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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: VA Toxicity Scale
Item count: 51 (51 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
C13249
Veterans Affairs Toxicity Scale - drug-related gastrointenstinal problem indicator
VAToxScaleGIProbInd
Indicate whether the patient has any drug-related gastrointestinal problems.
Does the patient have any drug-related gastrointestinal problems?
Yes;No;
Yes;No;
Alphanumeric
All toxicity is scored relative to normal for the participant/subject before starting medication
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q1
 
Single Pre-Defined Value Selected
       
C13250
Veterans Affairs Toxicity Scale - gastrointenstinal problem transient or occassionally score
VAToxScaleGIProbTransOccScore
Circle the pre-specified scores for gastrointestional symptoms (distress, nausea, vomitting) if these symptoms occur transiently or occassionally after medication.
Transient or Occasionally after medication
3;5;10;
Transient occasional distress;Transient occasional nausea;Transient occasional vomiting;
Numeric Values
For gastrointestinal problems (distress, nausea, vomiting), circle the highest applicable score for participant/subject symptoms and enter it in the appropriate score box. Enter zero on the other two score lines.
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q1a
 
Single Pre-Defined Value Selected
       
C13251
Veterans Affairs Toxicity Scale - gastrointenstinal problem often score
VAToxScaleGIOftScore
Circle the pre-specified scores for gastrointestional symptoms (distress, nausea, vomitting) if these symptoms occur transiently or occassionally after medication.
Often after medication
5;10;25;
Often distress;Often nausea;Often vomiting;
Numeric Values
For gastrointestinal problems (distress, nausea, vomiting), circle the highest applicable score for participant/subject symptoms and enter it in the appropriate score box. Enter zero on the other two score lines.
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q1b
 
Single Pre-Defined Value Selected
       
C13252
Veterans Affairs Toxicity Scale - gastrointenstinal problem often during the day score
VAToxScaleGIDayScore
Circle the pre-specified scores for gastrointestional symptoms (distress, nausea, vomitting) if these symptoms occur often and during the day after medication
Often during the day
10;25;50;
Often during the day distress;Often during the day nausea;Often during the day vomiting;
Numeric Values
For gastrointestinal problems (distress, nausea, vomiting), circle the highest applicable score for participant/subject symptoms and enter it in the appropriate score box. Enter zero on the other two score lines.
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q1c
 
Single Pre-Defined Value Selected
       
C13253
Veterans Affairs Toxicity Scale - gastrointenstinal problem other text
VAToxScaleGIOthTxt
The free-text field to specify drug-related gastrointestinal problems other than distress, nausea or vomiting as part of the Veterans Affairs (VA) Toxicity Scale.
specify drug-related gastrointestional problems other than distress, nausea or vomiting in text
  
Alphanumeric
Answer for Q1a - Q1c, as applicable; Specify other drug-related gastrointestinal problems if applicable.
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q1 other
255
Free-Form Entry
       
C13254
Veterans Affairs Toxicity Scale - hematopoietic system problems indicator
VAToxScaleHematInd
Indicate whether or not the patient has any drug-related hematopoietic system problems
Does the patient have hematopoietic system problems?
Yes;No;
Yes;No;
Alphanumeric
If yes, proceed to 2a. If no, skip to part A Q3. If yes, enter a score for each the following (enter zero if not present).
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q2
 
Single Pre-Defined Value Selected
       
C13255
Veterans Affairs Toxicity Scale - reduced platelet count score
VAToxScaleReduPlatScore
Pre-specified scores for the reduced platelet count <75,000 (seen on more than 1 test) under two situations: drug under observation or drug discontinued. If not present, enter zero for the score
circle and enter the higher score that applies to your reduced platelet count <75,000 (seen on more than 1 test): drug under observation or drug discontinued.
25;50;
Under observation;Drug discontinued;
Numeric Values
Record a score. If not present, record as zero. Circle one score only if "yes" to "reduced WBC". Enter the higher score that applies under column "Score".
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q2a
 
Single Pre-Defined Value Selected
       
C13256
Veterans Affairs Toxicity Scale - reduced WBC count score
VAToxScaleReduWBCScore
Pre-specified scores for the reduced WBC <2,000 (1000 granulacytes) (seen on more than 1 test) or discontinued drug
circle and enter the higher score that applies to your reduced WBC <2,000 (1000 granulacytes) (seen on more than 1 test): drug under observation or drug discontinued.
25;50;
Under observation;Drug discontinued;
Numeric Values
Record a score. If not present, record as zero. Circle one score only if "yes" to "reduced WBC". Enter the higher score that applies under column "Score".
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q2b
 
Single Pre-Defined Value Selected
       
C13257
Veterans Affairs Toxicity Scale - hematopoietic problems other text
VAToxScaleHematOthTxt
Text to describe hematopoietic problem other than reduced plateletes and WBC problems, if applicable
Describe other hematopoietic problem
  
Alphanumeric
Describe and record score, if applicable. Describe other hematopoietic problem, if applicable.
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q2c
255
Free-Form Entry
       
C13258
Veterans Affairs Toxicity Scale - hematopoietic problems total score
VAToxScaleHematTotScore
Summation of the circled scores for hematopoietic system problems on the Veterans Affairs Toxicity Scale.
Sum the circled scores for hemotopoietic system problems and enter the total score
  
Numeric Values
Record the total score as the summation of Q2a - Q2c
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q2d
 
Free-Form Entry
0
150
     
C17645
Veterans Affairs Toxicity Scale - hematopoietic problems other score
VAToxScalHematOthScore
Score hematopoietic problem other than reduced platelets and WBC problems, if applicable
Score other hematopoietic problem
  
Numeric Values
Enter a score only if other hematopoietic problem is described. Instructions for each of the CDEs is included on the CRF F1128, or see Cramer et al (1983).
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@gmail.com
Adult;Pediatric
Supplemental
3.0
7/15/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
  
Free-Form Entry
0
50
     
C13259
Veterans Affairs Toxicity Scale - hypersensitivity indicator
VAToxScaleHypersensInd
Indicate whether or not patient has a hypersensitivity reaction to the drug (general maculopapular rash)
Does patient have a hypersensitivity reaction to the study drug (general maculopapular rash)?
Yes;No;
Yes;No;
Alphanumeric
If yes, proceed to scoring "part A Q3a." If No, Skip to "part A Q4"
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q3
 
Single Pre-Defined Value Selected
       
C13260
Veterans Affairs Toxicity Scale - hypersensitivity score
VAToxScaleHypersensScore
Pre-specified scores for two degrees of hypersensitivity reaction: transient (stopped with treatment) or severe (did not stop with treatment)
If yes, score one of the following that applies: transient (stopped with treatment); severe (did not stop with treatment)
15;50;
Transient (stopped with treatment);Severe (did not stop with treatment);
Numeric Values
Circle and enter the score that applies under column Score
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q3a
 
Single Pre-Defined Value Selected
       
C13261
Veterans Affairs Toxicity Scale - impotence indicator
VAToxScaleImpotenInd
Indicate whether or not patient has impotence (libido or potency) problems related to drug use
Does patient have problems with impotence (libido or potency) related to drug use?
Yes;No;
Yes;No;
Alphanumeric
If yes, proceed to scoring "part A Q4a." If No, Skip to next question "part A Q5"
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q4
 
Single Pre-Defined Value Selected
       
C13262
Veterans Affairs Toxicity Scale - impotence score
VAToxScaleImpotenScore
Pre-specified scores based on the severity of impotence: transient, occassional or tolerable; continuous or intolerable
If yes, score one of the following: transient, occassional or tolerable; continuous or intolerable
20;50;
Transient, occasional or tolerable;Continuous or intolerable;
Numeric Values
Circle and enter the score that applies under column Score
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q4a
 
Single Pre-Defined Value Selected
       
C13263
Veterans Affairs Toxicity Scale - hyponatremia indicator
VAToxScaleHyponatInd
Indicator for whether the participant/subject had a blood laboratory value where serum sodium concentration was less than 120 mmol/L
Does patient have hyponatremia with serum sodium <120 mmol/L?
Yes;No;
Yes;No;
Alphanumeric
No instructions available
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q5
 
Single Pre-Defined Value Selected
       
C13264
Veterans Affairs Toxicity Scale - hyponatremia score
VAToxScaleHyponatScore
The score to indicate whether the participant/subject had a blood laboratory value where serum sodium concentration was less than 120 mmol/L
If yes, circle the score "50" and enter under column "Score".
50;
50;
Numeric Values
Enter the score only if "Yes" to hyponatremia. If yes, give score of 50
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q5a
 
Single Pre-Defined Value Selected
       
C13265
Veterans Affairs Toxicity Scale - liver abnormality indicator
VAToxScaleLivAbnrmlyInd
Indicate whether or not patient has drug-related abnormal liver functions (SGOT, SGPT repeatedly more than twice normal).
Does patient have liver disease (related to drug) with abnormal liver function tests (SGOT, SGPT repeatedly more than twice normal)? (Verify with liver consultant).
Yes;No;
Yes;No;
Alphanumeric
If yes, proceed to "part A Q6a" for scoring under this question. If No, Skip to next question "part A Q7"
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q6
 
Single Pre-Defined Value Selected
       
C13266
Veterans Affairs Toxicity Scale - liver abnormality score
VAToxScaleLivAbnrmlyScore
Pre-specified scores for two degrees of drug-related liver disease with abnormal liver function tests (SGOT, SGPT repeatedly more than twice normal): drug under observation; drug discontinued
If yes, score one of the following: if under observation; if drug discontinued.
25;50;
Under observation;Drug discontinued;
Numeric Values
Record score based on description - Circle and enter score under column "Score" only if "yes" to liver disease in this question
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q6a
 
Single Pre-Defined Value Selected
       
C13267
Veterans Affairs Toxicity Scale - weight change indicator
VAToxScaleWgtChngInd
Indicate whether the participant/subject had a change in weight, either gain or loss
Has patient gained or lost weight?
Yes;No;
Yes;No;
Alphanumeric
If yes, proceed to "part A Q7a" If No, Skip to "part A Q8"
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q7
 
Single Pre-Defined Value Selected
       
C13268
Veterans Affairs Toxicity Scale - weight change type
VAToxScaleWgtGainLosTyp
The type of weight change If the patient has weight change
If the patient has gained or lost weight, which (gained or lost weight) was it?
Gain;Loss;
Gain;Loss;
Alphanumeric
Select one of these two (responses) only if answer of Yes was given for Has patient gained or lost weight?
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q7a
 
Single Pre-Defined Value Selected
       
C13269
Veterans Affairs Toxicity Scale - weight change range
VAToxScaleWgtChngRang
The ranked value that indicates different ranges of weight gain or loss.
If the patient has gained or lost weight, select the score for one of the following that applies: Small (4-6 lbs); Moderate (7-12 lbs); Large (13-18 lbs)
3;10;20;
Small (4-6 lbs);Moderate (7-12 lbs);Large (13-18 lbs);
Numeric Values
Record score for both weight gain and weight loss, if applicable. Circle one of the three scores only if "yes" to the question "Has patient gained or lost weight?" and enter under column "Score"
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q7b
 
Single Pre-Defined Value Selected
       
C13270
Veterans Affairs Toxicity Scale - weight change score
VAToxScaleWgtChngScore
The semiquantitative score applied for the range of weight gained or lost.
If yes, score one of the following:Small (4-6 lbs);Moderate (7-12 lbs);Large (13-18 lbs)
3;10;20;
Small (4-6 lbs);Moderate (7-12 lbs);Large (13-18 lbs);
Numeric Values
Enter the applicable score under column "Score" only if "yes" to the question "Has patient gained or lost weight?" Record the total score as the summation of Q7a - Q7b
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q7c
 
Single Pre-Defined Value Selected
       
C13271
Veterans Affairs Toxicity Scale - hair quantity/texture indicator
VAToxScaleHairInd
Indicate whether or not patient has any changes in hair quantity or texture since starting drug
Does the patient have any changes in hair quantity or texture since starting drug?
Yes;No;
Yes;No;
Alphanumeric
If yes, proceed to "part A Q8a" and score all that apply. If No, Skip to the next question (part A Q9)
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q8
 
Single Pre-Defined Value Selected
       
C13272
Veterans Affairs Toxicity Scale - hair loss score
VAToxSystHairLosScore
Pre-specified scores for hair loss: Mild (notice excess hair in comb);Moderate (visible thinning of hair or hair loss in clumps);Severe (visible alopecia or exceedingly bothersome to patient)
If yes, score hair loss if applies: Mild (notice excess hair in comb);Moderate (visible thinning of hair or hair loss in clumps);Severe (visible alopecia or exceedingly bothersome to patient)
5;20;50;
Mild (notice excess hair in comb);Moderate (visible thinning of hair or hair loss in clumps);Severe (visible alopecia or exceedingly bothersome to patient);
Numeric Values
Only answered if Yes is answered for Q8
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q8a
 
Single Pre-Defined Value Selected
       
C13273
Veterans Affairs Toxicity Scale - hair texture score
VAToxSystHairTexScore
Score for hair texture or changes other than loss (e.g. becoming coarse, fine, curly)
Score if appliable: hair texture or changes other than loss (e.g. becoming coarse, fine, curly)
5;
Hair texture or changes other than loss (e.g. becoming coarse, fine, curly);
Numeric Values
Only answered if Yes is answered for Q8
Cramer J et al. A method of quantification for the evaluation of antiepileptic drug therapy. Neurology. 1983; 33[Suppl] 11: 26-37. Contact: joyce.cramer@yale.edu
Adult
Supplemental
3.0
8/28/2013
Aliases for variable name not defined
VA Toxicity Scale
Adverse Events
Safety Data
VA Toxicity Scale part A Q8b
 
Single Pre-Defined Value Selected
       
09-25-2017
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