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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: 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
Record the type of device. Core for all prospective intervention studies
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Devices Log
Devices
Treatment/Intervention Data
 
4000
Free-Form Entry
       
C14515
Device implanted type
DevImpTyp
The type of device used
Device Name
VNS;DBS;RNS;Other, specify;
VNS (Vagus Nerve Stimulation);DBS (Deep Brain Stimulation);RNS (Responsive Neurostimulation System);Other, specify;
Alphanumeric
Record the type of device. Core for all prospective intervention studies
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Devices Log
Devices
Treatment/Intervention Data
Device type
 
Single Pre-Defined Value Selected
       
C18564
Device log line number
DevLogLineNum
The referenced line number of the entry on the 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
Devices Log
Devices
Treatment/Intervention Data
  
Free-Form Entry
0
20
     
C14516
Device implanted implant date and time
DevImpImplantDateTime
Date (and time, if applicable and known) the device was implanted and became functional.
Date of Initial Implant
  
Date or Date & Time
Record the date of initial implant. Core for all prospective intervention studies. 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
Devices Log
Devices
Treatment/Intervention Data
Device implant date and time
 
Free-Form Entry
       
C14517
Device manufacturer name
DevManufName
The company responsible for development of the device
Device Manufacturer
  
Alphanumeric
Record the device manufacturer. Core for all prospective intervention studies
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Devices Log
Devices
Treatment/Intervention Data
Device manufacturer name
255
Free-Form Entry
       
C14518
Device component type
DevCompTyp
The name of a part of the device that has a registration number or serial number
Device Component Registration number or Serial number
INS;Lead;Extension;
Implanted Nerve Stimulator (INS);Lead;Extension;
Alphanumeric
Select the component(s) of the device as applicable. Core for all prospective intervention studies
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Devices Log
Devices
Treatment/Intervention Data
Device component type
 
Single Pre-Defined Value Selected
       
C14519
Device component registration or serial number
DevCompRegstrnSerialNum
The registration number or serial number of the device and component(s) to distinguish it from other devices (extension if applicable)
Device Component Registration number or Serial number
  
Numeric Values
Enter all applicable device registration or serial number(s). Core for all prospective intervention studies
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Devices Log
Devices
Treatment/Intervention Data
Device registration or serial number
 
Free-Form Entry
       
C18956
Device stimulation target anatomic other text
DevStimTargAntmicOTH
The free-text field related to 'Device stimulation target anatomic site' specifying other text. The target of stimulation the device acts upon (where the device lead is located)
Other, specify
  
Alphanumeric
Indicate stimulation target of device. Choose only one. Core for all prospective intervention studies
No references available
Adult;Pediatric
Supplemental
1.0
10/5/2012
Aliases for variable name not defined
Devices Log
Devices
Treatment/Intervention Data
 
4000
Free-Form Entry
       
C14520
Device stimulation target anatomic site
DevStimTargAntmicSite
The target of stimulation the device acts upon (where the device lead is located)
Stimulation Target
Left Vagus Nerve;Hippocampus;Hippocampus: Left side;Hippocampus: Right side;AN;AN: Unilateral;AN: Bilateral;Other, specify;
Left Vagus Nerve;Hippocampus;Hippocampus: Left side;Hippocampus: Right side;AN;AN: Unilateral;AN: Bilateral;Other, specify;
Alphanumeric
Indicate stimulation target of device. Choose only one. Core for all prospective intervention studies
No references available
Adult;Pediatric
Supplemental
1.0
10/5/2012
Aliases for variable name not defined
Devices Log
Devices
Treatment/Intervention Data
Device stimulation target anatomic site
 
Single Pre-Defined Value Selected
       
C14521
Device lead type
DevLeadTyp
Type of insulated wires (leads) for the device implanted
Type of Lead
VNS;Depth;Strip;Other, specify;
VNS (Vagus Nerve Stimulation);Depth;Strip;Other, specify;
Alphanumeric
Choose all that apply; if other specify. Core for all prospective intervention studies
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Devices Log
Devices
Treatment/Intervention Data
Device lead type
 
Multiple Pre-Defined Values Selected
       
C18957
Device lead other text
DevLeadOTH
The free-text field related to 'Device lead type' specifying other text. Type of insulated wires (leads) for the device implanted
Type of Lead
  
Alphanumeric
Choose all that apply; if other specify. Core for all prospective intervention studies
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Devices Log
Devices
Treatment/Intervention Data
 
4000
Free-Form Entry
       
C14522
Device lead contact count
DevLeadContctCt
The number of contacts of the insulated wires (leads)
Number of Contacts
  
Numeric Values
Indicate number of contacts for lead, if applicable. Core for all prospective intervention studies
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Devices Log
Devices
Treatment/Intervention Data
Device lead contact number
 
Free-Form Entry
       
C18958
Device neurostimulator anatomic other text
DevNeurostimAntmicOTH
The free-text field related to 'Device neurostimulator anatomic site' specifying other text. The location in the body of where the device is providing electrical stimulation
Other, specify
  
Alphanumeric
Choose all that apply; if other specify. Core for all prospective intervention studies
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Devices Log
Devices
Treatment/Intervention Data
 
4000
Free-Form Entry
       
C14523
Device neurostimulator anatomic site
DevNeurostimAntmicSite
The location in the body of where the device is providing electrical stimulation
Location of Neurostimulator
Right chest;Left chest;Other, specify;
Right chest;Left chest;Other, specify;
Alphanumeric
Choose all that apply; if other specify. Core for all prospective intervention studies
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Devices Log
Devices
Treatment/Intervention Data
Device neurostimulator anatomic site
 
Multiple Pre-Defined Values Selected
       
C14524
Device permanent explant date
DevPermExplantDate
Date the device was removed from the subject
Date of Permanent Explant
  
Date or Date & Time
As applicable, complete the Implanted Devices Log if (device) not explanted. Core for all prospective intervention studies. 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
Devices Log
Devices
Treatment/Intervention Data
Device permanent explant date and time
 
Free-Form Entry
       
C14525
Device part left in the body indicator
DevPartLftInBodyInd
An indicator of whether any part of the device was left in the subject's body after the device was removed, with identification of the part
Is any part of the device left in the body?
Yes;No;
Yes;No;
Alphanumeric
Indicate if any part of device is remaining in body after therapy. Record in the log along with the location of the part. Core for all prospective intervention studies
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Devices Log
Devices
Treatment/Intervention Data
Device part left in the body indicator
 
Single Pre-Defined Value Selected
       
C14527
Device discontinuation reason
DevDisctRsn
The reason the subject discontinued use of the device
If applicable, Reason for Discontinuation
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 reason for discontinuation, if applicable Core for all prospective intervention studies
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Devices Log
Devices
Treatment/Intervention Data
Device discontinuation reason
 
Single Pre-Defined Value Selected
       
C18959
Device discontinuation other text
DevDisctOTH
The free-text field related to 'Device discontinuation reason' specifying other text. The reason the subject discontinued use of the device
Other, specify
  
Alphanumeric
Indicate reason for discontinuation, if applicable Core for all prospective intervention studies
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
Devices Log
Devices
Treatment/Intervention Data
 
4000
Free-Form Entry
       
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
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
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
Devices Log
Devices
Treatment/Intervention Data
 
255
Free-Form Entry
       
05-26-2017
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