ID

38637

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 (1)
  1. 10/29/19 10/29/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 29, 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

Vital Signs

1 forms  
  1. StudyEvent: ODM
    1. Vital Signs
AM Semi-supine
Description

AM Semi-supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522019
UMLS CUI-3
C0332170
Actual time
Description

Vital Signs, Semi-erect, Time, Morning

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0332170
Blood pressure - Systolic
Description

Systolic pressure, Semi-erect, Morning

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0332170
mm[Hg]
Blood pressure - Diastolic
Description

Diastolic blood pressure, Semi-erect, Morning

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0332170
mm[Hg]
Heart rate
Description

Heart rate, Semi-erect, Morning

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0332170
bpm
AM Standing
Description

AM Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522014
UMLS CUI-3
C0332170
Actual time
Description

Vital Signs, Erect, Time, Morning

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0332170
Blood pressure - Systolic
Description

Systolic pressure, Erect, Morning

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0332170
mm[Hg]
Blood pressure - Diastolic
Description

Diastolic blood pressure, Erect, Morning

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0332170
mm[Hg]
Heart rate
Description

Heart rate, Erect, Morning

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0332170
bpm
Noon Semi-supine
Description

Noon Semi-supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522019
UMLS CUI-3
C0585020
Actual time
Description

Vital Signs, Semi-erect, Time, Noon

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0585020
Blood pressure - Systolic
Description

Systolic pressure, Semi-erect, Noon

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0585020
mm[Hg]
Blood pressure - Diastolic
Description

Diastolic blood pressure, Semi-erect, Noon

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0585020
mm[Hg]
Heart rate
Description

Heart rate, Semi-erect, Noon

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0585020
bpm
Noon Standing
Description

Noon Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522014
UMLS CUI-3
C0585020
Actual time
Description

Vital Signs, Erect, Time, Noon

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0585020
Blood pressure - Systolic
Description

Systolic pressure, Erect, Noon

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0585020
mm[Hg]
Blood pressure - Diastolic
Description

Diastolic blood pressure, Erect, Noon

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0585020
mm[Hg]
Heart rate
Description

Heart rate, Erect, Noon

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0585020
bpm
PM Semi-supine
Description

PM Semi-supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522019
UMLS CUI-3
C0587117
Actual time
Description

Vital Signs, Semi-erect, Time, Evening

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0587117
Blood pressure - Systolic
Description

Systolic pressure, Semi-erect, Evening

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0587117
mm[Hg]
Blood pressure - Diastolic
Description

Diastolic blood pressure, Semi-erect, Evening

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0587117
mm[Hg]
Heart rate
Description

Heart rate, Semi-erect, Evening

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0587117
bpm
PM Standing
Description

PM Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522014
UMLS CUI-3
C0587117
Actual time
Description

Vital Signs, Erect, Time, Evening

Data type

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0587117
Blood pressure - Systolic
Description

Systolic pressure, Erect, Evening

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0587117
mm[Hg]
Blood pressure - Diastolic
Description

Diastolic blood pressure, Erect, Evening

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0587117
mm[Hg]
Heart rate
Description

Heart rate, Erect, Evening

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0587117
bpm
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Similar models

Vital Signs

1 forms
  1. StudyEvent: ODM
    1. Vital Signs
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
AM Semi-supine
C0518766 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Vital Signs, Semi-erect, Time, Morning
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Systolic pressure, Semi-erect, Morning
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
Diastolic blood pressure, Semi-erect, Morning
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
Heart rate, Semi-erect, Morning
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
Item Group
AM Standing
C0518766 (UMLS CUI-1)
C0522014 (UMLS CUI-2)
C0332170 (UMLS CUI-3)
Vital Signs, Erect, Time, Morning
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0332170 (UMLS CUI [1,4])
Systolic pressure, Erect, Morning
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
Diastolic blood pressure, Erect, Morning
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
Heart rate, Erect, Morning
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0332170 (UMLS CUI [1,3])
Item Group
Noon Semi-supine
C0518766 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
C0585020 (UMLS CUI-3)
Vital Signs, Semi-erect, Time, Noon
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0585020 (UMLS CUI [1,4])
Systolic pressure, Semi-erect, Noon
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0585020 (UMLS CUI [1,3])
Diastolic blood pressure, Semi-erect, Noon
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0585020 (UMLS CUI [1,3])
Heart rate, Semi-erect, Noon
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0585020 (UMLS CUI [1,3])
Item Group
Noon Standing
C0518766 (UMLS CUI-1)
C0522014 (UMLS CUI-2)
C0585020 (UMLS CUI-3)
Vital Signs, Erect, Time, Noon
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0585020 (UMLS CUI [1,4])
Systolic pressure, Erect, Noon
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0585020 (UMLS CUI [1,3])
Diastolic blood pressure, Erect, Noon
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0585020 (UMLS CUI [1,3])
Heart rate, Erect, Noon
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0585020 (UMLS CUI [1,3])
Item Group
PM Semi-supine
C0518766 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Vital Signs, Semi-erect, Time, Evening
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0587117 (UMLS CUI [1,4])
Systolic pressure, Semi-erect, Evening
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
Diastolic blood pressure, Semi-erect, Evening
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
Heart rate, Semi-erect, Evening
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
Item Group
PM Standing
C0518766 (UMLS CUI-1)
C0522014 (UMLS CUI-2)
C0587117 (UMLS CUI-3)
Vital Signs, Erect, Time, Evening
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0587117 (UMLS CUI [1,4])
Systolic pressure, Erect, Evening
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
Diastolic blood pressure, Erect, Evening
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
Heart rate, Erect, Evening
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0587117 (UMLS CUI [1,3])
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