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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 - gastrointestinal problem transient or occasionally score | VAToxScaleGIProbTransOccScore | Circle the pre-specified scores for gastrointestinal symptoms (distress, nausea, vomiting) if these symptoms occur transiently or occasionally after medication, as part of the Veterans Affairs (VA) Toxicity Scale. | 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 - gastrointestinal problem often score | VAToxScaleGIOftScore | Circle the pre-specified scores for gastrointestinal symptoms (distress, nausea, vomiting) if these symptoms occur often after medication as part of the Veterans Affairs (VA) Toxicity Scale. | 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 | | | | | | | |
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 | | | | | | | |
C13274 | Veterans Affairs Toxicity Scale - hirsutism score | VAToxSystHirsutScore | Pre-specified scores for hirsutism (excess hair growth): Moderate (noticeable on face, trunk or limbs); severe (excessive and bothersome to patients) | pre-specified scores for hirsutism (excess hair growth): Moderate (noticeable on face, trunk or limbs); severe (excessive and bothersome to patients) | 20;50; | Moderate (noticeable on face, trunk or limbs);Severe (excessive and 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 Q8c | | Single Pre-Defined Value Selected | | | | | | | |