ID

38637

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

  1. 29-10-19 29-10-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

29 oktober 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363

Vital Signs

  1. StudyEvent: ODM
    1. Vital Signs
AM Semi-supine
Beschrijving

AM Semi-supine

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

Vital Signs, Semi-erect, Time, Morning

Datatype

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
Beschrijving

Systolic pressure, Semi-erect, Morning

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0332170
mm[Hg]
Blood pressure - Diastolic
Beschrijving

Diastolic blood pressure, Semi-erect, Morning

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0332170
mm[Hg]
Heart rate
Beschrijving

Heart rate, Semi-erect, Morning

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0332170
bpm
AM Standing
Beschrijving

AM Standing

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

Vital Signs, Erect, Time, Morning

Datatype

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
Beschrijving

Systolic pressure, Erect, Morning

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0332170
mm[Hg]
Blood pressure - Diastolic
Beschrijving

Diastolic blood pressure, Erect, Morning

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0332170
mm[Hg]
Heart rate
Beschrijving

Heart rate, Erect, Morning

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0332170
bpm
Noon Semi-supine
Beschrijving

Noon Semi-supine

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

Vital Signs, Semi-erect, Time, Noon

Datatype

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
Beschrijving

Systolic pressure, Semi-erect, Noon

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0585020
mm[Hg]
Blood pressure - Diastolic
Beschrijving

Diastolic blood pressure, Semi-erect, Noon

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0585020
mm[Hg]
Heart rate
Beschrijving

Heart rate, Semi-erect, Noon

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0585020
bpm
Noon Standing
Beschrijving

Noon Standing

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

Vital Signs, Erect, Time, Noon

Datatype

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
Beschrijving

Systolic pressure, Erect, Noon

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0585020
mm[Hg]
Blood pressure - Diastolic
Beschrijving

Diastolic blood pressure, Erect, Noon

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0585020
mm[Hg]
Heart rate
Beschrijving

Heart rate, Erect, Noon

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0585020
bpm
PM Semi-supine
Beschrijving

PM Semi-supine

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

Vital Signs, Semi-erect, Time, Evening

Datatype

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
Beschrijving

Systolic pressure, Semi-erect, Evening

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0587117
mm[Hg]
Blood pressure - Diastolic
Beschrijving

Diastolic blood pressure, Semi-erect, Evening

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0587117
mm[Hg]
Heart rate
Beschrijving

Heart rate, Semi-erect, Evening

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522019
UMLS CUI [1,3]
C0587117
bpm
PM Standing
Beschrijving

PM Standing

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

Vital Signs, Erect, Time, Evening

Datatype

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
Beschrijving

Systolic pressure, Erect, Evening

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0587117
mm[Hg]
Blood pressure - Diastolic
Beschrijving

Diastolic blood pressure, Erect, Evening

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0587117
mm[Hg]
Heart rate
Beschrijving

Heart rate, Erect, Evening

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0522014
UMLS CUI [1,3]
C0587117
bpm

Similar models

Vital Signs

  1. StudyEvent: ODM
    1. Vital Signs
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial