of0
Export
 
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:
Sub-Domain: History of Disease/Injury Event
CRF: Medical History of SMA - SMA
Item count: 9 (9 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 of SMA - SMA
History of Disease/Injury Event
Disease/Injury Related Events
Medical history taken date and time
 
Free-Form Entry
     
2179659
 
C12618
Age first suspected something different range
Age1stSuspectDifferentRng
Age range of participant/subject when it was first suspected that something might be "different"
At what age was it first suspected that something might be different?
Fetal;At birth;1-2 months;3-6 months;7-12 months;13-24 months;25-36 months;37 months - 10 years;11 - 20 years;21-30 years;
Fetal;At birth;1-2 months;3-6 months;7-12 months;13-24 months;25-36 months;37 months - 10 years;11 - 20 years;21-30 years;
Alphanumeric
Choose one
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Medical History of SMA - SMA
History of Disease/Injury Event
Disease/Injury Related Events
Age first suspected something different range
 
Single Pre-Defined Value Selected
       
C12632
Spinal muscular atrophy symptom type
SMASymptmTyp
Type of all spinal muscular atrophy (SMA) symptoms or signs exhibited by the participant/subject
Signs and Symptoms
Abnormal position of hands/feet;Joint contractures;Joint hyperlaxity;Joint dislocation;Club foot;Weakness;Breathing problems;Failure to Thrive;Feeding/swallowing problems;Constipation;Spine abnormality;Eye abnormality;Cognitive abnormality;Speech delay;
Abnormal position of hands/feet;Joint contractures;Joint hyperlaxity;Joint dislocation;Club foot;Weakness;Breathing problems;Failure to Thrive;Feeding/swallowing problems;Constipation;Spine abnormality;Eye abnormality;Cognitive abnormality;Speech delay;
Alphanumeric
Record whether the participant/subject exhibited each sign
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Medical History of SMA - SMA
History of Disease/Injury Event
Disease/Injury Related Events
SMA symptom or sign type
 
Single Pre-Defined Value Selected
       
C12633
Spinal muscular atrophy symptom indicator
SMASymptmInd
Indicator whether the participant/subject exhibits the selected spinal muscular atrophy (SMA) symptom or sign
NULL
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Answer for each first sign of SMA
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Medical History of SMA - SMA
History of Disease/Injury Event
Disease/Injury Related Events
SMA symptom or sign indicator
 
Single Pre-Defined Value Selected
       
C10500
Symptom onset age value
SymptomOnsetAgeVal
Age when symptoms first experienced
If yes, indicate age when first noticed
  
Numeric Values
Answer should be recorded in years. History can be obtained from participant/ subject, family member, friend, or chart/ medical record. Answered for all joint conditions and signs, except for Club Foot. If age is unknown, record as Age Unknown for Weakness, Breathing problems, Failure to thrive, Feeding/ swallowing problems, Constipation, Spine abnormality, Eye abnormality, Cognitive abnormality, and Speech delay
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Medical History of SMA - SMA
History of Disease/Injury Event
Disease/Injury Related Events
Symptom onset age value
 
Free-Form Entry
       
C12634
Spinal muscular atrophy symptom joint type
SMASymptmJntTyp
Type of joint-related spinal muscular atrophy (SMA) symptom or sign exhibited by the participant/subject
NULL
Joint contractures;Joint hyperlaxity;Joint dislocation;
Joint contractures;Joint hyperlaxity;Joint dislocation;
Alphanumeric
For each joint condition that affects the participant/subject record the anatomic site and laterality
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Medical History of SMA - SMA
History of Disease/Injury Event
Disease/Injury Related Events
Joint condition type
 
Single Pre-Defined Value Selected
       
C12635
Spinal muscular atrophy symptom joint type anatomic site
SMASymptmJntTypAntmicSite
Anatomic site of the selected type of joint-related spinal muscular atrophy (SMA) symptom or sign exhibited by the participant/subject
If Yes, indicate location
Elbows;Wrists;Fingers;Hips;Knees;Ankles;Toes;
Elbows;Wrists;Fingers;Hips;Knees;Ankles;Toes;
Alphanumeric
Answer for' Joint contractures', 'Joint Hyperlaxity', and 'Joint dislocation'
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Medical History of SMA - SMA
History of Disease/Injury Event
Disease/Injury Related Events
Joint condition anatomic site
 
Single Pre-Defined Value Selected
       
C12636
Spinal muscular atrophy symptom hip dislocate side indicator
SMASymptmHipDislocSideInd
Indicator of the side of the body on which the participant/subject has a dislocated hip
If Hip dislocation
Right;Left;Bilateral;
Right;Left;Bilateral (both sides);
Alphanumeric
Only answered if "Hips" was answered for "Joint dislocation"
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Medical History of SMA - SMA
History of Disease/Injury Event
Disease/Injury Related Events
Hip dislocation laterality type
 
Single Pre-Defined Value Selected
       
C12637
Spinal muscular atrophy symptom club foot side indicator
SMASymptmClubFootSideInd
Indicator of the side of the body on which the participant/subject has a club foot
If yes, indicate location
Right;Left;Bilateral;
Right;Left;Bilateral (both feet);
Alphanumeric
Choose one
No references available
Adult;Pediatric
Supplemental
3.0
7/25/2013
Aliases for variable name not defined
Medical History of SMA - SMA
History of Disease/Injury Event
Disease/Injury Related Events
Club foot laterality type
 
Single Pre-Defined Value Selected
       
12-17-2018
Page 1 of 1