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CDE Detailed Report
This report contains detailed information about the selected CDEs.
Note: If at least one CDE was selected from a copyright- or trademark-protected instrument/scale then all of the CDEs from that instrument/scale are included in this report.
Disease: Friedreich's Ataxia
Sub-Domain: General Health History
CRF: Medical History
Item count: 47 (47 distinct CDEs)
CDE ID
CDE Name
Variable Name
Definition / Description
Question Text
Permissible Value
Description
Data Type
Instructions
References
Population
Classification (e.g., Core)
Version #
Version Date
Aliases for Variable Name
CRF Module / Guideline
© or TM
Sub-Domain
Domain
Previous Title
Size
Input Restrictions
Min Value
Max Value
Measurement Type
LOINC ID
SNOMED
caDSR ID
CDISC ID
C00314
Medical history taken date and time
MedclHistTakenDateTime
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
Core
3.0
7/25/2013
PT_REL_MED_HIST_DT
Medical History
General Health History
Participant History and Family History
Medical history taken date and time
 
Free-Form Entry
     
2179659
 
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.
Does the participant/subject have a history of any medical problems/conditions in the following body systems?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Choose one for each body system.
No references available
Adult;Pediatric
Core
3.0
7/22/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Medical history for body system indicator
 
Single Pre-Defined Value Selected
       
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.
Body System
Constitutional symptoms (e.g., fever, weight loss);Eyes;Ears, Nose, Mouth, Throat;Cardiovascular;Respiratory;Gastrointestinal;Genitourinary;Musculoskeletal;Integumentary (skin and/or breast);Psychiatric;Endocrine;Hematologic/Lymphatic;Allergic/Immunologic;Hepatobiliary;
Constitutional symptoms (e.g., fever, weight loss);Eyes;Ears, Nose, Mouth, Throat;Cardiovascular;Respiratory;Gastrointestinal;Genitourinary;Musculoskeletal;Integumentary (skin and/or breast);Psychiatric;Endocrine;Hematologic/Lymphatic;Allergic/Immunologic;Hepatobiliary;
Alphanumeric
Enter all significant medical history items, including surgeries, EXCEPT the problem/condition that is the focus of this study. Use only one line per description.;Each body system is pre-populated on the case report form. Record the physical exam results for each.
Review of Symptoms from Centers for Medicare and Medicaid Services https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Body system category
 
Single Pre-Defined Value Selected
     
2002895
 
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
Other, specify
  
Alphanumeric
Enter all significant medical history items, including surgeries, EXCEPT the problem/condition that is the focus of this study. Use only one line per description.;Each body system is pre-populated on the case report form. Record the physical exam results for each.
Review of Symptoms from Centers for Medicare and Medicaid Services https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/eval_mgmt_serv_guide-ICN006764.pdf
Adult;Pediatric
Supplemental
1.0
5/27/2014
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
 
4000
Free-Form Entry
     
2002895
 
C00322
Medical history condition text
MedclHistCondTxt
Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history
Medical History Term
  
Alphanumeric
Enter all significant medical history items, including surgeries, EXCEPT the problem/condition that is the focus of this study. Use only one line per description.
No references available
Adult;Pediatric
Core
3.0
7/25/2013
Refer to SCI CDE Annotated Form
Medical History
General Health History
Participant History and Family History
Medical history condition text
4000
Free-Form Entry
     
2003874
 
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
Medical History Term
  
Alphanumeric
Code each of the medical history conditions using SNOMED CT
SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html)
Adult;Pediatric
Core
3.0
7/25/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Medical history condition SNOMED CT code
255
Free-Form Entry
       
C00317
Medical history condition start date and time
MedclHistCondStrtDateTime
Date (and time, if applicable and known) for the start of an event in the participant's/subject's medical history
Start Date
  
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
3.0
7/25/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Medical history condition start date and time
 
Free-Form Entry
     
2543596
 
C00319
Medical history condition ongoing indicator
MedclHistCondOngoingInd
Indicator of whether a medical condition/disease experienced by the participant/subject is ongoing
Ongoing?
Yes;No;
Yes;No;
Alphanumeric
Check Yes or No to indicate if the medical condition/disease is still present.
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Medical history condition ongoing indicator
 
Single Pre-Defined Value Selected
     
2736881
 
C00316
Medical history condition end date and time
MedclHistCondEndDateTime
Date (and time, if applicable and known) for the end of an event in the participant's/subject's medical history
End Date
  
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
3.0
7/25/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
Medical history condition end date and time
 
Free-Form Entry
     
3145557
 
C00315
Medical history global assessment indicator
MedclHistGlobalAssmtInd
Indicator of whether the participant/subject has a history of any medical problems/conditions
Documented medical history:
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
MED_HIST_YN
Medical History
General Health History
Participant History and Family History
Medical history global assessment indicator
 
Single Pre-Defined Value Selected
     
3145578
 
C17476
Cardiovascular history condition indicator
CardioHistCondInd
Indicator as to whether the participant/subject has or had a cardiac condition or complication
Cardiac condition
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/15/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C17469
Cardiovascular history arrhythmia indicator
CardioHistArrhythInd
Indicator as to whether the participant/subject has or had a cardiac arrhythmia
Arrhythmia
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/15/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C17466
Cardiovascular history arrhythmia atrial fibrillation indicator
CardioHistArrhythAtrialFibInd
Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of atrial fibrillation
Atrial fibrillation
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/15/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C17467
Cardiovascular history arrhythmia atrial flutter indicator
CardioHistArrhythAtrialFlutInd
Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of atrial flutter
Atrial flutter
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/15/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C17471
Cardiovascular history arrhythmia supraventricular tachycardia indicator
CardioHistArrhythSupraTachInd
Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of supraventricular tachycardia
Supraventricular tachycardia
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/15/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C17472
Cardiovascular history arrhythmia ventricular tachycardia indicator
CardioHistArrhythVentTachInd
Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of ventricular tachycardia
Ventricular tachycardia
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/15/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C17468
Cardiovascular history arrhythmia bradycardia indicator
CardioHistArrhythBradycardInd
Indicator as to whether the participant/subject has or had a cardiac arrhythmia in the form of bradycardia
Bradycardia
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/15/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C17470
Cardiovascular history arrhythmia other text
CardioHistArrhythOtherTxt
Text description of any cardiac arrhythmia the participant/subject has or had in a form other than atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia, or bradycardia
Other, specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/15/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
 
255
Free-Form Entry
       
C17478
Cardiovascular history heart failure indicator
CardioHistHeartFailureInd
Indicator as to whether the participant/subject has ever experienced heart failure
Heart failure
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/15/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C17479
Cardiovascular history ischemia heart disease indicator
CardioHistIschHeartDiseaseInd
Indicator as to whether the participant/subject has or had ischemia heart disease
Ischemia heart disease
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/15/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C17463
Cardiovascular history abnormal echocardiogram indicator
CardioHistAbnrmlECGInd
Indicator as to whether the participant/subject has or had an abnormal echocardiogram (ECG)
Abnormal echocardiogram
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/15/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C17464
Cardiovascular history abnormal echocardiogram left ventricular hypertrophy indicator
CardioHistAbnrmlECGLVHInd
Indicator as to whether the participant/subject has or had an abnormal echocardiogram (ECG) specifically exhibiting left ventricular hypertrophy (LVH)
LVH
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/15/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C17462
Cardiovascular history abnormal echocardiogram decreased left ventricular function indicator
CardioHistAbnrmlECGDecLVFnInd
Indicator as to whether the participant/subject has or had an abnormal echocardiogram (ECG) specifically exhibiting decreased left ventricular (LV) function
Decreased LV function
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/15/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C17465
Cardiovascular history abnormal echocardiogram other text
CardioHistAbnrmlECGOtherTxt
Text description of any abnormal characteristics other than left ventricular hypertrophy (LVH), or decreased left ventricular (LV) function that the participant/subject has ever exhibited on an echocardiogram (ECG)
Other, specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/15/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
 
255
Free-Form Entry
       
C17474
Cardiovascular history cardiac surgery indicator
CardioHistCardSurgInd
Indicator as to whether the participant/subject has had cardiac surgery or mechanical intervention
Cardiac surgery/mechanical intervention
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/15/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C17475
Cardiovascular history cardiac surgery type
CardioHistCardSurgTyp
Type of cardiac surgery or mechanical intervention the participant/subject underwent
If Yes, indicate type
Coronary artery bypass graft;Cardiac valve surgery, including non-open surgery;Pacemaker;Implantable cardiac defibrillator;Other, specify;
Coronary artery bypass graft (CABG);Cardiac valve surgery, including non-open surgery (i.e. percutaneous valvuloplasty);Pacemaker;Implantable cardiac defibrillator;Other, specify;
Alphanumeric
Choose all that apply
No references available
Adult;Pediatric
Supplemental
3.0
7/15/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Multiple Pre-Defined Values Selected
       
07-21-2019
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