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4425

Descrizione

ODM derived from http://clinicaltrials.gov/show/NCT00803309

collegamento

http://clinicaltrials.gov/show/NCT00803309

Keywords

versioni (4)
  1. 09/12/13 09/12/13 - Martin Dugas
  2. 25/03/14 25/03/14 - Martin Dugas
  3. 16/04/14 16/04/14 - Julian Varghese
  4. 20/09/21 20/09/21 -
Caricato su

9 dicembre 2013

DOI

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Licenza

Creative Commons BY-NC 3.0 Legacy
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    Eligibility NCT00803309 Hepatitis C, Chronic

    Tedesco Inglese

    Eligibility

    1 moduli  
    1. StudyEvent: Eligibility
      1. Eligibility
    Einschlusskriterien
    Descrizione

    Einschlusskriterien

    Alias
    UMLS CUI 2011AA
    CL425202
    Alter mindestens 18 Jahre
    Descrizione

    age at least 18 Years

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0001779
    SNOMED CT 2011_0131
    397669002
    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
    Descrizione

    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

    Tipo di dati

    boolean

    Alias
    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
    UMLS CUI 2011AA
    C0220847
    SNOMED CT 2011_0131
    62944002
    MedDRA 14.1
    10019752
    UMLS CUI 2011AA
    C0017431
    UMLS CUI 2011AA
    C0205448
    SNOMED CT 2011_0131
    19338005
    UMLS CUI 2011AA
    C0205449
    SNOMED CT 2011_0131
    421291004
    UMLS CUI 2011AA
    C0524910
    SNOMED CT 2011_0131
    128302006
    MedDRA 14.1
    10008912
    ICD-10-CM Version 2010
    B18.2
    UMLS CUI 2011AA
    C0011900
    SNOMED CT 2011_0131
    439401001
    LOINC Version 232
    MTHU008876
    UMLS CUI 2011AA
    C0032105
    SNOMED CT 2011_0131
    50863008
    LOINC Version 232
    MTHU002157
    UMLS CUI 2011AA
    C0369335
    SNOMED CT 2011_0131
    121204002
    LOINC Version 232
    MTHU001816
    UMLS CUI 2011AA
    C0281863
    MedDRA 14.1
    10019747
    Compensated liver disease (Child-Pugh Grade A clinical classification)
    Descrizione

    Compensated liver disease (Child-Pugh Grade A clinical classification)

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0205432
    SNOMED CT 2011_0131
    17275008
    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
    C2347612
    UMLS CUI 2011AA
    C0441800
    SNOMED CT 2011_0131
    258349007
    LOINC Version 232
    MTHU003112
    UMLS CUI 2011AA
    C1706281
    SNOMED CT 2011_0131
    422097006
    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
    Descrizione

    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

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0043210
    SNOMED CT 2011_0131
    224526002
    UMLS CUI 2011AA
    C1148523
    UMLS CUI 2011AA
    C0237399
    UMLS CUI 2011AA
    C0430057
    SNOMED CT 2011_0131
    167254001
    MedDRA 14.1
    10036577
    UMLS CUI 2011AA
    C0430061
    SNOMED CT 2011_0131
    166435006
    UMLS CUI 2011AA
    CL426012
    UMLS CUI 2011AA
    C0015780
    SNOMED CT 2011_0131
    248152002
    HL7 V3 2006_05
    F
    UMLS CUI 2011AA
    C0024554
    SNOMED CT 2011_0131
    248153007
    HL7 V3 2006_05
    M
    UMLS CUI 2011AA
    C0700589
    SNOMED CT 2011_0131
    146680009
    MedDRA 14.1
    10010808
    UMLS CUI 2011AA
    C0009905
    SNOMED CT 2011_0131
    59261009
    UMLS CUI 2011AA
    C0021900
    SNOMED CT 2011_0131
    268460000
    MedDRA 14.1
    10022745
    UMLS CUI 2011AA
    C0677582
    UMLS CUI 2011AA
    C0042241
    SNOMED CT 2011_0131
    20359006
    UMLS CUI 2011AA
    CL424925
    UMLS CUI 2011AA
    C0038288
    MedDRA 14.1
    10062116
    UMLS CUI 2011AA
    C0232970
    SNOMED CT 2011_0131
    76498008
    UMLS CUI 2011AA
    C0004764
    SNOMED CT 2011_0131
    225370004
    Ongoing treatment with 1.5 µg/kg Peg-Interferon alpha-2b (PegIntron) and > 10.6 mg/kg ribavirin (Rebetol)
    Descrizione

    Ongoing treatment with 1.5 µg/kg Peg-Interferon alpha-2b (PegIntron) and > 10.6 mg/kg ribavirin (Rebetol)

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0750536
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0796545
    SNOMED CT 2011_0131
    395823000
    UMLS CUI 2011AA
    C0035525
    SNOMED CT 2011_0131
    387188005
    LOINC Version 232
    MTHU018696
    No rapid virological response (HCV-RNA positive after week 4 of the ongoing therapy)
    Descrizione

    No rapid virological response (HCV-RNA positive after week 4 of the ongoing therapy)

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C1518422
    UMLS CUI 2011AA
    C0439831
    SNOMED CT 2011_0131
    255358001
    UMLS CUI 2011AA
    C1155328
    UMLS CUI 2011AA
    C0855842
    MedDRA 14.1
    10019750
    UMLS CUI 2011AA
    C0439230
    SNOMED CT 2011_0131
    258705008
    HL7 V3 2006_05
    WK
    UMLS CUI 2011AA
    C0205450
    SNOMED CT 2011_0131
    9362000
    UMLS CUI 2011AA
    C0039798
    Willingness to give written informed consent and willingness to participate to and to comply with the study protocol
    Descrizione

    Willingness to give written informed consent and willingness to participate to and to comply with the study protocol

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0600109
    SNOMED CT 2011_0131
    225466006
    UMLS CUI 2011AA
    C0184704
    SNOMED CT 2011_0131
    55149002
    UMLS CUI 2011AA
    C0679823
    HL7 V3 2006_05
    PART
    UMLS CUI 2011AA
    C0525058
    Ausschlusskriterien
    Descrizione

    Ausschlusskriterien

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

    Women with ongoing pregnancy or breast feeding

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0043210
    SNOMED CT 2011_0131
    224526002
    UMLS CUI 2011AA
    C0032961
    SNOMED CT 2011_0131
    289908002
    MedDRA 14.1
    10036556
    LOINC Version 232
    MTHU035048
    UMLS CUI 2011AA
    C0006147
    MedDRA 14.1
    10006247
    Male partners of women who are pregnant
    Descrizione

    Male partners of women who are pregnant

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0024554
    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
    Descrizione

    Positive tests at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg, anti-HIV, HIV-RNA

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C1335447
    UMLS CUI 2011AA
    C1409616
    UMLS CUI 2011AA
    C0062524
    SNOMED CT 2011_0131
    32609007
    LOINC Version 232
    MTHU004541
    UMLS CUI 2011AA
    C1442155
    LOINC Version 232
    MTHU021816
    UMLS CUI 2011AA
    C0019168
    SNOMED CT 2011_0131
    22290004
    LOINC Version 232
    MTHU001814
    UMLS CUI 2011AA
    C0948759
    MedDRA 14.1
    10052020
    UMLS CUI 2011AA
    C1442155
    LOINC Version 232
    MTHU021816
    UMLS CUI 2011AA
    C0019167
    SNOMED CT 2011_0131
    60605004
    LOINC Version 232
    MTHU004548
    UMLS CUI 2011AA
    C0856918
    MedDRA 14.1
    10002725
    UMLS CUI 2011AA
    C0877327
    MedDRA 14.1
    10049826
    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)
    Descrizione

    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)

    Tipo di dati

    boolean

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

    History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0155789
    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
    UMLS CUI 2011AA
    C0348080
    SNOMED CT 2011_0131
    260905004
    HL7 V3 2006_05
    COND
    UMLS CUI 2011AA
    C0332290
    SNOMED CT 2011_0131
    385433004
    UMLS CUI 2011AA
    C0745744
    MedDRA 14.1
    10050060
    Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening
    Descrizione

    Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening

    Tipo di dati

    boolean

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

    Absolute neutrophil count (ANC) <750 cells/mm3 at screening

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0948762
    MedDRA 14.1
    10052033
    UMLS CUI 2011AA
    C1409616
    Platelet count <50,000 cells/mm3 at screening
    Descrizione

    Platelet count <50,000 cells/mm3 at screening

    Tipo di dati

    boolean

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

    Hb <10 g/dl at screening

    Tipo di dati

    boolean

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

    Dose modification of Peg-Interferon alpha-2b (PegIntron) or ribavirin (Rebetol) during the first 4 weeks of the ongoing therapy

    Tipo di dati

    boolean

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

    Interferon alpha or ribavirin therapy at any time point before the actual ongoing treatment

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C1610033
    UMLS CUI 2011AA
    C0035525
    SNOMED CT 2011_0131
    387188005
    LOINC Version 232
    MTHU018696
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C0237400
    UMLS CUI 2011AA
    C0039798
    < 80% adherence to treatment of the ongoing treatment until randomization (week 20-22 of ongoing treatment)
    Descrizione

    < 80% adherence to treatment of the ongoing treatment until randomization (week 20-22 of ongoing treatment)

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0205412
    SNOMED CT 2011_0131
    71978007
    UMLS CUI 2011AA
    C1171369
    UMLS CUI 2011AA
    CL415091
    UMLS CUI 2011AA
    C0034656
    Serum creatinine level >1.5 times the upper limit of normal at screening
    Descrizione

    Serum creatinine level >1.5 times the upper limit of normal at screening

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0201976
    SNOMED CT 2011_0131
    113075003
    MedDRA 14.1
    10040230
    UMLS CUI 2011AA
    C1519815
    UMLS CUI 2011AA
    C1409616
    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
    Descrizione

    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

    Tipo di dati

    boolean

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

    History of a severe seizure disorder or current anticonvulsant use

    Tipo di dati

    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)
    Descrizione

    History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0012634
    SNOMED CT 2011_0131
    64572001
    UMLS CUI 2011AA
    C0332281
    SNOMED CT 2011_0131
    47429007
    UMLS CUI 2011AA
    C0020962
    SNOMED CT 2011_0131
    116003000
    LOINC Version 232
    MTHU013246
    UMLS CUI 2011AA
    C0021390
    SNOMED CT 2011_0131
    24526004
    MedDRA 14.1
    10021972
    UMLS CUI 2011AA
    C0043117
    SNOMED CT 2011_0131
    32273002
    MedDRA 14.1
    10021245
    ICD-10-CM Version 2010
    D69.3
    UMLS CUI 2011AA
    C0409974
    SNOMED CT 2011_0131
    200936003
    MedDRA 14.1
    10025134
    ICD-10-CM Version 2010
    L93
    ICD-9-CM Version 2011
    695.4
    UMLS CUI 2011AA
    C0002880
    SNOMED CT 2011_0131
    413603009
    MedDRA 14.1
    10002046
    ICD-9-CM Version 2011
    283.0
    UMLS CUI 2011AA
    C0011644
    SNOMED CT 2011_0131
    89155008
    MedDRA 14.1
    10039710
    UMLS CUI 2011AA
    C0205082
    SNOMED CT 2011_0131
    24484000
    UMLS CUI 2011AA
    C0033860
    SNOMED CT 2011_0131
    9014002
    MedDRA 14.1
    10037153
    ICD-10-CM Version 2010
    L40
    UMLS CUI 2011AA
    C0003873
    SNOMED CT 2011_0131
    69896004
    MedDRA 14.1
    10039073
    ICD-10-CM Version 2010
    M06.9
    ICD-9-CM Version 2011
    714.0
    History or any other evidence of autoimmune diseases
    Descrizione

    History or any other evidence of autoimmune diseases

    Tipo di dati

    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
    Descrizione

    History or other evidence of chronic pulmonary disease associated with functional limitation

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0332120
    SNOMED CT 2011_0131
    18669006
    UMLS CUI 2011AA
    C0746102
    SNOMED CT 2011_0131
    413839001
    UMLS CUI 2011AA
    C0332281
    SNOMED CT 2011_0131
    47429007
    UMLS CUI 2011AA
    C0205245
    SNOMED CT 2011_0131
    40143009
    UMLS CUI 2011AA
    C0449295
    SNOMED CT 2011_0131
    246175000
    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)
    Descrizione

    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)

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0018799
    SNOMED CT 2011_0131
    56265001
    MedDRA 14.1
    10061024
    UMLS CUI 2011AA
    C1319795
    SNOMED CT 2011_0131
    420913000
    MedDRA 14.1
    10064081
    UMLS CUI 2011AA
    C1319796
    SNOMED CT 2011_0131
    422293003
    MedDRA 14.1
    10064082
    UMLS CUI 2011AA
    C0027051
    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
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C0982327
    UMLS CUI 2011AA
    C0035525
    SNOMED CT 2011_0131
    387188005
    LOINC Version 232
    MTHU018696
    UMLS CUI 2011AA
    C0039798
    UMLS CUI 2011AA
    C0042514
    SNOMED CT 2011_0131
    25569003
    MedDRA 14.1
    10065341
    ICD-10-CM Version 2010
    I47.2
    CTCAE 1105E
    E10239
    UMLS CUI 2011AA
    C0002965
    SNOMED CT 2011_0131
    4557003
    MedDRA 14.1
    10002388
    ICD-10-CM Version 2010
    I20.0
    ICD-9-CM Version 2011
    411.1
    Evidence of thyroid disease that is poorly controlled on prescribed medications
    Descrizione

    Evidence of thyroid disease that is poorly controlled on prescribed medications

    Tipo di dati

    boolean

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

    Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)

    Tipo di dati

    boolean

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

    History of major organ transplantation with an existing functional graft

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0205164
    SNOMED CT 2011_0131
    255603008
    UMLS CUI 2011AA
    C0029216
    MedDRA 14.1
    10061890
    LOINC Version 232
    MTHU000173
    UMLS CUI 2011AA
    C0205245
    SNOMED CT 2011_0131
    40143009
    UMLS CUI 2011AA
    C0332835
    SNOMED CT 2011_0131
    24486003
    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
    Descrizione

    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

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0205082
    SNOMED CT 2011_0131
    24484000
    UMLS CUI 2011AA
    C0221423
    SNOMED CT 2011_0131
    39104002
    MedDRA 14.1
    10040658
    ICD-10-CM Version 2010
    R69
    UMLS CUI 2011AA
    C0006826
    SNOMED CT 2011_0131
    363346000
    MedDRA 14.1
    10028997
    LOINC Version 232
    MTHU010328
    ICD-10-CM Version 2010
    C00-C96
    UMLS CUI 2011AA
    C0348080
    SNOMED CT 2011_0131
    260905004
    HL7 V3 2006_05
    COND
    UMLS CUI 2011AA
    C0678227
    SNOMED CT 2011_0131
    23981006
    UMLS CUI 2011AA
    C0030705
    SNOMED CT 2011_0131
    116154003
    UMLS CUI 2011AA
    C1548788
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    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
    Descrizione

    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

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    CL421546
    SNOMED CT 2011_0131
    392521001
    UMLS CUI 2011AA
    C0205373
    SNOMED CT 2011_0131
    31099001
    UMLS CUI 2011AA
    C0920425
    UMLS CUI 2011AA
    CL412323
    UMLS CUI 2011AA
    C0038317
    SNOMED CT 2011_0131
    116566001
    UMLS CUI 2011AA
    C0034619
    Patients with evidence for tuberculosis
    Descrizione

    Patients with evidence for tuberculosis

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0332120
    SNOMED CT 2011_0131
    18669006
    UMLS CUI 2011AA
    C0041296
    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
    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
    Descrizione

    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

    Tipo di dati

    boolean

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

    Any investigational drug and/or participation in another clinical study prior 6 months to the actual ongoing antiviral treatment

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C0013230
    UMLS CUI 2011AA
    C0679823
    HL7 V3 2006_05
    PART
    UMLS CUI 2011AA
    C0205394
    SNOMED CT 2011_0131
    74964007
    UMLS CUI 2011AA
    C0008976
    SNOMED CT 2011_0131
    110465008
    UMLS CUI 2011AA
    C0332152
    SNOMED CT 2011_0131
    288556008
    UMLS CUI 2011AA
    C0205452
    SNOMED CT 2011_0131
    68244004
    UMLS CUI 2011AA
    C0439231
    SNOMED CT 2011_0131
    258706009
    HL7 V3 2006_05
    MO
    Limited contractual capability
    Descrizione

    Limited contractual capability

    Tipo di dati

    boolean

    Alias
    UMLS CUI 2011AA
    C0439801
    SNOMED CT 2011_0131
    255469002
    UMLS CUI 2011AA
    C0332522
    HL7 V3 2006_05
    CNTRCT
    UMLS CUI 2011AA
    C2698977
    Ritorna all'inizio della pagina

    Similar models

    Eligibility

    1 moduli
    1. StudyEvent: Eligibility
      1. Eligibility
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Einschlusskriterien
    CL425202 (UMLS CUI 2011AA)
    age at least 18 Years
    Item
    Alter mindestens 18 Jahre
    boolean
    C0001779 (UMLS CUI 2011AA)
    397669002 (SNOMED CT 2011_0131)
    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
    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
    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)
    C0220847 (UMLS CUI 2011AA)
    62944002 (SNOMED CT 2011_0131)
    10019752 (MedDRA 14.1)
    C0017431 (UMLS CUI 2011AA)
    C0205448 (UMLS CUI 2011AA)
    19338005 (SNOMED CT 2011_0131)
    C0205449 (UMLS CUI 2011AA)
    421291004 (SNOMED CT 2011_0131)
    C0524910 (UMLS CUI 2011AA)
    128302006 (SNOMED CT 2011_0131)
    10008912 (MedDRA 14.1)
    B18.2 (ICD-10-CM Version 2010)
    C0011900 (UMLS CUI 2011AA)
    439401001 (SNOMED CT 2011_0131)
    MTHU008876 (LOINC Version 232)
    C0032105 (UMLS CUI 2011AA)
    50863008 (SNOMED CT 2011_0131)
    MTHU002157 (LOINC Version 232)
    C0369335 (UMLS CUI 2011AA)
    121204002 (SNOMED CT 2011_0131)
    MTHU001816 (LOINC Version 232)
    C0281863 (UMLS CUI 2011AA)
    10019747 (MedDRA 14.1)
    Compensated liver disease (Child-Pugh Grade A clinical classification)
    Item
    Compensated liver disease (Child-Pugh Grade A clinical classification)
    boolean
    C0205432 (UMLS CUI 2011AA)
    17275008 (SNOMED CT 2011_0131)
    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)
    C2347612 (UMLS CUI 2011AA)
    C0441800 (UMLS CUI 2011AA)
    258349007 (SNOMED CT 2011_0131)
    MTHU003112 (LOINC Version 232)
    C1706281 (UMLS CUI 2011AA)
    422097006 (SNOMED CT 2011_0131)
    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
    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
    C0043210 (UMLS CUI 2011AA)
    224526002 (SNOMED CT 2011_0131)
    C1148523 (UMLS CUI 2011AA)
    C0237399 (UMLS CUI 2011AA)
    C0430057 (UMLS CUI 2011AA)
    167254001 (SNOMED CT 2011_0131)
    10036577 (MedDRA 14.1)
    C0430061 (UMLS CUI 2011AA)
    166435006 (SNOMED CT 2011_0131)
    CL426012 (UMLS CUI 2011AA)
    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)
    C0700589 (UMLS CUI 2011AA)
    146680009 (SNOMED CT 2011_0131)
    10010808 (MedDRA 14.1)
    C0009905 (UMLS CUI 2011AA)
    59261009 (SNOMED CT 2011_0131)
    C0021900 (UMLS CUI 2011AA)
    268460000 (SNOMED CT 2011_0131)
    10022745 (MedDRA 14.1)
    C0677582 (UMLS CUI 2011AA)
    C0042241 (UMLS CUI 2011AA)
    20359006 (SNOMED CT 2011_0131)
    CL424925 (UMLS CUI 2011AA)
    C0038288 (UMLS CUI 2011AA)
    10062116 (MedDRA 14.1)
    C0232970 (UMLS CUI 2011AA)
    76498008 (SNOMED CT 2011_0131)
    C0004764 (UMLS CUI 2011AA)
    225370004 (SNOMED CT 2011_0131)
    Ongoing treatment with 1.5 µg/kg Peg-Interferon alpha-2b (PegIntron) and > 10.6 mg/kg ribavirin (Rebetol)
    Item
    Ongoing treatment with 1.5 µg/kg Peg-Interferon alpha-2b (PegIntron) and > 10.6 mg/kg ribavirin (Rebetol)
    boolean
    C0750536 (UMLS CUI 2011AA)
    C0039798 (UMLS CUI 2011AA)
    C0796545 (UMLS CUI 2011AA)
    395823000 (SNOMED CT 2011_0131)
    C0035525 (UMLS CUI 2011AA)
    387188005 (SNOMED CT 2011_0131)
    MTHU018696 (LOINC Version 232)
    No rapid virological response (HCV-RNA positive after week 4 of the ongoing therapy)
    Item
    No rapid virological response (HCV-RNA positive after week 4 of the ongoing therapy)
    boolean
    C1518422 (UMLS CUI 2011AA)
    C0439831 (UMLS CUI 2011AA)
    255358001 (SNOMED CT 2011_0131)
    C1155328 (UMLS CUI 2011AA)
    C0855842 (UMLS CUI 2011AA)
    10019750 (MedDRA 14.1)
    C0439230 (UMLS CUI 2011AA)
    258705008 (SNOMED CT 2011_0131)
    WK (HL7 V3 2006_05)
    C0205450 (UMLS CUI 2011AA)
    9362000 (SNOMED CT 2011_0131)
    C0039798 (UMLS CUI 2011AA)
    Willingness to give written informed consent and willingness to participate to and to comply with the study protocol
    Item
    Willingness to give written informed consent and willingness to participate to and to comply with the study protocol
    boolean
    C0600109 (UMLS CUI 2011AA)
    225466006 (SNOMED CT 2011_0131)
    C0184704 (UMLS CUI 2011AA)
    55149002 (SNOMED CT 2011_0131)
    C0679823 (UMLS CUI 2011AA)
    PART (HL7 V3 2006_05)
    C0525058 (UMLS CUI 2011AA)
    Item Group
    Ausschlusskriterien
    CL425201 (UMLS CUI 2011AA)
    Women with ongoing pregnancy or breast feeding
    Item
    Women with ongoing pregnancy or breast feeding
    boolean
    C0043210 (UMLS CUI 2011AA)
    224526002 (SNOMED CT 2011_0131)
    C0032961 (UMLS CUI 2011AA)
    289908002 (SNOMED CT 2011_0131)
    10036556 (MedDRA 14.1)
    MTHU035048 (LOINC Version 232)
    C0006147 (UMLS CUI 2011AA)
    10006247 (MedDRA 14.1)
    Male partners of women who are pregnant
    Item
    Male partners of women who are pregnant
    boolean
    C0024554 (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 at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg, anti-HIV, HIV-RNA
    Item
    Positive tests at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg, anti-HIV, HIV-RNA
    boolean
    C1335447 (UMLS CUI 2011AA)
    C1409616 (UMLS CUI 2011AA)
    C0062524 (UMLS CUI 2011AA)
    32609007 (SNOMED CT 2011_0131)
    MTHU004541 (LOINC Version 232)
    C1442155 (UMLS CUI 2011AA)
    MTHU021816 (LOINC Version 232)
    C0019168 (UMLS CUI 2011AA)
    22290004 (SNOMED CT 2011_0131)
    MTHU001814 (LOINC Version 232)
    C0948759 (UMLS CUI 2011AA)
    10052020 (MedDRA 14.1)
    C1442155 (UMLS CUI 2011AA)
    MTHU021816 (LOINC Version 232)
    C0019167 (UMLS CUI 2011AA)
    60605004 (SNOMED CT 2011_0131)
    MTHU004548 (LOINC Version 232)
    C0856918 (UMLS CUI 2011AA)
    10002725 (MedDRA 14.1)
    C0877327 (UMLS CUI 2011AA)
    10049826 (MedDRA 14.1)
    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)
    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
    C1699700 (UMLS CUI 2011AA)
    MEDCCAT (HL7 V3 2006_05)
    C0341439 (UMLS CUI 2011AA)
    328383001 (SNOMED CT 2011_0131)
    10008953 (MedDRA 14.1)
    CL411789 (UMLS CUI 2011AA)
    C0220847 (UMLS CUI 2011AA)
    62944002 (SNOMED CT 2011_0131)
    10019752 (MedDRA 14.1)
    C0018995 (UMLS CUI 2011AA)
    399187006 (SNOMED CT 2011_0131)
    10018872 (MedDRA 14.1)
    E83.119 (ICD-10-CM Version 2010)
    C0241910 (UMLS CUI 2011AA)
    408335007 (SNOMED CT 2011_0131)
    10003827 (MedDRA 14.1)
    K75.4 (ICD-10-CM Version 2010)
    571.42 (ICD-9-CM Version 2011)
    C0023896 (UMLS CUI 2011AA)
    41309000 (SNOMED CT 2011_0131)
    10001627 (MedDRA 14.1)
    K70.9 (ICD-10-CM Version 2010)
    571.3 (ICD-9-CM Version 2011)
    C0040537 (UMLS CUI 2011AA)
    420239005 (SNOMED CT 2011_0131)
    History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
    Item
    History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
    boolean
    C0155789 (UMLS CUI 2011AA)
    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)
    C0348080 (UMLS CUI 2011AA)
    260905004 (SNOMED CT 2011_0131)
    COND (HL7 V3 2006_05)
    C0332290 (UMLS CUI 2011AA)
    385433004 (SNOMED CT 2011_0131)
    C0745744 (UMLS CUI 2011AA)
    10050060 (MedDRA 14.1)
    Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening
    Item
    Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening
    boolean
    C0023890 (UMLS CUI 2011AA)
    19943007 (SNOMED CT 2011_0131)
    10019641 (MedDRA 14.1)
    K74.60 (ICD-10-CM Version 2010)
    C0221198 (UMLS CUI 2011AA)
    49755003 (SNOMED CT 2011_0131)
    C0242114 (UMLS CUI 2011AA)
    C0023903 (UMLS CUI 2011AA)
    126851005 (SNOMED CT 2011_0131)
    10019695 (MedDRA 14.1)
    C22.0 (ICD-10-CM Version 2010)
    C1409616 (UMLS CUI 2011AA)
    Absolute neutrophil count (ANC) <750 cells/mm3 at screening
    Item
    Absolute neutrophil count (ANC) <750 cells/mm3 at screening
    boolean
    C0948762 (UMLS CUI 2011AA)
    10052033 (MedDRA 14.1)
    C1409616 (UMLS CUI 2011AA)
    Platelet count <50,000 cells/mm3 at screening
    Item
    Platelet count <50,000 cells/mm3 at screening
    boolean
    C1287267 (UMLS CUI 2011AA)
    365632008 (SNOMED CT 2011_0131)
    777-3 (LOINC Version 232)
    C1409616 (UMLS CUI 2011AA)
    Hb <10 g/dl at screening
    Item
    Hb <10 g/dl at screening
    boolean
    C0019046 (UMLS CUI 2011AA)
    38082009 (SNOMED CT 2011_0131)
    10019481 (MedDRA 14.1)
    LP14449-0 (LOINC Version 232)
    C1409616 (UMLS CUI 2011AA)
    Dose modification of Peg-Interferon alpha-2b (PegIntron) or ribavirin (Rebetol) during the first 4 weeks of the ongoing therapy
    Item
    Dose modification of Peg-Interferon alpha-2b (PegIntron) or ribavirin (Rebetol) during the first 4 weeks of the ongoing therapy
    boolean
    C1707811 (UMLS CUI 2011AA)
    C0796545 (UMLS CUI 2011AA)
    395823000 (SNOMED CT 2011_0131)
    C0035525 (UMLS CUI 2011AA)
    387188005 (SNOMED CT 2011_0131)
    MTHU018696 (LOINC Version 232)
    C0205435 (UMLS CUI 2011AA)
    255216001 (SNOMED CT 2011_0131)
    C0439231 (UMLS CUI 2011AA)
    258706009 (SNOMED CT 2011_0131)
    MO (HL7 V3 2006_05)
    C0039798 (UMLS CUI 2011AA)
    Interferon alpha or ribavirin therapy at any time point before the actual ongoing treatment
    Item
    Interferon alpha or ribavirin therapy at any time point before the actual ongoing treatment
    boolean
    C1610033 (UMLS CUI 2011AA)
    C0035525 (UMLS CUI 2011AA)
    387188005 (SNOMED CT 2011_0131)
    MTHU018696 (LOINC Version 232)
    C0039798 (UMLS CUI 2011AA)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C0237400 (UMLS CUI 2011AA)
    C0039798 (UMLS CUI 2011AA)
    < 80% adherence to treatment of the ongoing treatment until randomization (week 20-22 of ongoing treatment)
    Item
    < 80% adherence to treatment of the ongoing treatment until randomization (week 20-22 of ongoing treatment)
    boolean
    C0205412 (UMLS CUI 2011AA)
    71978007 (SNOMED CT 2011_0131)
    C1171369 (UMLS CUI 2011AA)
    CL415091 (UMLS CUI 2011AA)
    C0034656 (UMLS CUI 2011AA)
    Serum creatinine level >1.5 times the upper limit of normal at screening
    Item
    Serum creatinine level >1.5 times the upper limit of normal at screening
    boolean
    C0201976 (UMLS CUI 2011AA)
    113075003 (SNOMED CT 2011_0131)
    10040230 (MedDRA 14.1)
    C1519815 (UMLS CUI 2011AA)
    C1409616 (UMLS CUI 2011AA)
    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
    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
    C0455498 (UMLS CUI 2011AA)
    161464003 (SNOMED CT 2011_0131)
    C0588008 (UMLS CUI 2011AA)
    310497006 (SNOMED CT 2011_0131)
    C0003289 (UMLS CUI 2011AA)
    372720008 (SNOMED CT 2011_0131)
    MTHU006782 (LOINC Version 232)
    C0040615 (UMLS CUI 2011AA)
    10784006 (SNOMED CT 2011_0131)
    MTHU003337 (LOINC Version 232)
    C2911479 (UMLS CUI 2011AA)
    Z91.5 (ICD-10-CM Version 2010)
    C0019993 (UMLS CUI 2011AA)
    394656005 (SNOMED CT 2011_0131)
    10054112 (MedDRA 14.1)
    C1948053 (UMLS CUI 2011AA)
    C0231170 (UMLS CUI 2011AA)
    21134002 (SNOMED CT 2011_0131)
    10013050 (MedDRA 14.1)
    DIS (HL7 V3 2006_05)
    CL420107 (UMLS CUI 2011AA)
    C0004936 (UMLS CUI 2011AA)
    74732009 (SNOMED CT 2011_0131)
    10037174 (MedDRA 14.1)
    F99 (ICD-10-CM Version 2010)
    290-319.99 (ICD-9-CM Version 2011)
    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 (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis)
    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
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0012634 (UMLS CUI 2011AA)
    64572001 (SNOMED CT 2011_0131)
    C0332281 (UMLS CUI 2011AA)
    47429007 (SNOMED CT 2011_0131)
    C0020962 (UMLS CUI 2011AA)
    116003000 (SNOMED CT 2011_0131)
    MTHU013246 (LOINC Version 232)
    C0021390 (UMLS CUI 2011AA)
    24526004 (SNOMED CT 2011_0131)
    10021972 (MedDRA 14.1)
    C0043117 (UMLS CUI 2011AA)
    32273002 (SNOMED CT 2011_0131)
    10021245 (MedDRA 14.1)
    D69.3 (ICD-10-CM Version 2010)
    C0409974 (UMLS CUI 2011AA)
    200936003 (SNOMED CT 2011_0131)
    10025134 (MedDRA 14.1)
    L93 (ICD-10-CM Version 2010)
    695.4 (ICD-9-CM Version 2011)
    C0002880 (UMLS CUI 2011AA)
    413603009 (SNOMED CT 2011_0131)
    10002046 (MedDRA 14.1)
    283.0 (ICD-9-CM Version 2011)
    C0011644 (UMLS CUI 2011AA)
    89155008 (SNOMED CT 2011_0131)
    10039710 (MedDRA 14.1)
    C0205082 (UMLS CUI 2011AA)
    24484000 (SNOMED CT 2011_0131)
    C0033860 (UMLS CUI 2011AA)
    9014002 (SNOMED CT 2011_0131)
    10037153 (MedDRA 14.1)
    L40 (ICD-10-CM Version 2010)
    C0003873 (UMLS CUI 2011AA)
    69896004 (SNOMED CT 2011_0131)
    10039073 (MedDRA 14.1)
    M06.9 (ICD-10-CM Version 2010)
    714.0 (ICD-9-CM Version 2011)
    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)
    History or other evidence of chronic pulmonary disease associated with functional limitation
    Item
    History or other evidence of chronic pulmonary disease associated with functional limitation
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0332120 (UMLS CUI 2011AA)
    18669006 (SNOMED CT 2011_0131)
    C0746102 (UMLS CUI 2011AA)
    413839001 (SNOMED CT 2011_0131)
    C0332281 (UMLS CUI 2011AA)
    47429007 (SNOMED CT 2011_0131)
    C0205245 (UMLS CUI 2011AA)
    40143009 (SNOMED CT 2011_0131)
    C0449295 (UMLS CUI 2011AA)
    246175000 (SNOMED CT 2011_0131)
    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)
    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
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0018799 (UMLS CUI 2011AA)
    56265001 (SNOMED CT 2011_0131)
    10061024 (MedDRA 14.1)
    C1319795 (UMLS CUI 2011AA)
    420913000 (SNOMED CT 2011_0131)
    10064081 (MedDRA 14.1)
    C1319796 (UMLS CUI 2011AA)
    422293003 (SNOMED CT 2011_0131)
    10064082 (MedDRA 14.1)
    C0027051 (UMLS CUI 2011AA)
    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)
    C0332152 (UMLS CUI 2011AA)
    288556008 (SNOMED CT 2011_0131)
    C0982327 (UMLS CUI 2011AA)
    C0035525 (UMLS CUI 2011AA)
    387188005 (SNOMED CT 2011_0131)
    MTHU018696 (LOINC Version 232)
    C0039798 (UMLS CUI 2011AA)
    C0042514 (UMLS CUI 2011AA)
    25569003 (SNOMED CT 2011_0131)
    10065341 (MedDRA 14.1)
    I47.2 (ICD-10-CM Version 2010)
    E10239 (CTCAE 1105E)
    C0002965 (UMLS CUI 2011AA)
    4557003 (SNOMED CT 2011_0131)
    10002388 (MedDRA 14.1)
    I20.0 (ICD-10-CM Version 2010)
    411.1 (ICD-9-CM Version 2011)
    Evidence of thyroid disease that is poorly controlled on prescribed medications
    Item
    Evidence of thyroid disease that is poorly controlled on prescribed medications
    boolean
    C0040128 (UMLS CUI 2011AA)
    14304000 (SNOMED CT 2011_0131)
    10043709 (MedDRA 14.1)
    E00-E07 (ICD-10-CM Version 2010)
    240-246.99 (ICD-9-CM Version 2011)
    C0205169 (UMLS CUI 2011AA)
    556001 (SNOMED CT 2011_0131)
    C2587213 (UMLS CUI 2011AA)
    31509003 (SNOMED CT 2011_0131)
    C0013227 (UMLS CUI 2011AA)
    Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)
    Item
    Evidence of severe retinopathy (e.g. CMV retinitis, macular degeneration)
    boolean
    C0205082 (UMLS CUI 2011AA)
    24484000 (SNOMED CT 2011_0131)
    CL365148 (UMLS CUI 2011AA)
    399625000 (SNOMED CT 2011_0131)
    10038923 (MedDRA 14.1)
    E10432 (CTCAE 1105E)
    C0206178 (UMLS CUI 2011AA)
    22455005 (SNOMED CT 2011_0131)
    10011835 (MedDRA 14.1)
    C0024437 (UMLS CUI 2011AA)
    422338006 (SNOMED CT 2011_0131)
    10025409 (MedDRA 14.1)
    MTHU020821 (LOINC Version 232)
    History of major organ transplantation with an existing functional graft
    Item
    History of major organ transplantation with an existing functional graft
    boolean
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0205164 (UMLS CUI 2011AA)
    255603008 (SNOMED CT 2011_0131)
    C0029216 (UMLS CUI 2011AA)
    10061890 (MedDRA 14.1)
    MTHU000173 (LOINC Version 232)
    C0205245 (UMLS CUI 2011AA)
    40143009 (SNOMED CT 2011_0131)
    C0332835 (UMLS CUI 2011AA)
    24486003 (SNOMED CT 2011_0131)
    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
    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
    C0205082 (UMLS CUI 2011AA)
    24484000 (SNOMED CT 2011_0131)
    C0221423 (UMLS CUI 2011AA)
    39104002 (SNOMED CT 2011_0131)
    10040658 (MedDRA 14.1)
    R69 (ICD-10-CM Version 2010)
    C0006826 (UMLS CUI 2011AA)
    363346000 (SNOMED CT 2011_0131)
    10028997 (MedDRA 14.1)
    MTHU010328 (LOINC Version 232)
    C00-C96 (ICD-10-CM Version 2010)
    C0348080 (UMLS CUI 2011AA)
    260905004 (SNOMED CT 2011_0131)
    COND (HL7 V3 2006_05)
    C0678227 (UMLS CUI 2011AA)
    23981006 (SNOMED CT 2011_0131)
    C0030705 (UMLS CUI 2011AA)
    116154003 (SNOMED CT 2011_0131)
    C1548788 (UMLS CUI 2011AA)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    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
    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
    CL421546 (UMLS CUI 2011AA)
    392521001 (SNOMED CT 2011_0131)
    C0205373 (UMLS CUI 2011AA)
    31099001 (SNOMED CT 2011_0131)
    C0920425 (UMLS CUI 2011AA)
    CL412323 (UMLS CUI 2011AA)
    C0038317 (UMLS CUI 2011AA)
    116566001 (SNOMED CT 2011_0131)
    C0034619 (UMLS CUI 2011AA)
    Patients with evidence for tuberculosis
    Item
    Patients with evidence for tuberculosis
    boolean
    C0332120 (UMLS CUI 2011AA)
    18669006 (SNOMED CT 2011_0131)
    C0041296 (UMLS CUI 2011AA)
    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)
    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
    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
    C0013146 (UMLS CUI 2011AA)
    26416006 (SNOMED CT 2011_0131)
    10013654 (MedDRA 14.1)
    LP36310-8 (LOINC Version 232)
    305.90 (ICD-9-CM Version 2011)
    C0560219 (UMLS CUI 2011AA)
    160592001 (SNOMED CT 2011_0131)
    C1554961 (UMLS CUI 2011AA)
    E (HL7 V3 2006_05)
    C0025605 (UMLS CUI 2011AA)
    51758009 (SNOMED CT 2011_0131)
    MTHU001002 (LOINC Version 232)
    C0006405 (UMLS CUI 2011AA)
    31684002 (SNOMED CT 2011_0131)
    MTHU006723 (LOINC Version 232)
    Any investigational drug and/or participation in another clinical study prior 6 months to the actual ongoing antiviral treatment
    Item
    Any investigational drug and/or participation in another clinical study prior 6 months to the actual ongoing antiviral treatment
    boolean
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C0013230 (UMLS CUI 2011AA)
    C0679823 (UMLS CUI 2011AA)
    PART (HL7 V3 2006_05)
    C0205394 (UMLS CUI 2011AA)
    74964007 (SNOMED CT 2011_0131)
    C0008976 (UMLS CUI 2011AA)
    110465008 (SNOMED CT 2011_0131)
    C0332152 (UMLS CUI 2011AA)
    288556008 (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)
    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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