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)
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)