0 Ratings
ID

38109

Description

Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

Keywords

Versions (1)
  1. 9/18/19 9/18/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 18, 2019

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License

Creative Commons BY-NC 3.0
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    Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036

    English

    Vital Signs

    1 forms  
    1. StudyEvent: ODM
      1. Vital Signs
    Dosing Date and Time
    Description

    Dosing Date and Time

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0178602
    UMLS CUI-3
    C0011008
    UMLS CUI-4
    C0040223
    Dosing date/time
    Description

    Vital Signs, Dosage, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Predose
    Description

    Predose

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0439565
    Actual time
    Description

    Vital signs, Pre-dose, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0439565
    UMLS CUI [1,3]
    C0040223
    Blood pressure - systolic
    Description

    Systolic Pressure, Pre-dose

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0439565
    mmHg
    Blood pressure - diastolic
    Description

    Diastolic blood pressure, Pre-dose

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0439565
    mmHg
    Heart rate
    Description

    Heart rate, Pre-dose

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0439565
    bpm
    1 Hour post dose
    Description

    1 Hour post dose

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0439568
    UMLS CUI-3
    C1442450
    Actual time
    Description

    Vital signs, Post-dose, 1 Hour, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1442450
    UMLS CUI [1,4]
    C0040223
    Blood pressure - systolic
    Description

    Systolic Pressure, Post-dose, 1 Hour

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1442450
    mmHg
    Blood pressure - diastolic
    Description

    Diastolic blood pressure, Post-dose, 1 Hour

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1442450
    mmHg
    Heart rate
    Description

    Heart rate, Post-dose, 1 Hour

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1442450
    bpm
    2 Hours post dose
    Description

    2 Hours post dose

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0439572
    Actual time
    Description

    Vital signs, 2 hours post-dose, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0439572
    UMLS CUI [1,3]
    C0040223
    Blood pressure - systolic
    Description

    Systolic Pressure, 2 hours post-dose

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0439572
    mmHg
    Blood pressure - diastolic
    Description

    Diastolic blood pressure, 2 hours post-dose

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0439572
    mmHg
    Heart rate
    Description

    Heart rate, 2 hours post-dose

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0439572
    bpm
    4 Hours post dose
    Description

    4 Hours post dose

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0439574
    Actual time
    Description

    Vital signs, 4 Hours post dose, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0439574
    UMLS CUI [1,3]
    C0040223
    Blood pressure - systolic
    Description

    Systolic Pressure, 4 Hours post dose

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0439574
    mmHg
    Blood pressure - diastolic
    Description

    Diastolic blood pressure, 4 Hours post dose

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0439574
    mmHg
    Heart rate
    Description

    Heart rate, 4 Hours post dose

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0439574
    bpm
    6 Hours post dose
    Description

    6 Hours post dose

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0439568
    UMLS CUI-3
    C1292428
    Actual time
    Description

    Vital signs, Post-dose, 6 Hours, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1292428
    UMLS CUI [1,4]
    C0040223
    Blood pressure - systolic
    Description

    Systolic Pressure, Post-dose, 6 Hours

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1292428
    mmHg
    Blood pressure - diastolic
    Description

    Diastolic blood pressure, Post-dose, 6 Hours

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1292428
    mmHg
    Heart rate
    Description

    Heart rate, Post-dose, 6 Hours

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1292428
    bpm
    8 Hours post dose
    Description

    8 Hours post dose

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0439568
    UMLS CUI-3
    C1292429
    Actual time
    Description

    Vital signs, Post-dose, 8 Hours, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1292429
    UMLS CUI [1,4]
    C0040223
    Blood pressure - systolic
    Description

    Systolic Pressure, Post-dose, 8 Hours

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1292429
    mmHg
    Blood pressure - diastolic
    Description

    Diastolic blood pressure, Post-dose, 8 Hours

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1292429
    mmHg
    Heart rate
    Description

    Heart rate, Post-dose, 8 Hours

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1292429
    bpm
    10 Hours post dose
    Description

    10 Hours post dose

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0439568
    UMLS CUI-3
    C1442445
    Actual time
    Description

    Vital signs, Post-dose, 10 Hours, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1442445
    UMLS CUI [1,4]
    C0040223
    Blood pressure - systolic
    Description

    Systolic Pressure, Post-dose, 10 Hours

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1442445
    mmHg
    Blood pressure - diastolic
    Description

    Diastolic blood pressure, Post-dose, 10 Hours

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1442445
    mmHg
    Heart rate
    Description

    Heart rate, Post-dose, 10 Hours

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1442445
    bpm
    12 Hours post dose
    Description

    12 Hours post dose

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0439568
    UMLS CUI-3
    C1292430
    Actual time
    Description

    Vital signs, Post-dose, 12 Hours, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1292430
    UMLS CUI [1,4]
    C0040223
    Blood pressure - systolic
    Description

    Systolic Pressure, Post-dose, 12 Hours

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1292430
    mmHg
    Blood pressure - diastolic
    Description

    Diastolic blood pressure, Post-dose, 12 Hours

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1292430
    mmHg
    Heart rate
    Description

    Heart rate, Post-dose, 12 Hours

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1292430
    bpm
    24 Hours post dose
    Description

    24 Hours post dose

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0439568
    UMLS CUI-3
    C1442770
    Actual time
    Description

    Vital signs, Post-dose, 24 Hours, Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1442770
    UMLS CUI [1,4]
    C0040223
    Blood pressure - systolic
    Description

    Systolic Pressure, Post-dose, 24 Hours

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1442770
    mmHg
    Blood pressure - diastolic
    Description

    Diastolic blood pressure, Post-dose, 24 Hours

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1442770
    mmHg
    Heart rate
    Description

    Heart rate, Post-dose, 24 Hours

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1442770
    bpm
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    Vital Signs

    1 forms
    1. StudyEvent: ODM
      1. Vital Signs
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Dosing Date and Time
    C0518766 (UMLS CUI-1)
    C0178602 (UMLS CUI-2)
    C0011008 (UMLS CUI-3)
    C0040223 (UMLS CUI-4)
    Vital Signs, Dosage, Date in time, Time
    Item
    Dosing date/time
    datetime
    C0518766 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Item Group
    Predose
    C0518766 (UMLS CUI-1)
    C0439565 (UMLS CUI-2)
    Vital signs, Pre-dose, Time
    Item
    Actual time
    time
    C0518766 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Systolic Pressure, Pre-dose
    Item
    Blood pressure - systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    Diastolic blood pressure, Pre-dose
    Item
    Blood pressure - diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    Heart rate, Pre-dose
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    Item Group
    1 Hour post dose
    C0518766 (UMLS CUI-1)
    C0439568 (UMLS CUI-2)
    C1442450 (UMLS CUI-3)
    Vital signs, Post-dose, 1 Hour, Time
    Item
    Actual time
    time
    C0518766 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1442450 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Systolic Pressure, Post-dose, 1 Hour
    Item
    Blood pressure - systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1442450 (UMLS CUI [1,3])
    Diastolic blood pressure, Post-dose, 1 Hour
    Item
    Blood pressure - diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1442450 (UMLS CUI [1,3])
    Heart rate, Post-dose, 1 Hour
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1442450 (UMLS CUI [1,3])
    Item Group
    2 Hours post dose
    C0518766 (UMLS CUI-1)
    C0439572 (UMLS CUI-2)
    Vital signs, 2 hours post-dose, Time
    Item
    Actual time
    time
    C0518766 (UMLS CUI [1,1])
    C0439572 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Systolic Pressure, 2 hours post-dose
    Item
    Blood pressure - systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0439572 (UMLS CUI [1,2])
    Diastolic blood pressure, 2 hours post-dose
    Item
    Blood pressure - diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0439572 (UMLS CUI [1,2])
    Heart rate, 2 hours post-dose
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0439572 (UMLS CUI [1,2])
    Item Group
    4 Hours post dose
    C0518766 (UMLS CUI-1)
    C0439574 (UMLS CUI-2)
    Vital signs, 4 Hours post dose, Time
    Item
    Actual time
    time
    C0518766 (UMLS CUI [1,1])
    C0439574 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Systolic Pressure, 4 Hours post dose
    Item
    Blood pressure - systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0439574 (UMLS CUI [1,2])
    Diastolic blood pressure, 4 Hours post dose
    Item
    Blood pressure - diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0439574 (UMLS CUI [1,2])
    Heart rate, 4 Hours post dose
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0439574 (UMLS CUI [1,2])
    Item Group
    6 Hours post dose
    C0518766 (UMLS CUI-1)
    C0439568 (UMLS CUI-2)
    C1292428 (UMLS CUI-3)
    Vital signs, Post-dose, 6 Hours, Time
    Item
    Actual time
    time
    C0518766 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1292428 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Systolic Pressure, Post-dose, 6 Hours
    Item
    Blood pressure - systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1292428 (UMLS CUI [1,3])
    Diastolic blood pressure, Post-dose, 6 Hours
    Item
    Blood pressure - diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1292428 (UMLS CUI [1,3])
    Heart rate, Post-dose, 6 Hours
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1292428 (UMLS CUI [1,3])
    Item Group
    8 Hours post dose
    C0518766 (UMLS CUI-1)
    C0439568 (UMLS CUI-2)
    C1292429 (UMLS CUI-3)
    Vital signs, Post-dose, 8 Hours, Time
    Item
    Actual time
    time
    C0518766 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1292429 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Systolic Pressure, Post-dose, 8 Hours
    Item
    Blood pressure - systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1292429 (UMLS CUI [1,3])
    Diastolic blood pressure, Post-dose, 8 Hours
    Item
    Blood pressure - diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1292429 (UMLS CUI [1,3])
    Heart rate, Post-dose, 8 Hours
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1292429 (UMLS CUI [1,3])
    Item Group
    10 Hours post dose
    C0518766 (UMLS CUI-1)
    C0439568 (UMLS CUI-2)
    C1442445 (UMLS CUI-3)
    Vital signs, Post-dose, 10 Hours, Time
    Item
    Actual time
    time
    C0518766 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1442445 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Systolic Pressure, Post-dose, 10 Hours
    Item
    Blood pressure - systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1442445 (UMLS CUI [1,3])
    Diastolic blood pressure, Post-dose, 10 Hours
    Item
    Blood pressure - diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1442445 (UMLS CUI [1,3])
    Heart rate, Post-dose, 10 Hours
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1442445 (UMLS CUI [1,3])
    Item Group
    12 Hours post dose
    C0518766 (UMLS CUI-1)
    C0439568 (UMLS CUI-2)
    C1292430 (UMLS CUI-3)
    Vital signs, Post-dose, 12 Hours, Time
    Item
    Actual time
    time
    C0518766 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1292430 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Systolic Pressure, Post-dose, 12 Hours
    Item
    Blood pressure - systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1292430 (UMLS CUI [1,3])
    Diastolic blood pressure, Post-dose, 12 Hours
    Item
    Blood pressure - diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1292430 (UMLS CUI [1,3])
    Heart rate, Post-dose, 12 Hours
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1292430 (UMLS CUI [1,3])
    Item Group
    24 Hours post dose
    C0518766 (UMLS CUI-1)
    C0439568 (UMLS CUI-2)
    C1442770 (UMLS CUI-3)
    Vital signs, Post-dose, 24 Hours, Time
    Item
    Actual time
    time
    C0518766 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1442770 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Systolic Pressure, Post-dose, 24 Hours
    Item
    Blood pressure - systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1442770 (UMLS CUI [1,3])
    Diastolic blood pressure, Post-dose, 24 Hours
    Item
    Blood pressure - diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1442770 (UMLS CUI [1,3])
    Heart rate, Post-dose, 24 Hours
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1442770 (UMLS CUI [1,3])
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