ID

38148

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. 22-09-19 22-09-19 -
  2. 24-10-19 24-10-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

22 september 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

Subject Logs

  1. StudyEvent: ODM
    1. Subject Logs
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Site
Beschrijving

Study Site

Datatype

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschrijving

Patient name

Datatype

text

Alias
UMLS CUI [1]
C1299487
Patient No
Beschrijving

Patients, Identification number

Datatype

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Date of Visit/Assessment
Beschrijving

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Beschrijving

Date of visit; Assessment Date

Datatype

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Log Status
Beschrijving

Log Status

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0449438
Did the subject experience a serious adverse event during the study?
Beschrijving

Serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Were any concomitant medications taken by the subject prior to screening and/or during the study?
Beschrijving

Concomitant Agent

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
Did the subject experience any non-serious adverse events during the study?
Beschrijving

Non-serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1]
C1518404

Similar models

Subject Logs

  1. StudyEvent: ODM
    1. Subject Logs
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient name
Item
Patient
text
C1299487 (UMLS CUI [1])
Patients, Identification number
Item
Patient No
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit; Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Log Status
C1708728 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Serious Adverse Event
Item
Did the subject experience a serious adverse event during the study?
boolean
C1519255 (UMLS CUI [1])
Concomitant Agent
Item
Were any concomitant medications taken by the subject prior to screening and/or during the study?
boolean
C2347852 (UMLS CUI [1])
Non-serious Adverse Event
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])

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