ID

38640

Beschrijving

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

Trefwoorden

Versies (1)
  1. 29-10-19 29-10-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

29 oktober 2019

DOI

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Licentie

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

Engels

Vital Signs

1 Formulieren  
  1. StudyEvent: ODM
    1. Vital Signs
Dosing Date and Time
Beschrijving

Dosing Date and Time

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0178602
UMLS CUI-3
C0011008
UMLS CUI-4
C0040223
Dosing date/time
Beschrijving

Experimental drug, Dosage, Date in time, Time

Datatype

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Semi-supine (PreDose 1)
Beschrijving

Semi-supine (PreDose 1)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522019
UMLS CUI-3
C0439565
Actual time
Beschrijving

Vital Signs, Semi-erect, Time, Pre-dose

Datatype

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439565
Blood pressure - Systolic
Beschrijving

Systolic pressure, Semi-erect, Pre-dose

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439565
mm[Hg]
Blood pressure - Diastolic
Beschrijving

Diastolic blood pressure, Semi-erect, Pre-dose

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439565
mm[Hg]
Heart rate
Beschrijving

Heart rate, Semi-erect, Pre-dose

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439565
bpm
Standing (PreDose 1)
Beschrijving

Standing (PreDose 1)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522014
UMLS CUI-3
C0439565
Actual time
Beschrijving

Vital Signs, Erect, Time, Pre-dose

Datatype

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439565
Blood pressure - Systolic
Beschrijving

Systolic pressure, Erect, Pre-dose

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439565
mm[Hg]
Blood pressure - Diastolic
Beschrijving

Diastolic blood pressure, Erect, Pre-dose

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439565
mm[Hg]
Heart rate
Beschrijving

Heart rate, Erect, Pre-dose

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439565
bpm
Semi-supine (PreDose 2)
Beschrijving

Semi-supine (PreDose 2)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522019
UMLS CUI-3
C0439565
Actual time
Beschrijving

Vital Signs, Semi-erect, Time, Pre-dose

Datatype

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439565
Blood pressure - Systolic
Beschrijving

Systolic pressure, Semi-erect, Pre-dose

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439565
mm[Hg]
Blood pressure - Diastolic
Beschrijving

Diastolic blood pressure, Semi-erect, Pre-dose

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439565
mm[Hg]
Heart rate
Beschrijving

Heart rate, Semi-erect, Pre-dose

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439565
bpm
Standing (PreDose 2)
Beschrijving

Standing (PreDose 2)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522014
UMLS CUI-3
C0439565
Actual time
Beschrijving

Vital Signs, Erect, Time, Pre-dose

Datatype

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439565
Blood pressure - Systolic
Beschrijving

Systolic pressure, Erect, Pre-dose

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439565
mm[Hg]
Blood pressure - Diastolic
Beschrijving

Diastolic blood pressure, Erect, Pre-dose

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439565
mm[Hg]
Heart rate
Beschrijving

Heart rate, Erect, Pre-dose

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439565
bpm
Semi-supine (PreDose 3)
Beschrijving

Semi-supine (PreDose 3)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522019
UMLS CUI-3
C0439565
Actual time
Beschrijving

Vital Signs, Semi-erect, Time, Pre-dose

Datatype

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439565
Blood pressure - Systolic
Beschrijving

Systolic pressure, Semi-erect, Pre-dose

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439565
mm[Hg]
Blood pressure - Diastolic
Beschrijving

Diastolic blood pressure, Semi-erect, Pre-dose

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439565
mm[Hg]
Heart rate
Beschrijving

Heart rate, Semi-erect, Pre-dose

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439565
bpm
Standing (PreDose 3)
Beschrijving

Standing (PreDose 3)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522014
UMLS CUI-3
C0439565
Actual time
Beschrijving

Vital Signs, Erect, Time, Pre-dose

Datatype

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439565
Blood pressure - Systolic
Beschrijving

Systolic pressure, Erect, Pre-dose

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439565
mm[Hg]
Blood pressure - Diastolic
Beschrijving

Diastolic blood pressure, Erect, Pre-dose

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439565
mm[Hg]
Heart rate
Beschrijving

Heart rate, Erect, Pre-dose

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439565
bpm
Post Dose Semi-supine
Beschrijving

Post Dose Semi-supine

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522019
UMLS CUI-3
C0439568
Actual time
Beschrijving

Vital Signs, Semi-erect, Time, Post-dose

Datatype

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439568
Blood pressure - Systolic
Beschrijving

Systolic pressure, Semi-erect, Post-dose

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439568
mm[Hg]
Blood pressure - Diastolic
Beschrijving

Diastolic blood pressure, Semi-erect, Post-dose

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439568
mm[Hg]
Heart rate
Beschrijving

Heart rate, Semi-erect, Post-dose

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0439568
bpm
Post Dose Standing
Beschrijving

Post Dose Standing

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522014
UMLS CUI-3
C0439568
Actual time
Beschrijving

Vital Signs, Erect, Time, Post-dose

Datatype

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0439568
Blood pressure - Systolic
Beschrijving

Systolic pressure, Erect, Post-dose

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439568
mm[Hg]
Blood pressure - Diastolic
Beschrijving

Diastolic blood pressure, Erect, Post-dose

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439568
mm[Hg]
Heart rate
Beschrijving

Heart rate, Erect, Post-dose

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0439568
bpm
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Similar models

Vital Signs

1 Formulieren
  1. StudyEvent: ODM
    1. Vital Signs
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Dosing Date and Time
C0304229 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
Experimental drug, Dosage, Date in time, Time
Item
Dosing date/time
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Semi-supine (PreDose 1)
C0518766 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
C0439565 (UMLS CUI-3)
Vital Signs, Semi-erect, Time, Pre-dose
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439565 (UMLS CUI [1,4])
Systolic pressure, Semi-erect, Pre-dose
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Diastolic blood pressure, Semi-erect, Pre-dose
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Heart rate, Semi-erect, Pre-dose
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Item Group
Standing (PreDose 1)
C0518766 (UMLS CUI-1)
C0522014 (UMLS CUI-2)
C0439565 (UMLS CUI-3)
Vital Signs, Erect, Time, Pre-dose
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439565 (UMLS CUI [1,4])
Systolic pressure, Erect, Pre-dose
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Diastolic blood pressure, Erect, Pre-dose
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Heart rate, Erect, Pre-dose
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Item Group
Semi-supine (PreDose 2)
C0518766 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
C0439565 (UMLS CUI-3)
Vital Signs, Semi-erect, Time, Pre-dose
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439565 (UMLS CUI [1,4])
Systolic pressure, Semi-erect, Pre-dose
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Diastolic blood pressure, Semi-erect, Pre-dose
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Heart rate, Semi-erect, Pre-dose
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Item Group
Standing (PreDose 2)
C0518766 (UMLS CUI-1)
C0522014 (UMLS CUI-2)
C0439565 (UMLS CUI-3)
Vital Signs, Erect, Time, Pre-dose
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439565 (UMLS CUI [1,4])
Systolic pressure, Erect, Pre-dose
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Diastolic blood pressure, Erect, Pre-dose
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Heart rate, Erect, Pre-dose
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Item Group
Semi-supine (PreDose 3)
C0518766 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
C0439565 (UMLS CUI-3)
Vital Signs, Semi-erect, Time, Pre-dose
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439565 (UMLS CUI [1,4])
Systolic pressure, Semi-erect, Pre-dose
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Diastolic blood pressure, Semi-erect, Pre-dose
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Heart rate, Semi-erect, Pre-dose
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Item Group
Standing (PreDose 3)
C0518766 (UMLS CUI-1)
C0522014 (UMLS CUI-2)
C0439565 (UMLS CUI-3)
Vital Signs, Erect, Time, Pre-dose
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439565 (UMLS CUI [1,4])
Systolic pressure, Erect, Pre-dose
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Diastolic blood pressure, Erect, Pre-dose
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Heart rate, Erect, Pre-dose
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Item Group
Post Dose Semi-supine
C0518766 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
Vital Signs, Semi-erect, Time, Post-dose
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439568 (UMLS CUI [1,4])
Systolic pressure, Semi-erect, Post-dose
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Diastolic blood pressure, Semi-erect, Post-dose
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Heart rate, Semi-erect, Post-dose
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Item Group
Post Dose Standing
C0518766 (UMLS CUI-1)
C0522014 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
Vital Signs, Erect, Time, Post-dose
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0439568 (UMLS CUI [1,4])
Systolic pressure, Erect, Post-dose
Item
Blood pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Diastolic blood pressure, Erect, Post-dose
Item
Blood pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Heart rate, Erect, Post-dose
Item
Heart rate
integer
C0018810 (UMLS CUI [1,1])
C0522014 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
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