CDE Detailed Report

Disease: Parkinson's Disease
Subdomain Name: History of Disease/Injury Event
CRF: Medical History of Parkinson's Disease

Displaying 1 - 11 of 11
CDE ID CDE Name Variable Name Definition Short Description 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 / Guidance) Subdomain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
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 Core 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

C08006 Symptoms first appear 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 Month/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 Core 3.10 2022-06-01 10:41:43.0 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events

Free-Form Entry

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 Month/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 Core 3.00 2013-07-24 11:38:01.2 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events

Free-Form Entry

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 Core 3.10 2022-06-01 10:47:00.0 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events

Multiple Pre-Defined Values Selected

C08009 Diagnostic feature criterion presence status DiagnosFtrCriterionPresnceStat Status of diagnostic feature or criterion 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 Core 5.00 2022-06-01 10:51:40.0 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C08012 Motor symptom Parkinsonian initial type MtSxPDIntlTyp 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 (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;Ambulatory/Axial Difficulties-Falls;Ambulatory/Axial Difficulties-Slowness of gait;Ambulatory/Axial Difficulties-Other abnormality of posture or gait (other, specify) 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 Core 4.00 2022-06-01 11:07:29.0 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 The free-text field to specify symptoms experienced by the participant/subject related to dystonia The free-text field to specify symptoms experienced by the participant/subject related to dystoni Dystonia (specify symptoms) Alphanumeric

No instructions available

No references available Adult Supplemental 3.10 2022-06-01 11:09:50.0 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events 255

Free-Form Entry

C19529 Motor symptom parkinsonian initial type ambulatory axial difficulty abnormal posture gait other text MtSxPDIntlTypAmbAxDfAbPstGtOTH The free-text field related to 'Motor symptom parkinsonian initial type', specifying ambulatory/axial difficulties-other abnormality of posture or gait other text. Type(s) of initial motor symptoms of Parkinson's disease described by the participant/subject. The free-text field related to 'Motor symptom parkinsonian initial type', specifying ambulatory/axial difficulties-other abnormality of posture or gait other tex Ambulatory/Axial Difficulties-Other abnormality of posture or gait (other, specify) Alphanumeric

Choose all that apply

No references available Adult Supplemental 4.10 2022-06-01 11:03:13.0 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events 4000

Free-Form Entry

C59020 Diagnosis certainty category DiagnosCertaintyCat Category of the clinician's certainty of the medical diagnosis of the disease or disorder Category of the clinician's certainty of the medical diagnosis of the disease or disorde Degree of Certainty of Diagnosis of PD Clinically established;Clinically probable Clinically established;Clinically probable Alphanumeric

No instructions available

Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. Adult Core 1.00 2022-06-01 11:17:48.0 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

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 exclusivel Dominant hand Left hand;Right hand;Both hands Left hand;Right hand;Both hands Alphanumeric

Choose one - the hand which the participant/subject uses predominantly, not necessarily the hand the participant/subject writes with exclusively

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

Single Pre-Defined Value Selected

2180147
C00314 Medical history taken date and time MedclHistTakenDateTime Date (and time, if applicable and known) the participant's medical history was taken Date (and time, if applicable and known) the participant '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 Core 3.20 2024-02-29 15:42:39.0 Medical History of Parkinson's Disease History of Disease/Injury Event Disease/Injury Related Events

Free-Form Entry

2179659
CSV