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22444

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Study part: Eligibility Criteria Worksheet Screening Visit.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

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  1. 04.06.17 04.06.17 -
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GlaxoSmithKline

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4. Juni 2017

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    Eligibility Criteria Worksheet Screening Visit Mepolizumab HES NCT00086658

    Englisch

    Eligibility Criteria Worksheet Screening Visit

    1 Formulare  
    INCLUSION CRITERIA
    Beschreibung

    INCLUSION CRITERIA

    Alias
    UMLS CUI-1
    C1512693 (Inclusion)
    1. Signed informed consent.
    Beschreibung

    Informed consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    2. Subjects with documented history of HES.
    Beschreibung

    HES is defined as: 1) peripheral blood eosinophilia (>1500 eosinophils/ μL) for at least 6 months, 2) signs and symptoms of organ system involvement or dysfunction that can be directly related to eosinophilia, 3) no evidence of parasitic, allergic, or other recognized causes of eosinophilia after comprehensive evaluation. Note: Subjects with sustained peripheral hypereosinophilia of >1500 eosinophils/μL for a duration of<6 months may be included if they meet the rest of the HES criteria accompanied by clear evidence of eosinophil tissue infiltration.

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI [1,2]
    C1540912 (Hypereosinophilic syndrome)
    SNOMED
    128835008
    3. Male or female, 18-75 years of age. A female subject is eligible to enter the study if she is: • Not pregnant or nursing • Of non-childbearing potential (i.e., women who had a hysterectomy, are post-menopausal which is defined as 1 year without menses, have both ovaries surgically removed, or have current documented tubule ligation); or • Of childbearing potential (i.e., women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at the Screening Visit, and agree to one of the following: 1). Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of investigational product until 3 months after the last dose of investigational product; or 2). Consistent and correct use of one of the following acceptable methods of birth control for one month prior to the start of the investigation product and three months after the last dose: • Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subjects; • Implants of levonorgestrel; • Injectable progestogen; • Any intrauterine device (IUD) with a documented failure rate of less than 1% per year; • Oral contraceptives (either combined or progestogen only) • Double-barrier methods including diaphragm or condom with a spermicide.
    Beschreibung

    Gender; Age; Pregnancy; Childbearing Potential; Contraceptive methods

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [2]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    UMLS CUI [3]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [4]
    C3831118 (Childbearing Potential)
    UMLS CUI [5]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    EXCLUSION CRITERIA
    Beschreibung

    EXCLUSION CRITERIA

    Alias
    UMLS CUI-1
    C0680251 (Exclusion Criteria)
    1. Subjects with life-threatening or other serious illness or clinical manifestation deemed inappropriate for inclusion in study per the principal investigator.
    Beschreibung

    Comorbidity

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0009488 (Comorbidity)
    2. Known secondary causes of eosinophilia: drug eruption and parasitic infection occurring within a year prior to the Screening Visit, history of graft-versus host disease, bullous pemphigoid, cystic fibrosis, rheumatoid arthritis and human immunodeficiency virus (HIV) infection
    Beschreibung

    Secondary eosinophilia drug eruption parasitic infection graft-versus host disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0272194 (Secondary eosinophilia)
    SNOMED
    30981000
    UMLS CUI [1,2]
    C0011609 (Drug Eruptions)
    SNOMED
    28926001
    UMLS CUI [1,3]
    C0747256 (Parasitic infection)
    UMLS CUI [1,4]
    C0018133 (Graft-vs-Host Disease)
    SNOMED
    234646005
    3. Known Churg-Strauss Syndrome
    Beschreibung

    Churg-Strauss Syndrome

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0008728 (Eosinophilic granulomatosis with polyangiitis)
    SNOMED
    82275008
    4. Known Wegener's Granulomatosis
    Beschreibung

    Wegeners Granulomatosis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3495801 (Granulomatosis with polyangiitis)
    SNOMED
    195353004
    5. Known lymphoma, hematological malignancy, advanced and metastatic solid tumors and/or subjects who are under chemotherapy, radiotherapy or interleukin 2 treatment
    Beschreibung

    medical history malignant Neoplasms; Therapy chemotherapy radiotherapy Interleukin-2 therapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926 (Medical History)
    SNOMED
    392521001
    LOINC
    LP6817-3
    UMLS CUI [1,2]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [2,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [2,2]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [2,3]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    UMLS CUI [2,4]
    C0199975 (Interleukin-2 therapy)
    SNOMED
    72255009
    6. Known history of allergic reaction to previous antibody therapy.
    Beschreibung

    Hypersensitivity antibody therapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0281176 (Antibody Therapy)
    7. Prior treatment with an anti-hIL-5 monoclonal antibody.
    Beschreibung

    Therapy monoclonal antibody

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C0003250 (Monoclonal Antibodies)
    SNOMED
    108807002
    8. Use of an investigational drug within 30 days of entering the study (Screening Visit).
    Beschreibung

    Investigational drug

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0013230 (Investigational New Drugs)
    9. Recent history or suspicion of current drug abuse or alcohol abuse within the last 6 months.
    Beschreibung

    Substance use disorder

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0038586 (Substance Use Disorders)
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Criteria Worksheet Screening Visit

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    INCLUSION CRITERIA
    C1512693 (UMLS CUI-1)
    Informed consent
    Item
    1. Signed informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Medical history Hypereosinophilic Syndrome
    Item
    2. Subjects with documented history of HES.
    boolean
    C0262926 (UMLS CUI [1,1])
    C1540912 (UMLS CUI [1,2])
    Gender; Age; Pregnancy; Childbearing Potential; Contraceptive methods
    Item
    3. Male or female, 18-75 years of age. A female subject is eligible to enter the study if she is: • Not pregnant or nursing • Of non-childbearing potential (i.e., women who had a hysterectomy, are post-menopausal which is defined as 1 year without menses, have both ovaries surgically removed, or have current documented tubule ligation); or • Of childbearing potential (i.e., women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at the Screening Visit, and agree to one of the following: 1). Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of investigational product until 3 months after the last dose of investigational product; or 2). Consistent and correct use of one of the following acceptable methods of birth control for one month prior to the start of the investigation product and three months after the last dose: • Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subjects; • Implants of levonorgestrel; • Injectable progestogen; • Any intrauterine device (IUD) with a documented failure rate of less than 1% per year; • Oral contraceptives (either combined or progestogen only) • Double-barrier methods including diaphragm or condom with a spermicide.
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    C0032961 (UMLS CUI [3])
    C3831118 (UMLS CUI [4])
    C0700589 (UMLS CUI [5])
    Item Group
    EXCLUSION CRITERIA
    C0680251 (UMLS CUI-1)
    Comorbidity
    Item
    1. Subjects with life-threatening or other serious illness or clinical manifestation deemed inappropriate for inclusion in study per the principal investigator.
    boolean
    C0009488 (UMLS CUI [1])
    Secondary eosinophilia drug eruption parasitic infection graft-versus host disease
    Item
    2. Known secondary causes of eosinophilia: drug eruption and parasitic infection occurring within a year prior to the Screening Visit, history of graft-versus host disease, bullous pemphigoid, cystic fibrosis, rheumatoid arthritis and human immunodeficiency virus (HIV) infection
    boolean
    C0272194 (UMLS CUI [1,1])
    C0011609 (UMLS CUI [1,2])
    C0747256 (UMLS CUI [1,3])
    C0018133 (UMLS CUI [1,4])
    Churg-Strauss Syndrome
    Item
    3. Known Churg-Strauss Syndrome
    boolean
    C0008728 (UMLS CUI [1])
    Wegeners Granulomatosis
    Item
    4. Known Wegener's Granulomatosis
    boolean
    C3495801 (UMLS CUI [1])
    medical history malignant Neoplasms; Therapy chemotherapy radiotherapy Interleukin-2 therapy
    Item
    5. Known lymphoma, hematological malignancy, advanced and metastatic solid tumors and/or subjects who are under chemotherapy, radiotherapy or interleukin 2 treatment
    boolean
    C0262926 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C0392920 (UMLS CUI [2,2])
    C1522449 (UMLS CUI [2,3])
    C0199975 (UMLS CUI [2,4])
    Hypersensitivity antibody therapy
    Item
    6. Known history of allergic reaction to previous antibody therapy.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0281176 (UMLS CUI [1,2])
    Therapy monoclonal antibody
    Item
    7. Prior treatment with an anti-hIL-5 monoclonal antibody.
    boolean
    C0087111 (UMLS CUI [1,1])
    C0003250 (UMLS CUI [1,2])
    Investigational drug
    Item
    8. Use of an investigational drug within 30 days of entering the study (Screening Visit).
    boolean
    C0013230 (UMLS CUI [1])
    Substance use disorder
    Item
    9. Recent history or suspicion of current drug abuse or alcohol abuse within the last 6 months.
    boolean
    C0038586 (UMLS CUI [1])
    Zum Seitenanfang zurückkehren 

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