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ID

44216

Descrição

Screening, Baseline and Visit 1 CRFs of DIMAT-MS and ALAIN studies for semantic analysis of Multiple Sclerosis study documentation. Provided by Prof. Dr. Luisa Klotz of the Department of Neurology of the University Hospital Muenster.

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Versões (4)
  1. 27/02/2018 27/02/2018 -
  2. 29/01/2019 29/01/2019 - Sarah Riepenhausen
  3. 13/04/2021 13/04/2021 - Dr. rer. medic Philipp Neuhaus
  4. 20/09/2021 20/09/2021 -
Titular dos direitos

Prof. Dr. Luisa Klotz

Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY-NC 3.0
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    Multiple sclerosis studies NCT02461069 NCT02419378

    Inglês

    Eligibility Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

    18 Formulários  
    Inclusion criteria
    Descrição

    Inclusion criteria

    Written informed consent must be obtained before any assessment is performed
    Descrição

    Code IN01

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Male and female subjects aged 18 - 60 years.
    Descrição

    Code IN02

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    Patients with RRMS, defined by 2010 revised McDonald criteria
    Descrição

    rrms

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0751967 (Multiple Sclerosis, Relapsing-Remitting)
    SNOMED
    426373005
    Patients with an Expanded Disability Status Scale (EDSS) score of 0-6.0.
    Descrição

    EDSS

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3830336 (EDSS - Expanded Disability Score)
    Patients with one of the following treatment status:
    Descrição

    ms treatment status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0026769 (Multiple Sclerosis)
    SNOMED
    24700007
    LOINC
    LA14298-6
    UMLS CUI [1,2]
    C0749659 (Treatment Status)
    MRI-scan of the brain ≤ 3 months at screening.
    Descrição

    MRI-scan of the brain

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0024485 (Magnetic Resonance Imaging)
    SNOMED
    312250003
    LOINC
    LP57602-2
    Exclusion criteria
    Descrição

    Exclusion criteria

    Known hypersensitivity to dimethyl fumarate or any ingredients of Tecfidera® (microcrystalline cellulose; croscarmellose-sodium; talcum; high dispersion, hydrophobic silicon dioxide; magnesiumstearate (Ph. Eur.); triethylcitrate; methacrylic acid-methacrylate copolymer (1:1) (Ph. Eur.); methacrylic acid-ethylacrylate copolymer (1:1)-dispersion 30% (Ph. Eur.), simeticon, sodiumdodecylsulfate, polysorbate 80, gelantine, titanium oxide (E171), brilliant blue (E133), hydrated Iron(III)-oxide hydroxide (E172), shellac, potassium hydroxide.
    Descrição

    hypersensitivity to dimethyl fumarate or any ingredients of Tecfidera

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0058218 (dimethyl fumarate)
    SNOMED
    724035008
    A MS-relapse within 30 days prior to screening.
    Descrição

    MS relapse

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0035020 (Relapse)
    SNOMED
    263855007
    Known history of active tuberculosis or active tuberculosis determined by a positive QuantiFERON® TB Gold test.
    Descrição

    tuberculosis or active tuberculosis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0041296 (Tuberculosis)
    SNOMED
    373576009
    LOINC
    LP28599-6
    Moderate to severe impairment of liver function or persisting elevations > 2 x ULN (confirmed by retest) of serum glutamic pyruvic transaminase/ alanine aminotransferase (SGPT/ALT), serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST), or direct bilirubin > 2 x ULN, except patients with confirmed Gilbert´s syndrome (Meulengracht´s disease).
    Descrição

    severe impairment of liver function or persisting elevations except patients with confirmed Gilbert´s syndrome (Meulengracht´s disease).

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    UMLS CUI [2]
    C0201836 (Alanine aminotransferase measurement)
    SNOMED
    34608000
    UMLS CUI [3]
    C0201836 (Alanine aminotransferase measurement)
    SNOMED
    34608000
    UMLS CUI [4]
    C0201899 (Aspartate aminotransferase measurement)
    SNOMED
    45896001
    UMLS CUI [5]
    C0201916 (Bilirubin, direct measurement)
    SNOMED
    39748002
    UMLS CUI [6]
    C0017551 (Gilbert Disease (disorder))
    SNOMED
    27503000
    Moderate to severe impairment of renal function, as shown by serum creatinine > 133 μmol/L (or > 1.5 mg/dL).
    Descrição

    serum creatinine

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    Patients with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia • Hematocrit <24% and/or hemoglobin < 8.0 g/dl and/or • Absolute white blood cell count < 4,000 cells/ mm³ (μL) and/or • Absolute neutrophils ≤ 1,500 cells/mm³ (μL) and/or • Platelet count < 150,000 cells/ mm³ (μL).
    Descrição

    Patients with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0018935 (Hematocrit procedure)
    SNOMED
    28317006
    LOINC
    LP15101-6
    UMLS CUI [2]
    C0518015 (Hemoglobin measurement)
    UMLS CUI [3]
    C0023508 (White Blood Cell Count procedure)
    SNOMED
    767002
    UMLS CUI [4]
    C0948762 (Absolute neutrophil count)
    UMLS CUI [5]
    C0032181 (Platelet Count measurement)
    SNOMED
    61928009
    UMLS CUI [6]
    C1254595 (Laboratory Results)
    Women of childbearing potential not utilizing highly effective contraception
    Descrição

    Women of childbearing potential not utilizing highly effective contraception

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3831118 (Childbearing Potential)
    UMLS CUI [2]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
    Descrição

    Mental condition

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3840291 (Mental condition)
    LOINC
    MTHU047984
    Subjects unlikely to comply with protocol as determined by investigator, e.g., uncooperative attitude, inability to return for follow-up visits (e.g. major physical disability), and known unlikelihood of completing the study.
    Descrição

    Patient Non-Compliance

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0376405 (Patient Non-Compliance)
    SNOMED
    7058009
    LOINC
    LP75189-8
    Clinically relevant cardiovascular, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the subject at risk by participating in the study.
    Descrição

    Cardiovascular Diseases | nervous system disorder | Endocrine System Diseases | Systemic disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0007222 (Cardiovascular Diseases)
    SNOMED
    49601007
    UMLS CUI [2]
    C0027765 (nervous system disorder)
    SNOMED
    118940003
    LOINC
    LA10590-0
    UMLS CUI [3]
    C0014130 (Endocrine System Diseases)
    SNOMED
    362969004
    UMLS CUI [4]
    C0442893 (Systemic disease)
    SNOMED
    56019007
    Subjects with ulcerative colitis or Crohn´s disease
    Descrição

    Crohn´s disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0010346 (Crohn Disease)
    SNOMED
    34000006
    Subjects with a congenital or acquired severe immunodeficiency, a history of cancer (except for basal or squamous cell skin lesions which have been surgically excised, with no evidence of metastasis), lymph proliferative disease, or any subject who has received lymphoid irradiation.
    Descrição

    Immunologic Deficiency Syndromes | Malignant Neoplasms | Lymphoproliferative Disorders | Carcinoma, Basosquamous | Lymphatic Irradiation

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021051 (Immunologic Deficiency Syndromes)
    SNOMED
    234532001
    LOINC
    MTHU054768
    UMLS CUI [2]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [3]
    C0024314 (Lymphoproliferative Disorders)
    SNOMED
    84631004
    UMLS CUI [4]
    C0007118 (Carcinoma, Basosquamous)
    SNOMED
    254702000
    UMLS CUI [5]
    C0024230 (Lymphatic Irradiation)
    Human immunodeficiency virus (HIV) positive, hepatitis B virus positive or hepatitis C virus positive subjects.
    Descrição

    HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019693 (HIV Infections)
    SNOMED
    86406008
    UMLS CUI [2]
    C0019163 (Hepatitis B)
    SNOMED
    66071002
    LOINC
    LA18126-5
    UMLS CUI [3]
    C0019196 (Hepatitis C)
    SNOMED
    50711007
    LOINC
    LA19423-5
    Acute or chronic infection
    Descrição

    Acute or chronic infection

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    UMLS CUI [2]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    History of drug or alcohol abuse.
    Descrição

    History of drug or alcohol abuse

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0681694 (history of AOD use)
    Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 4 weeks prior to screening.
    Descrição

    Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 4 weeks prior to screening.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0149783 (Steroid therapy)
    SNOMED
    297279009
    UMLS CUI [2]
    C0149783 (Steroid therapy)
    SNOMED
    297279009
    Prior or concomitant use of cytokine therapy or intravenous immunoglobulins in the 3 months prior to screening.
    Descrição

    Cytokine therapy | Immunoglobulins, Intravenous

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0199974 (Cytokine therapy)
    SNOMED
    84501003
    UMLS CUI [2]
    C0085297 (immunoglobulins, intravenous)
    Prior use of alemtuzumab or cladribine.
    Descrição

    Prior use of alemtuzumab or cladribine

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0383429 (alemtuzumab)
    SNOMED
    391632007
    UMLS CUI [1,2]
    C2114510 (previous therapy)
    UMLS CUI [2,1]
    C0092801 (cladribine)
    SNOMED
    108800000
    UMLS CUI [2,2]
    C2114510 (previous therapy)
    Prior use (within 1 year) of fingolimod (Gilenya®) or natalizumab (Tysabri®).
    Descrição

    Prior use (within 1 year) of fingolimod (Gilenya®) or natalizumab (Tysabri®).

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1699926 (fingolimod)
    SNOMED
    449000008
    UMLS CUI [2]
    C1172734 (natalizumab)
    SNOMED
    414804006
    UMLS CUI [3,1]
    C2114510 (previous therapy)
    UMLS CUI [3,2]
    C0021079 (Therapeutic immunosuppression)
    SNOMED
    86553008
    Prior use (within 2 years) of mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporine, methotrexate or mycophenolate mofetil.
    Descrição

    Mitoxantrone | Azathioprine | Cyclophosphamide | Cyclosporine | Methotrexate | mycophenolate mofetil

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0026259 (mitoxantrone)
    SNOMED
    108791001
    UMLS CUI [2]
    C0004482 (azathioprine)
    SNOMED
    111165009
    UMLS CUI [3]
    C0010583 (cyclophosphamide)
    SNOMED
    74470007
    UMLS CUI [4]
    C0010592 (cyclosporine)
    SNOMED
    387467008
    UMLS CUI [5]
    C0025677 (methotrexate)
    SNOMED
    68887009
    UMLS CUI [6]
    C0209368 (mycophenolate mofetil)
    SNOMED
    386976000
    UMLS CUI [7,1]
    C2114510 (previous therapy)
    UMLS CUI [7,2]
    C0021079 (Therapeutic immunosuppression)
    SNOMED
    86553008
    UMLS CUI [7,3]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    Prior treatment with teriflunomide or leflunomide, unless successful washout, confirmed by plasma concentration of < 0.02 µg/ml.
    Descrição

    teriflunomide | leflunomide

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1718383 (teriflunomide)
    SNOMED
    703785006
    UMLS CUI [2]
    C0063041 (leflunomide)
    SNOMED
    109143003
    Prior use of any investigational drug in the 6 months preceding screening
    Descrição

    Investigational New Drugs

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0013230 (Investigational New Drugs)
    Pregnant or breast-feeding women.
    Descrição

    Patient currently pregnant | Breast Feeding

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0549206 (Patient currently pregnant)
    SNOMED
    77386006
    LOINC
    LA14670-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    Signature Screening Visit 1
    Descrição

    Signature Screening Visit 1

    Signature Date
    Descrição

    Signature date

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C2346576 (Investigator Signature)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Signature investigator
    Descrição

    Signature investigator

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
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    Similar models

    Eligibility Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

    18 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Inclusion criteria
    Written informed consent
    Item
    Written informed consent must be obtained before any assessment is performed
    boolean
    C0021430 (UMLS CUI [1])
    age
    Item
    Male and female subjects aged 18 - 60 years.
    boolean
    C0001779 (UMLS CUI [1])
    rrms
    Item
    Patients with RRMS, defined by 2010 revised McDonald criteria
    boolean
    C0751967 (UMLS CUI [1])
    EDSS
    Item
    Patients with an Expanded Disability Status Scale (EDSS) score of 0-6.0.
    boolean
    C3830336 (UMLS CUI [1])
    ms treatment status
    Item
    Patients with one of the following treatment status:
    boolean
    C0026769 (UMLS CUI [1,1])
    C0749659 (UMLS CUI [1,2])
    MRI-scan of the brain
    Item
    MRI-scan of the brain ≤ 3 months at screening.
    boolean
    C0024485 (UMLS CUI [1])
    Item Group
    Exclusion criteria
    hypersensitivity to dimethyl fumarate or any ingredients of Tecfidera
    Item
    Known hypersensitivity to dimethyl fumarate or any ingredients of Tecfidera® (microcrystalline cellulose; croscarmellose-sodium; talcum; high dispersion, hydrophobic silicon dioxide; magnesiumstearate (Ph. Eur.); triethylcitrate; methacrylic acid-methacrylate copolymer (1:1) (Ph. Eur.); methacrylic acid-ethylacrylate copolymer (1:1)-dispersion 30% (Ph. Eur.), simeticon, sodiumdodecylsulfate, polysorbate 80, gelantine, titanium oxide (E171), brilliant blue (E133), hydrated Iron(III)-oxide hydroxide (E172), shellac, potassium hydroxide.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0058218 (UMLS CUI [1,2])
    MS relapse
    Item
    A MS-relapse within 30 days prior to screening.
    boolean
    C0035020 (UMLS CUI [1])
    tuberculosis or active tuberculosis
    Item
    Known history of active tuberculosis or active tuberculosis determined by a positive QuantiFERON® TB Gold test.
    boolean
    C0041296 (UMLS CUI [1])
    severe impairment of liver function or persisting elevations except patients with confirmed Gilbert´s syndrome (Meulengracht´s disease).
    Item
    Moderate to severe impairment of liver function or persisting elevations > 2 x ULN (confirmed by retest) of serum glutamic pyruvic transaminase/ alanine aminotransferase (SGPT/ALT), serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST), or direct bilirubin > 2 x ULN, except patients with confirmed Gilbert´s syndrome (Meulengracht´s disease).
    boolean
    C0232741 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    C0201836 (UMLS CUI [3])
    C0201899 (UMLS CUI [4])
    C0201916 (UMLS CUI [5])
    C0017551 (UMLS CUI [6])
    serum creatinine
    Item
    Moderate to severe impairment of renal function, as shown by serum creatinine > 133 μmol/L (or > 1.5 mg/dL).
    boolean
    C0201976 (UMLS CUI [1])
    Patients with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia
    Item
    Patients with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia • Hematocrit <24% and/or hemoglobin < 8.0 g/dl and/or • Absolute white blood cell count < 4,000 cells/ mm³ (μL) and/or • Absolute neutrophils ≤ 1,500 cells/mm³ (μL) and/or • Platelet count < 150,000 cells/ mm³ (μL).
    boolean
    C0018935 (UMLS CUI [1])
    C0518015 (UMLS CUI [2])
    C0023508 (UMLS CUI [3])
    C0948762 (UMLS CUI [4])
    C0032181 (UMLS CUI [5])
    C1254595 (UMLS CUI [6])
    Women of childbearing potential not utilizing highly effective contraception
    Item
    Women of childbearing potential not utilizing highly effective contraception
    boolean
    C3831118 (UMLS CUI [1])
    C0700589 (UMLS CUI [2])
    Mental condition
    Item
    Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
    boolean
    C3840291 (UMLS CUI [1])
    Patient Non-Compliance
    Item
    Subjects unlikely to comply with protocol as determined by investigator, e.g., uncooperative attitude, inability to return for follow-up visits (e.g. major physical disability), and known unlikelihood of completing the study.
    boolean
    C0376405 (UMLS CUI [1])
    Cardiovascular Diseases | nervous system disorder | Endocrine System Diseases | Systemic disease
    Item
    Clinically relevant cardiovascular, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the subject at risk by participating in the study.
    boolean
    C0007222 (UMLS CUI [1])
    C0027765 (UMLS CUI [2])
    C0014130 (UMLS CUI [3])
    C0442893 (UMLS CUI [4])
    Crohn´s disease
    Item
    Subjects with ulcerative colitis or Crohn´s disease
    boolean
    C0010346 (UMLS CUI [1])
    Immunologic Deficiency Syndromes | Malignant Neoplasms | Lymphoproliferative Disorders | Carcinoma, Basosquamous | Lymphatic Irradiation
    Item
    Subjects with a congenital or acquired severe immunodeficiency, a history of cancer (except for basal or squamous cell skin lesions which have been surgically excised, with no evidence of metastasis), lymph proliferative disease, or any subject who has received lymphoid irradiation.
    boolean
    C0021051 (UMLS CUI [1])
    C0006826 (UMLS CUI [2])
    C0024314 (UMLS CUI [3])
    C0007118 (UMLS CUI [4])
    C0024230 (UMLS CUI [5])
    HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
    Item
    Human immunodeficiency virus (HIV) positive, hepatitis B virus positive or hepatitis C virus positive subjects.
    boolean
    C0019693 (UMLS CUI [1])
    C0019163 (UMLS CUI [2])
    C0019196 (UMLS CUI [3])
    Acute or chronic infection
    Item
    Acute or chronic infection
    boolean
    C0009450 (UMLS CUI [1])
    C0009450 (UMLS CUI [2])
    History of drug or alcohol abuse
    Item
    History of drug or alcohol abuse.
    boolean
    C0681694 (UMLS CUI [1])
    Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 4 weeks prior to screening.
    Item
    Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 4 weeks prior to screening.
    boolean
    C0149783 (UMLS CUI [1])
    C0149783 (UMLS CUI [2])
    Cytokine therapy | Immunoglobulins, Intravenous
    Item
    Prior or concomitant use of cytokine therapy or intravenous immunoglobulins in the 3 months prior to screening.
    boolean
    C0199974 (UMLS CUI [1])
    C0085297 (UMLS CUI [2])
    Prior use of alemtuzumab or cladribine
    Item
    Prior use of alemtuzumab or cladribine.
    boolean
    C0383429 (UMLS CUI [1,1])
    C2114510 (UMLS CUI [1,2])
    C0092801 (UMLS CUI [2,1])
    C2114510 (UMLS CUI [2,2])
    Prior use (within 1 year) of fingolimod (Gilenya®) or natalizumab (Tysabri®).
    Item
    Prior use (within 1 year) of fingolimod (Gilenya®) or natalizumab (Tysabri®).
    boolean
    C1699926 (UMLS CUI [1])
    C1172734 (UMLS CUI [2])
    C2114510 (UMLS CUI [3,1])
    C0021079 (UMLS CUI [3,2])
    Mitoxantrone | Azathioprine | Cyclophosphamide | Cyclosporine | Methotrexate | mycophenolate mofetil
    Item
    Prior use (within 2 years) of mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporine, methotrexate or mycophenolate mofetil.
    boolean
    C0026259 (UMLS CUI [1])
    C0004482 (UMLS CUI [2])
    C0010583 (UMLS CUI [3])
    C0010592 (UMLS CUI [4])
    C0025677 (UMLS CUI [5])
    C0209368 (UMLS CUI [6])
    C2114510 (UMLS CUI [7,1])
    C0021079 (UMLS CUI [7,2])
    C0205394 (UMLS CUI [7,3])
    teriflunomide | leflunomide
    Item
    Prior treatment with teriflunomide or leflunomide, unless successful washout, confirmed by plasma concentration of < 0.02 µg/ml.
    boolean
    C1718383 (UMLS CUI [1])
    C0063041 (UMLS CUI [2])
    Investigational New Drugs
    Item
    Prior use of any investigational drug in the 6 months preceding screening
    boolean
    C0013230 (UMLS CUI [1])
    Patient currently pregnant | Breast Feeding
    Item
    Pregnant or breast-feeding women.
    boolean
    C0549206 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Item Group
    Signature Screening Visit 1
    Signature date
    Item
    Signature Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Signature investigator
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    Signature investigator
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    C2346576 (UMLS CUI [1])
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