0 Ratings

ID

3710

Description

ODM derived from http://clinicaltrials.gov/show/NCT01243177

Link

http://clinicaltrials.gov/show/NCT01243177

Keywords

  1. 2/22/13 2/22/13 - Martin Dugas
  2. 9/20/21 9/20/21 -
Uploaded on

February 22, 2013

DOI

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License

Creative Commons BY 4.0

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    Eligibility NCT01243177 Epilepsy

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Inclusion Criteria
    Description

    Inclusion Criteria

    age at least 16 Years
    Description

    age at least 16 Years

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    SNOMED CT 2011_0131
    397669002 (undefined)
    Subject able to comply with study requirements
    Description

    Subject able to comply with study requirements

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0085732 (Ability)
    SNOMED CT 2011_0131
    371150009 (undefined)
    UMLS CUI 2011AA
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    SNOMED CT 2011_0131
    405078008 (undefined)
    UMLS CUI 2011AA
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    SNOMED CT 2011_0131
    110465008 (undefined)
    UMLS CUI 2011AA
    C1514873 (Requirement)
    Subject is 16 years and older (female, male). Minors will be included in countries only if legally permitted
    Description

    Subject is 16 years and older (female, male). Minors will be included in countries only if legally permitted

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0015780 (undefined)
    SNOMED CT 2011_0131
    248152002 (undefined)
    HL7 V3 2006_05
    F (undefined)
    UMLS CUI 2011AA
    C0024554 (undefined)
    SNOMED CT 2011_0131
    248153007 (undefined)
    HL7 V3 2006_05
    M (undefined)
    UMLS CUI 2011AA
    C0026193 (Minor (person))
    SNOMED CT 2011_0131
    410599005 (undefined)
    UMLS CUI 2011AA
    C0750557 (If)
    UMLS CUI 2011AA
    C1301860 (Legal)
    SNOMED
    398165009
    SNOMED CT 2011_0131
    398165009 (undefined)
    UMLS CUI 2011AA
    C0521104 (permission)
    SNOMED
    75554001
    SNOMED CT 2011_0131
    75554001 (undefined)
    Subject has newly or recently diagnosed epilepsy experiencing partial onset seizures (POS) or generalized tonic-clonic seizures with at least 2 unprovoked seizures separated by 48 hours in the year before enrollment with 1 seizures 3 months before enrollment
    Description

    Subject has newly or recently diagnosed epilepsy experiencing partial onset seizures (POS) or generalized tonic-clonic seizures with at least 2 unprovoked seizures separated by 48 hours in the year before enrollment with 1 seizures 3 months before enrollment

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C2585997 (New diagnosis (finding))
    SNOMED
    441308009
    SNOMED CT 2011_0131
    441308009 (undefined)
    UMLS CUI 2011AA
    C0014544 (Epilepsy)
    SNOMED
    84757009
    LOINC
    MTHU020586
    SNOMED CT 2011_0131
    84757009 (undefined)
    MedDRA 14.1
    10015037 (undefined)
    LOINC Version 232
    MTHU020586 (undefined)
    ICD-10-CM Version 2010
    G40.9 (undefined)
    ICD-9-CM Version 2011
    345.9 (undefined)
    UMLS CUI 2011AA
    C0234974 (Simple Partial Seizures)
    SNOMED
    117891000119100
    SNOMED CT 2011_0131
    79348005 (undefined)
    MedDRA 14.1
    10040703 (undefined)
    UMLS CUI 2011AA
    C0494475 (Tonic - clonic seizures)
    SNOMED
    54200006
    SNOMED CT 2011_0131
    54200006 (undefined)
    MedDRA 14.1
    10044000 (undefined)
    ICD-10-CM Version 2010
    G40.3 (undefined)
    UMLS CUI 2011AA
    C1518422 (Negation)
    LOINC
    LA21291-2
    UMLS CUI 2011AA
    C1444748 (Triggered by)
    SNOMED
    410659000
    SNOMED CT 2011_0131
    410658008 (undefined)
    UMLS CUI 2011AA
    C0036572 (Seizures)
    SNOMED
    91175000
    LOINC
    LA15899-0
    SNOMED CT 2011_0131
    91175000 (undefined)
    MedDRA 14.1
    10039910 (undefined)
    ICD-9-CM Version 2011
    780.39 (undefined)
    Subject has normal electroencephalogram (EEG) which must be normal or consistent with partial onset seizures (POS) and a Computerized Axial Tomography (CT) scan or Magnetic Resonance Imaging (MRI) with diagnosis of POS or generalized tonic clonic seizures (without clear focal origin) within year before enrollment
    Description

    Subject has normal electroencephalogram (EEG) which must be normal or consistent with partial onset seizures (POS) and a Computerized Axial Tomography (CT) scan or Magnetic Resonance Imaging (MRI) with diagnosis of POS or generalized tonic clonic seizures (without clear focal origin) within year before enrollment

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0560017 (EEG normal)
    SNOMED
    164717000
    SNOMED CT 2011_0131
    164717000 (undefined)
    MedDRA 14.1
    10014409 (undefined)
    UMLS CUI 2011AA
    C0332290 (Consistent with)
    SNOMED
    385433004
    SNOMED CT 2011_0131
    385433004 (undefined)
    UMLS CUI 2011AA
    C0234974 (Simple Partial Seizures)
    SNOMED
    117891000119100
    SNOMED CT 2011_0131
    79348005 (undefined)
    MedDRA 14.1
    10040703 (undefined)
    UMLS CUI 2011AA
    C0810430 (Computerized axial tomography (CT) scan)
    UMLS CUI 2011AA
    C0024485 (Magnetic Resonance Imaging)
    SNOMED
    312250003
    LOINC
    LP57602-2
    SNOMED CT 2011_0131
    113091000 (undefined)
    MedDRA 14.1
    10028049 (undefined)
    UMLS CUI 2011AA
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    SNOMED CT 2011_0131
    439401001 (undefined)
    LOINC Version 232
    MTHU008876 (undefined)
    UMLS CUI 2011AA
    C0234974 (Simple Partial Seizures)
    SNOMED
    117891000119100
    SNOMED CT 2011_0131
    79348005 (undefined)
    MedDRA 14.1
    10040703 (undefined)
    UMLS CUI 2011AA
    C0494475 (Tonic - clonic seizures)
    SNOMED
    54200006
    SNOMED CT 2011_0131
    54200006 (undefined)
    MedDRA 14.1
    10044000 (undefined)
    ICD-10-CM Version 2010
    G40.3 (undefined)
    Exclusion Criteria
    Description

    Exclusion Criteria

    Subject has a history or presence of seizures of other types than partial-onset (IA, IB, IC with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures (eg, myoclonic, absence)
    Description

    Subject has a history or presence of seizures of other types than partial-onset (IA, IB, IC with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures (eg, myoclonic, absence)

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0036572 (Seizures)
    SNOMED
    91175000
    LOINC
    LA15899-0
    SNOMED CT 2011_0131
    91175000 (undefined)
    MedDRA 14.1
    10039910 (undefined)
    ICD-9-CM Version 2011
    780.39 (undefined)
    UMLS CUI 2011AA
    C0456387 (Class)
    SNOMED
    277046005
    SNOMED CT 2011_0131
    277046005 (undefined)
    UMLS CUI 2011AA
    C0450344 (alphanumeric label - 1A)
    SNOMED
    264653008
    LOINC
    LA19241-1
    SNOMED CT 2011_0131
    264653008 (undefined)
    UMLS CUI 2011AA
    C0450345 (1B)
    SNOMED
    264654002
    LOINC
    LA19242-9
    SNOMED CT 2011_0131
    264654002 (undefined)
    UMLS CUI 2011AA
    C0205447 (One)
    SNOMED
    38112003
    SNOMED CT 2011_0131
    38112003 (undefined)
    UMLS CUI 2011AA
    C0439106 (Upper case Roman letter C)
    SNOMED
    257962003
    SNOMED CT 2011_0131
    257962003 (undefined)
    UMLS CUI 2011AA
    C0014550 (Myoclonic Epilepsy)
    SNOMED CT 2011_0131
    37356005 (undefined)
    MedDRA 14.1
    10054859 (undefined)
    UMLS CUI 2011AA
    C0014553 (Absence Epilepsy)
    SNOMED
    432241000124101
    SNOMED CT 2011_0131
    79631006 (undefined)
    MedDRA 14.1
    10000332 (undefined)
    ICD-10-CM Version 2010
    G40.3 (undefined)
    Subject has a history or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time (ie, <20 minutes) with or without function regained between 2 ictal events
    Description

    Subject has a history or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time (ie, <20 minutes) with or without function regained between 2 ictal events

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0036572 (Seizures)
    SNOMED
    91175000
    LOINC
    LA15899-0
    SNOMED CT 2011_0131
    91175000 (undefined)
    MedDRA 14.1
    10039910 (undefined)
    ICD-9-CM Version 2011
    780.39 (undefined)
    UMLS CUI 2011AA
    CL382928 (undefined)
    UMLS CUI 2011AA
    C0449774 (Patterns)
    SNOMED
    272135003
    SNOMED CT 2011_0131
    272135003 (undefined)
    UMLS CUI 2011AA
    C1806781 (Short)
    SNOMED
    367450005
    LOINC
    LA19631-3
    SNOMED CT 2011_0131
    367450005 (undefined)
    UMLS CUI 2011AA
    C0439582 (undefined)
    SNOMED CT 2011_0131
    272117007 (undefined)
    Subject has a history, clinical, or Electroencephalogram (EEG) finding suggestive of idiopathic generalized epilepsy (IGE) at randomization
    Description

    Subject has a history, clinical, or Electroencephalogram (EEG) finding suggestive of idiopathic generalized epilepsy (IGE) at randomization

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0013819 (Electroencephalography)
    SNOMED
    54550000
    LOINC
    LP6239-0
    SNOMED CT 2011_0131
    54550000 (undefined)
    MedDRA 14.1
    10014407 (undefined)
    ICD-9-CM Version 2011
    89.14 (undefined)
    UMLS CUI 2011AA
    C0038659 (therapeutic suggestion)
    UMLS CUI 2011AA
    C0270850 (Idiopathic generalized epilepsy)
    SNOMED
    36803009
    SNOMED CT 2011_0131
    36803009 (undefined)
    MedDRA 14.1
    10071081 (undefined)
    ICD-10-CM Version 2010
    G40.3 (undefined)
    Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events which could be confused with seizures
    Description

    Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events which could be confused with seizures

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    SNOMED CT 2011_0131
    439401001 (undefined)
    LOINC Version 232
    MTHU008876 (undefined)
    UMLS CUI 2011AA
    C0349245 (Dissociative convulsions)
    SNOMED
    191714002
    SNOMED CT 2011_0131
    191714002 (undefined)
    MedDRA 14.1
    10037148 (undefined)
    ICD-10-CM Version 2010
    F44.5 (undefined)
    UMLS CUI 2011AA
    C0009946 (Conversion disorder)
    SNOMED
    20734000
    SNOMED CT 2011_0131
    20734000 (undefined)
    MedDRA 14.1
    10010893 (undefined)
    ICD-10-CM Version 2010
    F44 (undefined)
    ICD-9-CM Version 2011
    300.11 (undefined)
    UMLS CUI 2011AA
    C2674681 (Nonepileptic tonic attacks)
    UMLS CUI 2011AA
    C0521102 (Interferes with)
    SNOMED
    78235001
    SNOMED CT 2011_0131
    78235001 (undefined)
    UMLS CUI 2011AA
    C0036572 (Seizures)
    SNOMED
    91175000
    LOINC
    LA15899-0
    SNOMED CT 2011_0131
    91175000 (undefined)
    MedDRA 14.1
    10039910 (undefined)
    ICD-9-CM Version 2011
    780.39 (undefined)
    Subject has any medical or psychiatric condition
    Description

    Subject has any medical or psychiatric condition

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1699700 (medical condition category)
    HL7 V3 2006_05
    MEDCCAT (undefined)
    UMLS CUI 2011AA
    C0809986 (Other mental conditions)
    Subject has a history of suicide attempt, has received professional counselling for suicidal ideation, or is currently experiencing active suicidal ideation
    Description

    Subject has a history of suicide attempt, has received professional counselling for suicidal ideation, or is currently experiencing active suicidal ideation

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C2911479 (Personal history of suicide attempt)
    ICD-10-CM Version 2010
    Z91.5 (undefined)
    UMLS CUI 2011AA
    C0010210 (Counseling)
    SNOMED
    129441002
    SNOMED CT 2011_0131
    409063005 (undefined)
    UMLS CUI 2011AA
    C0424000 (Feeling suicidal (finding))
    SNOMED
    6471006
    LOINC
    LA6394-6
    SNOMED CT 2011_0131
    6471006 (undefined)
    MedDRA 14.1
    10042458 (undefined)
    ICD-9-CM Version 2011
    V62.84 (undefined)
    CTCAE 1105E
    E12964 (undefined)
    UMLS CUI 2011AA
    CL430050 (undefined)
    MedDRA 14.1
    10071456 (undefined)
    Prior use of felbamate or vigabatrin is not allowed
    Description

    Prior use of felbamate or vigabatrin is not allowed

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1554075 (InclusionNotMandatory <Not permitted>)
    HL7 V3 2006_05
    NP (undefined)
    UMLS CUI 2011AA
    C0332152 (Before)
    SNOMED
    236874000
    SNOMED CT 2011_0131
    288556008 (undefined)
    UMLS CUI 2011AA
    C1524063 (Use of)
    SNOMED
    260676000
    SNOMED CT 2011_0131
    260676000 (undefined)
    UMLS CUI 2011AA
    C0060135 (felbamate)
    SNOMED
    371387009
    SNOMED CT 2011_0131
    371387009 (undefined)
    LOINC Version 232
    MTHU015105 (undefined)
    UMLS CUI 2011AA
    C0048044 (vigabatrin)
    SNOMED
    310283001
    SNOMED CT 2011_0131
    322976008 (undefined)
    LOINC Version 232
    MTHU012453 (undefined)
    Subject has received treatment with phenobarbital or primidone within 28 days prior to Visit 1
    Description

    Subject has received treatment with phenobarbital or primidone within 28 days prior to Visit 1

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0039798 (therapeutic aspects)
    UMLS CUI 2011AA
    C0031412 (phenobarbital)
    SNOMED
    51073002
    SNOMED CT 2011_0131
    51073002 (undefined)
    LOINC Version 232
    MTHU003431 (undefined)
    UMLS CUI 2011AA
    C0033148 (primidone)
    SNOMED
    47120002
    SNOMED CT 2011_0131
    47120002 (undefined)
    LOINC Version 232
    MTHU003369 (undefined)
    UMLS CUI 2011AA
    C0439231 (month)
    SNOMED
    258706009
    SNOMED CT 2011_0131
    258706009 (undefined)
    HL7 V3 2006_05
    MO (undefined)
    UMLS CUI 2011AA
    C0332152 (Before)
    SNOMED
    236874000
    SNOMED CT 2011_0131
    288556008 (undefined)
    UMLS CUI 2011AA
    C1554196 (undefined)
    HL7 V3 2006_05
    ENC (undefined)
    UMLS CUI 2011AA
    C0205447 (One)
    SNOMED
    38112003
    SNOMED CT 2011_0131
    38112003 (undefined)
    Subject is taking benzodiazepines for a nonepilepsy indication
    Description

    Subject is taking benzodiazepines for a nonepilepsy indication

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1512806 (Intake)
    UMLS CUI 2011AA
    C0005064 (Benzodiazepines)
    LOINC
    LP15014-1
    SNOMED CT 2011_0131
    16047007 (undefined)
    LOINC Version 232
    MTHU001123 (undefined)
    UMLS CUI 2011AA
    C1518422 (Negation)
    LOINC
    LA21291-2
    UMLS CUI 2011AA
    C0014544 (Epilepsy)
    SNOMED
    84757009
    LOINC
    MTHU020586
    SNOMED CT 2011_0131
    84757009 (undefined)
    MedDRA 14.1
    10015037 (undefined)
    LOINC Version 232
    MTHU020586 (undefined)
    ICD-10-CM Version 2010
    G40.9 (undefined)
    ICD-9-CM Version 2011
    345.9 (undefined)
    UMLS CUI 2011AA
    CL335836 (undefined)
    Benzodiazepines as rescue therapy for epilepsy may have been used as needed in this time period, but not more frequently than once per week)
    Description

    Benzodiazepines as rescue therapy for epilepsy may have been used as needed in this time period, but not more frequently than once per week)

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C0005064 (Benzodiazepines)
    LOINC
    LP15014-1
    SNOMED CT 2011_0131
    16047007 (undefined)
    LOINC Version 232
    MTHU001123 (undefined)
    UMLS CUI 2011AA
    C0175673 (Bale out)
    SNOMED
    25876001
    SNOMED CT 2011_0131
    25876001 (undefined)
    UMLS CUI 2011AA
    C0039798 (therapeutic aspects)
    UMLS CUI 2011AA
    C0439090 (Less Than or Equal to)
    SNOMED
    276137008
    SNOMED CT 2011_0131
    276137008 (undefined)
    HL7 V3 2006_05
    LE (undefined)
    UMLS CUI 2011AA
    C0558293 (Once a week)
    SNOMED
    225769003
    LOINC
    LA26461-6
    SNOMED CT 2011_0131
    225769003 (undefined)
    Subject has been treated for epilepsy with any antiepileptic drug (AED) (including benzodiazepines) in the last 6 months before Visit 1 (however, acute and subacute seizure treatment is accepted with a maximum of 2 weeks duration and if treatment was stopped at least 1 week before Visit 1
    Description

    Subject has been treated for epilepsy with any antiepileptic drug (AED) (including benzodiazepines) in the last 6 months before Visit 1 (however, acute and subacute seizure treatment is accepted with a maximum of 2 weeks duration and if treatment was stopped at least 1 week before Visit 1

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    CL415147 (undefined)
    UMLS CUI 2011AA
    C0014544 (Epilepsy)
    SNOMED
    84757009
    LOINC
    MTHU020586
    SNOMED CT 2011_0131
    84757009 (undefined)
    MedDRA 14.1
    10015037 (undefined)
    LOINC Version 232
    MTHU020586 (undefined)
    ICD-10-CM Version 2010
    G40.9 (undefined)
    ICD-9-CM Version 2011
    345.9 (undefined)
    UMLS CUI 2011AA
    C0003299 (Antiepileptic Agents)
    SNOMED CT 2011_0131
    255632006 (undefined)
    LOINC Version 232
    MTHU006781 (undefined)
    UMLS CUI 2011AA
    C0005064 (Benzodiazepines)
    LOINC
    LP15014-1
    SNOMED CT 2011_0131
    16047007 (undefined)
    LOINC Version 232
    MTHU001123 (undefined)
    UMLS CUI 2011AA
    C1517741 (Last)
    LOINC
    LP200101-6
    UMLS CUI 2011AA
    C0205452 (Six)
    SNOMED
    68244004
    LOINC
    LP20594-5
    SNOMED CT 2011_0131
    68244004 (undefined)
    UMLS CUI 2011AA
    C0439231 (month)
    SNOMED
    258706009
    SNOMED CT 2011_0131
    258706009 (undefined)
    HL7 V3 2006_05
    MO (undefined)
    Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion, has a history of alcohol or drug abuse within the previous 2 years
    Description

    Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion, has a history of alcohol or drug abuse within the previous 2 years

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1699700 (medical condition category)
    HL7 V3 2006_05
    MEDCCAT (undefined)
    UMLS CUI 2011AA
    C0521102 (Interferes with)
    SNOMED
    78235001
    SNOMED CT 2011_0131
    78235001 (undefined)
    UMLS CUI 2011AA
    C0678745 (drug absorption)
    UMLS CUI 2011AA
    C0699903 (drug distribution (pharmacokinetics))
    UMLS CUI 2011AA
    C0683140 (Drug Metabolism)
    UMLS CUI 2011AA
    C0683141 (drug excretion)
    UMLS CUI 2011AA
    C0221628 (History of alcohol abuse)
    SNOMED
    371434005
    SNOMED CT 2011_0131
    371434005 (undefined)
    UMLS CUI 2011AA
    C1299544 (History of substance abuse)
    SNOMED
    371435006
    SNOMED CT 2011_0131
    371435006 (undefined)
    Asian ancestry and tests positive for HLA-B*1502 allele
    Description

    Asian ancestry and tests positive for HLA-B*1502 allele

    Data type

    boolean

    Alias
    UMLS CUI 2011AA
    C1257906 (Asian Continental Ancestry Group)
    UMLS CUI 2011AA
    C1335447 (Positive Laboratory Test Result)
    UMLS CUI 2011AA
    CL430141 (undefined)
    MedDRA 14.1
    10071592 (undefined)
    UMLS CUI 2011AA
    C0002085 (Alleles)
    SNOMED
    9109004
    SNOMED CT 2011_0131
    9109004 (undefined)

    Similar models

    Eligibility

    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion Criteria
    age at least 16 Years
    Item
    age at least 16 Years
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    Subject able to comply with study requirements
    Item
    Subject able to comply with study requirements
    boolean
    C0085732 (UMLS CUI 2011AA)
    371150009 (SNOMED CT 2011_0131)
    C1321605 (UMLS CUI 2011AA)
    405078008 (SNOMED CT 2011_0131)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C1514873 (UMLS CUI 2011AA)
    Subject is 16 years and older (female, male). Minors will be included in countries only if legally permitted
    Item
    Subject is 16 years and older (female, male). Minors will be included in countries only if legally permitted
    boolean
    C0015780 (UMLS CUI 2011AA)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    C0024554 (UMLS CUI 2011AA)
    248153007 (SNOMED CT 2011_0131)
    M (HL7 V3 2006_05)
    C0026193 (UMLS CUI 2011AA)
    410599005 (SNOMED CT 2011_0131)
    C0750557 (UMLS CUI 2011AA)
    C1301860 (UMLS CUI 2011AA)
    398165009 (SNOMED CT 2011_0131)
    C0521104 (UMLS CUI 2011AA)
    75554001 (SNOMED CT 2011_0131)
    Subject has newly or recently diagnosed epilepsy experiencing partial onset seizures (POS) or generalized tonic-clonic seizures with at least 2 unprovoked seizures separated by 48 hours in the year before enrollment with 1 seizures 3 months before enrollment
    Item
    Subject has newly or recently diagnosed epilepsy experiencing partial onset seizures (POS) or generalized tonic-clonic seizures with at least 2 unprovoked seizures separated by 48 hours in the year before enrollment with 1 seizures 3 months before enrollment
    boolean
    C2585997 (UMLS CUI 2011AA)
    441308009 (SNOMED CT 2011_0131)
    C0014544 (UMLS CUI 2011AA)
    84757009 (SNOMED CT 2011_0131)
    10015037 (MedDRA 14.1)
    MTHU020586 (LOINC Version 232)
    G40.9 (ICD-10-CM Version 2010)
    345.9 (ICD-9-CM Version 2011)
    C0234974 (UMLS CUI 2011AA)
    79348005 (SNOMED CT 2011_0131)
    10040703 (MedDRA 14.1)
    C0494475 (UMLS CUI 2011AA)
    54200006 (SNOMED CT 2011_0131)
    10044000 (MedDRA 14.1)
    G40.3 (ICD-10-CM Version 2010)
    C1518422 (UMLS CUI 2011AA)
    C1444748 (UMLS CUI 2011AA)
    410658008 (SNOMED CT 2011_0131)
    C0036572 (UMLS CUI 2011AA)
    91175000 (SNOMED CT 2011_0131)
    10039910 (MedDRA 14.1)
    780.39 (ICD-9-CM Version 2011)
    Subject has normal electroencephalogram (EEG) which must be normal or consistent with partial onset seizures (POS) and a Computerized Axial Tomography (CT) scan or Magnetic Resonance Imaging (MRI) with diagnosis of POS or generalized tonic clonic seizures (without clear focal origin) within year before enrollment
    Item
    Subject has normal electroencephalogram (EEG) which must be normal or consistent with partial onset seizures (POS) and a Computerized Axial Tomography (CT) scan or Magnetic Resonance Imaging (MRI) with diagnosis of POS or generalized tonic clonic seizures (without clear focal origin) within year before enrollment
    boolean
    C0560017 (UMLS CUI 2011AA)
    164717000 (SNOMED CT 2011_0131)
    10014409 (MedDRA 14.1)
    C0332290 (UMLS CUI 2011AA)
    385433004 (SNOMED CT 2011_0131)
    C0234974 (UMLS CUI 2011AA)
    79348005 (SNOMED CT 2011_0131)
    10040703 (MedDRA 14.1)
    C0810430 (UMLS CUI 2011AA)
    C0024485 (UMLS CUI 2011AA)
    113091000 (SNOMED CT 2011_0131)
    10028049 (MedDRA 14.1)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0234974 (UMLS CUI 2011AA)
    79348005 (SNOMED CT 2011_0131)
    10040703 (MedDRA 14.1)
    C0494475 (UMLS CUI 2011AA)
    54200006 (SNOMED CT 2011_0131)
    10044000 (MedDRA 14.1)
    G40.3 (ICD-10-CM Version 2010)
    Item Group
    Exclusion Criteria
    Subject has a history or presence of seizures of other types than partial-onset (IA, IB, IC with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures (eg, myoclonic, absence)
    Item
    Subject has a history or presence of seizures of other types than partial-onset (IA, IB, IC with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures (eg, myoclonic, absence)
    boolean
    C0036572 (UMLS CUI 2011AA)
    91175000 (SNOMED CT 2011_0131)
    10039910 (MedDRA 14.1)
    780.39 (ICD-9-CM Version 2011)
    C0456387 (UMLS CUI 2011AA)
    277046005 (SNOMED CT 2011_0131)
    C0450344 (UMLS CUI 2011AA)
    264653008 (SNOMED CT 2011_0131)
    C0450345 (UMLS CUI 2011AA)
    264654002 (SNOMED CT 2011_0131)
    C0205447 (UMLS CUI 2011AA)
    38112003 (SNOMED CT 2011_0131)
    C0439106 (UMLS CUI 2011AA)
    257962003 (SNOMED CT 2011_0131)
    C0014550 (UMLS CUI 2011AA)
    37356005 (SNOMED CT 2011_0131)
    10054859 (MedDRA 14.1)
    C0014553 (UMLS CUI 2011AA)
    79631006 (SNOMED CT 2011_0131)
    10000332 (MedDRA 14.1)
    G40.3 (ICD-10-CM Version 2010)
    Subject has a history or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time (ie, <20 minutes) with or without function regained between 2 ictal events
    Item
    Subject has a history or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time (ie, <20 minutes) with or without function regained between 2 ictal events
    boolean
    C0036572 (UMLS CUI 2011AA)
    91175000 (SNOMED CT 2011_0131)
    10039910 (MedDRA 14.1)
    780.39 (ICD-9-CM Version 2011)
    CL382928 (UMLS CUI 2011AA)
    C0449774 (UMLS CUI 2011AA)
    272135003 (SNOMED CT 2011_0131)
    C1806781 (UMLS CUI 2011AA)
    367450005 (SNOMED CT 2011_0131)
    C0439582 (UMLS CUI 2011AA)
    272117007 (SNOMED CT 2011_0131)
    Subject has a history, clinical, or Electroencephalogram (EEG) finding suggestive of idiopathic generalized epilepsy (IGE) at randomization
    Item
    Subject has a history, clinical, or Electroencephalogram (EEG) finding suggestive of idiopathic generalized epilepsy (IGE) at randomization
    boolean
    C0013819 (UMLS CUI 2011AA)
    54550000 (SNOMED CT 2011_0131)
    10014407 (MedDRA 14.1)
    89.14 (ICD-9-CM Version 2011)
    C0038659 (UMLS CUI 2011AA)
    C0270850 (UMLS CUI 2011AA)
    36803009 (SNOMED CT 2011_0131)
    10071081 (MedDRA 14.1)
    G40.3 (ICD-10-CM Version 2010)
    Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events which could be confused with seizures
    Item
    Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events which could be confused with seizures
    boolean
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0349245 (UMLS CUI 2011AA)
    191714002 (SNOMED CT 2011_0131)
    10037148 (MedDRA 14.1)
    F44.5 (ICD-10-CM Version 2010)
    C0009946 (UMLS CUI 2011AA)
    20734000 (SNOMED CT 2011_0131)
    10010893 (MedDRA 14.1)
    F44 (ICD-10-CM Version 2010)
    300.11 (ICD-9-CM Version 2011)
    C2674681 (UMLS CUI 2011AA)
    C0521102 (UMLS CUI 2011AA)
    78235001 (SNOMED CT 2011_0131)
    C0036572 (UMLS CUI 2011AA)
    91175000 (SNOMED CT 2011_0131)
    10039910 (MedDRA 14.1)
    780.39 (ICD-9-CM Version 2011)
    Subject has any medical or psychiatric condition
    Item
    Subject has any medical or psychiatric condition
    boolean
    C1699700 (UMLS CUI 2011AA)
    MEDCCAT (HL7 V3 2006_05)
    C0809986 (UMLS CUI 2011AA)
    Subject has a history of suicide attempt, has received professional counselling for suicidal ideation, or is currently experiencing active suicidal ideation
    Item
    Subject has a history of suicide attempt, has received professional counselling for suicidal ideation, or is currently experiencing active suicidal ideation
    boolean
    C2911479 (UMLS CUI 2011AA)
    Z91.5 (ICD-10-CM Version 2010)
    C0010210 (UMLS CUI 2011AA)
    409063005 (SNOMED CT 2011_0131)
    C0424000 (UMLS CUI 2011AA)
    6471006 (SNOMED CT 2011_0131)
    10042458 (MedDRA 14.1)
    V62.84 (ICD-9-CM Version 2011)
    E12964 (CTCAE 1105E)
    CL430050 (UMLS CUI 2011AA)
    10071456 (MedDRA 14.1)
    Prior use of felbamate or vigabatrin is not allowed
    Item
    Prior use of felbamate or vigabatrin is not allowed
    boolean
    C1554075 (UMLS CUI 2011AA)
    NP (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C1524063 (UMLS CUI 2011AA)
    260676000 (SNOMED CT 2011_0131)
    C0060135 (UMLS CUI 2011AA)
    371387009 (SNOMED CT 2011_0131)
    MTHU015105 (LOINC Version 232)
    C0048044 (UMLS CUI 2011AA)
    322976008 (SNOMED CT 2011_0131)
    MTHU012453 (LOINC Version 232)
    Subject has received treatment with phenobarbital or primidone within 28 days prior to Visit 1
    Item
    Subject has received treatment with phenobarbital or primidone within 28 days prior to Visit 1
    boolean
    C0039798 (UMLS CUI 2011AA)
    C0031412 (UMLS CUI 2011AA)
    51073002 (SNOMED CT 2011_0131)
    MTHU003431 (LOINC Version 232)
    C0033148 (UMLS CUI 2011AA)
    47120002 (SNOMED CT 2011_0131)
    MTHU003369 (LOINC Version 232)
    C0439231 (UMLS CUI 2011AA)
    258706009 (SNOMED CT 2011_0131)
    MO (HL7 V3 2006_05)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C1554196 (UMLS CUI 2011AA)
    ENC (HL7 V3 2006_05)
    C0205447 (UMLS CUI 2011AA)
    38112003 (SNOMED CT 2011_0131)
    Subject is taking benzodiazepines for a nonepilepsy indication
    Item
    Subject is taking benzodiazepines for a nonepilepsy indication
    boolean
    C1512806 (UMLS CUI 2011AA)
    C0005064 (UMLS CUI 2011AA)
    16047007 (SNOMED CT 2011_0131)
    MTHU001123 (LOINC Version 232)
    C1518422 (UMLS CUI 2011AA)
    C0014544 (UMLS CUI 2011AA)
    84757009 (SNOMED CT 2011_0131)
    10015037 (MedDRA 14.1)
    MTHU020586 (LOINC Version 232)
    G40.9 (ICD-10-CM Version 2010)
    345.9 (ICD-9-CM Version 2011)
    CL335836 (UMLS CUI 2011AA)
    Benzodiazepines as rescue therapy for epilepsy may have been used as needed in this time period, but not more frequently than once per week)
    Item
    Benzodiazepines as rescue therapy for epilepsy may have been used as needed in this time period, but not more frequently than once per week)
    boolean
    C0005064 (UMLS CUI 2011AA)
    16047007 (SNOMED CT 2011_0131)
    MTHU001123 (LOINC Version 232)
    C0175673 (UMLS CUI 2011AA)
    25876001 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    C0439090 (UMLS CUI 2011AA)
    276137008 (SNOMED CT 2011_0131)
    LE (HL7 V3 2006_05)
    C0558293 (UMLS CUI 2011AA)
    225769003 (SNOMED CT 2011_0131)
    Subject has been treated for epilepsy with any antiepileptic drug (AED) (including benzodiazepines) in the last 6 months before Visit 1 (however, acute and subacute seizure treatment is accepted with a maximum of 2 weeks duration and if treatment was stopped at least 1 week before Visit 1
    Item
    Subject has been treated for epilepsy with any antiepileptic drug (AED) (including benzodiazepines) in the last 6 months before Visit 1 (however, acute and subacute seizure treatment is accepted with a maximum of 2 weeks duration and if treatment was stopped at least 1 week before Visit 1
    boolean
    CL415147 (UMLS CUI 2011AA)
    C0014544 (UMLS CUI 2011AA)
    84757009 (SNOMED CT 2011_0131)
    10015037 (MedDRA 14.1)
    MTHU020586 (LOINC Version 232)
    G40.9 (ICD-10-CM Version 2010)
    345.9 (ICD-9-CM Version 2011)
    C0003299 (UMLS CUI 2011AA)
    255632006 (SNOMED CT 2011_0131)
    MTHU006781 (LOINC Version 232)
    C0005064 (UMLS CUI 2011AA)
    16047007 (SNOMED CT 2011_0131)
    MTHU001123 (LOINC Version 232)
    C1517741 (UMLS CUI 2011AA)
    C0205452 (UMLS CUI 2011AA)
    68244004 (SNOMED CT 2011_0131)
    C0439231 (UMLS CUI 2011AA)
    258706009 (SNOMED CT 2011_0131)
    MO (HL7 V3 2006_05)
    Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion, has a history of alcohol or drug abuse within the previous 2 years
    Item
    Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion, has a history of alcohol or drug abuse within the previous 2 years
    boolean
    C1699700 (UMLS CUI 2011AA)
    MEDCCAT (HL7 V3 2006_05)
    C0521102 (UMLS CUI 2011AA)
    78235001 (SNOMED CT 2011_0131)
    C0678745 (UMLS CUI 2011AA)
    C0699903 (UMLS CUI 2011AA)
    C0683140 (UMLS CUI 2011AA)
    C0683141 (UMLS CUI 2011AA)
    C0221628 (UMLS CUI 2011AA)
    371434005 (SNOMED CT 2011_0131)
    C1299544 (UMLS CUI 2011AA)
    371435006 (SNOMED CT 2011_0131)
    Asian ancestry and tests positive for HLA-B*1502 allele
    Item
    Asian ancestry and tests positive for HLA-B*1502 allele
    boolean
    C1257906 (UMLS CUI 2011AA)
    C1335447 (UMLS CUI 2011AA)
    CL430141 (UMLS CUI 2011AA)
    10071592 (MedDRA 14.1)
    C0002085 (UMLS CUI 2011AA)
    9109004 (SNOMED CT 2011_0131)

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