| | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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 | | | | | | | |