ID

43274

Description

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

Link

http://clinicaltrials.gov/show/NCT01243177

Keywords

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

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01243177 Epilepsy

German English

Eligibility

1 forms  
  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
SNOMED CT 2011_0131
397669002
Subject able to comply with study requirements
Description

Subject able to comply with study requirements

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1514873
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
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0026193
SNOMED CT 2011_0131
410599005
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C1301860
SNOMED CT 2011_0131
398165009
UMLS CUI 2011AA
C0521104
SNOMED CT 2011_0131
75554001
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
SNOMED CT 2011_0131
441308009
UMLS CUI 2011AA
C0014544
SNOMED CT 2011_0131
84757009
MedDRA 14.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
UMLS CUI 2011AA
C0234974
SNOMED CT 2011_0131
79348005
MedDRA 14.1
10040703
UMLS CUI 2011AA
C0494475
SNOMED CT 2011_0131
54200006
MedDRA 14.1
10044000
ICD-10-CM Version 2010
G40.3
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1444748
SNOMED CT 2011_0131
410658008
UMLS CUI 2011AA
C0036572
SNOMED CT 2011_0131
91175000
MedDRA 14.1
10039910
ICD-9-CM Version 2011
780.39
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
SNOMED CT 2011_0131
164717000
MedDRA 14.1
10014409
UMLS CUI 2011AA
C0332290
SNOMED CT 2011_0131
385433004
UMLS CUI 2011AA
C0234974
SNOMED CT 2011_0131
79348005
MedDRA 14.1
10040703
UMLS CUI 2011AA
C0810430
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0234974
SNOMED CT 2011_0131
79348005
MedDRA 14.1
10040703
UMLS CUI 2011AA
C0494475
SNOMED CT 2011_0131
54200006
MedDRA 14.1
10044000
ICD-10-CM Version 2010
G40.3
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
SNOMED CT 2011_0131
91175000
MedDRA 14.1
10039910
ICD-9-CM Version 2011
780.39
UMLS CUI 2011AA
C0456387
SNOMED CT 2011_0131
277046005
UMLS CUI 2011AA
C0450344
SNOMED CT 2011_0131
264653008
UMLS CUI 2011AA
C0450345
SNOMED CT 2011_0131
264654002
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439106
SNOMED CT 2011_0131
257962003
UMLS CUI 2011AA
C0014550
SNOMED CT 2011_0131
37356005
MedDRA 14.1
10054859
UMLS CUI 2011AA
C0014553
SNOMED CT 2011_0131
79631006
MedDRA 14.1
10000332
ICD-10-CM Version 2010
G40.3
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
SNOMED CT 2011_0131
91175000
MedDRA 14.1
10039910
ICD-9-CM Version 2011
780.39
UMLS CUI 2011AA
CL382928
UMLS CUI 2011AA
C0449774
SNOMED CT 2011_0131
272135003
UMLS CUI 2011AA
C1806781
SNOMED CT 2011_0131
367450005
UMLS CUI 2011AA
C1948053
SNOMED CT 2011_0131
272117007
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
SNOMED CT 2011_0131
54550000
MedDRA 14.1
10014407
ICD-9-CM Version 2011
89.14
UMLS CUI 2011AA
C0038659
UMLS CUI 2011AA
C0270850
SNOMED CT 2011_0131
36803009
MedDRA 14.1
10071081
ICD-10-CM Version 2010
G40.3
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
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0349245
SNOMED CT 2011_0131
191714002
MedDRA 14.1
10037148
ICD-10-CM Version 2010
F44.5
UMLS CUI 2011AA
C0009946
SNOMED CT 2011_0131
20734000
MedDRA 14.1
10010893
ICD-10-CM Version 2010
F44
ICD-9-CM Version 2011
300.11
UMLS CUI 2011AA
C2674681
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0036572
SNOMED CT 2011_0131
91175000
MedDRA 14.1
10039910
ICD-9-CM Version 2011
780.39
Subject has any medical or psychiatric condition
Description

Subject has any medical or psychiatric condition

Data type

boolean

Alias
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C0809986
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
ICD-10-CM Version 2010
Z91.5
UMLS CUI 2011AA
C0010210
SNOMED CT 2011_0131
409063005
UMLS CUI 2011AA
C0424000
SNOMED CT 2011_0131
6471006
MedDRA 14.1
10042458
ICD-9-CM Version 2011
V62.84
CTCAE 1105E
E12964
UMLS CUI 2011AA
CL430050
MedDRA 14.1
10071456
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
HL7 V3 2006_05
NP
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0060135
SNOMED CT 2011_0131
371387009
LOINC Version 232
MTHU015105
UMLS CUI 2011AA
C0048044
SNOMED CT 2011_0131
322976008
LOINC Version 232
MTHU012453
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
UMLS CUI 2011AA
C0031412
SNOMED CT 2011_0131
51073002
LOINC Version 232
MTHU003431
UMLS CUI 2011AA
C0033148
SNOMED CT 2011_0131
47120002
LOINC Version 232
MTHU003369
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
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
UMLS CUI 2011AA
C0005064
SNOMED CT 2011_0131
16047007
LOINC Version 232
MTHU001123
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0014544
SNOMED CT 2011_0131
84757009
MedDRA 14.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
UMLS CUI 2011AA
CL335836
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
SNOMED CT 2011_0131
16047007
LOINC Version 232
MTHU001123
UMLS CUI 2011AA
C0175673
SNOMED CT 2011_0131
25876001
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0439090
SNOMED CT 2011_0131
276137008
HL7 V3 2006_05
LE
UMLS CUI 2011AA
C0558293
SNOMED CT 2011_0131
225769003
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
UMLS CUI 2011AA
C0014544
SNOMED CT 2011_0131
84757009
MedDRA 14.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
UMLS CUI 2011AA
C0003299
SNOMED CT 2011_0131
255632006
LOINC Version 232
MTHU006781
UMLS CUI 2011AA
C0005064
SNOMED CT 2011_0131
16047007
LOINC Version 232
MTHU001123
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
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
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0678745
UMLS CUI 2011AA
C0699903
UMLS CUI 2011AA
C0683140
UMLS CUI 2011AA
C0683141
UMLS CUI 2011AA
C0221628
SNOMED CT 2011_0131
371434005
UMLS CUI 2011AA
C1299544
SNOMED CT 2011_0131
371435006
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
UMLS CUI 2011AA
C1335447
UMLS CUI 2011AA
CL430141
MedDRA 14.1
10071592
UMLS CUI 2011AA
C0002085
SNOMED CT 2011_0131
9109004
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Similar models

Eligibility

1 forms
  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
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0086582 (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)
C1948053 (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)
C1512346 (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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