0 Ratings
ID

38534

Description

Study ID: 109035 Clinical Study ID: 109035 Study Title: A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00896363 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK163090 1 mg, GSK163090 Placebo, GSK163090 3 mg Trade Name: Study Indication: Depressive Disorder

Keywords

Versions (3)
  1. 10/24/19 10/24/19 -
  2. 10/24/19 10/24/19 -
  3. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 24, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363

    English

    Subject Migraine Diary - Treatment Period T3

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Study Contact’s Name
    Description

    Contact person

    Data type

    text

    Alias
    UMLS CUI [1]
    C0337611
    Clinic Telephone Number
    Description

    Clinic, Telephone Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442592
    UMLS CUI [1,2]
    C1515258
    Today’s Clinic Visit Date
    Description

    Clinic, Date of visit

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0442592
    UMLS CUI [1,2]
    C1320303
    Next Scheduled Clinic Visit Date
    Description

    Date next clinic visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C2735342
    Subject Identifier
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Study Drug and Migraine Diary
    Description

    Study Drug and Migraine Diary

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C0149931
    UMLS CUI-3
    C3890583
    Date your migraine headache pain started
    Description

    Migraine Disorder, Pain, Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0030193
    UMLS CUI [1,3]
    C0808070
    Time your migraine headache pain started
    Description

    Migraine Disorder, Pain, Start time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0030193
    UMLS CUI [1,3]
    C1301880
    Time your migraine headache pain started
    Description

    Migraine Disorder, Pain, Start time

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0030193
    UMLS CUI [1,3]
    C1301880
    Date you took the study drug
    Description

    Experimental drug, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0011008
    Time you took the study drug
    Description

    Experimental drug, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0040223
    Time you took the study drug
    Description

    Experimental drug, Time

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0040223
    Date your migraine headache pain stopped
    Description

    Migraine Disorder, Pain, End Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0030193
    UMLS CUI [1,3]
    C0806020
    Time your migraine headache pain stopped
    Description

    Migraine Disorder, Pain, End time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0030193
    UMLS CUI [1,3]
    C1522314
    Time your migraine headache pain stopped
    Description

    Migraine Disorder, Pain, End time

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0149931
    UMLS CUI [1,2]
    C0030193
    UMLS CUI [1,3]
    C1522314
    Medications Taken Diary
    Description

    Medications Taken Diary

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C3890583
    Drug Name
    Description

    Pharmaceutical Preparations, Subject Diary, Medication name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C3890583
    UMLS CUI [1,3]
    C2360065
    Date Taken
    Description

    Pharmaceutical Preparations, Subject Diary, Date in time, Taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C3890583
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C1883727
    Time Taken
    Description

    Pharmaceutical Preparations, Subject Diary, Time, Taken

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C3890583
    UMLS CUI [1,3]
    C0040223
    UMLS CUI [1,4]
    C1883727
    Time Taken
    Description

    Pharmaceutical Preparations, Subject Diary, Time, Taken

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C3890583
    UMLS CUI [1,3]
    C0040223
    UMLS CUI [1,4]
    C1883727
    Blood Pressure / Exercise / Migraine Headache Pain Information
    Description

    Blood Pressure / Exercise / Migraine Headache Pain Information

    Alias
    UMLS CUI-1
    C0005823
    UMLS CUI-2
    C0015259
    UMLS CUI-3
    C014993
    UMLS CUI-4
    C1533716
    Date Blood Pressure Measurements Taken
    Description

    Blood pressure measurement, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3826646
    UMLS CUI [1,2]
    C0011008
    Time Blood Pressure Measurements Taken
    Description

    Blood pressure measurement, Time

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3826646
    UMLS CUI [1,2]
    C0040223
    Did you exercise in the 30 minutes before your blood pressure measurements were taken?
    Description

    Blood pressure measurement, Exercise, Before

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3826646
    UMLS CUI [1,2]
    C0015259
    UMLS CUI [1,3]
    C0332152
    Indicate the intensity of any migraine headache pain you had at the time you took your blood pressure measurements.
    Description

    Blood pressure measurement, Migraine Disorders, Symptom intensity

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3826646
    UMLS CUI [1,2]
    C0149931
    UMLS CUI [1,3]
    C0518690
    Alcohol Use Diary
    Description

    Alcohol Use Diary

    Alias
    UMLS CUI-1
    C0001948
    UMLS CUI-2
    C3890583
    Did you consume alcohol in the 24 hours before (day before) or on the day you took your blood pressure measurements at home?
    Description

    Alcohol consumption, Before, Blood pressure measurement

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C3826646
    Number of Units
    Description

    Alcohol consumption, Units, Numbers

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0439148
    UMLS CUI [1,3]
    C0237753
    Date Consumed
    Description

    Alcohol consumption, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0011008
    Time Consumed
    Description

    Alcohol consumption, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0040223
    Time Consumed
    Description

    Alcohol consumption, Time

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0040223
    Caffeine Use Diary
    Description

    Caffeine Use Diary

    Alias
    UMLS CUI-1
    C2006086
    UMLS CUI-2
    C3890583
    Did you consume caffeine in the 24 hours before (day before) or on the day you took your blood pressure measurements at home?
    Description

    Caffeine Use, Before, Blood pressure measurement

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2006086
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C3826646
    Number of Units
    Description

    Caffeine Use, Units, Numbers

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2006086
    UMLS CUI [1,2]
    C0439148
    UMLS CUI [1,3]
    C0237753
    Date Consumed
    Description

    Caffeine Use, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2006086
    UMLS CUI [1,2]
    C0011008
    Time Consumed
    Description

    Caffeine Use, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C2006086
    UMLS CUI [1,2]
    C0040223
    Time Consumed
    Description

    Caffeine Use, Time

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2006086
    UMLS CUI [1,2]
    C0040223
    Smoking/Tobacco Use Diary
    Description

    Smoking/Tobacco Use Diary

    Alias
    UMLS CUI-1
    C0543414
    UMLS CUI-2
    C3890583
    Did you smoke and/or use tobacco in the 24 hours before (day before) or on the day you took your blood pressure measurements at home?
    Description

    Tobacco Use, Before, Blood pressure measurement

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C3826646
    Number of Units
    Description

    Tobacco Use, Units, Numbers

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C0439148
    UMLS CUI [1,3]
    C0237753
    Date Consumed
    Description

    Tobacco Use, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C0011008
    Time Consumed
    Description

    Tobacco Use, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C0040223
    Time Consumed
    Description

    Tobacco Use, Time

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C0040223
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    Similar models

    Subject Migraine Diary - Treatment Period T3

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Contact person
    Item
    Study Contact’s Name
    text
    C0337611 (UMLS CUI [1])
    Clinic, Telephone Number
    Item
    Clinic Telephone Number
    integer
    C0442592 (UMLS CUI [1,1])
    C1515258 (UMLS CUI [1,2])
    Clinic, Date of visit
    Item
    Today’s Clinic Visit Date
    date
    C0442592 (UMLS CUI [1,1])
    C1320303 (UMLS CUI [1,2])
    Date next clinic visit
    Item
    Next Scheduled Clinic Visit Date
    date
    C2735342 (UMLS CUI [1])
    Clinical Trial Subject Unique Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Study Drug and Migraine Diary
    C0304229 (UMLS CUI-1)
    C0149931 (UMLS CUI-2)
    C3890583 (UMLS CUI-3)
    Migraine Disorder, Pain, Start Date
    Item
    Date your migraine headache pain started
    date
    C0149931 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    Migraine Disorder, Pain, Start time
    Item
    Time your migraine headache pain started
    time
    C0149931 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    C1301880 (UMLS CUI [1,3])
    Item
    Time your migraine headache pain started
    text
    C0149931 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    C1301880 (UMLS CUI [1,3])
    Migraine Disorder, Pain, Start time
    Code List
    Time your migraine headache pain started
    CL Item
    AM (1)
    CL Item
    PM (2)
    Experimental drug, Date in time
    Item
    Date you took the study drug
    date
    C0304229 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Experimental drug, Time
    Item
    Time you took the study drug
    time
    C0304229 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Time you took the study drug
    text
    C0304229 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Experimental drug, Time
    Code List
    Time you took the study drug
    CL Item
    AM (1)
    CL Item
    PM (2)
    Migraine Disorder, Pain, End Date
    Item
    Date your migraine headache pain stopped
    date
    C0149931 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [1,3])
    Migraine Disorder, Pain, End time
    Item
    Time your migraine headache pain stopped
    time
    C0149931 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    C1522314 (UMLS CUI [1,3])
    Item
    Time your migraine headache pain stopped
    text
    C0149931 (UMLS CUI [1,1])
    C0030193 (UMLS CUI [1,2])
    C1522314 (UMLS CUI [1,3])
    Migraine Disorder, Pain, End time
    Code List
    Time your migraine headache pain stopped
    CL Item
    AM (1)
    CL Item
    PM (2)
    Item Group
    Medications Taken Diary
    C0013227 (UMLS CUI-1)
    C3890583 (UMLS CUI-2)
    Pharmaceutical Preparations, Subject Diary, Medication name
    Item
    Drug Name
    text
    C0013227 (UMLS CUI [1,1])
    C3890583 (UMLS CUI [1,2])
    C2360065 (UMLS CUI [1,3])
    Pharmaceutical Preparations, Subject Diary, Date in time, Taken
    Item
    Date Taken
    date
    C0013227 (UMLS CUI [1,1])
    C3890583 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C1883727 (UMLS CUI [1,4])
    Pharmaceutical Preparations, Subject Diary, Time, Taken
    Item
    Time Taken
    time
    C0013227 (UMLS CUI [1,1])
    C3890583 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    C1883727 (UMLS CUI [1,4])
    Item
    Time Taken
    text
    C0013227 (UMLS CUI [1,1])
    C3890583 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    C1883727 (UMLS CUI [1,4])
    Pharmaceutical Preparations, Subject Diary, Time, Taken
    Code List
    Time Taken
    CL Item
    AM (1)
    CL Item
    PM (2)
    Item Group
    Blood Pressure / Exercise / Migraine Headache Pain Information
    C0005823 (UMLS CUI-1)
    C0015259 (UMLS CUI-2)
    C014993 (UMLS CUI-3)
    C1533716 (UMLS CUI-4)
    Blood pressure measurement, Date in time
    Item
    Date Blood Pressure Measurements Taken
    date
    C3826646 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Time Blood Pressure Measurements Taken
    text
    C3826646 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Blood pressure measurement, Time
    Code List
    Time Blood Pressure Measurements Taken
    CL Item
    AM (1)
    CL Item
    PM (2)
    Blood pressure measurement, Exercise, Before
    Item
    Did you exercise in the 30 minutes before your blood pressure measurements were taken?
    boolean
    C3826646 (UMLS CUI [1,1])
    C0015259 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    Item
    Indicate the intensity of any migraine headache pain you had at the time you took your blood pressure measurements.
    text
    C3826646 (UMLS CUI [1,1])
    C0149931 (UMLS CUI [1,2])
    C0518690 (UMLS CUI [1,3])
    Blood pressure measurement, Migraine Disorders, Symptom intensity
    Code List
    Indicate the intensity of any migraine headache pain you had at the time you took your blood pressure measurements.
    CL Item
    None  (1)
    CL Item
    Mild  (2)
    CL Item
    Moderate  (3)
    CL Item
    Severe (4)
    Item Group
    Alcohol Use Diary
    C0001948 (UMLS CUI-1)
    C3890583 (UMLS CUI-2)
    Alcohol consumption, Before, Blood pressure measurement
    Item
    Did you consume alcohol in the 24 hours before (day before) or on the day you took your blood pressure measurements at home?
    boolean
    C0001948 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C3826646 (UMLS CUI [1,3])
    Alcohol consumption, Units, Numbers
    Item
    Number of Units
    integer
    C0001948 (UMLS CUI [1,1])
    C0439148 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    Alcohol consumption, Date in time
    Item
    Date Consumed
    date
    C0001948 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Alcohol consumption, Time
    Item
    Time Consumed
    time
    C0001948 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Time Consumed
    text
    C0001948 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Alcohol consumption, Time
    Code List
    Time Consumed
    CL Item
    AM (1)
    CL Item
    PM (2)
    Item Group
    Caffeine Use Diary
    C2006086 (UMLS CUI-1)
    C3890583 (UMLS CUI-2)
    Caffeine Use, Before, Blood pressure measurement
    Item
    Did you consume caffeine in the 24 hours before (day before) or on the day you took your blood pressure measurements at home?
    text
    C2006086 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C3826646 (UMLS CUI [1,3])
    Caffeine Use, Units, Numbers
    Item
    Number of Units
    integer
    C2006086 (UMLS CUI [1,1])
    C0439148 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    Caffeine Use, Date in time
    Item
    Date Consumed
    date
    C2006086 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Caffeine Use, Time
    Item
    Time Consumed
    time
    C2006086 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Time Consumed
    text
    C2006086 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Alcohol consumption, Time
    Code List
    Time Consumed
    CL Item
    AM (1)
    CL Item
    PM (2)
    Item Group
    Smoking/Tobacco Use Diary
    C0543414 (UMLS CUI-1)
    C3890583 (UMLS CUI-2)
    Tobacco Use, Before, Blood pressure measurement
    Item
    Did you smoke and/or use tobacco in the 24 hours before (day before) or on the day you took your blood pressure measurements at home?
    text
    C0543414 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C3826646 (UMLS CUI [1,3])
    Tobacco Use, Units, Numbers
    Item
    Number of Units
    integer
    C0543414 (UMLS CUI [1,1])
    C0439148 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    Tobacco Use, Date in time
    Item
    Date Consumed
    date
    C0543414 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Tobacco Use, Time
    Item
    Time Consumed
    time
    C0543414 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Time Consumed
    text
    C0543414 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Alcohol consumption, Time
    Code List
    Time Consumed
    CL Item
    AM (1)
    CL Item
    PM (2)
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