0 Avaliações
ID

43457

Descrição

Chronic Hepatitis C: Optimization of Treatment for Patients infected With HCV-genotype 2 or 3: 12 vs. 24 Weeks of Treatment Extension for Patients Without Rapid Virological Response see http://clinicaltrials.gov/show/NCT00803309

Link

http://clinicaltrials.gov/show/NCT00803309

Palavras-chave

Versões (4)
  1. 09/12/2013 09/12/2013 - Martin Dugas
  2. 25/03/2014 25/03/2014 - Martin Dugas
  3. 16/04/2014 16/04/2014 - Julian Varghese
  4. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility NCT00803309 Hepatitis C, Chronic

    Alemão Inglês

    Eligibility Hepatitis C NCT00803309

    1 Formulários  
    Einschlusskriterien
    Descrição

    Einschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425202
    Alter mindestens 18 Jahre
    Descrição

    age at least 18 Years

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    397669002
    UMLS CUI-1
    C0001779
    Male and female patients with HCV-genotype 2/3 chronic hepatitis C documented by detectable plasma HCV RNA (> 15 IU/mL) and positivity of anti-HCV antibodies
    Descrição

    Chronic hepatitis C, HCV-genotype 2/3, HCV RNA and anti-HCV positive

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    248153007
    HL7 V3 2006_05
    M
    SNOMED CT 2011_0131
    248152002
    HL7 V3 2006_05
    F
    SNOMED CT 2011_0131
    62944002
    MedDRA 14.1
    10019752
    SNOMED CT 2011_0131
    19338005
    SNOMED CT 2011_0131
    421291004
    SNOMED CT 2011_0131
    128302006
    MedDRA 14.1
    10008912
    ICD-10-CM Version 2010
    B18.2
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    SNOMED CT 2011_0131
    50863008
    LOINC Version 232
    MTHU002157
    SNOMED CT 2011_0131
    121204002
    LOINC Version 232
    MTHU001816
    MedDRA 14.1
    10019747
    UMLS CUI-1
    C0524910
    UMLS CUI-2
    C0369335
    UMLS CUI-3
    C0281863
    Compensated liver disease (Child-Pugh Grade A clinical classification)
    Descrição

    Compensated liver disease

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    17275008
    SNOMED CT 2011_0131
    235856003
    MedDRA 14.1
    10024670
    ICD-10-CM Version 2010
    K76.9
    ICD-9-CM Version 2011
    573.9
    SNOMED CT 2011_0131
    258349007
    LOINC Version 232
    MTHU003112
    SNOMED CT 2011_0131
    422097006
    UMLS CUI-1
    C0205432
    UMLS CUI-2
    C0023895
    UMLS CUI-3
    C4050412
    UMLS CUI-4
    C0441800
    UMLS CUI-5
    C1706281
    Negative urine or blood pregnancy test (one of the both, for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 7 months after treatment end. This includes using birth control pills (no interaction with investigational drugs), IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state. At least one contraception method must be of barrier method
    Descrição

    Non-pregnant, effective contraception

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    224526002
    SNOMED CT 2011_0131
    167254001
    MedDRA 14.1
    10036577
    SNOMED CT 2011_0131
    166435006
    SNOMED CT 2011_0131
    248152002
    HL7 V3 2006_05
    F
    SNOMED CT 2011_0131
    248153007
    HL7 V3 2006_05
    M
    SNOMED CT 2011_0131
    146680009
    MedDRA 14.1
    10010808
    SNOMED CT 2011_0131
    59261009
    SNOMED CT 2011_0131
    268460000
    MedDRA 14.1
    10022745
    SNOMED CT 2011_0131
    20359006
    MedDRA 14.1
    10062116
    SNOMED CT 2011_0131
    76498008
    SNOMED CT 2011_0131
    225370004
    UMLS CUI-1
    C0043210
    UMLS CUI-2
    C1148523
    UMLS CUI-3
    C0237399
    UMLS CUI-4
    C0430057
    UMLS CUI-5
    C0430061
    UMLS CUI-6
    CL426012
    UMLS CUI-7
    C0086287
    UMLS CUI-8
    C0086582
    UMLS CUI-9
    C0700589
    UMLS CUI-10
    C0009905
    UMLS CUI-11
    C0021900
    UMLS CUI-12
    C0677582
    UMLS CUI-13
    C0042241
    UMLS CUI-14
    CL424925
    UMLS CUI-15
    C0038288
    UMLS CUI-16
    C0232970
    UMLS CUI-17
    C0004764
    Ongoing treatment with 1.5 µg/kg Peg-Interferon alpha-2b (PegIntron) and > 10.6 mg/kg ribavirin (Rebetol)
    Descrição

    Current therapy with Peg-Interferon alpha-2b and ribavirin

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    395823000
    SNOMED CT 2011_0131
    387188005
    LOINC Version 232
    MTHU018696
    UMLS CUI-1
    C2827774
    UMLS CUI-2
    C0796545
    UMLS CUI-3
    C0035525
    No rapid virological response (HCV-RNA positive after week 4 of the ongoing therapy)
    Descrição

    No rapid virological response

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    255358001
    MedDRA 14.1
    10019750
    SNOMED CT 2011_0131
    258705008
    HL7 V3 2006_05
    WK
    SNOMED CT 2011_0131
    9362000
    UMLS CUI-1
    C1518422
    UMLS CUI-2
    C0456962
    UMLS CUI-3
    C1155328
    Willingness to give written informed consent and willingness to participate to and to comply with the study protocol
    Descrição

    Willingness to comply with study protocol

    Tipo de dados

    boolean

    Alias
    UMLS CUI-4
    C0021430
    Ausschlusskriterien
    Descrição

    Ausschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425201
    Women with ongoing pregnancy or breast feeding
    Descrição

    Ongoing pregnancy or breast feeding

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    224526002
    SNOMED CT 2011_0131
    289908002
    MedDRA 14.1
    10036556
    LOINC Version 232
    MTHU035048
    MedDRA 14.1
    10006247
    UMLS CUI-1
    C0032961
    UMLS CUI-2
    C0006147
    Male partners of women who are pregnant
    Descrição

    Male partners of women who are pregnant

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0086582
    SNOMED CT 2011_0131
    248153007
    HL7 V3 2006_05
    M
    UMLS CUI 2011AA
    C0682323
    SNOMED CT 2011_0131
    262043009
    HL7 V3 2006_05
    SIGOTHR
    UMLS CUI 2011AA
    C0043210
    SNOMED CT 2011_0131
    224526002
    UMLS CUI 2011AA
    C0549206
    MedDRA 14.1
    10036586
    Positive tests at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg, anti-HIV, HIV-RNA
    Descrição

    Positive tests for Hepatitis A/B/C, HIV

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    32609007
    LOINC Version 232
    MTHU004541
    LOINC Version 232
    MTHU021816
    SNOMED CT 2011_0131
    22290004
    LOINC Version 232
    MTHU001814
    MedDRA 14.1
    10052020
    LOINC Version 232
    MTHU021816
    SNOMED CT 2011_0131
    60605004
    LOINC Version 232
    MTHU004548
    MedDRA 14.1
    10002725
    MedDRA 14.1
    10049826
    UMLS CUI-1
    C1335447
    UMLS CUI-2
    C1409616
    UMLS CUI-3
    C0062524
    UMLS CUI-4
    C1442155
    UMLS CUI-5
    C0019168
    UMLS CUI-6
    C0948759
    UMLS CUI-7
    C1442155
    UMLS CUI-8
    C0019167
    UMLS CUI-9
    C0856918
    UMLS CUI-10
    C0877327
    History or other evidence of a medical condition associated with chronic liver disease other than HCV associated (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
    Descrição

    non-HCV chronic liver disease

    Tipo de dados

    boolean

    Alias
    HL7 V3 2006_05
    MEDCCAT
    SNOMED CT 2011_0131
    328383001
    MedDRA 14.1
    10008953
    SNOMED CT 2011_0131
    62944002
    MedDRA 14.1
    10019752
    SNOMED CT 2011_0131
    399187006
    MedDRA 14.1
    10018872
    ICD-10-CM Version 2010
    E83.119
    SNOMED CT 2011_0131
    408335007
    MedDRA 14.1
    10003827
    ICD-10-CM Version 2010
    K75.4
    ICD-9-CM Version 2011
    571.42
    SNOMED CT 2011_0131
    41309000
    MedDRA 14.1
    10001627
    ICD-10-CM Version 2010
    K70.9
    ICD-9-CM Version 2011
    571.3
    SNOMED CT 2011_0131
    420239005
    UMLS CUI-1
    C1699700
    UMLS CUI-2
    C0341439
    UMLS CUI-3
    CL411789
    UMLS CUI-4
    C0220847
    UMLS CUI-5
    C0018995
    UMLS CUI-6
    C0241910
    UMLS CUI-7
    C0023896
    UMLS CUI-8
    C0040537
    History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
    Descrição

    Bleeding from esophageal varices, decompensated liver disease

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    17709002
    MedDRA 14.1
    10030210
    ICD-10-CM Version 2010
    I85.01
    ICD-9-CM Version 2011
    456.0
    CTCAE 1105E
    E10682
    SNOMED CT 2011_0131
    260905004
    HL7 V3 2006_05
    COND
    SNOMED CT 2011_0131
    385433004
    MedDRA 14.1
    10050060
    UMLS CUI-1
    C0155789
    UMLS CUI-2
    C0348080
    UMLS CUI-3
    C0332290
    UMLS CUI-4
    C0745744
    Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening
    Descrição

    Liver cirrhosis and suspected hepatic malignancy

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    19943007
    MedDRA 14.1
    10019641
    ICD-10-CM Version 2010
    K74.60
    SNOMED CT 2011_0131
    49755003
    SNOMED CT 2011_0131
    126851005
    MedDRA 14.1
    10019695
    ICD-10-CM Version 2010
    C22.0
    UMLS CUI-1
    C0023890
    UMLS CUI-2
    C0221198
    UMLS CUI-3
    C0242114
    UMLS CUI-4
    C0023903
    UMLS CUI-5
    C1409616
    Absolute neutrophil count (ANC) <750 cells/mm3 at screening
    Descrição

    Neutropenia

    Tipo de dados

    boolean

    Alias
    MedDRA 14.1
    10052033
    UMLS CUI-1
    C0948762
    UMLS CUI-2
    C1409616
    Platelet count <50,000 cells/mm3 at screening
    Descrição

    Low platelet count

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    365632008
    LOINC Version 232
    777-3
    UMLS CUI-1
    C1287267
    UMLS CUI-2
    C1409616
    Hb <10 g/dl at screening
    Descrição

    Anemia

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    38082009
    MedDRA 14.1
    10019481
    LOINC Version 232
    LP14449-0
    UMLS CUI-1
    C0019046
    UMLS CUI-2
    C1409616
    Dose modification of Peg-Interferon alpha-2b (PegIntron) or ribavirin (Rebetol) during the first 4 weeks of the ongoing therapy
    Descrição

    Dose modification of Peg-Interferon alpha-2b or ribavirin

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    395823000
    SNOMED CT 2011_0131
    387188005
    LOINC Version 232
    MTHU018696
    SNOMED CT 2011_0131
    255216001
    SNOMED CT 2011_0131
    258706009
    HL7 V3 2006_05
    MO
    UMLS CUI-1
    C1707811
    UMLS CUI-2
    C0796545
    UMLS CUI-3
    C0035525
    UMLS CUI-4
    C0205435
    UMLS CUI-5
    C0439231
    UMLS CUI-6
    C0039798
    Interferon alpha or ribavirin therapy at any time point before the actual ongoing treatment
    Descrição

    Previous therapy with Interferon alpha or ribavirin

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    387188005
    LOINC Version 232
    MTHU018696
    SNOMED CT 2011_0131
    288556008
    UMLS CUI-1
    C1610033
    UMLS CUI-2
    C0035525
    UMLS CUI-3
    C0039798
    UMLS CUI-4
    C0332152
    UMLS CUI-5
    C0237400
    UMLS CUI-6
    C0039798
    < 80% adherence to treatment of the ongoing treatment until randomization (week 20-22 of ongoing treatment)
    Descrição

    Low adherence to ongoing treatment

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    71978007
    UMLS CUI-1
    C0205412
    UMLS CUI-2
    C1171369
    UMLS CUI-3
    CL415091
    UMLS CUI-4
    C0034656
    Serum creatinine level >1.5 times the upper limit of normal at screening
    Descrição

    Serum creatinine elevated

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    113075003
    MedDRA 14.1
    10040230
    UMLS CUI-1
    C0201976
    UMLS CUI-2
    C1519815
    History of severe psychiatric disease, especially depression (ICD 10 codes F30-F33). Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time. Patients are excluded if any history of suicidal attempts is evident. If hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease are documented, psychiatric consultation is mandatory. Patients with a mild or moderate psychiatric disease (ICD 10 codes F32.0, F32.1, F33.0, F33.1) are only allowed to be included into the trial if a regular monitoring by a psychiatrist is performed during the trial
    Descrição

    History of severe psychiatric disease, especially depression

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    161464003
    SNOMED CT 2011_0131
    310497006
    SNOMED CT 2011_0131
    372720008
    LOINC Version 232
    MTHU006782
    SNOMED CT 2011_0131
    10784006
    LOINC Version 232
    MTHU003337
    ICD-10-CM Version 2010
    Z91.5
    SNOMED CT 2011_0131
    394656005
    MedDRA 14.1
    10054112
    SNOMED CT 2011_0131
    21134002
    MedDRA 14.1
    10013050
    HL7 V3 2006_05
    DIS
    SNOMED CT 2011_0131
    74732009
    MedDRA 14.1
    10037174
    ICD-10-CM Version 2010
    F99
    ICD-9-CM Version 2011
    290-319.99
    UMLS CUI-1
    C0455498
    UMLS CUI-2
    C0588008
    UMLS CUI-3
    C0003289
    UMLS CUI-4
    C0040615
    UMLS CUI-5
    C2911479
    UMLS CUI-6
    C0019993
    UMLS CUI-7
    C1948053
    UMLS CUI-8
    C0231170
    UMLS CUI-9
    CL420107
    UMLS CUI-10
    C0004936
    History of a severe seizure disorder or current anticonvulsant use
    Descrição

    History of a severe seizure disorder or current anticonvulsant use

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0852425
    MedDRA 14.1
    10039912
    UMLS CUI 2011AA
    C1524063
    SNOMED CT 2011_0131
    260676000
    UMLS CUI 2011AA
    C0003299
    SNOMED CT 2011_0131
    255632006
    LOINC Version 232
    MTHU006781
    History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
    Descrição

    History of immunologically mediated disease

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    392521001
    SNOMED CT 2011_0131
    64572001
    SNOMED CT 2011_0131
    47429007
    SNOMED CT 2011_0131
    116003000
    LOINC Version 232
    MTHU013246
    SNOMED CT 2011_0131
    24526004
    MedDRA 14.1
    10021972
    SNOMED CT 2011_0131
    32273002
    MedDRA 14.1
    10021245
    ICD-10-CM Version 2010
    D69.3
    SNOMED CT 2011_0131
    200936003
    MedDRA 14.1
    10025134
    ICD-10-CM Version 2010
    L93
    ICD-9-CM Version 2011
    695.4
    SNOMED CT 2011_0131
    413603009
    MedDRA 14.1
    10002046
    ICD-9-CM Version 2011
    283.0
    SNOMED CT 2011_0131
    89155008
    MedDRA 14.1
    10039710
    SNOMED CT 2011_0131
    24484000
    SNOMED CT 2011_0131
    9014002
    MedDRA 14.1
    10037153
    ICD-10-CM Version 2010
    L40
    SNOMED CT 2011_0131
    69896004
    MedDRA 14.1
    10039073
    ICD-10-CM Version 2010
    M06.9
    ICD-9-CM Version 2011
    714.0
    UMLS CUI-1
    CL421546
    UMLS CUI-2
    C0012634
    UMLS CUI-3
    C0332281
    UMLS CUI-4
    C0020962
    UMLS CUI-5
    C0021390
    UMLS CUI-6
    C0398650
    UMLS CUI-7
    C0409974
    UMLS CUI-8
    C0002880
    UMLS CUI-9
    C0011644
    UMLS CUI-10
    C0205082
    UMLS CUI-11
    C0033860
    UMLS CUI-12
    C0003873
    History or any other evidence of autoimmune diseases
    Descrição

    History or any other evidence of autoimmune diseases

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C0004364
    SNOMED CT 2011_0131
    85828009
    MedDRA 14.1
    10061664
    ICD-10-CM Version 2010
    M30-M36
    CTCAE 1105E
    E11258
    History or other evidence of chronic pulmonary disease associated with functional limitation
    Descrição

    Chronic pulmonary disease

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    392521001
    SNOMED CT 2011_0131
    18669006
    SNOMED CT 2011_0131
    413839001
    SNOMED CT 2011_0131
    47429007
    SNOMED CT 2011_0131
    40143009
    SNOMED CT 2011_0131
    246175000
    UMLS CUI-1
    CL421546
    UMLS CUI-2
    C0332120
    UMLS CUI-3
    C0746102
    UMLS CUI-4
    C0332281
    UMLS CUI-5
    C0205245
    UMLS CUI-6
    C0449295
    History of significant cardiac disease that could be worsened by acute anemia (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months prior to treatment with Peg-Interferon/ribavirin therapy, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
    Descrição

    History of significant cardiac disease

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    392521001
    SNOMED CT 2011_0131
    56265001
    MedDRA 14.1
    10061024
    SNOMED CT 2011_0131
    420913000
    MedDRA 14.1
    10064081
    SNOMED CT 2011_0131
    422293003
    MedDRA 14.1
    10064082
    SNOMED CT 2011_0131
    22298006
    MedDRA 14.1
    10028596
    LOINC Version 232
    MTHU035551
    ICD-10-CM Version 2010
    I21-I22
    ICD-9-CM Version 2011
    410
    CTCAE 1105E
    E10152
    SNOMED CT 2011_0131
    288556008
    SNOMED CT 2011_0131
    387188005
    LOINC Version 232
    MTHU018696
    SNOMED CT 2011_0131
    25569003
    MedDRA 14.1
    10065341
    ICD-10-CM Version 2010
    I47.2
    CTCAE 1105E
    E10239
    SNOMED CT 2011_0131
    4557003
    MedDRA 14.1
    10002388
    ICD-10-CM Version 2010
    I20.0
    ICD-9-CM Version 2011
    411.1
    UMLS CUI-1
    CL421546
    UMLS CUI-2
    C0018799
    UMLS CUI-3
    C1319795
    UMLS CUI-4
    C1319796
    UMLS CUI-5
    C0027051
    UMLS CUI-6
    C0332152
    UMLS CUI-7
    C0982327
    UMLS CUI-8
    C0035525
    UMLS CUI-9
    C0039798
    UMLS CUI-10
    C0042514
    UMLS CUI-11
    C0002965
    Evidence of thyroid disease that is poorly controlled on prescribed medications
    Descrição

    Poorly controlled thyroid disease

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    14304000
    MedDRA 14.1
    10043709
    ICD-10-CM Version 2010
    E00-E07
    ICD-9-CM Version 2011
    240-246.99
    SNOMED CT 2011_0131
    556001
    SNOMED CT 2011_0131
    31509003
    UMLS CUI-1
    C0040128
    UMLS CUI-2
    C0205169
    UMLS CUI-3
    C2587213
    UMLS CUI-4
    C0013227
    Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)
    Descrição

    Severe retinopathy

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    24484000
    SNOMED CT 2011_0131
    399625000
    MedDRA 14.1
    10038923
    CTCAE 1105E
    E10432
    SNOMED CT 2011_0131
    22455005
    MedDRA 14.1
    10011835
    SNOMED CT 2011_0131
    422338006
    MedDRA 14.1
    10025409
    LOINC Version 232
    MTHU020821
    UMLS CUI-1
    C0205082
    UMLS CUI-2
    CL365148
    UMLS CUI-3
    C0206178
    UMLS CUI-4
    C0024437
    History of major organ transplantation with an existing functional graft
    Descrição

    Major organ transplantation

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    392521001
    SNOMED CT 2011_0131
    255603008
    MedDRA 14.1
    10061890
    LOINC Version 232
    MTHU000173
    SNOMED CT 2011_0131
    40143009
    SNOMED CT 2011_0131
    24486003
    UMLS CUI-1
    CL421546
    UMLS CUI-2
    C0205164
    UMLS CUI-3
    C0029216
    UMLS CUI-4
    C0205245
    UMLS CUI-5
    C0332835
    History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
    Descrição

    Severe illness

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    24484000
    SNOMED CT 2011_0131
    39104002
    MedDRA 14.1
    10040658
    ICD-10-CM Version 2010
    R69
    SNOMED CT 2011_0131
    363346000
    MedDRA 14.1
    10028997
    LOINC Version 232
    MTHU010328
    ICD-10-CM Version 2010
    C00-C96
    SNOMED CT 2011_0131
    260905004
    HL7 V3 2006_05
    COND
    SNOMED CT 2011_0131
    23981006
    SNOMED CT 2011_0131
    116154003
    SNOMED CT 2011_0131
    110465008
    UMLS CUI-1
    C0205082
    UMLS CUI-2
    C0221423
    UMLS CUI-3
    C0006826
    UMLS CUI-4
    C0348080
    UMLS CUI-5
    C0678227
    UMLS CUI-6
    C0030705
    UMLS CUI-7
    C1548788
    UMLS CUI-8
    C0008976
    History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
    Descrição

    Systemic anti-neoplastic or immunomodulatory treatment

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    392521001
    SNOMED CT 2011_0131
    31099001
    SNOMED CT 2011_0131
    116566001
    UMLS CUI-1
    CL421546
    UMLS CUI-2
    C0205373
    UMLS CUI-3
    C0920425
    UMLS CUI-4
    CL412323
    UMLS CUI-5
    C0038317
    UMLS CUI-6
    C0034619
    Patients with evidence for tuberculosis
    Descrição

    Tuberculosis

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    18669006
    SNOMED CT 2011_0131
    56717001
    MedDRA 14.1
    10044755
    LOINC Version 232
    MTHU020835
    ICD-10-CM Version 2010
    A15-A19
    ICD-9-CM Version 2011
    010-018.99
    UMLS CUI-1
    C0041296
    Drug abuse within 6 months prior to the first dose of study drug and excessive alcohol consumption. Patients on methadone/polamidone/buprenorphine programs are not excluded
    Descrição

    Drug abuse

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    26416006
    MedDRA 14.1
    10013654
    LOINC Version 232
    LP36310-8
    ICD-9-CM Version 2011
    305.90
    SNOMED CT 2011_0131
    160592001
    HL7 V3 2006_05
    E
    SNOMED CT 2011_0131
    51758009
    LOINC Version 232
    MTHU001002
    SNOMED CT 2011_0131
    31684002
    LOINC Version 232
    MTHU006723
    UMLS CUI-1
    C0013146
    UMLS CUI-2
    C0560219
    UMLS CUI-3
    C1554961
    UMLS CUI-4
    C0025605
    UMLS CUI-5
    C0006405
    Any investigational drug and/or participation in another clinical study prior 6 months to the actual ongoing antiviral treatment
    Descrição

    Participation in another clinical study

    Tipo de dados

    boolean

    Alias
    SNOMED CT 2011_0131
    74964007
    HL7 V3 2006_05
    PART
    SNOMED CT 2011_0131
    74964007
    SNOMED CT 2011_0131
    110465008
    SNOMED CT 2011_0131
    288556008
    SNOMED CT 2011_0131
    68244004
    SNOMED CT 2011_0131
    258706009
    HL7 V3 2006_05
    MO
    UMLS CUI-1
    C0205394
    UMLS CUI-2
    C0013230
    UMLS CUI-3
    C0679823
    UMLS CUI-4
    C0205394
    UMLS CUI-5
    C0008976
    UMLS CUI-6
    C0332152
    UMLS CUI-7
    C0205452
    UMLS CUI-8
    C0439231
    Limited contractual capability
    Descrição

    Limited contractual capability

    Tipo de dados

    boolean

    Alias
    UMLS CUI 2011AA
    C0439801
    SNOMED CT 2011_0131
    255469002
    UMLS CUI 2011AA
    C0332522
    HL7 V3 2006_05
    CNTRCT
    UMLS CUI 2011AA
    C2698977
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    Similar models

    Eligibility Hepatitis C NCT00803309

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Einschlusskriterien
    CL425202 (UMLS CUI 2011AA)
    age at least 18 Years
    Item
    Alter mindestens 18 Jahre
    boolean
    397669002 (SNOMED CT 2011_0131)
    C0001779 (UMLS CUI-1)
    Chronic hepatitis C, HCV-genotype 2/3, HCV RNA and anti-HCV positive
    Item
    Male and female patients with HCV-genotype 2/3 chronic hepatitis C documented by detectable plasma HCV RNA (> 15 IU/mL) and positivity of anti-HCV antibodies
    boolean
    248153007 (SNOMED CT 2011_0131)
    M (HL7 V3 2006_05)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    62944002 (SNOMED CT 2011_0131)
    10019752 (MedDRA 14.1)
    19338005 (SNOMED CT 2011_0131)
    421291004 (SNOMED CT 2011_0131)
    128302006 (SNOMED CT 2011_0131)
    10008912 (MedDRA 14.1)
    B18.2 (ICD-10-CM Version 2010)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    50863008 (SNOMED CT 2011_0131)
    MTHU002157 (LOINC Version 232)
    121204002 (SNOMED CT 2011_0131)
    MTHU001816 (LOINC Version 232)
    10019747 (MedDRA 14.1)
    C0524910 (UMLS CUI-1)
    C0369335 (UMLS CUI-2)
    C0281863 (UMLS CUI-3)
    Compensated liver disease
    Item
    Compensated liver disease (Child-Pugh Grade A clinical classification)
    boolean
    17275008 (SNOMED CT 2011_0131)
    235856003 (SNOMED CT 2011_0131)
    10024670 (MedDRA 14.1)
    K76.9 (ICD-10-CM Version 2010)
    573.9 (ICD-9-CM Version 2011)
    258349007 (SNOMED CT 2011_0131)
    MTHU003112 (LOINC Version 232)
    422097006 (SNOMED CT 2011_0131)
    C0205432 (UMLS CUI-1)
    C0023895 (UMLS CUI-2)
    C4050412 (UMLS CUI-3)
    C0441800 (UMLS CUI-4)
    C1706281 (UMLS CUI-5)
    Non-pregnant, effective contraception
    Item
    Negative urine or blood pregnancy test (one of the both, for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 7 months after treatment end. This includes using birth control pills (no interaction with investigational drugs), IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state. At least one contraception method must be of barrier method
    boolean
    224526002 (SNOMED CT 2011_0131)
    167254001 (SNOMED CT 2011_0131)
    10036577 (MedDRA 14.1)
    166435006 (SNOMED CT 2011_0131)
    248152002 (SNOMED CT 2011_0131)
    F (HL7 V3 2006_05)
    248153007 (SNOMED CT 2011_0131)
    M (HL7 V3 2006_05)
    146680009 (SNOMED CT 2011_0131)
    10010808 (MedDRA 14.1)
    59261009 (SNOMED CT 2011_0131)
    268460000 (SNOMED CT 2011_0131)
    10022745 (MedDRA 14.1)
    20359006 (SNOMED CT 2011_0131)
    10062116 (MedDRA 14.1)
    76498008 (SNOMED CT 2011_0131)
    225370004 (SNOMED CT 2011_0131)
    C0043210 (UMLS CUI-1)
    C1148523 (UMLS CUI-2)
    C0237399 (UMLS CUI-3)
    C0430057 (UMLS CUI-4)
    C0430061 (UMLS CUI-5)
    CL426012 (UMLS CUI-6)
    C0086287 (UMLS CUI-7)
    C0086582 (UMLS CUI-8)
    C0700589 (UMLS CUI-9)
    C0009905 (UMLS CUI-10)
    C0021900 (UMLS CUI-11)
    C0677582 (UMLS CUI-12)
    C0042241 (UMLS CUI-13)
    CL424925 (UMLS CUI-14)
    C0038288 (UMLS CUI-15)
    C0232970 (UMLS CUI-16)
    C0004764 (UMLS CUI-17)
    Current therapy with Peg-Interferon alpha-2b and ribavirin
    Item
    Ongoing treatment with 1.5 µg/kg Peg-Interferon alpha-2b (PegIntron) and > 10.6 mg/kg ribavirin (Rebetol)
    boolean
    395823000 (SNOMED CT 2011_0131)
    387188005 (SNOMED CT 2011_0131)
    MTHU018696 (LOINC Version 232)
    C2827774 (UMLS CUI-1)
    C0796545 (UMLS CUI-2)
    C0035525 (UMLS CUI-3)
    No rapid virological response
    Item
    No rapid virological response (HCV-RNA positive after week 4 of the ongoing therapy)
    boolean
    255358001 (SNOMED CT 2011_0131)
    10019750 (MedDRA 14.1)
    258705008 (SNOMED CT 2011_0131)
    WK (HL7 V3 2006_05)
    9362000 (SNOMED CT 2011_0131)
    C1518422 (UMLS CUI-1)
    C0456962 (UMLS CUI-2)
    C1155328 (UMLS CUI-3)
    Willingness to comply with study protocol
    Item
    Willingness to give written informed consent and willingness to participate to and to comply with the study protocol
    boolean
    C0021430 (UMLS CUI-4)
    Item Group
    Ausschlusskriterien
    CL425201 (UMLS CUI 2011AA)
    Ongoing pregnancy or breast feeding
    Item
    Women with ongoing pregnancy or breast feeding
    boolean
    224526002 (SNOMED CT 2011_0131)
    289908002 (SNOMED CT 2011_0131)
    10036556 (MedDRA 14.1)
    MTHU035048 (LOINC Version 232)
    10006247 (MedDRA 14.1)
    C0032961 (UMLS CUI-1)
    C0006147 (UMLS CUI-2)
    Male partners of women who are pregnant
    Item
    Male partners of women who are pregnant
    boolean
    C0086582 (UMLS CUI 2011AA)
    248153007 (SNOMED CT 2011_0131)
    M (HL7 V3 2006_05)
    C0682323 (UMLS CUI 2011AA)
    262043009 (SNOMED CT 2011_0131)
    SIGOTHR (HL7 V3 2006_05)
    C0043210 (UMLS CUI 2011AA)
    224526002 (SNOMED CT 2011_0131)
    C0549206 (UMLS CUI 2011AA)
    10036586 (MedDRA 14.1)
    Positive tests for Hepatitis A/B/C, HIV
    Item
    Positive tests at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg, anti-HIV, HIV-RNA
    boolean
    32609007 (SNOMED CT 2011_0131)
    MTHU004541 (LOINC Version 232)
    MTHU021816 (LOINC Version 232)
    22290004 (SNOMED CT 2011_0131)
    MTHU001814 (LOINC Version 232)
    10052020 (MedDRA 14.1)
    MTHU021816 (LOINC Version 232)
    60605004 (SNOMED CT 2011_0131)
    MTHU004548 (LOINC Version 232)
    10002725 (MedDRA 14.1)
    10049826 (MedDRA 14.1)
    C1335447 (UMLS CUI-1)
    C1409616 (UMLS CUI-2)
    C0062524 (UMLS CUI-3)
    C1442155 (UMLS CUI-4)
    C0019168 (UMLS CUI-5)
    C0948759 (UMLS CUI-6)
    C1442155 (UMLS CUI-7)
    C0019167 (UMLS CUI-8)
    C0856918 (UMLS CUI-9)
    C0877327 (UMLS CUI-10)
    non-HCV chronic liver disease
    Item
    History or other evidence of a medical condition associated with chronic liver disease other than HCV associated (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
    boolean
    MEDCCAT (HL7 V3 2006_05)
    328383001 (SNOMED CT 2011_0131)
    10008953 (MedDRA 14.1)
    62944002 (SNOMED CT 2011_0131)
    10019752 (MedDRA 14.1)
    399187006 (SNOMED CT 2011_0131)
    10018872 (MedDRA 14.1)
    E83.119 (ICD-10-CM Version 2010)
    408335007 (SNOMED CT 2011_0131)
    10003827 (MedDRA 14.1)
    K75.4 (ICD-10-CM Version 2010)
    571.42 (ICD-9-CM Version 2011)
    41309000 (SNOMED CT 2011_0131)
    10001627 (MedDRA 14.1)
    K70.9 (ICD-10-CM Version 2010)
    571.3 (ICD-9-CM Version 2011)
    420239005 (SNOMED CT 2011_0131)
    C1699700 (UMLS CUI-1)
    C0341439 (UMLS CUI-2)
    CL411789 (UMLS CUI-3)
    C0220847 (UMLS CUI-4)
    C0018995 (UMLS CUI-5)
    C0241910 (UMLS CUI-6)
    C0023896 (UMLS CUI-7)
    C0040537 (UMLS CUI-8)
    Bleeding from esophageal varices, decompensated liver disease
    Item
    History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
    boolean
    17709002 (SNOMED CT 2011_0131)
    10030210 (MedDRA 14.1)
    I85.01 (ICD-10-CM Version 2010)
    456.0 (ICD-9-CM Version 2011)
    E10682 (CTCAE 1105E)
    260905004 (SNOMED CT 2011_0131)
    COND (HL7 V3 2006_05)
    385433004 (SNOMED CT 2011_0131)
    10050060 (MedDRA 14.1)
    C0155789 (UMLS CUI-1)
    C0348080 (UMLS CUI-2)
    C0332290 (UMLS CUI-3)
    C0745744 (UMLS CUI-4)
    Liver cirrhosis and suspected hepatic malignancy
    Item
    Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening
    boolean
    19943007 (SNOMED CT 2011_0131)
    10019641 (MedDRA 14.1)
    K74.60 (ICD-10-CM Version 2010)
    49755003 (SNOMED CT 2011_0131)
    126851005 (SNOMED CT 2011_0131)
    10019695 (MedDRA 14.1)
    C22.0 (ICD-10-CM Version 2010)
    C0023890 (UMLS CUI-1)
    C0221198 (UMLS CUI-2)
    C0242114 (UMLS CUI-3)
    C0023903 (UMLS CUI-4)
    C1409616 (UMLS CUI-5)
    Neutropenia
    Item
    Absolute neutrophil count (ANC) <750 cells/mm3 at screening
    boolean
    10052033 (MedDRA 14.1)
    C0948762 (UMLS CUI-1)
    C1409616 (UMLS CUI-2)
    Low platelet count
    Item
    Platelet count <50,000 cells/mm3 at screening
    boolean
    365632008 (SNOMED CT 2011_0131)
    777-3 (LOINC Version 232)
    C1287267 (UMLS CUI-1)
    C1409616 (UMLS CUI-2)
    Anemia
    Item
    Hb <10 g/dl at screening
    boolean
    38082009 (SNOMED CT 2011_0131)
    10019481 (MedDRA 14.1)
    LP14449-0 (LOINC Version 232)
    C0019046 (UMLS CUI-1)
    C1409616 (UMLS CUI-2)
    Dose modification of Peg-Interferon alpha-2b or ribavirin
    Item
    Dose modification of Peg-Interferon alpha-2b (PegIntron) or ribavirin (Rebetol) during the first 4 weeks of the ongoing therapy
    boolean
    395823000 (SNOMED CT 2011_0131)
    387188005 (SNOMED CT 2011_0131)
    MTHU018696 (LOINC Version 232)
    255216001 (SNOMED CT 2011_0131)
    258706009 (SNOMED CT 2011_0131)
    MO (HL7 V3 2006_05)
    C1707811 (UMLS CUI-1)
    C0796545 (UMLS CUI-2)
    C0035525 (UMLS CUI-3)
    C0205435 (UMLS CUI-4)
    C0439231 (UMLS CUI-5)
    C0039798 (UMLS CUI-6)
    Previous therapy with Interferon alpha or ribavirin
    Item
    Interferon alpha or ribavirin therapy at any time point before the actual ongoing treatment
    boolean
    387188005 (SNOMED CT 2011_0131)
    MTHU018696 (LOINC Version 232)
    288556008 (SNOMED CT 2011_0131)
    C1610033 (UMLS CUI-1)
    C0035525 (UMLS CUI-2)
    C0039798 (UMLS CUI-3)
    C0332152 (UMLS CUI-4)
    C0237400 (UMLS CUI-5)
    C0039798 (UMLS CUI-6)
    Low adherence to ongoing treatment
    Item
    < 80% adherence to treatment of the ongoing treatment until randomization (week 20-22 of ongoing treatment)
    boolean
    71978007 (SNOMED CT 2011_0131)
    C0205412 (UMLS CUI-1)
    C1171369 (UMLS CUI-2)
    CL415091 (UMLS CUI-3)
    C0034656 (UMLS CUI-4)
    Serum creatinine elevated
    Item
    Serum creatinine level >1.5 times the upper limit of normal at screening
    boolean
    113075003 (SNOMED CT 2011_0131)
    10040230 (MedDRA 14.1)
    C0201976 (UMLS CUI-1)
    C1519815 (UMLS CUI-2)
    History of severe psychiatric disease, especially depression
    Item
    History of severe psychiatric disease, especially depression (ICD 10 codes F30-F33). Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time. Patients are excluded if any history of suicidal attempts is evident. If hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease are documented, psychiatric consultation is mandatory. Patients with a mild or moderate psychiatric disease (ICD 10 codes F32.0, F32.1, F33.0, F33.1) are only allowed to be included into the trial if a regular monitoring by a psychiatrist is performed during the trial
    boolean
    161464003 (SNOMED CT 2011_0131)
    310497006 (SNOMED CT 2011_0131)
    372720008 (SNOMED CT 2011_0131)
    MTHU006782 (LOINC Version 232)
    10784006 (SNOMED CT 2011_0131)
    MTHU003337 (LOINC Version 232)
    Z91.5 (ICD-10-CM Version 2010)
    394656005 (SNOMED CT 2011_0131)
    10054112 (MedDRA 14.1)
    21134002 (SNOMED CT 2011_0131)
    10013050 (MedDRA 14.1)
    DIS (HL7 V3 2006_05)
    74732009 (SNOMED CT 2011_0131)
    10037174 (MedDRA 14.1)
    F99 (ICD-10-CM Version 2010)
    290-319.99 (ICD-9-CM Version 2011)
    C0455498 (UMLS CUI-1)
    C0588008 (UMLS CUI-2)
    C0003289 (UMLS CUI-3)
    C0040615 (UMLS CUI-4)
    C2911479 (UMLS CUI-5)
    C0019993 (UMLS CUI-6)
    C1948053 (UMLS CUI-7)
    C0231170 (UMLS CUI-8)
    CL420107 (UMLS CUI-9)
    C0004936 (UMLS CUI-10)
    History of a severe seizure disorder or current anticonvulsant use
    Item
    History of a severe seizure disorder or current anticonvulsant use
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0852425 (UMLS CUI 2011AA)
    10039912 (MedDRA 14.1)
    C1524063 (UMLS CUI 2011AA)
    260676000 (SNOMED CT 2011_0131)
    C0003299 (UMLS CUI 2011AA)
    255632006 (SNOMED CT 2011_0131)
    MTHU006781 (LOINC Version 232)
    History of immunologically mediated disease
    Item
    History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
    boolean
    392521001 (SNOMED CT 2011_0131)
    64572001 (SNOMED CT 2011_0131)
    47429007 (SNOMED CT 2011_0131)
    116003000 (SNOMED CT 2011_0131)
    MTHU013246 (LOINC Version 232)
    24526004 (SNOMED CT 2011_0131)
    10021972 (MedDRA 14.1)
    32273002 (SNOMED CT 2011_0131)
    10021245 (MedDRA 14.1)
    D69.3 (ICD-10-CM Version 2010)
    200936003 (SNOMED CT 2011_0131)
    10025134 (MedDRA 14.1)
    L93 (ICD-10-CM Version 2010)
    695.4 (ICD-9-CM Version 2011)
    413603009 (SNOMED CT 2011_0131)
    10002046 (MedDRA 14.1)
    283.0 (ICD-9-CM Version 2011)
    89155008 (SNOMED CT 2011_0131)
    10039710 (MedDRA 14.1)
    24484000 (SNOMED CT 2011_0131)
    9014002 (SNOMED CT 2011_0131)
    10037153 (MedDRA 14.1)
    L40 (ICD-10-CM Version 2010)
    69896004 (SNOMED CT 2011_0131)
    10039073 (MedDRA 14.1)
    M06.9 (ICD-10-CM Version 2010)
    714.0 (ICD-9-CM Version 2011)
    CL421546 (UMLS CUI-1)
    C0012634 (UMLS CUI-2)
    C0332281 (UMLS CUI-3)
    C0020962 (UMLS CUI-4)
    C0021390 (UMLS CUI-5)
    C0398650 (UMLS CUI-6)
    C0409974 (UMLS CUI-7)
    C0002880 (UMLS CUI-8)
    C0011644 (UMLS CUI-9)
    C0205082 (UMLS CUI-10)
    C0033860 (UMLS CUI-11)
    C0003873 (UMLS CUI-12)
    History or any other evidence of autoimmune diseases
    Item
    History or any other evidence of autoimmune diseases
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C0004364 (UMLS CUI 2011AA)
    85828009 (SNOMED CT 2011_0131)
    10061664 (MedDRA 14.1)
    M30-M36 (ICD-10-CM Version 2010)
    E11258 (CTCAE 1105E)
    Chronic pulmonary disease
    Item
    History or other evidence of chronic pulmonary disease associated with functional limitation
    boolean
    392521001 (SNOMED CT 2011_0131)
    18669006 (SNOMED CT 2011_0131)
    413839001 (SNOMED CT 2011_0131)
    47429007 (SNOMED CT 2011_0131)
    40143009 (SNOMED CT 2011_0131)
    246175000 (SNOMED CT 2011_0131)
    CL421546 (UMLS CUI-1)
    C0332120 (UMLS CUI-2)
    C0746102 (UMLS CUI-3)
    C0332281 (UMLS CUI-4)
    C0205245 (UMLS CUI-5)
    C0449295 (UMLS CUI-6)
    History of significant cardiac disease
    Item
    History of significant cardiac disease that could be worsened by acute anemia (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months prior to treatment with Peg-Interferon/ribavirin therapy, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
    boolean
    392521001 (SNOMED CT 2011_0131)
    56265001 (SNOMED CT 2011_0131)
    10061024 (MedDRA 14.1)
    420913000 (SNOMED CT 2011_0131)
    10064081 (MedDRA 14.1)
    422293003 (SNOMED CT 2011_0131)
    10064082 (MedDRA 14.1)
    22298006 (SNOMED CT 2011_0131)
    10028596 (MedDRA 14.1)
    MTHU035551 (LOINC Version 232)
    I21-I22 (ICD-10-CM Version 2010)
    410 (ICD-9-CM Version 2011)
    E10152 (CTCAE 1105E)
    288556008 (SNOMED CT 2011_0131)
    387188005 (SNOMED CT 2011_0131)
    MTHU018696 (LOINC Version 232)
    25569003 (SNOMED CT 2011_0131)
    10065341 (MedDRA 14.1)
    I47.2 (ICD-10-CM Version 2010)
    E10239 (CTCAE 1105E)
    4557003 (SNOMED CT 2011_0131)
    10002388 (MedDRA 14.1)
    I20.0 (ICD-10-CM Version 2010)
    411.1 (ICD-9-CM Version 2011)
    CL421546 (UMLS CUI-1)
    C0018799 (UMLS CUI-2)
    C1319795 (UMLS CUI-3)
    C1319796 (UMLS CUI-4)
    C0027051 (UMLS CUI-5)
    C0332152 (UMLS CUI-6)
    C0982327 (UMLS CUI-7)
    C0035525 (UMLS CUI-8)
    C0039798 (UMLS CUI-9)
    C0042514 (UMLS CUI-10)
    C0002965 (UMLS CUI-11)
    Poorly controlled thyroid disease
    Item
    Evidence of thyroid disease that is poorly controlled on prescribed medications
    boolean
    14304000 (SNOMED CT 2011_0131)
    10043709 (MedDRA 14.1)
    E00-E07 (ICD-10-CM Version 2010)
    240-246.99 (ICD-9-CM Version 2011)
    556001 (SNOMED CT 2011_0131)
    31509003 (SNOMED CT 2011_0131)
    C0040128 (UMLS CUI-1)
    C0205169 (UMLS CUI-2)
    C2587213 (UMLS CUI-3)
    C0013227 (UMLS CUI-4)
    Severe retinopathy
    Item
    Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)
    boolean
    24484000 (SNOMED CT 2011_0131)
    399625000 (SNOMED CT 2011_0131)
    10038923 (MedDRA 14.1)
    E10432 (CTCAE 1105E)
    22455005 (SNOMED CT 2011_0131)
    10011835 (MedDRA 14.1)
    422338006 (SNOMED CT 2011_0131)
    10025409 (MedDRA 14.1)
    MTHU020821 (LOINC Version 232)
    C0205082 (UMLS CUI-1)
    CL365148 (UMLS CUI-2)
    C0206178 (UMLS CUI-3)
    C0024437 (UMLS CUI-4)
    Major organ transplantation
    Item
    History of major organ transplantation with an existing functional graft
    boolean
    392521001 (SNOMED CT 2011_0131)
    255603008 (SNOMED CT 2011_0131)
    10061890 (MedDRA 14.1)
    MTHU000173 (LOINC Version 232)
    40143009 (SNOMED CT 2011_0131)
    24486003 (SNOMED CT 2011_0131)
    CL421546 (UMLS CUI-1)
    C0205164 (UMLS CUI-2)
    C0029216 (UMLS CUI-3)
    C0205245 (UMLS CUI-4)
    C0332835 (UMLS CUI-5)
    Severe illness
    Item
    History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
    boolean
    24484000 (SNOMED CT 2011_0131)
    39104002 (SNOMED CT 2011_0131)
    10040658 (MedDRA 14.1)
    R69 (ICD-10-CM Version 2010)
    363346000 (SNOMED CT 2011_0131)
    10028997 (MedDRA 14.1)
    MTHU010328 (LOINC Version 232)
    C00-C96 (ICD-10-CM Version 2010)
    260905004 (SNOMED CT 2011_0131)
    COND (HL7 V3 2006_05)
    23981006 (SNOMED CT 2011_0131)
    116154003 (SNOMED CT 2011_0131)
    110465008 (SNOMED CT 2011_0131)
    C0205082 (UMLS CUI-1)
    C0221423 (UMLS CUI-2)
    C0006826 (UMLS CUI-3)
    C0348080 (UMLS CUI-4)
    C0678227 (UMLS CUI-5)
    C0030705 (UMLS CUI-6)
    C1548788 (UMLS CUI-7)
    C0008976 (UMLS CUI-8)
    Systemic anti-neoplastic or immunomodulatory treatment
    Item
    History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
    boolean
    392521001 (SNOMED CT 2011_0131)
    31099001 (SNOMED CT 2011_0131)
    116566001 (SNOMED CT 2011_0131)
    CL421546 (UMLS CUI-1)
    C0205373 (UMLS CUI-2)
    C0920425 (UMLS CUI-3)
    CL412323 (UMLS CUI-4)
    C0038317 (UMLS CUI-5)
    C0034619 (UMLS CUI-6)
    Tuberculosis
    Item
    Patients with evidence for tuberculosis
    boolean
    18669006 (SNOMED CT 2011_0131)
    56717001 (SNOMED CT 2011_0131)
    10044755 (MedDRA 14.1)
    MTHU020835 (LOINC Version 232)
    A15-A19 (ICD-10-CM Version 2010)
    010-018.99 (ICD-9-CM Version 2011)
    C0041296 (UMLS CUI-1)
    Drug abuse
    Item
    Drug abuse within 6 months prior to the first dose of study drug and excessive alcohol consumption. Patients on methadone/polamidone/buprenorphine programs are not excluded
    boolean
    26416006 (SNOMED CT 2011_0131)
    10013654 (MedDRA 14.1)
    LP36310-8 (LOINC Version 232)
    305.90 (ICD-9-CM Version 2011)
    160592001 (SNOMED CT 2011_0131)
    E (HL7 V3 2006_05)
    51758009 (SNOMED CT 2011_0131)
    MTHU001002 (LOINC Version 232)
    31684002 (SNOMED CT 2011_0131)
    MTHU006723 (LOINC Version 232)
    C0013146 (UMLS CUI-1)
    C0560219 (UMLS CUI-2)
    C1554961 (UMLS CUI-3)
    C0025605 (UMLS CUI-4)
    C0006405 (UMLS CUI-5)
    Participation in another clinical study
    Item
    Any investigational drug and/or participation in another clinical study prior 6 months to the actual ongoing antiviral treatment
    boolean
    74964007 (SNOMED CT 2011_0131)
    PART (HL7 V3 2006_05)
    74964007 (SNOMED CT 2011_0131)
    110465008 (SNOMED CT 2011_0131)
    288556008 (SNOMED CT 2011_0131)
    68244004 (SNOMED CT 2011_0131)
    258706009 (SNOMED CT 2011_0131)
    MO (HL7 V3 2006_05)
    C0205394 (UMLS CUI-1)
    C0013230 (UMLS CUI-2)
    C0679823 (UMLS CUI-3)
    C0205394 (UMLS CUI-4)
    C0008976 (UMLS CUI-5)
    C0332152 (UMLS CUI-6)
    C0205452 (UMLS CUI-7)
    C0439231 (UMLS CUI-8)
    Limited contractual capability
    Item
    Limited contractual capability
    boolean
    C0439801 (UMLS CUI 2011AA)
    255469002 (SNOMED CT 2011_0131)
    C0332522 (UMLS CUI 2011AA)
    CNTRCT (HL7 V3 2006_05)
    C2698977 (UMLS CUI 2011AA)
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