ID

11904

Descrição

Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential; ODM derived from: https://clinicaltrials.gov/show/NCT02419378 Principal Investigator Prof. Dr. Dr. Sven Meuth, University Hospital Muenster, Germany

Link

https://clinicaltrials.gov/show/NCT02419378

Palavras-chave

Versões (4)
  1. 18/08/2015 18/08/2015 - Martin Dugas
  2. 22/05/2016 22/05/2016 -
  3. 28/05/2016 28/05/2016 -
  4. 27/09/2021 27/09/2021 -
Transferido a

18 de agosto de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy
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    Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02419378

    Inglês

    Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02419378

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    1. signed informed consent form (icf)
    Descrição

    signed informed consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    2. age 18 to 55 years old (inclusive) as of the date the icf is signed
    Descrição

    2. age 18 to 55 years old (inclusive) as of the date the icf is signed

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    3. diagnosis of ms according to the mcdonald criteria 2010 and cranial mri scan demonstrating white matter lesions attributable to ms within 5 years before screening
    Descrição

    3. diagnosis of ms according to the mcdonald criteria 2010 and cranial mri scan demonstrating white matter lesions attributable to ms within 5 years before screening

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0026769
    UMLS CUI [1,2]
    C0917711
    4. onset of ms symptoms (as determined by a neurologist, either at present or retrospectively) within 5 years of the date the icf is signed
    Descrição

    4. onset of ms symptoms (as determined by a neurologist, either at present or retrospectively) within 5 years of the date the icf is signed

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0332162
    5. edss score 0.0 to 4.0 (inclusive) at screening
    Descrição

    5. edss score 0.0 to 4.0 (inclusive) at screening

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0451246
    6. ≥2 ms relapses within 24 months or clinical (≥1 relapse) or mri (new gadolinium enhancing lesions) disease activity under therapy with interferon beta, glatirameracetate, natalizumab or fingolimod
    Descrição

    6. ≥2 ms relapses within 24 months or clinical (≥1 relapse) or mri (new gadolinium enhancing lesions) disease activity under therapy with interferon beta, glatirameracetate, natalizumab or fingolimod

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2707252
    7. indicated to receive alemtuzumab according to the investigator's assessment
    Descrição

    7. indicated to receive alemtuzumab according to the investigator's assessment

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1548948
    8. completion of all vaccinations required by the applicable immunization guidelines published by "ständige impfkommission" (stiko)
    Descrição

    8. completion of all vaccinations required by the applicable immunization guidelines published by "ständige impfkommission" (stiko)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0042196
    9. history of chickenpox or positive test for antibodies against varicella zoster virus (vzv)
    Descrição

    9. history of chickenpox or positive test for antibodies against varicella zoster virus (vzv)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0008049
    UMLS CUI [2]
    C0042338
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    1. participation in another clinical trial at present or within 4 weeks of study entry. there may be exceptions at the discretion of the investigator.
    Descrição

    1. participation in another clinical trial at present or within 4 weeks of study entry. there may be exceptions at the discretion of the investigator.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    2. has any progressive form of ms
    Descrição

    2. has any progressive form of ms

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1095979
    3. hypersensitivity to the active substance, or to any of the excipients of lemtrada
    Descrição

    3. hypersensitivity to the active substance, or to any of the excipients of lemtrada

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C1372955
    4. medical, psychiatric, cognitive, or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
    Descrição

    4. medical, psychiatric, cognitive, or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [2,1]
    C0525058
    5. any disability acquired from trauma or another illness that could interfere with evaluation of disability due to ms
    Descrição

    5. any disability acquired from trauma or another illness that could interfere with evaluation of disability due to ms

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0231170
    6. major systemic disease or other illness that would, in the opinion of the investigator, compromise patient safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease or other conditions that may predispose to hemorrhage
    Descrição

    6. major systemic disease or other illness that would, in the opinion of the investigator, compromise patient safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease or other conditions that may predispose to hemorrhage

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0442893
    7. known bleeding disorder (e.g,. dysfibrinogenemia, factor ix deficiency, hemophilia, von willebrand's disease, disseminated intravascular coagulation (dic), fibrinogen deficiency, or clotting factor deficiency)
    Descrição

    7. known bleeding disorder (e.g,. dysfibrinogenemia, factor ix deficiency, hemophilia, von willebrand's disease, disseminated intravascular coagulation (dic), fibrinogen deficiency, or clotting factor deficiency)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3251812
    8. significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis
    Descrição

    8. significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0004364
    9. history of malignancy, except basal skin cell carcinoma
    Descrição

    9. history of malignancy, except basal skin cell carcinoma

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    10. major psychiatric disorder that is not adequately controlled by treatment
    Descrição

    10. major psychiatric disorder that is not adequately controlled by treatment

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0004936
    UMLS CUI [1,2]
    C0205318
    11. epileptic seizures that are not adequately controlled by treatment
    Descrição

    11. epileptic seizures that are not adequately controlled by treatment

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0036572
    UMLS CUI [1,2]
    C0205318
    12. active infection, e.g., deep-tissue infection, that the investigator considers sufficiently serious to preclude study participation
    Descrição

    12. active infection, e.g., deep-tissue infection, that the investigator considers sufficiently serious to preclude study participation

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    13. in the investigator's opinion, is at high risk for infection (e.g., indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection)
    Descrição

    13. in the investigator's opinion, is at high risk for infection (e.g., indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0582147
    14. seropositivity for human immunodeficiency virus (hiv)
    Descrição

    14. seropositivity for human immunodeficiency virus (hiv)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    15. infection with hepatitis c virus
    Descrição

    15. infection with hepatitis c virus

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019196
    16. past or present hepatitis b infection (positive hepatitis b serology)
    Descrição

    16. past or present hepatitis b infection (positive hepatitis b serology)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0019163
    17. active infection with human cytomegaly virus (hcmv), epstein-barr virus (ebv), varicella-zoster virus (vzv)
    Descrição

    17. active infection with human cytomegaly virus (hcmv), epstein-barr virus (ebv), varicella-zoster virus (vzv)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0010825
    UMLS CUI [2]
    C0014644
    UMLS CUI [3]
    C0042338
    18. latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis.
    Descrição

    18. latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0041296
    19. invasive fungal infections in history and at present
    Descrição

    19. invasive fungal infections in history and at present

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0026946
    20. cervical cytology other than pap I or pap II (papanicolaou) or cervical high risk human papillomavirus (hpv) positivity
    Descrição

    20. cervical cytology other than pap I or pap II (papanicolaou) or cervical high risk human papillomavirus (hpv) positivity

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0856201
    21. any other illness or infection (latent or active) that, in the investigator's opinion, could be exacerbated by study medication
    Descrição

    21. any other illness or infection (latent or active) that, in the investigator's opinion, could be exacerbated by study medication

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3843746
    22. cd4+ t-cell count (absolute cd3+cd4+) <lower limit of normal (lln) at screening
    Descrição

    22. cd4+ t-cell count (absolute cd3+cd4+) <lower limit of normal (lln) at screening

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1855068
    23. cd8+ t-cell count (absolute cd3+cd8+) <lln at screening
    Descrição

    23. cd8+ t-cell count (absolute cd3+cd8+) <lln at screening

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3810110
    24. b-cell count (absolute cd19+) <lln at screening
    Descrição

    24. b-cell count (absolute cd19+) <lln at screening

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3540683
    UMLS CUI [1,2]
    C0205216
    25. absolute neutrophil count <lln at screening
    Descrição

    25. absolute neutrophil count <lln at screening

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1168174
    26. confirmed platelet count < the lln of the evaluating laboratory at screening or documented at <100,000/μl within the past year on a sample without platelet clumping
    Descrição

    26. confirmed platelet count < the lln of the evaluating laboratory at screening or documented at <100,000/μl within the past year on a sample without platelet clumping

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0040034
    27. presence (i.e., above the uln) of anti-thyroid stimulating hormone receptor antibodies (anti-tshr) and anti-thyroid peroxidase antibody (anti-tpo)
    Descrição

    27. presence (i.e., above the uln) of anti-thyroid stimulating hormone receptor antibodies (anti-tshr) and anti-thyroid peroxidase antibody (anti-tpo)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0370061
    UMLS CUI [1,2]
    C0076635
    28. any hepatic or renal function value grade 2 or higher at screening, with the exception of hyperbilirubinemia due to gilbert's syndrome. see table below, drawn from the national cancer institute (nci) common terminology criteria for adverse events v4.0 (ctcae), published 28 may 2009.
    Descrição

    28. any hepatic or renal function value grade 2 or higher at screening, with the exception of hyperbilirubinemia due to gilbert's syndrome. see table below, drawn from the national cancer institute (nci) common terminology criteria for adverse events v4.0 (ctcae), published 28 may 2009.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0151746
    UMLS CUI [2,1]
    C0086565
    bilirubin >1.5 × uln
    Descrição

    bilirubin >1.5 × uln

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201913
    sgot/ast >3.0 × uln
    Descrição

    sgot/ast >3.0 × uln

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201899
    sgpt/alt >3.0 × uln
    Descrição

    sgpt/alt >3.0 × uln

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201836
    alkaline phosphatase >2.5 × uln
    Descrição

    alkaline phosphatase >2.5 × uln

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201850
    creatinine > 1.5 × uln
    Descrição

    creatinine > 1.5 × uln

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    29. vaccination less than 6 weeks prior to study inclusion.
    Descrição

    29. vaccination less than 6 weeks prior to study inclusion.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0042196
    30. treatment with antineoplastic or immunosuppressive drugs within 8 weeks prior to study inclusion
    Descrição

    30. treatment with antineoplastic or immunosuppressive drugs within 8 weeks prior to study inclusion

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0003392
    UMLS CUI [2,1]
    C0499076
    31. intolerance of pulsed corticosteroids, especially a history of steroid psychosis
    Descrição

    31. intolerance of pulsed corticosteroids, especially a history of steroid psychosis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0749014
    32. inability to undergo mri with gadolinium administration
    Descrição

    32. inability to undergo mri with gadolinium administration

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0024485
    33. of childbearing potential with a positive serum pregnancy test, pregnant or lactating
    Descrição

    33. of childbearing potential with a positive serum pregnancy test, pregnant or lactating

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0549206
    UMLS CUI [2]
    C2828358
    34. female patients of childbearing potential: unwilling to agree to use a reliable and acceptable contraceptive method (pearl index <1) throughout the study period. these methods include: hormone releasing intrauterine device (iud), hormonal-based contraception, surgical sterilization, abstinence, or double-barrier contraception (condom and occlusive cap [diaphragm or cervical cap combined with spermicide]).
    Descrição

    34. female patients of childbearing potential: unwilling to agree to use a reliable and acceptable contraceptive method (pearl index <1) throughout the study period. these methods include: hormone releasing intrauterine device (iud), hormonal-based contraception, surgical sterilization, abstinence, or double-barrier contraception (condom and occlusive cap [diaphragm or cervical cap combined with spermicide]).

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0700589
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    Eligibility Multiple Sclerosis, Relapsing-Remitting NCT02419378

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    signed informed consent
    Item
    1. signed informed consent form (icf)
    boolean
    C0021430 (UMLS CUI [1])
    age
    Item
    2. age 18 to 55 years old (inclusive) as of the date the icf is signed
    boolean
    C0001779 (UMLS CUI [1])
    Multiple Sclerosis; McDonald criteria and MRI Scan
    Item
    3. diagnosis of ms according to the mcdonald criteria 2010 and cranial mri scan demonstrating white matter lesions attributable to ms within 5 years before screening
    boolean
    C0026769 (UMLS CUI [1,1])
    C0917711 (UMLS CUI [1,2])
    Onset of symptoms within 5 years
    Item
    4. onset of ms symptoms (as determined by a neurologist, either at present or retrospectively) within 5 years of the date the icf is signed
    boolean
    C1457887 (UMLS CUI [1,1])
    C0332162 (UMLS CUI [1,2])
    EDSS score
    Item
    5. edss score 0.0 to 4.0 (inclusive) at screening
    boolean
    C0451246 (UMLS CUI [1])
    Active disease
    Item
    6. ≥2 ms relapses within 24 months or clinical (≥1 relapse) or mri (new gadolinium enhancing lesions) disease activity under therapy with interferon beta, glatirameracetate, natalizumab or fingolimod
    boolean
    C2707252 (UMLS CUI [1])
    Medical Judgment
    Item
    7. indicated to receive alemtuzumab according to the investigator's assessment
    boolean
    C1548948 (UMLS CUI [1,1])
    Vaccinations
    Item
    8. completion of all vaccinations required by the applicable immunization guidelines published by "ständige impfkommission" (stiko)
    boolean
    C0042196 (UMLS CUI [1])
    Chickenpox; VZV
    Item
    9. history of chickenpox or positive test for antibodies against varicella zoster virus (vzv)
    boolean
    C0008049 (UMLS CUI [1,1])
    C0042338 (UMLS CUI [2])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    Other trial
    Item
    1. participation in another clinical trial at present or within 4 weeks of study entry. there may be exceptions at the discretion of the investigator.
    boolean
    C2348568 (UMLS CUI [1])
    Progressive Multiple Sclerosis
    Item
    2. has any progressive form of ms
    boolean
    C1095979 (UMLS CUI [1])
    Hypersensitivity to active substance
    Item
    3. hypersensitivity to the active substance, or to any of the excipients of lemtrada
    boolean
    C0020517 (UMLS CUI [1,1])
    C1372955 (UMLS CUI [1,2])
    Informed Consent | Protocol Compliance
    Item
    4. medical, psychiatric, cognitive, or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
    boolean
    C0021430 (UMLS CUI [1,1])
    C0525058 (UMLS CUI [2,1])
    Disability
    Item
    5. any disability acquired from trauma or another illness that could interfere with evaluation of disability due to ms
    boolean
    C0231170 (UMLS CUI [1])
    Major disease
    Item
    6. major systemic disease or other illness that would, in the opinion of the investigator, compromise patient safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease or other conditions that may predispose to hemorrhage
    boolean
    C0442893 (UMLS CUI [1])
    Bleeding disorder
    Item
    7. known bleeding disorder (e.g,. dysfibrinogenemia, factor ix deficiency, hemophilia, von willebrand's disease, disseminated intravascular coagulation (dic), fibrinogen deficiency, or clotting factor deficiency)
    boolean
    C3251812 (UMLS CUI [1])
    Autoimmune Diseases
    Item
    8. significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis
    boolean
    C0004364 (UMLS CUI [1,1])
    malignancy, except basal skin cell carcinoma
    Item
    9. history of malignancy, except basal skin cell carcinoma
    boolean
    C0006826 (UMLS CUI [1])
    Psychiatric disorder, uncontrolled
    Item
    10. major psychiatric disorder that is not adequately controlled by treatment
    boolean
    C0004936 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    Seizures, uncontrolled
    Item
    11. epileptic seizures that are not adequately controlled by treatment
    boolean
    C0036572 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    Active infection
    Item
    12. active infection, e.g., deep-tissue infection, that the investigator considers sufficiently serious to preclude study participation
    boolean
    C0009450 (UMLS CUI [1])
    high risk of infection
    Item
    13. in the investigator's opinion, is at high risk for infection (e.g., indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection)
    boolean
    C0582147 (UMLS CUI [1,1])
    HIV positive
    Item
    14. seropositivity for human immunodeficiency virus (hiv)
    boolean
    C0019699 (UMLS CUI [1])
    Hepatitis C
    Item
    15. infection with hepatitis c virus
    boolean
    C0019196 (UMLS CUI [1])
    hepatitis b
    Item
    16. past or present hepatitis b infection (positive hepatitis b serology)
    boolean
    C0019163 (UMLS CUI [1])
    CMV | EBV | VZV infection
    Item
    17. active infection with human cytomegaly virus (hcmv), epstein-barr virus (ebv), varicella-zoster virus (vzv)
    boolean
    C0010825 (UMLS CUI [1])
    C0014644 (UMLS CUI [2])
    C0042338 (UMLS CUI [3])
    Tuberculosis
    Item
    18. latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis.
    boolean
    C0041296 (UMLS CUI [1])
    Fungal infection
    Item
    19. invasive fungal infections in history and at present
    boolean
    C0026946 (UMLS CUI [1])
    Cervical cytology
    Item
    20. cervical cytology other than pap I or pap II (papanicolaou) or cervical high risk human papillomavirus (hpv) positivity
    boolean
    C0856201 (UMLS CUI [1,1])
    other illness
    Item
    21. any other illness or infection (latent or active) that, in the investigator's opinion, could be exacerbated by study medication
    boolean
    C3843746 (UMLS CUI [1])
    CD4+ low
    Item
    22. cd4+ t-cell count (absolute cd3+cd4+) <lower limit of normal (lln) at screening
    boolean
    C1855068 (UMLS CUI [1])
    CD8+ low
    Item
    23. cd8+ t-cell count (absolute cd3+cd8+) <lln at screening
    boolean
    C3810110 (UMLS CUI [1])
    CD19+ low
    Item
    24. b-cell count (absolute cd19+) <lln at screening
    boolean
    C3540683 (UMLS CUI [1,1])
    C0205216 (UMLS CUI [1,2])
    ANC low
    Item
    25. absolute neutrophil count <lln at screening
    boolean
    C1168174 (UMLS CUI [1])
    Thrombopenia
    Item
    26. confirmed platelet count < the lln of the evaluating laboratory at screening or documented at <100,000/μl within the past year on a sample without platelet clumping
    boolean
    C0040034 (UMLS CUI [1])
    Anti-thyrotropin antibody | Thyroid peroxidase antibody
    Item
    27. presence (i.e., above the uln) of anti-thyroid stimulating hormone receptor antibodies (anti-tshr) and anti-thyroid peroxidase antibody (anti-tpo)
    boolean
    C0370061 (UMLS CUI [1,1])
    C0076635 (UMLS CUI [1,2])
    Abnormal renal function | abnormal hepatic function
    Item
    28. any hepatic or renal function value grade 2 or higher at screening, with the exception of hyperbilirubinemia due to gilbert's syndrome. see table below, drawn from the national cancer institute (nci) common terminology criteria for adverse events v4.0 (ctcae), published 28 may 2009.
    boolean
    C0151746 (UMLS CUI [1,1])
    C0086565 (UMLS CUI [2,1])
    Bilirubin, total
    Item
    bilirubin >1.5 × uln
    boolean
    C0201913 (UMLS CUI [1])
    AST
    Item
    sgot/ast >3.0 × uln
    boolean
    C0201899 (UMLS CUI [1])
    ALT
    Item
    sgpt/alt >3.0 × uln
    boolean
    C0201836 (UMLS CUI [1])
    Alkaline phosphatase
    Item
    alkaline phosphatase >2.5 × uln
    boolean
    C0201850 (UMLS CUI [1])
    Creatinine
    Item
    creatinine > 1.5 × uln
    boolean
    C0201976 (UMLS CUI [1])
    vaccination
    Item
    29. vaccination less than 6 weeks prior to study inclusion.
    boolean
    C0042196 (UMLS CUI [1])
    Antineoplastic drug | Immunosuppressive drug
    Item
    30. treatment with antineoplastic or immunosuppressive drugs within 8 weeks prior to study inclusion
    boolean
    C0003392 (UMLS CUI [1,1])
    C0499076 (UMLS CUI [2,1])
    Steroid intolerance
    Item
    31. intolerance of pulsed corticosteroids, especially a history of steroid psychosis
    boolean
    C0749014 (UMLS CUI [1,1])
    MRI
    Item
    32. inability to undergo mri with gadolinium administration
    boolean
    C0024485 (UMLS CUI [1])
    pregnant | lactating
    Item
    33. of childbearing potential with a positive serum pregnancy test, pregnant or lactating
    boolean
    C0549206 (UMLS CUI [1])
    C2828358 (UMLS CUI [2])
    Contraception
    Item
    34. female patients of childbearing potential: unwilling to agree to use a reliable and acceptable contraceptive method (pearl index <1) throughout the study period. these methods include: hormone releasing intrauterine device (iud), hormonal-based contraception, surgical sterilization, abstinence, or double-barrier contraception (condom and occlusive cap [diaphragm or cervical cap combined with spermicide]).
    boolean
    C0700589 (UMLS CUI [1,1])
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