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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: Adverse Events
CRF: Adverse Event Tracking Log
Item count: 13 (13 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
C18659
Unexpected adverse event indicator
UnexpectAdvrsEvntInd
The indicator of whether the adverse event is unexpected
Serious Adverse Event
Yes;No;
Yes;No;
Alphanumeric
Choose Yes or No. This question should be answered YES if the AE was not previously identified as an adverse event associated with use of the investigational drug or medical device, based on those described in the Investigator’s Brochure. An event may also be identified as unexpected if the adverse event increased in frequency or severity than what is described by the Investigator’s Brochure.
No references available
Adult;Pediatric
Supplemental
1.0
1/30/2014
Aliases for variable name not defined
Adverse Event Tracking Log
Adverse Events
Safety Data
  
Single Pre-Defined Value Selected
       
C02308
Adverse event during study indicator
AdvrsEvntDuringStudyInd
Indicator of whether the participant/subject experienced any adverse events during the study
Has the participant/subject had any adverse events during the study?
Yes;No;
Yes;No;
Alphanumeric
Choose one. If answered Yes, at least one AE must be recorded.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
AE_YN
Adverse Event Tracking Log
Adverse Events
Safety Data
Adverse event during study indicator
 
Single Pre-Defined Value Selected
     
2188132;3177812
 
C02307
Adverse event verbatim term text
AdvrsEvntVerbatimTermText
Text that describes the adverse event word for word as described by the participant/subject
Adverse Event
  
Alphanumeric
Any untoward medical occurrence in a study participant/subject that does not necessarily have a causal relationship with the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study intervention or study procedure, whether or not related to the study intervention or procedure. Each AE should be listed on a separate line. Any worsening of a baseline condition or reoccurrence of a baseline condition that had previously ended for a time should be listed as an AE. Events, such as nausea and vomiting are considered two events, and therefore should be listed on separate lines. A participant/subject may experience an unexpected AE. An unexpected adverse reaction has a nature or severity of which is not consistent with the study intervention description (e.g. Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product). The unexpected AE must be reported, whether related to the study intervention or not, with as much detail as is available.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
AE_VERBATIM_TRM_TXT
Adverse Event Tracking Log
Adverse Events
Safety Data
Adverse event verbatim term text
4000
Free-Form Entry
     
2188132
 
C02310
Adverse event CTCAE low level term name
AdvrsEvntCTCAELowLvlTermName
Text that represents the Common Terminology Criteria for Adverse Events (CTCAE) low level term name for an adverse event.
   
Alphanumeric
Code the adverse event verbatim text with the Common Terminology Criteria for Adverse Events (CTCAE) low level term name. CTCAE is a freely available standard terminology for adverse event data.
Common Terminology Criteria for Adverse Events (CTCAE) v4.0 (http://evs.nci.nih.gov/ftp1/CTCAE/About.html)
Adult;Pediatric
Supplemental
3.0
8/28/2013
CTCAE4_LLT_NM
Adverse Event Tracking Log
Adverse Events
Safety Data
Adverse event CTCAE low level term name
255
Free-Form Entry
     
3125302
 
C02311
Adverse event MedDRA lower level term code
AdvsEvntMedDRALowerLvlTermCode
Code that corresponds to the Medical Dictionary for Regulatory Activities (MedDRA) Lower Level Term (LLT) for an adverse event
   
Alphanumeric
Code the adverse event verbatim text with the Medical Dictionary for Regulatory Activities (MedDRA) Lower Level Term (LLT) codes.
Medical Dictionary for Regulatory Activities (http://www.meddramsso.com/index.asp)
Adult;Pediatric
Supplemental
3.0
7/18/2013
CTCAE4_M_LLTMEDDRACD
Adverse Event Tracking Log
Adverse Events
Safety Data
Adverse event MedDRA lower level term code
255
Free-Form Entry
     
3133353
 
C02306
Adverse event start date and time
AdvrsEvntStartDateTime
Date (and time, if applicable and known) on which the adverse event was first evident
Start Date
  
Date or Date & Time
Record the date (and time) the adverse event started. If a previously recorded AE worsens, a new record should be created with a new start date. There should be no AE start date prior to the date of the informed consent. Any AE that started prior to the informed consent date belongs instead in the medical history. If an item recorded on the medical history worsens during the study, the date of the worsening is entered as an AE with the start date as the date the condition worsened. 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
7/18/2013
AE_ONSET_DT
Adverse Event Tracking Log
Adverse Events
Safety Data
Adverse event start date and time
 
Free-Form Entry
     
2744993
 
C02301
Adverse event end date and time
AdverseEvntEndDateTime
Date (and time, if applicable and known) on which the adverse event discontinued/stopped
End Date
  
Date or Date & Time
Record the date (and time) the adverse event stopped or worsened. If an AE worsens, record an end date and create a new AE record with a new start date and severity. 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
7/18/2013
AE_RESOLV_ALDT
Adverse Event Tracking Log
Adverse Events
Safety Data
Adverse event end date and time
 
Free-Form Entry
     
2189843
 
C02305
Adverse event severity grade scale
AdvrsEvntSeverScale
The grading scale of the severity or intensity of the adverse event
Severity
Grade 1;Grade 2;Grade 3;Grade 4;Grade 5;
Mild: asymptomatic or mild symtoms, clinical or diagnostic observations only, intervention not indicated.;Moderate: minimal, local or noninvasive intervention indicated, limiting age-appropriate Activities of Daily Living.;Severe or medically significant but not immediately life-threatening: hospitalization or prolongation of hospitalization indicated, disabling, limiting self care Activities of Daily Living;Life-threatening consequences: urgent intervention indicated;Death related to adverse event;
Alphanumeric
Choose the one severity that best describes the investigator's assessment of the intensity of the AE. The five severity grades are from the Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Severe events interrupt the participant's/subject's normal daily activities and generally require systemic drug therapy or other treatment; they are usually incapacitating. Consequently, a change in severity may constitute a new reportable AE. Severity is not synonymous with seriousness. A severe rash is not likely to be an SAE. Likewise, a severe headache is not necessarily an SAE. However, mild chest pain may result in a day's hospitalization and thus is an SAE. It is helpful to define the severity categories in the protocol or Manual of Operations to obtain consistency in reporting across sites.
Common Terminology Criteria for Adverse Events (CTCAE) v4.0 (http://evs.nci.nih.gov/ftp1/CTCAE/About.html)
Adult;Pediatric
Supplemental
4.0
7/22/2013
CTC_AE_REP_GD
Adverse Event Tracking Log
Adverse Events
Safety Data
Adverse event severity scale
 
Single Pre-Defined Value Selected
     
2201188
 
C02304
Adverse event relatedness scale
AdvrsEvntRelatednessScale
Scale of the causality between the treatment modality/intervention and the specific adverse event
Investigator Assessment of Causality
Unrelated;Unlikely;Probable;Possible;Definite;
Unrelated;Unlikely;Probable;Possible;Definite;
Alphanumeric
Choose one. Record the investigator’s assessment as to whether there is at least a reasonable possibility that the AE is related to (or caused by) use of the study intervention. Definitions for each of the relatedness responses should be supplied in the protocol.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
CTC_AE_ATTR_SCALE
Adverse Event Tracking Log
Adverse Events
Safety Data
Adverse event relatedness scale
 
Single Pre-Defined Value Selected
     
1285
 
C02300
Adverse event study intervention action taken type
AdvEvntStdyIntrvntActTakenTyp
Type of action taken for adverse event in relation to study intervention
Action Taken With Study Intervention
None;Study Intervention Interrupted;Study Intervention Discontinued;Study Intervention Modified;
None;Study Intervention Interrupted;Study Intervention Discontinued;Study Intervention Modified;
Alphanumeric
Choose one. If treatment was required, then the corresponding treatment needs to be recorded on the Prior and Concomitant Medications CRF.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
AE_ACT_STDY_INTRVN
Adverse Event Tracking Log
Adverse Events
Safety Data
Adverse event study intervention action taken type
 
Single Pre-Defined Value Selected
     
3141289
 
C14272
Adverse event AED action taken text
AdverseEventAEDActTxt
Text of action taken with the anti-epileptic drug (AED) due to the adverse event
   
Alphanumeric
Choose one.
No references available
Adult;Pediatric
Supplemental
1.0
10/5/2012
Aliases for variable name not defined
Adverse Event Tracking Log
Adverse Events
Safety Data
Adverse event AED action taken type
255
Free-Form Entry
       
C02303
Adverse event outcome status
AdvrsEvntOutcomStatus
Final status of the participant/subject related to the adverse event
Outcome
Recovered/Resolved;Recovered/Resolved with Sequelae;Recovering/Resolving;Not Recovered/Not Resolved;Fatal;Unknown;
Recovered/Resolved;Recovered/Resolved with Sequelae;Recovering/Resolving;Not Recovered/Not Resolved;Fatal;Unknown;
Alphanumeric
Choose one outcome. The outcome of an AE may not be captured at the visit during which it was first reported, but must eventually be captured to provide a complete picture of the event. Entering the outcome of an AE may be deferred until the AE is resolved, or the participant/subject completes the study. For AEs that have not resolved at the time of a study visit, the outcome should be marked as "Not recovered/not resolved" on the AE case report form.
No references available
Adult;Pediatric
Supplemental
3.0
7/22/2013
AE_OUTCOME_TXT_TP
Adverse Event Tracking Log
Adverse Events
Safety Data
Adverse event outcome status
 
Single Pre-Defined Value Selected
     
2746517
 
C02309
Serious adverse event indicator
SeriousAdvrsEvntInd
The indicator of whether the adverse event is serious.
Serious Adverse Event
Yes;No;
Yes;No;
Alphanumeric
Choose either Yes or No. This question should only be answered YES if the outcome of the AE results in at least one of the following: death; a life-threatening adverse drug experience; results in inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacity; or a congenital anomaly/birth defect. If an AE is serious, this provides a trigger that additional information must be provided by the site investigator. The site investigator then completes a Serious Adverse Event (SAE) form. Additionally, the site institution and/or IRB may also have an SAE form and procedures for reporting SAEs.
No references available
Adult;Pediatric
Supplemental
3.0
8/28/2013
AE_SERIOUS_IND
Adverse Event Tracking Log
Adverse Events
Safety Data
Serious adverse event indicator
 
Single Pre-Defined Value Selected
     
2199908
 
07-24-2017
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