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CDE table
CDE GroupingCDE NameCDE LocationCDE DefinitionCodeListRecommended Data TypeLengthRecommended FormatVersion NumberVersion Date
Absolute Neutrophil CountANCLaboratory Tests - Epilepsy (Study Specific Forms) What was the value of the Absolute Neutrophil Count (ANC) test? String10 09/15/2008
Absolute Neutrophil CountANC_UNITLaboratory Tests - Epilepsy (Study Specific Forms) What unit was the Absolute Neutrophil Count (ANC) test value recorded in? String25 09/15/2008
Absolute Neutrophil CountANC_ABNORMALLaboratory Tests - Epilepsy (Study Specific Forms) Is the Absolute Neutrophil Count (ANC) test value abnormal?No; Yes; Unknown   09/15/2008
Absolute Neutrophil CountANC_TIME_DATELaboratory Tracking - Epilepsy (Study Specific Forms) Date sample collected for Absolute Neutrophil Count test Date/time MM/DD/20YY09/15/2008
Absolute Neutrophil CountANC_TIME_CLOCKLaboratory Tracking - Epilepsy (Study Specific Forms) Time value sample collected for Absolute Neutrophil Count test Date/time HH:MM09/15/2008
Absolute Neutrophil CountANC_TIME_CLOCK_UNITLaboratory Tracking - Epilepsy (Study Specific Forms) Indicates whether time sample collected for Absolute Neutrophil Count test is AM, PM, or 24-hour clockAM; PM; 24-hour clockNumeric  09/15/2008
Absolute Neutrophil CountANC_NOT_DONELaboratory Tracking - Epilepsy (Study Specific Forms) Checked/Selected if Absolute Neutrophil Count test NOT performed Numeric  09/15/2008
Absolute Neutrophil CountANC_COMMENTSLaboratory Tracking - Epilepsy (Study Specific Forms) Comments regarding Absolute Neutrophil Count test String100 09/15/2008
Adverse Event (AE) recordAE_SEQUENCEAdverse Events (Core Forms) Sequence number given to the adverse event based on the order it was recorded on the CRF/eCRFIntegersNumeric  311/6/2008
Adverse Event (AE) recordAE_EVENT_DESCRIPTIONAdverse Events (Core Forms) Verbatim name of the Adverse Event (AE) that the subject experienced String100 311/6/2008
Adverse Event (AE) recordAE_START_TIMEAdverse Events (Core Forms) The date on which the adverse event started Date/time MM/DD/20YY311/6/2008
Adverse Event (AE) recordAE_SEVERITYAdverse Events (Core Forms) Severity of the adverse eventMild; Moderate; SevereNumeric  311/6/2008
Adverse Event (AE) recordAE_RELATEDNESSAdverse Events (Core Forms) Relatedness of the adverse event to the study interventionNot Related; Possibly Related; Probably RelatedNumeric  311/6/2008
Adverse Event (AE) recordAE_OUTCOMEAdverse Events (Core Forms) Outcome of the adverse eventResolved without effects; Resolved with effects; Unresolved; Death; UnknownNumeric  311/6/2008
Adverse Event (AE) recordAE_SERIOUSAdverse Events (Core Forms) Indicates whether the event was a Serious Adverse Event (SAE)No; YesNumeric  311/6/2008
Adverse Event (AE) recordAE_END_TIMEAdverse Events (Core Forms) The date on which the adverse event ended Date/time MM/DD/20YY311/6/2008
AgeDATE_OF_BIRTHDemographics (Core Forms) Date of birth of the subject Date/time MM/DD/YYYY311/6/2008
Alcohol UseDRINK_ALCOHOLBehavioral History at Baseline (Core Forms) Does the subject currently drink alcoholic beverages (e.g., beer, ale, wine, wine coolers, liquor, cocktails/mixed drinks containing alcohol)?No; YesNumeric  311/6/2008
Alcohol UseDRANK_ALCOHOLBehavioral History at Baseline (Core Forms) Was there another time when the subject did drink alcoholic beverages? No; YesNumeric  311/6/2008
Alcohol UseDRANK_ALCOHOL_YEARSBehavioral History at Baseline (Core Forms) Approximately how many years has the subject drunk alcoholic beverages? String10 311/6/2008
Alcohol UseDRANK_ALCOHOL_FREQUENCYBehavioral History at Baseline (Core Forms) During those years, on average, how often did the subject drink alcoholic beverages? Daily; 2 to 3 times per week; 1 time per week; 2 to 3 times per month; 1 time per month; <1 time per monthNumeric  311/6/2008
Alcohol UseDRANK_ALCOHOL_AMOUNTBehavioral History at Baseline (Core Forms) On occasions when the subject drank during those years, on average, how much did they drink? String10 311/6/2008
ALT (SGPT) ALTLaboratory Tests (Core Forms) What was the value of the ALT test? String10 23/17/2008
ALT (SGPT) ALT_UNITLaboratory Tests (Core Forms) What unit was the ALT test value recorded in? String25 23/17/2008
ALT (SGPT) ALT_ABNORMALLaboratory Tests (Core Forms) Is the ALT test value abnormal?No; Yes; UnknownNumeric  23/17/2008
ALT (SGPT)ALT_TIME_DATELaboratory Tracking (Core Forms) Date sample collected for ALT test Date/time MM/DD/20YY23/17/2008
ALT (SGPT)ALT_TIME_CLOCKLaboratory Tracking (Core Forms) Time value sample collected for ALT test Date/time HH:MM23/17/2008
ALT (SGPT)ALT_TIME_CLOCK_UNITLaboratory Tracking (Core Forms) Indicates whether time sample collected for ALT test is AM, PM, or 24-hour clockAM; PM; 24-hour clockNumeric  23/17/2008
ALT (SGPT)ALT_NOT_DONELaboratory Tracking (Core Forms) Checked/Selected if ALT test NOT performed Numeric  23/17/2008
ALT (SGPT)ALT_COMMENTSLaboratory Tracking (Core Forms) Comments regarding ALT test String100 23/17/2008
Amino AcidsAMINO_ACIDSLaboratory Tests - Epilepsy (Study Specific Forms) What was the value of the Amino Acids test? String10 09/15/2008
Amino AcidsAMINO_ACIDS_UNITLaboratory Tests - Epilepsy (Study Specific Forms) What unit was the Amino Acids test value recorded in? String25 09/15/2008
Amino AcidsAMINO_ACIDS_ABNORMALLaboratory Tests - Epilepsy (Study Specific Forms) Is the Amino Acids test value abnormal?No; Yes; Unknown   09/15/2008
Amino AcidsAMINO_ACIDS_TIME_DATELaboratory Tracking - Epilepsy (Study Specific Forms) Date sample collected for Amino Acids test Date/time MM/DD/20YY09/15/2008
Amino AcidsAMINO_ACIDS_TIME_CLOCKLaboratory Tracking - Epilepsy (Study Specific Forms) Time value sample collected for Amino Acids test Date/time HH:MM09/15/2008
Amino AcidsAMINO_ACIDS_TIME_CLOCK_UNITLaboratory Tracking - Epilepsy (Study Specific Forms) Indicates whether time sample collected for Amino Acids test is AM, PM, or 24-hour clockAM; PM; 24-hour clockNumeric  09/15/2008
Amino AcidsAMINO_ACIDS_NOT_DONELaboratory Tracking - Epilepsy (Study Specific Forms) Checked/Selected if Amino Acids test NOT performed Numeric  09/15/2008
Amino AcidsAMINO_ACIDS_COMMENTSLaboratory Tracking - Epilepsy (Study Specific Forms) Comments regarding Amino Acids test String100 09/15/2008
AmmoniaAMMONIALaboratory Tests - Epilepsy (Study Specific Forms) What was the value of the Ammonia test? String10 09/15/2008
AmmoniaAMMONIA_UNITLaboratory Tests - Epilepsy (Study Specific Forms) What unit was the Ammonia test value recorded in? String25 09/15/2008
AmmoniaAMMONIA_ABNORMALLaboratory Tests - Epilepsy (Study Specific Forms) Is the Ammonia test value abnormal?No; Yes; Unknown   09/15/2008
AmmoniaAMMONIA_TIME_DATELaboratory Tracking - Epilepsy (Study Specific Forms) Date sample collected for Ammonia test Date/time MM/DD/20YY09/15/2008
AmmoniaAMMONIA_TIME_CLOCKLaboratory Tracking - Epilepsy (Study Specific Forms) Time value sample collected for Ammonia test Date/time HH:MM09/15/2008
AmmoniaAMMONIA_TIME_CLOCK_UNITLaboratory Tracking - Epilepsy (Study Specific Forms) Indicates whether time sample collected for Ammonia test is AM, PM, or 24-hour clockAM; PM; 24-hour clockNumeric  09/15/2008
AmmoniaAMMONIA_NOT_DONELaboratory Tracking - Epilepsy (Study Specific Forms) Checked/Selected if Ammonia test NOT performed Numeric  09/15/2008
AmmoniaAMMONIA_COMMENTSLaboratory Tracking - Epilepsy (Study Specific Forms) Comments regarding Ammonia test String100 09/15/2008
Anti-Epileptic Drug (AED) RecordAEDL_SEQUENCEAnti-Epileptic Drug (AED) Plasma Level Log (Study Specific Forms) Sequence number given to the AED sample based on the order it was recorded on the CRF/eCRF Numeric  09/15/2008
Anti-Epileptic Drug (AED) RecordAEDL_TIMEAnti-Epileptic Drug (AED) Plasma Level Log (Study Specific Forms) Date blood sample collected for AED plasma level Date/time MM/DD/YYYY09/15/2008
Anti-Epileptic Drug (AED) RecordAEDL_NAMEAnti-Epileptic Drug (AED) Plasma Level Log (Study Specific Forms) Name of the Anti-Epileptic Drug (AED) for which the plasma level test was run String100 09/15/2008
Anti-Epileptic Drug (AED) RecordAEDL_TIMINGAnti-Epileptic Drug (AED) Plasma Level Log (Study Specific Forms) Timing for when the AED blood sample was collectedTrough; Peak; RandomNumeric  09/15/2008
Anti-Epileptic Drug (AED) RecordAEDL_LEVELAnti-Epileptic Drug (AED) Plasma Level Log (Study Specific Forms) AED level detected in the plasma sample String10 09/15/2008
Anti-Epileptic Drug (AED) RecordAEDL_UNITAnti-Epileptic Drug (AED) Plasma Level Log (Study Specific Forms) Unit for the AED level detected in the plasma sample String25 09/15/2008
Anti-Epileptic Drug (AED) RecordAEDL_LEVEL_DESCRIPTIONAnti-Epileptic Drug (AED) Plasma Level Log (Study Specific Forms) Qualitatively describes the AED level compared to the therapeutic range for the AEDSub therapeutic range; Therapeutic range; Higher than therapeutic, no toxicities noted; Toxic; Unknown; Not doneNumeric  09/15/2008
Any Adverse EventsAE_ANY_EVENTSAdverse Events (Core Forms) Has the subject had any adverse events during the study?No; YesNumeric  311/6/2008
Any Concomitant AEDs?CM_AED_ANYPrior and Concomitant Anti-Epileptic Drugs (AEDs) (Study Specific Forms) Did the subject take any non-study AEDs ___ days before or during the study?Yes; NoNumeric  09/15/2008
Any Prior/Concomitant MedicationsCM_ANY_MEDICATIONSPrior and Concomitant Medications (Core Forms) Did the subject take any non-study medications ___ days before or during the study?No; YesNumeric  311/6/2008
AST (SGOT) ASTLaboratory Tests (Core Forms) What was the value of the AST test? String10 23/17/2008
AST (SGOT) AST_UNITLaboratory Tests (Core Forms) What unit was the AST test value recorded in? String25 23/17/2008
AST (SGOT) AST_ABNORMALLaboratory Tests (Core Forms) Is the AST test value abnormal?No; Yes; UnknownNumeric  23/17/2008
AST (SGOT)AST_TIME_DATELaboratory Tracking (Core Forms) Date sample collected for AST test Date/time MM/DD/20YY23/17/2008
AST (SGOT)AST_TIME_CLOCKLaboratory Tracking (Core Forms) Time value sample collected for AST test Date/time HH:MM23/17/2008
AST (SGOT)AST_TIME_CLOCK_UNITLaboratory Tracking (Core Forms) Indicates whether time sample collected for AST test is AM, PM, or 24-hour clockAM; PM; 24-hour clockNumeric  23/17/2008
AST (SGOT)AST_NOT_DONELaboratory Tracking (Core Forms) Checked/Selected if AST test NOT performed Numeric  23/17/2008
AST (SGOT)AST_COMMENTSLaboratory Tracking (Core Forms) Comments regarding AST test String100 23/17/2008
BasophilsBASOPHILSLaboratory Tests - Epilepsy (Study Specific Forms) What was the value of the Basophils test? String10 09/15/2008
BasophilsBASOPHILS_UNITLaboratory Tests - Epilepsy (Study Specific Forms) What unit was the Basophils test value recorded in? String25 09/15/2008
BasophilsBASOPHILS_ABNORMALLaboratory Tests - Epilepsy (Study Specific Forms) Is the Basophils test value abnormal?No; Yes; Unknown   09/15/2008
BasophilsBASOPHILS_TIME_DATELaboratory Tracking - Epilepsy (Study Specific Forms) Date sample collected for Basophils test Date/time MM/DD/20YY09/15/2008
BasophilsBASOPHILS_TIME_CLOCKLaboratory Tracking - Epilepsy (Study Specific Forms) Time value sample collected for Basophils test Date/time HH:MM09/15/2008
BasophilsBASOPHILS_TIME_CLOCK_UNITLaboratory Tracking - Epilepsy (Study Specific Forms) Indicates whether time sample collected for Basophils test is AM, PM, or 24-hour clockAM; PM; 24-hour clockNumeric  09/15/2008
BasophilsBASOPHILS_NOT_DONELaboratory Tracking - Epilepsy (Study Specific Forms) Checked/Selected if Basophils test NOT performed Numeric  09/15/2008
BasophilsBASOPHILS_COMMENTSLaboratory Tracking - Epilepsy (Study Specific Forms) Comments regarding Basophils test String100 09/15/2008
BDI Total ScoreBDI_SADNESSBeck Depression Inventory (BDI) (Study Specific Forms) Sadness0 = I do not feel sad; 1 = I feel sad; 2 = I am sad all the time and I can’t snap out if it; 3 = I am so sad or unhappy that I can’t stand itNumeric  09/15/2008
BDI Total ScoreBDI_FUTUREBeck Depression Inventory (BDI) (Study Specific Forms) Future0 = I am not particularly discouraged about the future; 1 = I feel discouraged about the future; 2 = I feel I have nothing to look forward to; 3 = I feel that the future is hopeless and that things cannot improveNumeric  09/15/2008
BDI Total ScoreBDI_FAILUREBeck Depression Inventory (BDI) (Study Specific Forms) Failure0 = I do not feel like a failure; 1 = I feel I have failed more than the average person; 2 = As I look back on my life, all I can see is a lot of failure; 3 = I feel I am a complete failure as a personNumeric  09/15/2008
BDI Total ScoreBDI_SATISFACTIONBeck Depression Inventory (BDI) (Study Specific Forms) Satisfaction0 = I get as much satisfaction out of things as I used to; 1 = I don’t enjoy things the way I used to; 2 = I don’t get real satisfaction out of anything anymore; 3 = I am dissatisfied or bored with everythingNumeric  09/15/2008
BDI Total ScoreBDI_GUILTYBeck Depression Inventory (BDI) (Study Specific Forms) Guilty0 = I don’t feel particularly guilty; 1 = I feel guilty a good part of the time; 2 = I feel guilty most of the time; 3 = I feel guilty all the timeNumeric  09/15/2008
BDI Total ScoreBDI_PUNISHEDBeck Depression Inventory (BDI) (Study Specific Forms) Punished0 = I don’t feel like I’m being punished; 1 = I feel I may be punished; 2 = I expect to be punished; 3 = I feel I am being punishedNumeric  09/15/2008
BDI Total ScoreBDI_DISAPPOINTEDBeck Depression Inventory (BDI) (Study Specific Forms) Disappointed0 = I don’t feel disappointed in myself; 1 = I am disappointed in myself; 2 = I am disgusted with myself; 3 = I hate myselfNumeric  09/15/2008
BDI Total ScoreBDI_BLAMEBeck Depression Inventory (BDI) (Study Specific Forms) Blame0 = I don’t feel I am worse than anybody else; 1 = I am critical of myself for my weakness or mistakes; 2 = I blame myself all the time for my faults; 3 = I blame myself for everything bad that happens Numeric  09/15/2008
BDI Total ScoreBDI_SUICIDALBeck Depression Inventory (BDI) (Study Specific Forms) Suicidal0 = I don’t have any thoughts of killing myself; 1 = I have thoughts of killing myself, but I would not carry them out; 2 = I would like to kill myself; 3 = I would kill myself if I had the chanceNumeric  09/15/2008
BDI Total ScoreBDI_CRYINGBeck Depression Inventory (BDI) (Study Specific Forms) Crying0 = I don’t cry anymore than usual; 1 = I cry more now than I used to; 2 = I cry all the time now; 3 = I used to be able to cry, but now I can’t cry even though I want toNumeric  09/15/2008
BDI Total ScoreBDI_IRRITABLEBeck Depression Inventory (BDI) (Study Specific Forms) Irritable0 = I am no more irritated than I ever am; 1 = I got annoyed or irritated more easily than I used to; 2 = I feel irritated all the time; 3 = I don’t get irritated at all the things that used to irritate meNumeric  09/15/2008
BDI Total ScoreBDI_INTERESTBeck Depression Inventory (BDI) (Study Specific Forms) Interest0 = I have no less interest in other people; 1 = I am less interested in other people than I used to be; 2 = I have lost most of my interest in other people; 3 = I have lost all of my interest in other peopleNumeric  09/15/2008
BDI Total ScoreBDI_DECISIONSBeck Depression Inventory (BDI) (Study Specific Forms) Decisions0 = I make decision [sic] about as well as I ever could; 1 = I put off making decisions more than I used to; 2 = I have greater difficulty in making decisions than before; 3 = I can’t make decisions at all anymoreNumeric  09/15/2008
BDI Total ScoreBDI_APPEARANCEBeck Depression Inventory (BDI) (Study Specific Forms) Appearance0 = I don’t feel I look any worse than I used to; 1 = I am worried that I am looking old or unattractive; 2 = I feel that there are permanent changes in my appearance that make me look unattractive; 3 = I believe I look uglyNumeric  09/15/2008
BDI Total ScoreBDI_WORKBeck Depression Inventory (BDI) (Study Specific Forms) Work0 = I can work about as well as before; 1 = It takes an extra effort to get started at doing something; 2 = I have to push myself very hard to do anything; 3 = I can’t do any work at allNumeric  09/15/2008
BDI Total ScoreBDI_SLEEPBeck Depression Inventory (BDI) (Study Specific Forms) Sleep0 = I can sleep as well as usual; 1 = I don’t sleep as well as I used to; 2 = I wake up 1-2 hours earlier than usual and find it hard to get back to sleep; 3 = I wake up several hours earlier than used to and cannot get back to sleepNumeric  09/15/2008
BDI Total ScoreBDI_TIREDBeck Depression Inventory (BDI) (Study Specific Forms) Tired0 = I don’t get more tired than usual; 1 = I get tired more easily than usual; 2 = I get tired from doing almost anything; 3 = I am too tired to do anythingNumeric  09/15/2008
BDI Total ScoreBDI_APPETITEBeck Depression Inventory (BDI) (Study Specific Forms) Appetite0 = My appetite is no more worse than usual; 1 = My appetite is not as good as it used to be; 2 = My appetite is much worse now; 3 = I have no appetite at all anymoreNumeric  09/15/2008
BDI Total ScoreBDI_WEIGHTBeck Depression Inventory (BDI) (Study Specific Forms) Weight0 = I haven’t lost much weight, if any, lately; 1 = I have lost more than 5 pounds; 2 = I have lost more than 10 pounds; 3 = I have lost more than 15 poundsNumeric  09/15/2008
BDI Total ScoreBDI_WEIGHT_EAT_LESSBeck Depression Inventory (BDI) (Study Specific Forms) I am purposely trying to lose weight by eating lessYes; NoNumeric  09/15/2008
BDI Total ScoreBDI_HEALTH_CONCERNBeck Depression Inventory (BDI) (Study Specific Forms) Health Concern0 = I am no more worried about my physical health; 1 = I am worried about physical problems and it’s hard to think of much else; 2 = I am very worried about physical problems and it’s hard to think of much else; 3 = I am so worried about my physical problems that I cannot think of anything elseNumeric  09/15/2008
BDI Total ScoreBDI_SEXBeck Depression Inventory (BDI) (Study Specific Forms) Sex0 = I have not noticed any recent change in my interest in sex; 1 = I am less interested in sex than I used to be; 2 = I am much less interested in sex now; 3 = I have lost interest in sex completelyNumeric  09/15/2008
Bicarbonate or Carbon Dioxide BICARBONATE_OR_CO2Laboratory Tests (Core Forms) What was the value of the Bicarbonate or Carbon Dioxide test? String10 23/17/2008
Bicarbonate or Carbon Dioxide BICARBONATE_OR_CO2_UNITLaboratory Tests (Core Forms) What unit was the Bicarbonate or Carbon Dioxide test value recorded in? String25 23/17/2008
Bicarbonate or Carbon Dioxide BICARBONATE_OR_CO2_ABNORMALLaboratory Tests (Core Forms) Is the Bicarbonate or Carbon Dioxide test value abnormal?No; Yes; UnknownNumeric  23/17/2008
Bicarbonate or Carbon DioxideBICARBONATE_OR_CO2_TIME_DATELaboratory Tracking (Core Forms) Date sample collected for Bicarbonate or CO2 test Date/time MM/DD/20YY23/17/2008
Bicarbonate or Carbon DioxideBICARBONATE_OR_CO2_TIME_CLOCKLaboratory Tracking (Core Forms) Time value sample collected for Bicarbonate or CO2 test Date/time HH:MM23/17/2008
Bicarbonate or Carbon DioxideBICARBONATE_OR_CO2_TIME_CLOCK_UNITLaboratory Tracking (Core Forms) Indicates whether time sample collected for Bicarbonate or CO2 test is AM, PM, or 24-hour clockAM; PM; 24-hour clockNumeric  23/17/2008


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