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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: Myotonic Muscular Dystrophy
Sub-Domain: General Health History
CRF: Medical History
Item count: 18 (18 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
Supplemental
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
 
C00315
Medical history global assessment indicator
MedclHistGlobalAssmtInd
Indicator of whether the participant/subject has a history of any medical problems/conditions
Does the participant/subject have a history of any medical problems/conditions in the following body systems?
Yes;No;
Yes;No;
Alphanumeric
If this question is answered NO then the rest of the form is blank. If the question is answered YES then the medical history for at least one body system should be recorded.
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
 
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);Neurological;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);Neurological;Psychiatric;Endocrine;Hematologic/Lymphatic;Allergic/Immunologic;Hepatobiliary;
Alphanumeric
Record the code number associated with the appropriate body system for each line of medical history. The numeric codes are provided for studies that will record the data on paper CRFs. In a database the body system can be used without the numeric codes.
Text term to identify a Review of Systems (ROS) component that consists of one or all members of an organ system, and/or additional medical questions.
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
 
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
Record one Medical History term per line. Surgeries in the medical history should also be recorded under this CDE. See the data dictionary for additional information on coding the condition using SNOMED CT.
Text term to identify a Review of Systems (ROS) component that consists of one or all members of an organ system, and/or additional medical questions.
SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html)
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
 
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
 
C19519
Disease condition associated name
DiseaseConditionAssociatedName
Name of associated disease/condition
Associated Disease/Condition
Thyroid condition;Diabetes mellitus;Rheumatoid arthritis;Systemic lupus erythematosus (SLE);Muscle disease;Epilepsy/Seizures;Cancer;Other disease/condition, specify;
Thyroid condition;Diabetes mellitus;Rheumatoid arthritis;Systemic lupus erythematosus (SLE);Muscle disease;Epilepsy/Seizures;Cancer;Other disease/condition, specify;
Alphanumeric
The questions in the following table should be explicitly asked to ensure a complete medical history is documented for conditions associated with Myotonic Dystrophy.
No references available
Adult;Pediatric
Supplemental
1.0
7/11/2014
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C18793
Medical history condition other text
MedHistCondOTH
The free-text field related to 'Medical history condition type' specifying other text. Pre-specified medical condition/disease asked about when collecting the medical history from the participant/subject or found documented in the medical record.
Other disease/condition, specify:
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/17/2013
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
 
4000
Free-Form Entry
       
C19520
Subject affected indicator
SubjectAffectedInd
Indicator for the subject's being affected
Subject Affected?
Yes;No;
Yes;No;
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
7/11/2014
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C19521
Thyroid condition type
ThyroidConditionTyp
Type of thyroid condition
Type
Hypothyroidism;Hyperthyroidism;Hashimoto's;
Hypothyroidism;Hyperthyroidism;Hashimoto's;
Alphanumeric
Indicate the type of thyroid condition
No references available
Adult;Pediatric
Supplemental
1.0
7/11/2014
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C06358
Diabetes mellitus type
DiabetesMellitusTyp
Type of diabetes mellitus
Type
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/24/2013
DIABTYHX
Medical History
General Health History
Participant History and Family History
Diabetes mellitus type
 
Single Pre-Defined Value Selected
       
C19676
Muscle disease hereditary type
MuscDisHeredTyp
Specify if muscle disease type is hereditary
Type
Hereditary, specify;
Hereditary, specify;
Alphanumeric
Indicate type of muscle disease
No references available
Adult;Pediatric
Supplemental
1.0
2/18/2015
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C19522
Muscle disease hereditary type specify text
MusclDiseasHerditryTypSpcfyTxt
Specify text for type of hereditary muscle disease
Type
  
Alphanumeric
Hereditary, specify
No references available
Adult;Pediatric
Supplemental
1.0
7/11/2014
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
 
4000
Free-Form Entry
       
C19677
Muscle disease inflammatory type
MuscDisInflammTyp
Specify if muscle disease type is inflammatory
Type
Inflammatory, specify;
Inflammatory, specify;
Alphanumeric
Indicate type of muscle disease
No references available
Adult;Pediatric
Supplemental
1.0
2/18/2015
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Single Pre-Defined Value Selected
       
C19523
Muscle disease inflammatory type specify text
MusclDiseasInflmtryTypSpcfyTxt
Specify text for type of inflammatory muscle disease
Type
  
Alphanumeric
Inflammatory, specify
No references available
Adult;Pediatric
Supplemental
1.0
7/11/2014
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
 
4000
Free-Form Entry
       
C17461
Cancer history type text
CancerHistTypTxt
Text description of the type of cancer the participant/subject was or is diagnosed with
Type
  
Alphanumeric
Type of cancer:
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
       
C19524
Diagnosis date
DiagnosisDate
Date of diagnosis
Diagnosis Date
  
Date or Date & Time
No instructions available
No references available
Adult;Pediatric
Supplemental
1.0
7/11/2014
Aliases for variable name not defined
Medical History
General Health History
Participant History and Family History
  
Free-Form Entry
       
12-10-2018
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