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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: Epilepsy
Sub-Domain: Patient Reported Outcomes
CRF: Seizure Diary
Item count: 6 (6 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
C10626
Condition diary date and time
CondDiaryDateTime
Date (and time, if applicable and known) the diary data are recorded
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.).
Supplemental - Highly Recommended
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
8/28/2013
Aliases for variable name not defined
Seizure Diary
Patient Reported Outcomes
Outcomes and End Points
Diary date and time
 
Free-Form Entry
       
C14136
Seizure daily diary no seizure indicator
SeizDlyDiaryNoSeizInd
The indicator of whether the participant/subject experienced NO seizures on the corresponding date
No Seizures
No seizures;
No seizures;
Alphanumeric
Mark the no seizure box if you did not have any seizures for a day.
Supplemental - Highly Recommended
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
8/28/2013
Aliases for variable name not defined
Seizure Diary
Patient Reported Outcomes
Outcomes and End Points
Diary day seizure indicator
 
Single Pre-Defined Value Selected
       
C10635
Seizure daily diary seizure type
SeizDlyDiarySeizTyp
Type of seizure experienced by the participant/subject on the specific date
Seizure code
Generalized Tonic Clonic (in any combination);Generalized Absence;Generalized Absence-Typical;Generalized Absence-Atypical;Generalized Absence-Myoclonic absence;Generalized Absence-Eyelid myoclonia;Generalized Myoclonic;Generalized Myoclonic-Myoclonic atonic;Generalized Myoclonic-Myoclonic tonic;Generalized Clonic;Generalized Tonic;Generalized Atonic;Epileptic spasms, focal or generalized;Focal without impairment of consciousness or responsiveness;Focal without impairment of consciousness or responsiveness -With observable motor or autonomic components (roughly corresponds to the concept of “simple partial seizure”);Focal without impairment of consciousness or responsiveness- Involving subjective sensory or psychic phenomena only (corresponds to the concept of “aura”);Focal with impairment of consciousness or responsiveness (roughly corresponds to the concept of “complex partial seizure”);Focal evolving to a bilateral, convulsive seizure (involving tonic, clonic, or tonic and clonic components - replaces the term “secondarily generalized seizure”);Unclassified seizure type;
Generalized Tonic Clonic (in any combination);Generalized Absence;Generalized Absence-Typical;Generalized Absence-Atypical;Generalized Absence-Myoclonic absence;Generalized Absence-Eyelid myoclonia;Generalized Myoclonic;Generalized Myoclonic-Myoclonic atonic;Generalized Myoclonic-Myoclonic tonic;Generalized Clonic;Generalized Tonic;Generalized Atonic;Epileptic spasms, focal or generalized;Focal without impairment of consciousness or responsiveness;Focal without impairment of consciousness or responsiveness -With observable motor or autonomic components (roughly corresponds to the concept of “simple partial seizure”);Focal without impairment of consciousness or responsiveness- Involving subjective sensory or psychic phenomena only (corresponds to the concept of “aura”);Focal with impairment of consciousness or responsiveness (roughly corresponds to the concept of “complex partial seizure”);Focal evolving to a bilateral, convulsive seizure (involving tonic, clonic, or tonic and clonic components - replaces the term “secondarily generalized seizure”);Unclassified seizure type;
Alphanumeric
Record the number of seizures and the type of seizure (using the assigned code) on the diary. The physician/coordinator will review the diary with the patient and ask them to describe each of his/her seizures. Each seizure type will then be classified using the standard seizure terminology and be assigned a single code (A - F) for use on the diary.
Supplemental - Highly Recommended
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
8/28/2013
Aliases for variable name not defined
Seizure Diary
Patient Reported Outcomes
Outcomes and End Points
Diary day seizure type
 
Single Pre-Defined Value Selected
       
C14138
Seizure daily diary seizure type count
SeizDlyDiarySeizTypCt
The number of seizures of the particular seizure type that the participant/subject experienced on the corresponding date
   
Numeric Values
Indicate number of seizures for each type of seizure identified.
Supplemental - Highly Recommended
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
8/28/2013
Aliases for variable name not defined
Seizure Diary
Patient Reported Outcomes
Outcomes and End Points
Diary day seizure type count
 
Free-Form Entry
0
99
     
C14139
Seizure diary completer type
SeizDiaryCompltrTyp
The type of person recording the diary data
Who is completing the seizure diary?
Participant/subject;Caregiver;Other, specify;
Participant/subject;Caregiver;Other, specify;
Alphanumeric
Choose only one
Supplemental - Highly Recommended
No references available
Adult;Pediatric
Supplemental–Highly Recommended
3.0
8/28/2013
Aliases for variable name not defined
Seizure Diary
Patient Reported Outcomes
Outcomes and End Points
Diary reporter type
 
Single Pre-Defined Value Selected
       
C18904
Seizure diary completer other text
SeizDiaryCompltrOTH
The free-text field related to 'Seizure diary completer type' specifying other text. The type of person recording the diary data
Other, specify
  
Alphanumeric
Choose only one
Supplemental - Highly Recommended
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Seizure Diary
Patient Reported Outcomes
Outcomes and End Points
 
4000
Free-Form Entry
       
09-25-2017
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