ID

3735

Description

ODM derived from http://clinicaltrials.gov/show/NCT01290679

Link

http://clinicaltrials.gov/show/NCT01290679

Keywords

Versions (2)
  1. 2/28/13 2/28/13 - Martin Dugas
  2. 9/20/21 9/20/21 -
Uploaded on

February 28, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility DRKS00005757 NCT01290679 Hepatitis C

German English

Eligibility

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

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Genotype 1 hepatitis C infection (confirmed at screening)
Description

Genotype 1 hepatitis C infection (confirmed at screening)

Data type

boolean

Alias
UMLS CUI 2011AA
C1148363
LOINC Version 232
MTHU014928
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0021311
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
patient has not received any prior treatment for hepatitis C
Description

patient has not received any prior treatment for hepatitis C

Data type

boolean

Alias
UMLS CUI 2011AA
C0332155
SNOMED CT 2011_0131
25265005
UMLS CUI 2011AA
C0019196
SNOMED CT 2011_0131
50711007
MedDRA 14.1
10019744
ICD-10-CM Version 2010
B19.20
ICD-9-CM Version 2011
070.7
patient must have had a liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis C infection
Description

patient must have had a liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis C infection

Data type

boolean

Alias
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0193388
SNOMED CT 2011_0131
86259008
MedDRA 14.1
10004791
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0449450
SNOMED CT 2011_0131
246105001
UMLS CUI 2011AA
C0524910
SNOMED CT 2011_0131
128302006
MedDRA 14.1
10008912
ICD-10-CM Version 2010
B18.2
must agree to use 2 forms of effective contraception throughout study (both males and females).
Description

must agree to use 2 forms of effective contraception throughout study (both males and females).

Data type

boolean

Alias
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
Exclusion Criteria
Description

Exclusion Criteria

Infection with HIV or non genotype 1 hepatitis C
Description

Infection with HIV or non genotype 1 hepatitis C

Data type

boolean

Alias
UMLS CUI 2011AA
C0019693
SNOMED CT 2011_0131
86406008
MedDRA 14.1
10020161
LOINC Version 232
MTHU020829
ICD-10-CM Version 2010
B20
ICD-9-CM Version 2011
042
UMLS CUI 2011AA
C0019196
SNOMED CT 2011_0131
50711007
MedDRA 14.1
10019744
ICD-10-CM Version 2010
B19.20
ICD-9-CM Version 2011
070.7
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0017431
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
liver disease not related to hepatitic C infection
Description

liver disease not related to hepatitic C infection

Data type

boolean

Alias
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
UMLS CUI 2011AA
CL414700
UMLS CUI 2011AA
C0019196
SNOMED CT 2011_0131
50711007
MedDRA 14.1
10019744
ICD-10-CM Version 2010
B19.20
ICD-9-CM Version 2011
070.7
Hepatic failure, Liver decompensation
Description

hepatic decompensation

Data type

boolean

Alias
UMLS CUI 2011AA
C0085605
SNOMED CT 2011_0131
59927004
MedDRA 14.1
10019663
ICD-10-CM Version 2010
K72.9
CTCAE 1105E
E11211
significant laboratory abnormalities or other active diseases
Description

significant laboratory abnormalities or other active diseases

Data type

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0438215
SNOMED CT 2011_0131
165346000
MedDRA 14.1
10023547
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C2707252
LOINC Version 232
MTHU031865
pregnant or planning to become pregnant
Description

pregnant or planning to become pregnant

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0032992
SNOMED CT 2011_0131
169565003
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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 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Genotype 1 hepatitis C infection (confirmed at screening)
Item
Genotype 1 hepatitis C infection (confirmed at screening)
boolean
C1148363 (UMLS CUI 2011AA)
MTHU014928 (LOINC Version 232)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
patient has not received any prior treatment for hepatitis C
Item
patient has not received any prior treatment for hepatitis C
boolean
C0332155 (UMLS CUI 2011AA)
25265005 (SNOMED CT 2011_0131)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
patient must have had a liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis C infection
Item
patient must have had a liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis C infection
boolean
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0193388 (UMLS CUI 2011AA)
86259008 (SNOMED CT 2011_0131)
10004791 (MedDRA 14.1)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C0449450 (UMLS CUI 2011AA)
246105001 (SNOMED CT 2011_0131)
C0524910 (UMLS CUI 2011AA)
128302006 (SNOMED CT 2011_0131)
10008912 (MedDRA 14.1)
B18.2 (ICD-10-CM Version 2010)
must agree to use 2 forms of effective contraception throughout study (both males and females).
Item
must agree to use 2 forms of effective contraception throughout study (both males and females).
boolean
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
Item Group
Exclusion Criteria
Infection with HIV or non genotype 1 hepatitis C
Item
Infection with HIV or non genotype 1 hepatitis C
boolean
C0019693 (UMLS CUI 2011AA)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
C1518422 (UMLS CUI 2011AA)
C0017431 (UMLS CUI 2011AA)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
liver disease not related to hepatitic C infection
Item
liver disease not related to hepatitic C infection
boolean
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
CL414700 (UMLS CUI 2011AA)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
hepatic decompensation
Item
Hepatic failure, Liver decompensation
boolean
C0085605 (UMLS CUI 2011AA)
59927004 (SNOMED CT 2011_0131)
10019663 (MedDRA 14.1)
K72.9 (ICD-10-CM Version 2010)
E11211 (CTCAE 1105E)
significant laboratory abnormalities or other active diseases
Item
significant laboratory abnormalities or other active diseases
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C2707252 (UMLS CUI 2011AA)
MTHU031865 (LOINC Version 232)
pregnant or planning to become pregnant
Item
pregnant or planning to become pregnant
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0032992 (UMLS CUI 2011AA)
169565003 (SNOMED CT 2011_0131)
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