0 Ratings
ID

29642

Description

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Laboratory Examinations: Pregnancy test, Drug screen, alcohol breath test, carbon monoxide test, haematology and clinical chemistry. Time: Treatment Period 1, Day 1, Pre-dose.

Link

https://clinicaltrials.gov/ct2/show/NCT00318630

Keywords

Versions (1)
  1. 4/10/18 4/10/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

April 10, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630

    English

    Laboratory Examination - Treatment Period 1, Day 1, Pre-dose

    1 forms  
    Pregnancy Test
    Description

    Pregnancy Test

    Alias
    UMLS CUI-1
    C0032976
    Pregnancy Test: Date sample taken
    Description

    Complete for Female Subjects Only.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0011008
    Pregnancy Test Results
    Description

    Pregnancy Test Results

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C1274040
    Drug Screen
    Description

    Drug Screen

    Alias
    UMLS CUI-1
    C0373483
    Date and Time of sample taken
    Description

    Day Month Year Hr:Min (00:00 - 23:59)

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0373483
    Cocaine: Mark the appropriate box
    Description

    If positive, exclude subject from the study.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0009170
    UMLS CUI [1,2]
    C1254595
    Benzodiazepines: Mark the appropriate box
    Description

    If positive, exclude subject from the study.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0005064
    UMLS CUI [1,2]
    C2826772
    Cannabis metabolites: Mark the appropriate box
    Description

    If positive, exclude subject from the study.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0936079
    UMLS CUI [1,2]
    C0870883
    UMLS CUI [1,3]
    C2826772
    Opiates: Mark the appropriate box
    Description

    If positive, exclude subject from the study.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0376196
    UMLS CUI [1,2]
    C2826772
    Amphetamine: Mark the appropriate box.
    Description

    If positive, exclude subject from the study.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0002667
    UMLS CUI [1,2]
    C2826772
    Barbiturates: Mark the appropriate box.
    Description

    If positive, exclude subject from the study.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0004745
    UMLS CUI [1,2]
    C2826772
    Methadone: Mark the appropriate box.
    Description

    If positive, exclude subject from the study.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0025605
    UMLS CUI [1,2]
    C2826772
    Alcohol breath test
    Description

    Alcohol breath test

    Alias
    UMLS CUI-1
    C0202306
    Date sample taken
    Description

    Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C0202306
    Results of Alcohol test, Mark one:
    Description

    If positive, exclude subject from the study.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0202306
    UMLS CUI [1,2]
    C1274040
    Carbon Monoxide test
    Description

    Carbon Monoxide test

    Alias
    UMLS CUI-1
    C0007018
    Carbon monoxide test, Date sample taken.
    Description

    Carbon monoxide test date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0007018
    UMLS CUI [1,2]
    C1302413
    Carbon monoxide results: Mark one.
    Description

    If positive, exclude subject from the study.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0007018
    UMLS CUI [1,2]
    C1254595
    Haematology
    Description

    Haematology

    Alias
    UMLS CUI-1
    C0018941
    Haematology: Date and time sample taken
    Description

    Day Month Year Hr : Min (00:00 - 23:59)

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Has the subject fasted?
    Description

    Fasting

    Data type

    text

    Alias
    UMLS CUI [1]
    C0015663
    White blood cell count (WBC) (absolute)
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0023508
    Red blood cell count (RBC) (absolute)
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0014772
    Haemoglobin (Hb)
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0518015
    Haematocrit (HCT)
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0018935
    Mean cell volume (MCV)
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C1948043
    Mean cell haemoglobin (MCH)
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0369183
    Mean cell haemoglobin concentration (MCHC)
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0474535
    Platelet count (absolute)
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0005821
    Reticulocytes (absolute)
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0206161
    Neutrophil count (absolute)
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0948762
    Lymphocyte count
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0200635
    Monocyte count (absolute)
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0750880
    Eosinophil count (absolute)
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0200638
    Basophil count (absolute)
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C1883362
    Clinical Chemistry
    Description

    Clinical Chemistry

    Alias
    UMLS CUI-1
    C0008000
    Date and time sample taken
    Description

    Date and time sample taken

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0200345
    Has the subject fasted?
    Description

    Fasting

    Data type

    text

    Alias
    UMLS CUI [1]
    C0015663
    Alkaline phasphatase
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0201850
    Alanine transaminase
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0201836
    Aspartate transaminase
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0004002
    Gamma-glutamyl transpeptidase
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0202035
    Lactate dehydrogenase
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0202113
    Urea
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0523961
    Sodium
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0337443
    Triglycerides
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0202236
    Albumin
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0201838
    Total protein
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0555903
    Total Bilirubin
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0201913
    Creatinine
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0201975
    Potassium
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0202194
    Glucose
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0337438
    Cholesterol
    Description

    Enter ’NR’ (the abbreviation for ’No result’) if the laboratory results are not available to report or if a lab error occurred.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0201950
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    Similar models

    Laboratory Examination - Treatment Period 1, Day 1, Pre-dose

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Pregnancy Test
    C0032976 (UMLS CUI-1)
    Pregnancy test Date
    Item
    Pregnancy Test: Date sample taken
    date
    C0032976 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Pregnancy Test Results
    text
    C0032976 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Pregnancy Test Results
    Code List
    Pregnancy Test Results
    CL Item
    Positive (Positive)
    CL Item
    Negative (Negative)
    Item Group
    Drug Screen
    C0373483 (UMLS CUI-1)
    Drug Screen Date and Time
    Item
    Date and Time of sample taken
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0373483 (UMLS CUI [1,3])
    Item
    Cocaine: Mark the appropriate box
    text
    C0009170 (UMLS CUI [1,1])
    C1254595 (UMLS CUI [1,2])
    Results of Cocaine Testing
    Code List
    Cocaine: Mark the appropriate box
    CL Item
    positive (positive)
    CL Item
    negative (negative)
    Item
    Benzodiazepines: Mark the appropriate box
    text
    C0005064 (UMLS CUI [1,1])
    C2826772 (UMLS CUI [1,2])
    Results of Cocaine Testing
    Code List
    Benzodiazepines: Mark the appropriate box
    CL Item
    positive (positive)
    CL Item
    negative (negative)
    Item
    Cannabis metabolites: Mark the appropriate box
    text
    C0936079 (UMLS CUI [1,1])
    C0870883 (UMLS CUI [1,2])
    C2826772 (UMLS CUI [1,3])
    Results of Cocaine Testing
    Code List
    Cannabis metabolites: Mark the appropriate box
    CL Item
    positive (positive)
    CL Item
    negative (negative)
    Item
    Opiates: Mark the appropriate box
    text
    C0376196 (UMLS CUI [1,1])
    C2826772 (UMLS CUI [1,2])
    Results of Cocaine Testing
    Code List
    Opiates: Mark the appropriate box
    CL Item
    positive (positive)
    CL Item
    negative (negative)
    Item
    Amphetamine: Mark the appropriate box.
    text
    C0002667 (UMLS CUI [1,1])
    C2826772 (UMLS CUI [1,2])
    Results of Amphetamine Testing
    Code List
    Amphetamine: Mark the appropriate box.
    CL Item
    positive (positive)
    CL Item
    negative (negative)
    Item
    Barbiturates: Mark the appropriate box.
    text
    C0004745 (UMLS CUI [1,1])
    C2826772 (UMLS CUI [1,2])
    Results of Amphetamine Testing
    Code List
    Barbiturates: Mark the appropriate box.
    CL Item
    positive (positive)
    CL Item
    negative (negative)
    Item
    Methadone: Mark the appropriate box.
    text
    C0025605 (UMLS CUI [1,1])
    C2826772 (UMLS CUI [1,2])
    Results of Amphetamine Testing
    Code List
    Methadone: Mark the appropriate box.
    CL Item
    positive (positive)
    CL Item
    negative (negative)
    Item Group
    Alcohol breath test
    C0202306 (UMLS CUI-1)
    Date sample taken
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1,1])
    C0202306 (UMLS CUI [1,2])
    Item
    Results of Alcohol test, Mark one:
    text
    C0202306 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Results of Alcohol test
    Code List
    Results of Alcohol test, Mark one:
    CL Item
    positive (positive)
    CL Item
    negative (negative)
    Item Group
    Carbon Monoxide test
    C0007018 (UMLS CUI-1)
    Carbon monoxide test date
    Item
    Carbon monoxide test, Date sample taken.
    date
    C0007018 (UMLS CUI [1,1])
    C1302413 (UMLS CUI [1,2])
    Item
    Carbon monoxide results: Mark one.
    text
    C0007018 (UMLS CUI [1,1])
    C1254595 (UMLS CUI [1,2])
    Carbon monoxide results
    Code List
    Carbon monoxide results: Mark one.
    CL Item
    positive (positive)
    CL Item
    negative (negative)
    Item Group
    Haematology
    C0018941 (UMLS CUI-1)
    Haematology sampling date and time
    Item
    Haematology: Date and time sample taken
    datetime
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item
    Has the subject fasted?
    text
    C0015663 (UMLS CUI [1])
    Fasting
    Code List
    Has the subject fasted?
    CL Item
    yes (y)
    CL Item
    no (n)
    White blood cell count
    Item
    White blood cell count (WBC) (absolute)
    text
    C0023508 (UMLS CUI [1])
    Red blood cell count
    Item
    Red blood cell count (RBC) (absolute)
    text
    C0014772 (UMLS CUI [1])
    Haemoglobin
    Item
    Haemoglobin (Hb)
    text
    C0518015 (UMLS CUI [1])
    Haematocrit
    Item
    Haematocrit (HCT)
    text
    C0018935 (UMLS CUI [1])
    Mean cell volume
    Item
    Mean cell volume (MCV)
    text
    C1948043 (UMLS CUI [1])
    Mean cell haemoglobin
    Item
    Mean cell haemoglobin (MCH)
    text
    C0369183 (UMLS CUI [1])
    Mean cell haemoglobin concentration
    Item
    Mean cell haemoglobin concentration (MCHC)
    text
    C0474535 (UMLS CUI [1])
    Platelet count
    Item
    Platelet count (absolute)
    text
    C0005821 (UMLS CUI [1])
    Reticulocytes
    Item
    Reticulocytes (absolute)
    text
    C0206161 (UMLS CUI [1])
    Neutrophil count
    Item
    Neutrophil count (absolute)
    text
    C0948762 (UMLS CUI [1])
    Lymphocyte count
    Item
    Lymphocyte count
    text
    C0200635 (UMLS CUI [1])
    Monocyte count
    Item
    Monocyte count (absolute)
    text
    C0750880 (UMLS CUI [1])
    Eosinophil count
    Item
    Eosinophil count (absolute)
    text
    C0200638 (UMLS CUI [1])
    Basophil count
    Item
    Basophil count (absolute)
    text
    C1883362 (UMLS CUI [1])
    Item Group
    Clinical Chemistry
    C0008000 (UMLS CUI-1)
    Date and time sample taken
    Item
    Date and time sample taken
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0200345 (UMLS CUI [1,3])
    Item
    Has the subject fasted?
    text
    C0015663 (UMLS CUI [1])
    Fasting
    Code List
    Has the subject fasted?
    CL Item
    yes (y)
    CL Item
    no (n)
    Alkaline phosphatase
    Item
    Alkaline phasphatase
    text
    C0201850 (UMLS CUI [1])
    Alanine transaminase
    Item
    Alanine transaminase
    text
    C0201836 (UMLS CUI [1])
    Aspartate transaminase
    Item
    Aspartate transaminase
    text
    C0004002 (UMLS CUI [1])
    Gamma-glutamyl transpeptidase
    Item
    Gamma-glutamyl transpeptidase
    text
    C0202035 (UMLS CUI [1])
    Lactate dehydrogenase
    Item
    Lactate dehydrogenase
    text
    C0202113 (UMLS CUI [1])
    Urea
    Item
    Urea
    text
    C0523961 (UMLS CUI [1])
    Sodium
    Item
    Sodium
    text
    C0337443 (UMLS CUI [1])
    Triglycerides
    Item
    Triglycerides
    text
    C0202236 (UMLS CUI [1])
    Albumin
    Item
    Albumin
    text
    C0201838 (UMLS CUI [1])
    Total protein
    Item
    Total protein
    text
    C0555903 (UMLS CUI [1])
    Total Bilirubin
    Item
    Total Bilirubin
    text
    C0201913 (UMLS CUI [1])
    Creatinine
    Item
    Creatinine
    text
    C0201975 (UMLS CUI [1])
    Potassium
    Item
    Potassium
    text
    C0202194 (UMLS CUI [1])
    Glucose
    Item
    Glucose
    text
    C0337438 (UMLS CUI [1])
    Cholesterol
    Item
    Cholesterol
    text
    C0201950 (UMLS CUI [1])
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