difficulties-Lack of arm swing;Ambulatory/Axial Difficulties-Leg dragging;Ambulatory/Axial Difficulties-Shuffling of gait;Ambulatory/Axial Difficulties-Postural imbalance (excluding falls);Ambulatory/Axial Difficulties-Falls;Ambulatory/Axial Difficulties-Slowness of gait;Ambulatory/Axial Difficulties-Other abnormality of posture or gait (other, specify) Alphanumeric

Choose all that apply

No references available Adult Supplemental 3.00 2013-07-22 09:34:41.527 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events

Multiple Pre-Defined Values Selected

C08013 Dystonia symptom text DystoniaSymptomTxt Symptoms experienced by the participant/subject related to dystonia. Symptoms experienced by the participant/subject related to dystonia. Initial Motor Symptoms, i.e., as described by the patient (please check all that apply) Alphanumeric

No instructions available

No references available Adult Supplemental 3.00 2013-07-22 09:34:41.527 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events 255

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C00314 Medical history taken date and time MedclHistTakenDateTime Date (and time, if applicable and known) the participant/subject's medical history was taken Date (and time, if applicable and known) the participant/subject's medical history was taken Date Medical History Taken Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events

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2179659
C08015 Motor symptom parkinsonian develop type MtrSymptmParkinsonianDvlpTyp Type(s) of motor symptoms of Parkinson's disease which developed over the course of Illness Type(s) of motor symptoms of Parkinson's disease which developed over the course of illness Motor Symptoms Developing Over the Course of Illness (please check all that apply) Tremor;Stiffness;Change in facial expression;Disturbances of dexterity;Micrographia;Weakness;Dystonia;Ambulatory/Axial Difficulties-Freezing;Ambulatory/Axial Difficulties-Lack of arm swing;Ambulatory/Axial Difficulties-Leg dragging;Ambulatory/Axial Difficulties-Shuffling of gait;Ambulatory/Axial Difficulties-Postural imbalance;Ambulatory/Axial Difficulties-Falls;Ambulatory/Axial Difficulties-Slowness of gait;Ambulatory/Axial Difficulties-Stooped posture;Ambulatory/Axial Difficulties-Other abnormality of posture or gait Tremor (including internal tremor);Stiffness;Change in facial expression;Disturbances of dexterity;Micrographia;Weakness;Dystonia;Ambulatory/Axial Difficulties-Freezing;Ambulatory/Axial Difficulties-Lack of arm swing;Ambulatory/Axial Difficulties-Leg dragging;Ambulatory/Axial Difficulties-Shuffling of gait;Ambulatory/Axial Difficulties-Postural imbalance (excluding falls);Ambulatory/Axial Difficulties-Falls;Ambulatory/Axial Difficulties-Slowness of gait;Ambulatory/Axial Difficulties-Stooped posture;Ambulatory/Axial Difficulties-Other abnormality of posture or gait (other, specify) Alphanumeric

Choose all that apply

No references available Adult Supplemental 3.00 2013-07-22 09:34:41.527 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events

Multiple Pre-Defined Values Selected

C02411 Laterality type LatTyp Laterality type relative to the anatomic site of the body examined or affected Laterality type relative to the anatomic site of the body examined or affected Side of Body of Initial Symptoms Bilateral;Left;Right;Unknown;Midline Bilateral;Left;Right;Unknown;Midline Alphanumeric

Choose one

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C18029 Other abnormality posture text OthrAbnrmlyPostureTxt Symptoms experienced by the participant/subject related to another abnormality of posture or gait. Symptoms experienced by the participant/subject related to another abnormality of posture or gait. Initial Motor Symptoms, i.e., as described by the patient (please check all that apply) Alphanumeric No references available Adult Supplemental 3.00 2013-07-20 10:46:24.96 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events 255

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CSV