ID

38742

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. 10/31/19 10/31/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 31, 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

Logs and Repeats

1 forms  
  1. StudyEvent: ODM
    1. Logs and Repeats
Date of Visit/Assessment
Description

Date of Visit/Assessment

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

Date of visit; Assessment Date

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
Description

Adverse Event/Concomitant Medication/Repeat Assessment Check Questions

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C2347852
UMLS CUI-3
C0220825
Were any concomitant medications taken by the subject during the study?
Description

Concomitant Agent

Data type

boolean

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

Non-serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1518404
Did the subject experience any serious adverse events during the study?
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Were any repeat haematology, clinical chemistry, or urinalysis samples taken?
Description

Hematology finding, Sampling, Repeat; Chemistry, Clinical, Sampling, Repeat; Urinalysis, Sampling, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0474523
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0205341
UMLS CUI [2,1]
C0008000
UMLS CUI [2,2]
C0870078
UMLS CUI [2,3]
C0205341
UMLS CUI [3,1]
C0042014
UMLS CUI [3,2]
C0870078
UMLS CUI [3,3]
C0205341
Were any repeat vital signs recorded?
Description

Vital signs, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
Were any repeat PK blood samples taken?
Description

Pharmacokinetic aspects, Sampling, Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0205341
Did the subject experience any possible suicidality-related serious adverse events during the study?
Description

Serious Adverse Event, Suicide

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0038661
Did the subject have a dose reduction?
Description

Dose Reduced

Data type

text

Alias
UMLS CUI [1]
C1707814
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Similar models

Logs and Repeats

1 forms
  1. StudyEvent: ODM
    1. Logs and Repeats
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
C2985720 (UMLS CUI [2])
Item Group
Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Concomitant Agent
Item
Were any concomitant medications taken by the subject 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])
Serious Adverse Event
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
Hematology finding, Sampling, Repeat; Chemistry, Clinical, Sampling, Repeat; Urinalysis, Sampling, Repeat
Item
Were any repeat haematology, clinical chemistry, or urinalysis samples taken?
boolean
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0008000 (UMLS CUI [2,1])
C0870078 (UMLS CUI [2,2])
C0205341 (UMLS CUI [2,3])
C0042014 (UMLS CUI [3,1])
C0870078 (UMLS CUI [3,2])
C0205341 (UMLS CUI [3,3])
Vital signs, Repeat
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Pharmacokinetic aspects, Sampling, Repeat
Item
Were any repeat PK blood samples taken?
boolean
C0031328 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Serious Adverse Event, Suicide
Item
Did the subject experience any possible suicidality-related serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1,1])
C0038661 (UMLS CUI [1,2])
Dose Reduced
Item
Did the subject have a dose reduction?
text
C1707814 (UMLS CUI [1])
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