CDE Detailed Report

Disease: Epilepsy
Sub-Domain: Adverse Events
CRF: VA Toxicity Scale

Displaying 1 - 50 of 50
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C13267 Veterans Affairs Toxicity Scale - weight change indicator VAToxScaleWgtChngInd Indicate whether the participant/subject had a change in weight, either gain or loss Indicate whether or not patient gained or lost weight as part of the Veterans Affairs (VA) Toxicity Scale. Has patient gained or lost weight? No;Yes No;Yes 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13279 Veterans Affairs Toxicity Scale - nystagmus score VAToxScaleNystagScore Nystagmus (not end point) The score as related to nystagmus (not end point) as part of the Veterans Affairs (VA) Toxicity Scale. Nystagmus 5;10 Horizontal;Vertical Numeric Values

Record score based on description

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 Supplemental 1.00 2012-10-05 00:00:00.0 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13290 Veterans Affairs Toxicity Scale - dizziness/lightheadedness often after meds score VAToxScaleDizzOftMedScore Score used to report occurrence of drug related dizziness or lightheadedness often after medication(s). The score as related to dizziness/lightheadedness often after meds as part of the Veterans Affairs (VA) Toxicity Scale. Often After Meds 5;10;25 Mild (symptoms recognizable but no interference with usual life);Moderate (interference with some daily activities);Severe (interference with all daily activities) Numeric Values

Record only the highest single 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

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 Text to describe hematopoietic problem other than reduced platelets and WBC problems as part of the Veterans Affairs (VA) Toxicity Scale. 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data 255

Free-Form Entry

C13268 Veterans Affairs Toxicity Scale - weight change type VAToxScaleWgtGainLosTyp The type of weight change If the patient has weight change The type of weight change If the patient has weight change as part of the Veterans Affairs (VA) Toxicity Scale. 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13280 Veterans Affairs Toxicity Scale - dysarthria score VAToxScaleDysaScore The score as related to dysarthria as part of the Veterans Affairs (VA) Toxicity Scale. The score as related to dysarthria as part of the Veterans Affairs (VA) Toxicity Scale. Dysarthria 5;10;30 Mild (intermittent slurring);Moderate (constant slurring, no difficulty communicating);Severe (understanding of speech difficult if topic unknown to listener) Numeric Values

Record score based on description

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 Supplemental 1.00 2012-10-05 00:00:00.0 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13291 Veterans Affairs Toxicity Scale - dizziness/lightheadedness often during day score VAToxScaleDizzOftDayScore Score used to report occurrence of drug related dizziness or lightheadedness often during the day. The score as related to dizziness/lightheadedness often during day as part of the Veterans Affairs (VA) Toxicity Scale. Often During Day 10;25;50 Mild (symptoms recognizable but no interference with usual Life);Moderate (interference with some daily activities);Severe (interference with all daily activities) Numeric Values

Record only the highest single 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

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. Summation of the circled scores for hematopoietic system problems in Question 2 as part of the Veterans Affairs (VA) 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Free-Form Entry

0 150
C13270 Veterans Affairs Toxicity Scale - weight change score VAToxScaleWgtChngScore The semiquantitative score applied for the range of weight gained or lost. Pre-specified scores for different range of weight gain or loss as part of the Veterans Affairs (VA) Toxicity Scale. 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13281 Veterans Affairs Toxicity Scale - gait score VAToxScaleGaitScore The score as related to gait, normal walking as part of the Veterans Affairs (VA) Toxicity Scale. The score as related to gait, normal walking as part of the Veterans Affairs (VA) Toxicity Scale. Gait, normal walking 5;15;25;50 Slight ataxia (slowness or unsteady turning);Mild ataxia (veer from side to side, difficulty with tandem gait);Moderate ataxia (unsteady, walks with wide base gait. tendency to fall toward one side or other);Severe gait disturbance (can walk only with assistance, some unsteadiness even when sitting) Numeric Values

Record score based on description

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 Supplemental 1.00 2012-10-05 00:00:00.0 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13292 Veterans Affairs Toxicity Scale - drug related headache transient or occasionally score VAToxScaleHeadchTransOccScore Score used to report occurrence of drug related headaches transiently or occasionally. The score as related to drug related headaches transient or occasionally after meds as part of the Veterans Affairs (VA) Toxicity Scale. Transient or Occasionally after medication 3;5;10 Mild (symptoms recognizable but no interference with usual Life);Moderate (interference with some daily activities);Severe (interference with all daily activities) Numeric Values

Record only the highest single 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13259 Veterans Affairs Toxicity Scale - hypersensitivity indicator VAToxScaleHypersensInd Indicate whether or not patient has a hypersensitivity reaction to the drug (general maculopapular rash) Indicate whether or not patient has a hypersensitivity reaction to the study drug (general maculopapular rash) as part of the Veterans Affairs (VA) Toxicity Scale. Does patient have a hypersensitivity reaction to the study drug (general maculopapular rash)? No;Yes No;Yes 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

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 Indicate whether or not patient has any changes in hair quantity or texture since starting drug as part of the Veterans Affairs (VA) Toxicity Scale. Does the patient have any changes in hair quantity or texture since starting drug? No;Yes No;Yes 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13249 Veterans Affairs Toxicity Scale - drug-related gastrointenstinal problem indicator VAToxScaleGIProbInd Indicate whether the patient has any drug-related gastrointestinal problems. Indicate whether or not the patient has any drug-related gastrointestinal problems as part of the Veterans Affairs (VA) Toxicity Scale. Does the patient have any drug-related gastrointestinal problems? No;Yes No;Yes 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13282 Veterans Affairs Toxicity Scale - rapid alternating movements score VAToxScaleRapAltMovScore Rapid Alternating Movements (hand on knee, flip side to side, grossly clumsy) The score as related to rapid alternating movements (hand on knee, flip side to side, grossly clumsy) as part of the Veterans Affairs (VA) Toxicity Scale. Rapid Alternating Movements 15 Rapid Alternating Movements (hand on knee, flip side to side, grossly clumsy) Numeric Values

Record score based on description

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 Supplemental 1.00 2012-10-05 00:00:00.0 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13293 Veterans Affairs Toxicity Scale - drug related headaches often after meds score VAToxScaleHeadOftMedScore Score used to report occurrence of drug related headaches often after medication(s). The score as related to drug related headaches often after meds as part of the Veterans Affairs (VA) Toxicity Scale. Often After Meds 5;10;25 Mild (symptoms recognizable but no interference with usual life);Moderate (interference with some daily activities);Severe (interference with all daily activities) Numeric Values

Record only the highest single 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

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) Pre-specified scores for two degrees of hypersensitivity reaction: transient (stopped with treatment) or severe (did not stop with treatment) as part of the Veterans Affairs (VA) Toxicity Scale. 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

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) Pre-specified scores for hair loss as part of the Veterans Affairs (VA) Toxicity Scale. 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

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. 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13283 Veterans Affairs Toxicity Scale - neurotoxicty rating score VAToxScaleNeuroToxRatScore Summation of scores to obtain the Neurotoxicty Rating Score on the Veterans Affairs Toxicity Scale Summation of scores to obtain the Neurotoxicty Rating Score on the Veterans Affairs Toxicity Scale Neurotoxicty Rating Score Alphanumeric

Circle type of tremor

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 Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data 255

Free-Form Entry

C13294 Veterans Affairs Toxicity Scale - drug related headaches often during day score VAToxScaleHeadOftDayScore Score used to report occurrence of drug related headaches often during the day. The score as related to drug related headaches often during day as part of the Veterans Affairs (VA) Toxicity Scale. Often During Day 10;25;50 Mild (symptoms recognizable but no interference with usual Life);Moderate (interference with some daily activities);Severe (interference with all daily activities) Numeric Values

Record only the highest single 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

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 Indicate whether or not patient has impotence (libido or potency) problems related to drug use as part of the Veterans Affairs (VA) Toxicity Scale. Does patient have problems with impotence (libido or potency) related to drug use? No;Yes No;Yes 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

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) The score for hair texture or changes other than loss (e.g. becoming coarse, fine, curly) as part of the Veterans Affairs (VA) Toxicity Scale. 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

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. 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13284 Veterans Affairs Toxicity Scale - tremor score VAToxScaleTremoScore Tremor (finger to nose, long reach; eyes open/eyes closed-resting and with arms extended forward) The score as related to tremor (finger to nose, long reach; eyes open/eyes closed-resting and with arms extended forward) as part of the Veterans Affairs (VA) Toxicity Scale. Tremor 10;25;35;50 Mild (intermittent tremor, not functionally important, noticeable by patient or doctor);Moderate (usually or often evident to patient/doctor on exam: may be embarrassing, but not significant compromise: skilled motor acts);Moderately Severe (frequent or constant tremor, compromises to some degree: writing, fine motor movement, etc.);Severe (disturbs everyday functioning (eating, writing, working) Numeric Values

Record score based on description

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 Supplemental 1.00 2012-10-05 00:00:00.0 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13295 Veterans Affairs Toxicity Scale - other neurotoxicity description text VAToxScaleOthNeuroToxDescTxt Description of other neurotoxicity as part of the Veterans Affairs Toxicity Scale. Description of other neurotoxicity as part of the Veterans Affairs Toxicity Scale. Other Neurotoxicity Description Alphanumeric

Describe other neurotoxicity symptoms only if applicable, and record 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data 255

Free-Form Entry

C13262 Veterans Affairs Toxicity Scale - impotence score VAToxScaleImpotenScore Pre-specified scores based on the severity of impotence: transient, occassional or tolerable; continuous or intolerable Pre-specified scores based on the severity of impotence: transient, occasional or tolerable; continuous or intolerable as part of the Veterans Affairs (VA) Toxicity Scale. 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

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) as part of the Veterans Affairs (VA) Toxicity Scale. 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

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 Circle the pre-specified scores for gastrointestinal symptoms (distress, nausea, vomiting) if these symptoms occur often and during the day after medication as part of the Veterans Affairs (VA) Toxicity Scale. 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13285 Veterans Affairs Toxicity Scale - total 1-6 score VAToxScaleTotItemScore Section A total score Section A total score as part of the Veterans Affairs (VA) Toxicity Scale. Enter total for items 1-6 Numeric Values

Record the total of part B, section A Q1-Q6. If more than one score, sum and multiply by 50%; if only one score, record 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@gmail.com Adult Supplemental 1.00 2012-10-05 00:00:00.0 VA Toxicity Scale Adverse Events Safety Data

Free-Form Entry

0 500
C13296 Veterans Affairs Toxicity Scale - total neurotoxicity score VAToxScaleTotalNeuroToxScore The total neurotoxicity score, as part of The Veterans Affairs (VA) Toxicity Scale. The total score, as part of the Veterans Affairs (VA) Toxicity Scale. Total Numeric Values

Sum of part B, section A Q7 through part B, section B Q13 (Neurotoxicity 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Free-Form Entry

0 50
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 Indicator for whether the participant/subject had a blood laboratory value where serum sodium concentration was less than 120 mmol/L as part of the Veterans Affairs (VA) Toxicity Scale. Does patient have hyponatremia with serum sodium <120 mmol/L? No;Yes No;Yes 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13275 Veterans Affairs Toxicity Scale - hair change total socre VAToxSystHairTotScore Total score for hair quantity or texture change Th total score for hair quantity or texture change as part of the Veterans Affairs (VA) Toxicity Scale. Sum the scores for hair quantity and/or texture changes under Question 8 Numeric Values

Record the total score as the summation of Q8a - Q8c

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 Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Free-Form Entry

0 105
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. 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data 255

Free-Form Entry

C13286 Veterans Affairs Toxicity Scale - sedation score VAToxScaleSedaScore Sedation (level of consciousness) The score as related to sedation (level of consciousness) as part of the Veterans Affairs (VA) Toxicity Scale. Sedation 5;10;25;50 Lethargic in early A.M. or evening;Occasionally sleepy during day;Often difficult staying awake;Stuporous Numeric Values

Record score based on description

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 Supplemental 1.00 2012-10-05 00:00:00.0 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C17645 Veterans Affairs Toxicity Scale - hematopoietic problems other score VAToxScalHematOthScore Score hematopoietic problem other than reduced platelets and WBC problems, if applicable The score as related to hematopoietic problem other than reduced plateletes and WBC problems as part of the Veterans Affairs (VA) Toxicity Scale. 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 3.00 2013-07-15 16:08:48.687 VA Toxicity Scale Adverse Events Safety Data

Free-Form Entry

0 50
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 The score as related to hyponatremia as part of the Veterans Affairs (VA) Toxicity Scale. 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13276 Veterans Affairs Toxicity Scale - toxicity other text VAToxScaleOthTxt Describe toxicity symptoms other than those shown from Question 1 to 8 on the Veterans Affairs Toxicity Scale Describe toxicity symptoms other than those shown above from Question 1 to 8 as part of the Veterans Affairs (VA) Toxicity Scale. Describe other symptoms if applicable Alphanumeric

Describe and record score, 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data 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 Indicate whether or not the patient has any drug-related hematopoietic system problems as part of the Veterans Affairs (VA) Toxicity Scale. Does the patient have hematopoietic system problems? No;Yes No;Yes 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13287 Veterans Affairs Toxicity Scale - affect and mood score VAToxScaleAffMooScore The score as related to affect and mood (depressing tension/agitation; anger/hostility; vigor/excitability; fatigue/apathy; confusion/thought disorder) as part of the Veterans Affairs (VA) Toxicity Scale. The score as related to affect and mood (depressing tension/agitation; anger/hostility; vigor/excitability; fatigue/apathy; confusion/thought disorder) as part of the Veterans Affairs (VA) Toxicity Scale. Affect and Mood 5;15;50 Mild (a disturbance is recognized by the patient, but it results in no interference with usual life);Moderate (the mood disturbance results in reduced abilities, but only periodically);Severe (continuous or nearly continuous mood disturbance interfering with usual life) Numeric Values

Record score based on description

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 Supplemental 1.00 2012-10-05 00:00:00.0 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C17646 Veterans Affairs Toxicity Scale - other neurotoxicity score VAToxScalOthNeurotoxScore The score for other neurotoxicity symptoms, as part of The Veterans Affairs (VA) Toxicity Scale. The score for other neurotoxicity symptoms, as part of the Veterans Affairs (VA) Toxicity Scale. Score other neurotoxicity symptoms if applicable Numeric Values

Score only if you described your other neurotoxicity symptoms. 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 3.00 2013-07-15 16:08:48.687 VA Toxicity Scale Adverse Events Safety Data

Free-Form Entry

0 50
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). Indicate whether or not patient has drug-related abnormal liver functions (SGOT, SGPT repeatedly more than twice normal) as part of the Veterans Affairs (VA) Toxicity Scale. Does patient have liver disease (related to drug) with abnormal liver function tests (SGOT, SGPT repeatedly more than twice normal)? (Verify with liver consultant). No;Yes No;Yes 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13277 Veterans Affairs Toxicity Scale - systematic sum score VAToxScaleSumScore Summation of scores of Question 1 to 9 on the Veterans Affairs Toxicity Scale Part A to yield Systematic Toxicity Score Summation of scores of Question 1 to 9 under Part A as part of the Veterans Affairs (VA) Toxicity Scale. Sum Systematic Toxicity Score (Part A, Question 1 to 9) Numeric Values

The sum of part A Q1 through 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Free-Form Entry

0 500
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 Pre-specified scores for reduced platelet count <75,000 (seen on more than 1 test) under two situations: drug under observation or drug discontinued as part of the Veterans Affairs (VA) Toxicity Scale. 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13288 Veterans Affairs Toxicity Scale - cognitive function score VAToxScaleCogFunScore The score as related to cognitive function (attention/concentration/language) as part of the Veterans Affairs (VA) Toxicity Scale. The score as related to cognitive function (attention/concentration/language) as part of the Veterans Affairs (VA) Toxicity Scale. Cognitive Function 5;15;50 Mild (symptoms recognizable but no interference with usual life);Moderate (interference with some daily activities);Severe (interference with all daily activities) Numeric Values

Record score based on description

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 Supplemental 1.00 2012-10-05 00:00:00.0 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C17647 Veterans Affairs Toxicity Scale - other toxicity score VAToxScalOthToxScore Score for other toxicity problems if applicable The score for other toxicity problems as part of the Veterans Affairs (VA) Toxicity Scale. Score other toxicity problems if applicable Numeric Values

Score only if description is given for "other (describe)". 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 3.00 2013-07-15 16:08:48.687 VA Toxicity Scale Adverse Events Safety Data

Free-Form Entry

0 50
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 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 as part of the Veterans Affairs (VA) Toxicity Scale. 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13278 Veterans Affairs Toxicity Scale - diplopia score VAToxScaleDiplopScore The score as related to diplopia as part of the Veterans Affairs (VA) Toxicity Scale. The score as related to diplopia as part of the Veterans Affairs (VA) Toxicity Scale. Dipoplia 15;30 Intermittent;Constant Numeric Values

Record score based on description

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 Supplemental 1.00 2012-10-05 00:00:00.0 VA Toxicity Scale Adverse Events Safety Data

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 Pre-specified scores for reduced WBC <2,000 (1000 granulocytes) (seen on more than 1 test) under two situations: drug under observation or drug discontinued as part of the Veterans Affairs (VA) Toxicity Scale.. 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

C13289 Veterans Affairs Toxicity Scale - dizziness transient or occasionally score VAToxScaleDizzTransOccScore Score used to report occurrence of drug related dizziness or lightheadedness transiently or occasionally. The score for dizziness/lightheadedness transient or occasionally after meds as part of the Veterans Affairs (VA) Toxicity Scale. Transient or Occasionally after medication 3;5;10 Mild (symptoms recognizable but no interference with usual Life);Moderate (interference with some daily activities);Severe (interference with all daily activities) Numeric Values

Record only the highest single 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@gmail.com Adult Supplemental 3.00 2013-08-28 16:08:00.453 VA Toxicity Scale Adverse Events Safety Data

Single Pre-Defined Value Selected

CSV