CDE Detailed Report

Disease: Huntington's Disease
Sub-Domain: History of Disease/Injury Event
CRF: Medical History of Huntington's Disease

Displaying 1 - 28 of 28
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
C14958 Diagnosis physician indicator DiagnosPhysicianInd Has diagnosis been made by a physician? Has diagnosis been made by a physician? Has diagnosis been made by a physician? Yes;No;Unknown Yes;No;Unknown Alphanumeric

If No or Unknown/Uncertain are answered, skip to question 10 - "Based on the information that is available, how confident is the investigator that this person has manifest Huntington disease?".

No references available Adult Supplemental 3.00 2013-07-14 19:48:50.273 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C17742 Physician specialty type PhysicianSpecialtyTyp The specialty of the physician who made the diagnosis The specialty of the physician who made the diagnosis If Yes, indicate specialty of the physician who made the initial diagnosis. Neurologist;Psychiatrist;Primary Care Physician;Other, specify Neurologist;Psychiatrist;Primary Care Physician;Other, specify Alphanumeric No references available Adult Supplemental 3.00 2013-08-30 17:06:52.8 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C14959 Diagnosis physician year date DiagnosPhysicianYrDate The year the physician diagnosed the participant/ subject The year the physician diagnosed the participant/ subject If Yes, indicate year of physician 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 Supplemental 3.00 2013-07-14 19:48:50.273 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events

Free-Form Entry

C17743 Physician confidence level basis type PhysicianConfidenceLvlBasisTyp What the physician confidence level is primarily based on What the physician confidence level is primarily based on Is physician confidence level primarily based on History;Examination;Genetic Testing History;Examination;Genetic Testing Alphanumeric

Choose all that apply

No references available Adult Supplemental 3.00 2013-08-30 17:06:52.8 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events

Multiple Pre-Defined Values Selected

C10506 Genetic diagnosis established indicator GeneticDiagnosEstablishedInd Whether a genetic diagnosis for the disease/disorder was established Whether a genetic diagnosis for the disease/disorder was established Was diagnosis based on genetic testing? Yes;No;Unknown Yes;No;Unknown Alphanumeric

If Yes or Unknown are selected, then skip to question 10 - "Based on the information that is available, how confident is the investigator that this person has manifest Huntington disease?"

No references available Adult;Pediatric Supplemental 3.00 2013-07-14 03:55:23.71 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C14960 Diagnosis based abnormality type DiagnosBasedAbnrmlyTyp What kind of abnormalities was the diagnosis based on? What kind of abnormalities was the diagnosis based on If No, what kind of abnormalitites was the diagnosis based on? Motor;Behavioral;Cognitive;Functional;Unknown Motor;Behavioral;Cognitive;Functional;Unknown Alphanumeric

Check all that apply

No references available Adult Supplemental 3.00 2013-07-14 19:48:50.273 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events

Multiple Pre-Defined Values Selected

C18153 Data unknown text DataUnknwnTxt The free-text field to Mark an "X" in to record if data are unknown or not available. The free-text field to Mark an "X" in to record if data are unknown or not available. Or data. If Yes, indicate year of physician diagnosis. Alphanumeric

Check box for Unknown

No references available Adult;Pediatric Supplemental 3.00 2013-07-17 09:26:36.973 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events 20

Free-Form Entry

C14941 Diagnosis certainty percentage range type DiagnosCertaintyPercenRangeTyp Option for the range of the clinician's certainty of the medical diagnosis of the disease or disorder Option for the range of the clinician's certainty of the medical diagnosis of the disease or disorder Based on the information that ia available, how confident is the investigator that this person has manifest Huntington disease? Less than 25%;Between 26-50%;Between 51-75%;Between 76-90%;Greater than 90% Less than 25%;Between 26-50%;Between 51-75%;Between 76-90%;Greater than 90% Alphanumeric

No additional instructions

No references available Adult Supplemental 3.00 2013-07-14 19:48:50.273 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C17733 Person completing form name PrsnCompletingFormName Name of person completing the form Name of person completing the form Name of person completing the form Alphanumeric No references available Adult Supplemental 3.00 2013-08-30 17:06:52.8 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events 255

Free-Form Entry

C18989 Huntingtons Disease motor symptom first appeared self report other text HDMotorSymptmFrstAppSelfRepOTH The free-text field related to 'Huntingtons Disease motor symptom first appeared self report type' specifying other text. The type of first motor symptoms described by the participant/subject The free-text field related to 'Huntingtons Disease motor symptom first appeared self report type' specifying other text. The type of first motor symptoms described by the participant/subject Other, specify Alphanumeric

Choose all that apply.

No references available Adult Supplemental 3.00 2013-07-14 19:48:50.273 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events 4000

Free-Form Entry

C14951 Motor symptom first appeared self report date and time MotrSympFrstApSelfRprtDateTime Date of the first motor symptom(s) as noted by the participant/subject Date of the first motor symptom(s) as noted by the participant/subject Date of first motor symtpom(s) as noted by participant/subject. 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.). If participant/subject is unable to answer the question (e.g. due to dementia, disability, etc.), Not Applicable should be selected.

No references available Adult Supplemental 3.00 2013-07-14 19:48:50.273 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events

Free-Form Entry

C17734 Person completing the form title text PrsnCompletingFormTitleTxt Title/Credentials/Training of the person completing the form Title/Credentials/Training of the person completing the form Title/Credentials/Training of the person completing the form Alphanumeric No references available Adult Supplemental 3.00 2013-08-30 17:06:52.8 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events 255

Free-Form Entry

C18990 Huntingtons Disease motor symptom first appeared informant other text HDMotorSymptmFrstAppInformaOTH The free-text field related to 'Huntingtons Disease motor symptom first appeared informant type' specifying other text. The type of initial motor symptoms of Huntington disease (HD) described by the informant The free-text field related to 'Huntingtons Disease motor symptom first appeared informant type' specifying other text. The type of initial motor symptoms of Huntington disease (HD) described by the informant Other, specify Alphanumeric

Choose all that apply.

No references available Adult Supplemental 3.00 2013-07-14 19:48:50.273 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events 4000

Free-Form Entry

C14952 Huntingtons Disease motor symptom first appeared self report type HDMotorSymptmFrstAppSelfRepTyp The type of first motor symptoms described by the participant/subject The type of first motor symptoms described by the participant/subject Indicate first motor symptom(s) as noted by participant/subject Chorea;Fine motor coordination;Gross motor coordination;Gait disorder;Balance impairment;Dysphagia;Dysarthria;Involuntary vocalization/sounds;Slowness of movement;Tremor;Other symptoms, specify;Unable to remember first symptom Chorea;Fine motor coordination;Gross motor coordination;Gait disorder;Balance impairment;Dysphagia;Dysarthria;Involuntary vocalization/sounds;Slowness of movement;Tremor;Other symptoms, specify (i.e., motor symptoms, involuntary movements);Unable to remember first symptom (s) Alphanumeric

Choose all that apply.

No references available Adult Supplemental 3.00 2013-07-14 19:48:50.273 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events

Multiple Pre-Defined Values Selected

C17735 Motor symptom first appeared self report status MotorSymptmFrstSelfReprtStatus The status of the first motor symptom(s) as noted by the participant/subject The status of the first motor symptom(s) as noted by the participant/subject Date of first motor symtpom(s) as noted by participant/subject. Not applicable Not applicable Alphanumeric

(skip to question 4)

No references available Adult Supplemental 3.00 2013-08-30 17:06:52.8 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C18991 Huntingtons Disease developing motor symptom other text HDDevelopingMotorSymptmOTH The free-text field related to 'Huntingtons Disease developing motor symptom type' specifying other text. Type(s) of motor symptoms of Huntington disease (HD) which developed over the course of Illness The free-text field related to 'Huntingtons Disease developing motor symptom type' specifying other text. Type(s) of motor symptoms of Huntington disease (HD) which developed over the course of Illness Other, specify Alphanumeric

Choose all that apply. Other, specify. This question should be answered by the physician based on direct observation and with input from the informant and participant/subject (as applicable).

No references available Adult Supplemental 3.00 2013-07-14 19:48:50.273 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events 4000

Free-Form Entry

C14953 Chorea anatomic site ChoreaAntmicSite Anatomic site of the participant's/subject's body affected by chorea Anatomic site of the participant's/subject's body affected by chorea If Chorea, indicate location Face;Upper extremities;Lower extremities;Trunk Face;Upper extremities;Lower extremities;Trunk Alphanumeric

Choose all that apply.

No references available Adult Supplemental 3.00 2013-07-14 19:48:50.273 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events

Multiple Pre-Defined Values Selected

C17736 Symptoms first appeared informant status MotorSymptmFrstApInformantStat The status whether the first motor symptom(s) were noted by the person completing the form. The status whether the first motor symptom(s) were noted by the person completing the form. Date of first motor symtpom(s) as noted by informant Not applicable Not applicable Alphanumeric

Skip to question 6

No references available Adult Supplemental 3.00 2013-08-30 17:06:52.8 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C19059 Informant participant relationship other text InformantPartcpntRelateOTH The free-text field related to 'Informant participant relationship type' specifying other text. The relationship of the informant to participant/subject The free-text field related to 'Informant participant relationship type' specifying other text. The relationship of the informant to participant/subject Other, specify Alphanumeric No references available Adult Supplemental 3.00 2013-08-30 17:06:52.8 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events 4000

Free-Form Entry

C14954 Motor symptom improvement since diagnosis indicator MotorSymptmImprvmntSncDiagInd the indicator whether motor symptoms have improved since the first diagnosis. The indicator whether motor symptoms have improved since the first diagnosis. Have motor symptoms improved since first diagnosis? Yes;No Yes;No Alphanumeric

No additional instructions

No references available Adult Supplemental 3.00 2013-07-14 19:48:50.273 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C17737 Chorea anatomic site informant type ChoreaAntmicSiteInformantTyp Anatomic site of the participant's/subject's body affected by chorea as noted by the informant Anatomic site of the participant's/subject's body affected by chorea as noted by the informant If Chorea, indicate location Face;Upper extremities;Lower extremities;Trunk Face;Upper extremities;Lower extremities;Trunk Alphanumeric

Choose all that apply.

No references available Adult Supplemental 3.00 2013-08-30 17:06:52.8 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events

Multiple Pre-Defined Values Selected

C19060 Physician specialty other text PhysicianSpecialtyOTH The free-text field related to 'Physician specialty type' specifying other text. The specialty of the physician who made the diagnosis The free-text field related to 'Physician specialty type' specifying other text. The specialty of the physician who made the diagnosis Other, specify Alphanumeric No references available Adult Supplemental 3.00 2013-08-30 17:06:52.8 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events 4000

Free-Form Entry

C14955 Motor symptom first appeared informant date MotorSymptmFrstAppInformanDate Date the first motor symptom(s) were noted by the person completing the form. Date the first motor symptom(s) were noted by the participant/subject. Date of first motor symtpom(s) as noted by informant 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.). Informant is a person that has known the participant/subject since symtpm(s) onset. If informant has not known participant/subject since symptom(s) onset, Not Applicable should be selected.

No references available Adult Supplemental 3.00 2013-07-14 19:48:50.273 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events

Free-Form Entry

C17738 Informant participant relationship type InformantPartcpntRelateTyp The relationship of the informant to participant/subject The relationship of the informant to participant/subject Indicate relationship of informant to particiapnt/subject Family member, specify;Friend;Study Investigator/Study Coordinator;Other, specify: Family member, specify;Friend;Study Investigator/Study Coordinator;Other, specify: Alphanumeric No references available Adult Supplemental 3.00 2013-08-30 17:06:52.8 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events

Single Pre-Defined Value Selected

C14956 Huntingtons Disease motor symptom first appeared informant type HDMotorSymptmFrstAppInformaTyp The type of initial motor symptoms of Huntington disease (HD) described by the informant The type of initial motor symptoms of Huntington disease (HD) described by the informant Indicate first motor symptom(s) as noted by informant Chorea;Fine motor coordination;Gross motor coordination;Gait disorder;Balance impairment;Dysphagia;Dysarthria;Involuntary vocalization/sounds;Slowness of movement;Tremor;Other symptoms, specify;Unable to remember first symptom Chorea;Fine motor coordination;Gross motor coordination;Gait disorder;Balance impairment;Dysphagia;Dysarthria;Involuntary vocalization/sounds;Slowness of movement;Tremor;Other symptoms, specify (i.e., motor symptoms, involuntary movements);Unable to remember first symptom (s) Alphanumeric

Choose all that apply.

No references available Adult Supplemental 3.00 2013-07-14 19:48:50.273 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events

Multiple Pre-Defined Values Selected

C17739 Informant participant family member relationship text InformtPartcpntFamMembReltTxt The free-text field to specify the relationship of the informant to a family member of the participant/subject. The free-text field to specify the relationship of the informant to a family member of the participant/subject. Family member, specify Alphanumeric No references available Adult Supplemental 3.00 2013-08-30 17:06:52.8 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events 255

Free-Form Entry

C14957 Huntingtons Disease developing motor symptom type HDDevelopingMotorSymptmTyp Type(s) of motor symptoms of Huntington disease (HD) which developed over the course of Illness Type(s) of motor symptoms of Huntington disease which developed over the course of Illness What additional motor symtpoms have developed over the course of the illness as noted by a physician? Chorea;Fine motor coordination;Gross motor coordination;Gait disorder;Balance impairment;Dysphagia;Dysarthria;Involuntary vocalization/sounds;Slowness of movement;Tremor;Other symptoms, specify;Unable to remember first symptom Chorea;Fine motor coordination;Gross motor coordination;Gait disorder;Balance impairment;Dysphagia;Dysarthria;Involuntary vocalization/sounds;Slowness of movement;Tremor;Other symptoms, specify (i.e., motor symptoms, involuntary movements);Unable to remember first symptom (s) Alphanumeric

Choose all that apply. Other, specify. This question should be answered by the physician based on direct observation and with input from the informant and participant/subject (as applicable).

No references available Adult Supplemental 3.00 2013-07-14 19:48:50.273 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events

Multiple Pre-Defined Values Selected

C17740 Chorea anatomic site physician developing type ChoreaAntmicSitePhysDevelpTyp Anatomic site of the participant's/subject's body affected by chorea as noted by a physician as a developing issues from disease. Anatomic site of the participant's/subject's body affected by chorea as noted by a physician as a developing issues from disease. If Chorea, indicate location Face;Upper extremities;Lower extremities;Trunk Face;Upper extremities;Lower extremities;Trunk Alphanumeric

Choose all that apply.

No references available Adult Supplemental 3.00 2013-08-30 17:06:52.8 Medical History of Huntington's Disease History of Disease/Injury Event Disease/Injury Related Events

Multiple Pre-Defined Values Selected

CSV