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32722

Beschreibung

Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. This document contains the forms: Hematology Data, Clinical Chemistry Data and Urinalysis. It has to filled in for screening, sessions 2, 3, 4, 5, 6 and 7. It also has to be filled in for Session 1.1. It also contains the worksheet for Serology Screen. It has to be filled in for screening (session 1)

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GlaxoSmithKline

Hochgeladen am

13. November 2018

DOI

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    Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877

    Englisch

    Hematology Data, Clinical Chemistry Data, Urinalysis,, Serology Screen

    1 Formulare  
    Administrative data
    Beschreibung

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Beschreibung

    Subject number

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Session Number
    Beschreibung

    Session Number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1883017
    UMLS CUI [1,2]
    C0750480
    Hematology Data
    Beschreibung

    Hematology Data

    Alias
    UMLS CUI-1
    C0474523
    Lab code
    Beschreibung

    (For GSK use only)

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0805701
    Date hematology sample taken
    Beschreibung

    Date hematology sample

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Time of sample
    Beschreibung

    00:00-23:59

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345
    Were there any clinically significant hematology abnormalities?
    Beschreibung

    If YES, record primary reason for the clinically significant abnormality in "Primary reason for clinically significant abnormality".

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0850715
    UMLS CUI [1,2]
    C2985739
    Hematology
    Beschreibung

    Hematology

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0474523
    Results of hematoloy finding
    Beschreibung

    Results of hematoloy finding

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0474523
    Primary reason for clinically significant abnormality
    Beschreibung

    Primary reason for clinically significant abnormality

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C2985739
    UMLS CUI [1,3]
    C0566251
    if other reason for abnormality, specify
    Beschreibung

    Other reason for abnormality

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C2985739
    UMLS CUI [1,3]
    C3840932
    Clinical Chemistry Data
    Beschreibung

    Clinical Chemistry Data

    Alias
    UMLS CUI-1
    C0008000
    Lab code
    Beschreibung

    (For GSK use only)

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0805701
    Date clinical chemistry sample taken
    Beschreibung

    Date clinical chemistry sample

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C0008000
    Time of sample
    Beschreibung

    00:00-23:59

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345
    Were there any clinically significant clinical chemistry abnormalities?
    Beschreibung

    If YES, record primary reason for the clinically significant abnormality in "Primary reason for clinically significant abnormality".

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C2985739
    Clinical chemistry
    Beschreibung

    Clinical chemistry

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0008000
    Results of Clinical chemistry
    Beschreibung

    Results of Clinical chemistry

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0008000
    Primary reason for clinically significant abnormality
    Beschreibung

    Primary reason for clinically significant abnormality

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C2985739
    UMLS CUI [1,3]
    C0566251
    if other reason for abnormality, specify
    Beschreibung

    Other reason for abnormality

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C2985739
    UMLS CUI [1,3]
    C3840932
    Urinalysis
    Beschreibung

    Urinalysis

    Alias
    UMLS CUI-1
    C0042014
    Lab code
    Beschreibung

    (For GSK use only)

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0805701
    Date Urinalysis sample taken
    Beschreibung

    Date Urinalysis sample

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C0042014
    Time of sample
    Beschreibung

    00:00-23:59

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345
    Were there any clinically significant urinalysis abnormalities?
    Beschreibung

    If YES, record primary reason for the clinically significant abnormality in "Primary reason for clinically significant abnormality".

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C2985739
    Urinalysis: Dip Stick
    Beschreibung

    Urinalysis: Dip Stick

    Alias
    UMLS CUI-1
    C0042014
    UMLS CUI-2
    C1160927
    Dip-sticks
    Beschreibung

    Dip-sticks

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1160927
    Results of Dip-sticks
    Beschreibung

    Enter numeric code in result column

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C1160927
    Primary reason for clinically significant abnormality
    Beschreibung

    Primary reason for clinically significant abnormality

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C2985739
    UMLS CUI [1,3]
    C0566251
    if other reason for abnormality, specify
    Beschreibung

    Other reason for abnormality

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C2985739
    UMLS CUI [1,3]
    C3840932
    Urinalysis: Sedimentary Microcopy
    Beschreibung

    Urinalysis: Sedimentary Microcopy

    Alias
    UMLS CUI-1
    C0042014
    UMLS CUI-2
    C2700128
    Sedimentary microscopy
    Beschreibung

    Sedimentary microscopy

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2700128
    Results of Sedimentary microscopy
    Beschreibung

    Results of Sedimentary microscopy

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C2700128
    Primary reason for clinically significant abnormality
    Beschreibung

    Primary reason for clinically significant abnormality

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C2985739
    UMLS CUI [1,3]
    C0566251
    if other reason for abnormality, specify
    Beschreibung

    Other reason for abnormality

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C2985739
    UMLS CUI [1,3]
    C3840932
    Serology Screen
    Beschreibung

    Serology Screen

    Alias
    UMLS CUI-1
    C0036743
    Date sample taken
    Beschreibung

    Date of sample

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Hepatitis B surface antigen
    Beschreibung

    If positive, EXCLUDE subject from the study.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0019168
    Hepatitis C antibody
    Beschreibung

    If positive, EXCLUDE subject from the study.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0201487
    HIV
    Beschreibung

    If positive, EXCLUDE subject from the study.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0019682
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    Ähnliche Modelle

    Hematology Data, Clinical Chemistry Data, Urinalysis,, Serology Screen

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Item
    Session Number
    integer
    C1883017 (UMLS CUI [1,1])
    C0750480 (UMLS CUI [1,2])
    Session Number
    Code List
    Session Number
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    1.1 (1.1)
    Item Group
    Hematology Data
    C0474523 (UMLS CUI-1)
    Lab code
    Item
    Lab code
    text
    C0022885 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Date hematology sample
    Item
    Date hematology sample taken
    date
    C1302413 (UMLS CUI [1])
    Time of sample
    Item
    Time of sample
    time
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    Item
    Were there any clinically significant hematology abnormalities?
    text
    C0850715 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    Clinically significant hematology abnormalities
    Code List
    Were there any clinically significant hematology abnormalities?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Hematology
    integer
    C0474523 (UMLS CUI [1])
    Hematology
    Code List
    Hematology
    CL Item
    Hemoglobin (1)
    CL Item
    Hematocrit (2)
    CL Item
    RBC (3)
    CL Item
    MCV (4)
    CL Item
    MCH (5)
    CL Item
    MCHC (6)
    CL Item
    Platelets (7)
    CL Item
    Total WBC (8)
    CL Item
    Neutrophils (9)
    CL Item
    Lymphocytes (10)
    CL Item
    Monocytes (11)
    CL Item
    Eosinophils (12)
    CL Item
    Basophils (13)
    CL Item
    Reticulocytes (14)
    Results of hematoloy finding
    Item
    Results of hematoloy finding
    text
    C1274040 (UMLS CUI [1,1])
    C0474523 (UMLS CUI [1,2])
    Item
    Primary reason for clinically significant abnormality
    text
    C1704258 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Primary reason for clinically significant abnormality
    Code List
    Primary reason for clinically significant abnormality
    CL Item
    Due to disease under study (D)
    CL Item
    Due to other concurrent disease (C)
    CL Item
    Reasonable possibility due to investigational product (T)
    CL Item
    Reasonable possibility due to other concomitant medication (M)
    CL Item
    Other, specify text in the box (X)
    Other reason for abnormality
    Item
    if other reason for abnormality, specify
    text
    C1704258 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    C3840932 (UMLS CUI [1,3])
    Item Group
    Clinical Chemistry Data
    C0008000 (UMLS CUI-1)
    Lab code
    Item
    Lab code
    text
    C0022885 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Date clinical chemistry sample
    Item
    Date clinical chemistry sample taken
    date
    C1302413 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    Time of sample
    Item
    Time of sample
    time
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    Item
    Were there any clinically significant clinical chemistry abnormalities?
    text
    C0008000 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    Clinically significant hematology abnormalities
    Code List
    Were there any clinically significant clinical chemistry abnormalities?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Clinical chemistry
    integer
    C0008000 (UMLS CUI [1])
    Clinical chemistry
    Code List
    Clinical chemistry
    CL Item
    Sodium (1)
    CL Item
    Potassium (2)
    CL Item
    Glucose (3)
    CL Item
    Total Protein (4)
    CL Item
    Albumin (5)
    CL Item
    Cholesterol (6)
    CL Item
    Triglycerides (7)
    CL Item
    Uric Acid (8)
    CL Item
    Creatinine (9)
    CL Item
    Urea (10)
    CL Item
    Total bilirubin (11)
    CL Item
    Alkaline Phosphatase (12)
    CL Item
    AST (SGOT) (13)
    CL Item
    ALT (SGPT) (14)
    CL Item
    GGT (15)
    CL Item
    Creatine kinase (16)
    Results of Clinical chemistry
    Item
    Results of Clinical chemistry
    text
    C1274040 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    Item
    Primary reason for clinically significant abnormality
    text
    C1704258 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Primary reason for clinically significant abnormality
    Code List
    Primary reason for clinically significant abnormality
    CL Item
    Due to disease under study (D)
    CL Item
    Due to other concurrent disease (C)
    CL Item
    Reasonable possibility due to investigational product (T)
    CL Item
    Reasonable possibility due to other concomitant medication (M)
    CL Item
    Other, specify text in the box (X)
    Other reason for abnormality
    Item
    if other reason for abnormality, specify
    text
    C1704258 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    C3840932 (UMLS CUI [1,3])
    Item Group
    Urinalysis
    C0042014 (UMLS CUI-1)
    Lab code
    Item
    Lab code
    text
    C0022885 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Date Urinalysis sample
    Item
    Date Urinalysis sample taken
    date
    C1302413 (UMLS CUI [1,1])
    C0042014 (UMLS CUI [1,2])
    Time of sample
    Item
    Time of sample
    time
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    Item
    Were there any clinically significant urinalysis abnormalities?
    text
    C0042014 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    Clinically significant hematology abnormalities
    Code List
    Were there any clinically significant urinalysis abnormalities?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    Urinalysis: Dip Stick
    C0042014 (UMLS CUI-1)
    C1160927 (UMLS CUI-2)
    Item
    Dip-sticks
    integer
    C1160927 (UMLS CUI [1])
    Dip-sticks
    Code List
    Dip-sticks
    CL Item
    Protein (1)
    CL Item
    Blood (2)
    CL Item
    Ketones (3)
    CL Item
    Glucose (4)
    CL Item
    Bilirubin (5)
    CL Item
    Leucocytes (6)
    Item
    Results of Dip-sticks
    integer
    C1274040 (UMLS CUI [1,1])
    C1160927 (UMLS CUI [1,2])
    Results of Dip-sticks
    Code List
    Results of Dip-sticks
    CL Item
    none or negative (0)
    CL Item
    trace (0.5)
    CL Item
    + or 1+ (1)
    CL Item
    ++ or 2+ (2)
    CL Item
    +++ or 3+ (3)
    CL Item
    ++++ or 4+ (4)
    Item
    Primary reason for clinically significant abnormality
    text
    C1704258 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Primary reason for clinically significant abnormality
    Code List
    Primary reason for clinically significant abnormality
    CL Item
    Due to disease under study (D)
    CL Item
    Due to other concurrent disease (C)
    CL Item
    Reasonable possibility due to investigational product (T)
    CL Item
    Reasonable possibility due to other concomitant medication (M)
    CL Item
    Other, specify text in the box (X)
    Other reason for abnormality
    Item
    if other reason for abnormality, specify
    text
    C1704258 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    C3840932 (UMLS CUI [1,3])
    Item Group
    Urinalysis: Sedimentary Microcopy
    C0042014 (UMLS CUI-1)
    C2700128 (UMLS CUI-2)
    Item
    Sedimentary microscopy
    integer
    C2700128 (UMLS CUI [1])
    Sedimentary microscopy
    Code List
    Sedimentary microscopy
    CL Item
    WBC (1)
    CL Item
    RBC (2)
    CL Item
    Hyaline casts (3)
    CL Item
    Granular casts (4)
    CL Item
    Cellular casts (5)
    Results of Sedimentary microscopy
    Item
    Results of Sedimentary microscopy
    text
    C1274040 (UMLS CUI [1,1])
    C2700128 (UMLS CUI [1,2])
    Item
    Primary reason for clinically significant abnormality
    text
    C1704258 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Primary reason for clinically significant abnormality
    Code List
    Primary reason for clinically significant abnormality
    CL Item
    Due to disease under study (D)
    CL Item
    Due to other concurrent disease (C)
    CL Item
    Reasonable possibility due to investigational product (T)
    CL Item
    Reasonable possibility due to other concomitant medication (M)
    CL Item
    Other, specify text in the box (X)
    Other reason for abnormality
    Item
    if other reason for abnormality, specify
    text
    C1704258 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    C3840932 (UMLS CUI [1,3])
    Item Group
    Serology Screen
    C0036743 (UMLS CUI-1)
    Date of sample
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1])
    Item
    Hepatitis B surface antigen
    text
    C0019168 (UMLS CUI [1])
    Hepatitis B surface antigen
    Code List
    Hepatitis B surface antigen
    CL Item
    Positive (P)
    CL Item
    Negative (N)
    Item
    Hepatitis C antibody
    text
    C0201487 (UMLS CUI [1])
    Hepatitis B surface antigen
    Code List
    Hepatitis C antibody
    CL Item
    Positive (P)
    CL Item
    Negative (N)
    Item
    HIV
    text
    C0019682 (UMLS CUI [1])
    Hepatitis B surface antigen
    Code List
    HIV
    CL Item
    Positive (P)
    CL Item
    Negative (N)
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