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34976

Description

Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. 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 furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains the Local Laboratory -haematology, clinical chemistry and urinalysis form. It has to be filled in for screening, for TP1-4 Day-1, TP1-4 24 h, and follow-up.

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Versions (2)
  1. 2/4/19 2/4/19 -
  2. 2/6/19 2/6/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

February 6, 2019

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Creative Commons BY-NC 3.0
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    Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888

    English

    Local Laboratory -haematology, clinical chemistry, urinalysis

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject identifier
    Description

    Subject identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit type
    Description

    Visit type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Treatment period Day type
    Description

    Only applicable for treatment periods.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2827038
    UMLS CUI [1,2]
    C0332307
    Local Laboratory - haematology
    Description

    Local Laboratory - haematology

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0474523
    Date of sample taken
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    Time of sample taken
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345
    Haematology test
    Description

    Haematology test

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0018941
    Result of haematology test
    Description

    If the laboratory results meet the protocol definition of an adverse event, record the details in the Non-Serious Adverse Events or Serious Adverse Event section(s).

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C1274040
    Local Laboratory - clinical chemistry
    Description

    Local Laboratory - clinical chemistry

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0008000
    Date of sample taken
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    Time of sample taken
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345
    Clinical Chemistry Test
    Description

    Note: FSH and LH are for females subjects only. FSH and LH are only for screening and unscheduled.

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0525044
    Result of Clinical Chemistry Test
    Description

    If the laboratory results meet the protocol definition of an adverse event, record the details on the Non-Serious Adverse Events page or Serious Adverse Event page.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0525044
    Urine dipstick test
    Description

    Urine dipstick test

    Alias
    UMLS CUI-1
    C0430370
    Date of sample taken
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    Time of sample taken
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345
    Result of dipstick
    Description

    Result of dipstick

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0430370
    UMLS CUI [1,2]
    C0456984
    Urinalysis - local
    Description

    Urinalysis - local

    Alias
    UMLS CUI-1
    C0042014
    Date of sample taken
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    Time of sample taken
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345
    Urinalysis Test
    Description

    Urinalysis Test

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0042014
    Result of Urinalysis test
    Description

    If the laboratory results are not available to report or if a lab error occurred, enter "NR" (the abbreviation for ’No Result’). If the laboratory test(s) need to be repeated, record results in the unscheduled form.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C1274040
    Was sedimentary microscopy performed?
    Description

    Note: Sedimentary microscopy should only be performed if any of the dipstick results are abnormal.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1518965
    UMLS CUI [1,2]
    C2700128
    Urinalysis (Microscopy) Test
    Description

    Urinalysis (Microscopy) Test

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0430397
    Result of Urinalysis (Microscopy) Test
    Description

    Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) section(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1274040
    UMLS CUI [1,2]
    C0430397
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    Similar models

    Local Laboratory -haematology, clinical chemistry, urinalysis

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject identifier
    Item
    Subject identifier
    text
    C2348585 (UMLS CUI [1])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Visit type
    Code List
    Visit type
    CL Item
    Screening (1)
    CL Item
    TP1 (2)
    CL Item
    TP2 (3)
    CL Item
    TP3 (4)
    CL Item
    TP4 (5)
    CL Item
    Follow-up (6)
    CL Item
    Unscheduled (7)
    Item
    Treatment period Day type
    integer
    C2827038 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Treatment period Day type
    Code List
    Treatment period Day type
    CL Item
    Day-1 (1)
    CL Item
    24h (2)
    Item Group
    Local Laboratory - haematology
    C0022885 (UMLS CUI-1)
    C0474523 (UMLS CUI-2)
    Date of sample taken
    Item
    Date of sample taken
    date
    C1302413 (UMLS CUI [1])
    Time of sample taken
    Item
    Time of sample taken
    time
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    Item
    Haematology test
    integer
    C0018941 (UMLS CUI [1])
    Haematology test
    Code List
    Haematology test
    CL Item
    Haemoglobin (1)
    CL Item
    RBC (2)
    CL Item
    MCV (3)
    CL Item
    MCH (4)
    CL Item
    MCHC (5)
    CL Item
    Haematocrit (6)
    CL Item
    Platelets (7)
    CL Item
    While Blood Cells (8)
    CL Item
    Neutrophils (9)
    CL Item
    Lymphocytes (10)
    CL Item
    Monocytes (11)
    CL Item
    Eosinophils (12)
    CL Item
    Basophils (13)
    Result of haematology test
    Item
    Result of haematology test
    text
    C0474523 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Item Group
    Local Laboratory - clinical chemistry
    C0022885 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    Date of sample taken
    Item
    Date of sample taken
    date
    C1302413 (UMLS CUI [1])
    Time of sample taken
    Item
    Time of sample taken
    time
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    Item
    Clinical Chemistry Test
    integer
    C0525044 (UMLS CUI [1])
    Clinical Chemistry Test
    Code List
    Clinical Chemistry Test
    CL Item
    Sodium (1)
    CL Item
    Potassium (2)
    CL Item
    Phosphate (3)
    CL Item
    Calcium (4)
    CL Item
    Chloride (5)
    CL Item
    Bicarbonate (6)
    CL Item
    Aspartate Transferase (AST) (7)
    CL Item
    Alanine Transferase (ALT) (8)
    CL Item
    Gamma GT (9)
    CL Item
    Alkaline Phosphatase (10)
    CL Item
    Total Protein (11)
    CL Item
    Globulin (12)
    CL Item
    Albumin (13)
    CL Item
    Total Bilirubin (14)
    CL Item
    Creatinine (15)
    CL Item
    Urea (16)
    CL Item
    Uric Acid (17)
    CL Item
    FSH (18)
    CL Item
    LH (19)
    CL Item
    Glucose (20)
    Result of Clinical Chemistry Test
    Item
    Result of Clinical Chemistry Test
    text
    C1274040 (UMLS CUI [1,1])
    C0525044 (UMLS CUI [1,2])
    Item Group
    Urine dipstick test
    C0430370 (UMLS CUI-1)
    Date of sample taken
    Item
    Date of sample taken
    date
    C1302413 (UMLS CUI [1])
    Time of sample taken
    Item
    Time of sample taken
    time
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    Item
    Result of dipstick
    text
    C0430370 (UMLS CUI [1,1])
    C0456984 (UMLS CUI [1,2])
    Result of dipstick
    Code List
    Result of dipstick
    CL Item
    Negative (NEG)
    CL Item
    Positive (POS)
    CL Item
    No result (NR)
    Item Group
    Urinalysis - local
    C0042014 (UMLS CUI-1)
    Date of sample taken
    Item
    Date of sample taken
    date
    C1302413 (UMLS CUI [1])
    Time of sample taken
    Item
    Time of sample taken
    time
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    Item
    Urinalysis Test
    integer
    C0042014 (UMLS CUI [1])
    Urinalysis Test
    Code List
    Urinalysis Test
    CL Item
    Protein (1)
    CL Item
    Blood (2)
    CL Item
    Ketones (3)
    CL Item
    Glucose (4)
    CL Item
    Bilirubin (5)
    Item
    Result of Urinalysis test
    text
    C0042014 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Result of Urinalysis test
    Code List
    Result of Urinalysis test
    CL Item
    none or negative (NEG)
    CL Item
    tracer (TRA)
    CL Item
    + or 1+ (1+)
    CL Item
    ++ or 2+ (2+)
    CL Item
    +++ or 3+ (3+)
    CL Item
    ++++ or 4+ (4+)
    CL Item
    +++++ or 5+ (5+)
    CL Item
    No result (NR)
    Item
    Was sedimentary microscopy performed?
    text
    C1518965 (UMLS CUI [1,1])
    C2700128 (UMLS CUI [1,2])
    Performance of sedimentary microscopy
    Code List
    Was sedimentary microscopy performed?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Urinalysis (Microscopy) Test
    integer
    C0430397 (UMLS CUI [1])
    Urinalysis (Microscopy) Test
    Code List
    Urinalysis (Microscopy) Test
    CL Item
    White Blood Cells (1)
    CL Item
    Red Blood Cells (2)
    CL Item
    Hyaline casts (3)
    CL Item
    Granular casts (4)
    CL Item
    Cellular casts (5)
    Result of Urinalysis (Microscopy) Test
    Item
    Result of Urinalysis (Microscopy) Test
    text
    C1274040 (UMLS CUI [1,1])
    C0430397 (UMLS CUI [1,2])
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