ID

43425

Description

ODM derived from http://clinicaltrials.gov/show/NCT00699283

Link

http://clinicaltrials.gov/show/NCT00699283

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
  3. 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 NCT00699283 Epilepsy

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 16 Years to 75 Years
Description

age 16 Years to 75 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Age between 16 and 75 years
Description

Subjects from 16 to 75 years, both inclusive.

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
Well-characterized focal epilepsy or epileptic syndrome.
Description

Well-characterized focal epilepsy or epileptic syndrome.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205170
SNOMED CT 2011_0131
20572008
UMLS CUI 2011AA
C1880022
UMLS CUI 2011AA
C0014547
SNOMED CT 2011_0131
230381009
MedDRA 14.1
10065337
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
C0039082
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period.
Description

Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period.

Data type

boolean

Alias
UMLS CUI 2011AA
C0439064
SNOMED CT 2011_0131
255204007
UMLS CUI 2011AA
C0728938
SNOMED CT 2011_0131
255609007
UMLS CUI 2011AA
C0332162
SNOMED CT 2011_0131
77374008
UMLS CUI 2011AA
C0036572
SNOMED CT 2011_0131
91175000
MedDRA 14.1
10039910
ICD-9-CM Version 2011
780.39
UMLS CUI 2011AA
C0175668
SNOMED CT 2011_0131
2603003
UMLS CUI 2011AA
C0311334
SNOMED CT 2011_0131
4619009
MedDRA 14.1
10018109
ICD-9-CM Version 2011
345.1
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0205454
SNOMED CT 2011_0131
7319005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C1442488
Subjects on a stable dose of at least 1 but no more than 2 concomitant AEDs with the second AED <= 50% of the minimum recommended maintenance dose.
Description

Subjects on a stable dose of at least 1 but no more than 2 concomitant AEDs with the second AED <= 50% of the minimum recommended maintenance dose.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0547044
SNOMED CT 2011_0131
263796003
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
C0003299
SNOMED CT 2011_0131
255632006
LOINC Version 232
MTHU006781
UMLS CUI 2011AA
C0205436
SNOMED CT 2011_0131
81170007
UMLS CUI 2011AA
C2825407
UMLS CUI 2011AA
C1524031
UMLS CUI 2011AA
C0034866
LOINC Version 232
MTHU036724
HL7 V3 2006_05
RMD
UMLS CUI 2011AA
C0024501
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Seizure type IA non-motor as only seizure type.
Description

Seizure type IA non-motor as only seizure type.

Data type

boolean

Alias
UMLS CUI 2011AA
C0234974
SNOMED CT 2011_0131
79348005
MedDRA 14.1
10040703
UMLS CUI 2011AA
C0751523
SNOMED CT 2011_0131
442512002
MedDRA 14.1
10057769
UMLS CUI 2011AA
C0205171
SNOMED CT 2011_0131
50607009
UMLS CUI 2011AA
C0036572
SNOMED CT 2011_0131
91175000
MedDRA 14.1
10039910
ICD-9-CM Version 2011
780.39
UMLS CUI 2011AA
C0332307
SNOMED CT 2011_0131
410657003
LOINC Version 232
MTHU013727
History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding Visit 1 or during Baseline.
Description

History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding Visit 1 or during Baseline.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0036572
SNOMED CT 2011_0131
91175000
MedDRA 14.1
10039910
ICD-9-CM Version 2011
780.39
UMLS CUI 2011AA
C0332183
SNOMED CT 2011_0131
70232002
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C2828393
UMLS CUI 2011AA
C0750480
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
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
UMLS CUI 2011AA
C1442488
Other serious uncontrolled disease.
Description

Other serious uncontrolled disease.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
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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
CL425202 (UMLS CUI 2011AA)
age 16 Years to 75 Years
Item
age 16 Years to 75 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Subjects from 16 to 75 years, both inclusive.
Item
Age between 16 and 75 years
boolean
C0001779 (UMLS CUI 2011AA)
Well-characterized focal epilepsy or epileptic syndrome.
Item
Well-characterized focal epilepsy or epileptic syndrome.
boolean
C0205170 (UMLS CUI 2011AA)
20572008 (SNOMED CT 2011_0131)
C1880022 (UMLS CUI 2011AA)
C0014547 (UMLS CUI 2011AA)
230381009 (SNOMED CT 2011_0131)
10065337 (MedDRA 14.1)
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)
C0039082 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period.
Item
Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period.
boolean
C0439064 (UMLS CUI 2011AA)
255204007 (SNOMED CT 2011_0131)
C0728938 (UMLS CUI 2011AA)
255609007 (SNOMED CT 2011_0131)
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C0036572 (UMLS CUI 2011AA)
91175000 (SNOMED CT 2011_0131)
10039910 (MedDRA 14.1)
780.39 (ICD-9-CM Version 2011)
C0175668 (UMLS CUI 2011AA)
2603003 (SNOMED CT 2011_0131)
C0311334 (UMLS CUI 2011AA)
4619009 (SNOMED CT 2011_0131)
10018109 (MedDRA 14.1)
345.1 (ICD-9-CM Version 2011)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0205454 (UMLS CUI 2011AA)
7319005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C1442488 (UMLS CUI 2011AA)
Subjects on a stable dose of at least 1 but no more than 2 concomitant AEDs with the second AED <= 50% of the minimum recommended maintenance dose.
Item
Subjects on a stable dose of at least 1 but no more than 2 concomitant AEDs with the second AED <= 50% of the minimum recommended maintenance dose.
boolean
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0547044 (UMLS CUI 2011AA)
263796003 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
CL415222 (UMLS CUI 2011AA)
C0003299 (UMLS CUI 2011AA)
255632006 (SNOMED CT 2011_0131)
MTHU006781 (LOINC Version 232)
C0205436 (UMLS CUI 2011AA)
81170007 (SNOMED CT 2011_0131)
C2825407 (UMLS CUI 2011AA)
C1524031 (UMLS CUI 2011AA)
C0034866 (UMLS CUI 2011AA)
MTHU036724 (LOINC Version 232)
RMD (HL7 V3 2006_05)
C0024501 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Seizure type IA non-motor as only seizure type.
Item
Seizure type IA non-motor as only seizure type.
boolean
C0234974 (UMLS CUI 2011AA)
79348005 (SNOMED CT 2011_0131)
10040703 (MedDRA 14.1)
C0751523 (UMLS CUI 2011AA)
442512002 (SNOMED CT 2011_0131)
10057769 (MedDRA 14.1)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0036572 (UMLS CUI 2011AA)
91175000 (SNOMED CT 2011_0131)
10039910 (MedDRA 14.1)
780.39 (ICD-9-CM Version 2011)
C0332307 (UMLS CUI 2011AA)
410657003 (SNOMED CT 2011_0131)
MTHU013727 (LOINC Version 232)
History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding Visit 1 or during Baseline.
Item
History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding Visit 1 or during Baseline.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0036572 (UMLS CUI 2011AA)
91175000 (SNOMED CT 2011_0131)
10039910 (MedDRA 14.1)
780.39 (ICD-9-CM Version 2011)
C0332183 (UMLS CUI 2011AA)
70232002 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C2828393 (UMLS CUI 2011AA)
C0750480 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
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)
C1442488 (UMLS CUI 2011AA)
Other serious uncontrolled disease.
Item
Other serious uncontrolled disease.
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
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