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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: Devices
CRF: Implanted Devices Log
Item count: 21 (21 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
C18955
Device implanted other text
DevImpOTH
The free-text field related to 'Device implanted type' specifying other text. The type of device used
Other, specify
  
Alphanumeric
Link to line number on the Devices Log form
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
 
4000
Free-Form Entry
       
C14515
Device implanted type
DevImpTyp
The type of device used
Device
VNS;DBS;RNS;Other, specify;
VNS (Vagus Nerve Stimulation);DBS (Deep Brain Stimulation);RNS (Responsive Neurostimulation System);Other, specify;
Alphanumeric
Link to line number on the Devices Log form
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
Device type
 
Single Pre-Defined Value Selected
       
C18557
Device implanted log line number
DevImpLogLineNum
The reference line number of the entry on the implanted device log.
Line number
  
Numeric Values
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
  
Free-Form Entry
0
20
     
C14502
Device start date and time
DevStrtDateTime
Date (and time, if applicable and known) the device was functional and therapy was started with the parameters specified
Start Date
  
Date or Date & Time
Record the date the implanted device started to provide therapy. 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
8/28/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
Device start date and time
 
Free-Form Entry
       
C14503
Device implanted removal date
DevImpRemovalDate
The date the device no longer provided therapy according to the parameters specified
Stop 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
8/28/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
Device end date and time
 
Free-Form Entry
       
C14504
Device implanted amperage value
DevImpAmperageVal
The electrical amperage (amplitude) as set in the implanted device (strength of the electric current)
Amplitude
  
Numeric Values
Record in mA
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
Device amplitude value
 
Free-Form Entry
  
milliampere
    
C14505
Device implanted voltage value
DevImpVoltageVal
The electrical voltage as set in the implanted device (strength of the electric current)
Voltage
  
Numeric Values
Record in volts (V)
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
Device voltage value
 
Free-Form Entry
  
Volt
    
C14506
Device implanted frequency
DevImpFreq
The electrical frequency (number of complete cycles of a periodic process occurring per unit time) as set in the implanted device
Frequency
  
Numeric Values
Record in hertz (Hz)
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
Device frequency value
 
Free-Form Entry
  
Hertz
    
C14507
Device implanted pulse width value
DevImpPulseWidthVal
The width of the electrical pulse as set in the implanted device
Pulse Width
  
Numeric Values
Record in microseconds (uSec)
McGraw-Hill Dictionary of Scientific and Technical Terms, 5th Edition, Sybil P. Parker, editor, McGraw-Hill, New York, 1994
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
Device pulse width value
 
Free-Form Entry
  
microsecond
    
C14508
Device implanted stimulation on duration
DevImpStimulationOnDur
Time in minutes of stimulation when the implanted device is on
Stimulation Duration ON
  
Numeric Values
Record in minutes (mins)
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
Device stimulation on duration
 
Free-Form Entry
  
minute
    
C14509
Device implanted stimulation off duration
DevImpStimulationOffDur
Time in minutes of stimulation when the implanted device is off
Stimulation Duration OFF
  
Numeric Values
Record in minutes (mins)
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
Device stimulation off duration
 
Free-Form Entry
  
minute
    
C14510
Device implanted positive electrode count
DevImpPosElectrodesCt
The number of positive electrodes used by the implanted device
Positive Electrode
  
Numeric Values
Indicate number of positive electrodes, if applicable
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
Device positive electrode count
 
Free-Form Entry
       
C14511
Device implanted positive electrode location text
DevImpPosElectrodesLocTxt
The location of positive electrodes from the implanted device
Positive Electrode
  
Alphanumeric
Indicate location of positive electrodes, if applicable
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
Device positive electrode location text
255
Free-Form Entry
       
C14512
Device implanted negative electrode count
DevImpNegElectrodesCt
The number of negative electrodes used by the implanted device
Negative Electrode
  
Numeric Values
Indicate number of negative electrodes, if applicable
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
Device negative electrode count
 
Free-Form Entry
       
C14513
Device implanted negative electrode location text
DevImpNegElectrodesLocTxt
The location of negative electrodes from the implanted device
Negative Electrode
  
Alphanumeric
Indicate location of negative electrodes, if applicable
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
Device negative electrode location text
255
Free-Form Entry
       
C18954
Device implanted modification other text
DevImpModOTH
The free-text field related to 'Device implanted modification reason' specifying other text. The reason for modification of parameters or electrode configuration of original implanted device
Other, specify
  
Alphanumeric
Indicate the reason for device modification. Choose all that apply.
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
 
4000
Free-Form Entry
       
C14514
Device implanted modification reason
DevImpModRsn
The reason for modification of parameters or electrode configuration of original implanted device
If applicable, reason for modifying parameters or electrode configuration
Serious device adverse effect(s), specify;Intolerable stimulation related adverse event, specify;Other adverse event, specify;Inadequate Seizure Control;Other, specify;
Serious device adverse effect(s), specify;Intolerable stimulation related adverse event, specify;Other adverse event, specify;Inadequate Seizure Control;Other, specify;
Alphanumeric
Indicate the reason for device modification. Choose all that apply.
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
Device modification of parameters or electrode configuration reason
 
Multiple Pre-Defined Values Selected
       
C18559
Device implanted serious adverse effect modification description text
DevImpSAEModDescrTxt
The reason for modification of original parameters or original electrode configuration of implanted device due to serious device adverse effect(s) specification
Serious Adverse Device Effect(s), specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
 
255
Free-Form Entry
       
C18556
Device implanted intolerable stimulation adverse effect modification description text
DevImpIntoleStimAEModDescTxt
The reason for modification of original parameters or original electrode configuration of implanted device due to intolerable stimulation related Adverse Event (AE), specification
Intolerable Stimulation Related Adverse Event, specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
 
255
Free-Form Entry
       
C18558
Device implanted other adverse effect modification description text
DevImpOthAEModDescTxt
The reason for modification of original parameters or original electrode configuration of implanted device due to other Adverse Event (AE), specification
Other Adverse Event, specify
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
 
255
Free-Form Entry
       
C18555
Device implanted comment text
DevImpCommentTxt
The free-text field to capture any comments related to an implanted device.
Comments
  
Alphanumeric
No instructions available
No references available
Adult;Pediatric
Supplemental
3.0
7/30/2013
Aliases for variable name not defined
Implanted Devices Log
Devices
Treatment/Intervention Data
 
255
Free-Form Entry
       
09-25-2017
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