ID
38144
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 (2)
- 9/22/19 9/22/19 -
- 10/24/19 10/24/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 22, 2019
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363
Screening
- StudyEvent: ODM
Description
Date of Visit/Assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Description
Subject Identification
Alias
- UMLS CUI-1
- C2348585
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Patient date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Childbearing Potential
Data type
text
Alias
- UMLS CUI [1]
- C3831118
Description
Ethnic group
Data type
text
Alias
- UMLS CUI [1]
- C0015031
Description
Your ancestry or national origin
Data type
text
Alias
- UMLS CUI [1]
- C3841890
Description
Pharmacogenetic (PGx) Research Consent / Blood Sample Collection
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
- UMLS CUI-3
- C0005834
Description
Pharmacogenetic Test, Informed Consent
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
Description
Pharmacogenetic Test, Informed Consent, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0011008
Description
Pharmacogenetic Test, Collection of blood specimen for laboratory procedure
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0005834
Description
Pharmacogenetic Test, Informed Consent, Reason and justification
Data type
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0566251
Description
Pharmacogenetic Test, Informed Consent, Reason and justification
Data type
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0566251
Description
Pharmacogenetic (PGx) Research Withdrawal of Consent
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
- UMLS CUI-3
- C2349954
Description
Pharmacogenetic Test, Informed Consent, Withdraw
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C2349954
Description
Pharmacogenetic Test, Informed Consent, Withdraw, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C2349954
- UMLS CUI [1,4]
- C0011008
Description
Pharmacogenetic Test, Blood specimen, Destruction, Request
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1948029
- UMLS CUI [1,4]
- C1272683
Description
Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
Data type
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1948029
- UMLS CUI [1,4]
- C1272683
- UMLS CUI [1,5]
- C0566251
Description
Pharmacogenetic Test, Blood specimen, Destruction, Request, Reason and justification
Data type
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0178913
- UMLS CUI [1,3]
- C1948029
- UMLS CUI [1,4]
- C1272683
- UMLS CUI [1,5]
- C0566251
Description
Screen Failure
Alias
- UMLS CUI-1
- C1710476
Description
Trial Screen Failure
Data type
boolean
Alias
- UMLS CUI [1]
- C1710476
Description
Trial Screen Failure, Reason and justification
Data type
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
Description
Trial Screen Failure, Reason and justification
Data type
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
Description
Trial Screen Failure, Clinical Study Case, Investigator Signature
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C1706256
- UMLS CUI [1,4]
- C2346576
Description
Eligibility Question
Alias
- UMLS CUI-1
- C0013893
Description
Eligibility Determination
Data type
boolean
Alias
- UMLS CUI [1]
- C0013893
Description
Inclusion
Data type
text
Alias
- UMLS CUI [1]
- C1512693
Description
Exclusion Criteria
Data type
text
Alias
- UMLS CUI [1]
- C0680251
Description
Status of Medications
Alias
- UMLS CUI-1
- C2347852
Description
Concomitant Agent
Data type
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Concomitant Agent, Sequence Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348184
Description
Concomitant Agent, Medication name
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Description
Concomitant Agent, Medication name, Reported Term
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
- UMLS CUI [1,3]
- C2826302
Description
Concomitant Agent, Pharmaceutical Preparations, Synonym
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0871468
Description
Concomitant Agent, Code
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0805701
Description
Concomitant Agent, Code, Failed
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0805701
- UMLS CUI [1,3]
- C0231175
Description
Concomitant Agent, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0011008
Description
Concomitant Agent, Time
Data type
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0040223
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Body Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Body Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body mass index
Data type
float
Measurement units
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Description
Systolic Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Systolic Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Systolic Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Systolic Pressure, Low, Average
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0205251
- UMLS CUI [1,3]
- C1510992
Description
Diastolic blood pressure, Low, Average
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0205251
- UMLS CUI [1,3]
- C1510992
Description
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
12 lead ECG, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Description
12 lead ECG, Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0018810
Description
12 lead ECG, P-R Interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Description
12 lead ECG, QRS complex duration
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Description
12 lead ECG, QT Interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Description
12 lead ECG, Electrocardiogram QT corrected interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Description
12 lead ECG, Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Description
12 lead ECG, QRS Axis
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429012
Description
12 lead ECG, RR interval
Data type
integer
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0489636
Description
Investigator Signature
Alias
- UMLS CUI-1
- C2346576
Description
Clinical Study Case, Investigator Signature
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1706256
- UMLS CUI [1,2]
- C2346576
Description
Clinical Study Case, Investigator Signature
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1706256
- UMLS CUI [1,2]
- C2346576
Similar models
Screening
- StudyEvent: ODM
C1300638 (UMLS CUI [1,2])
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C0021430 (UMLS CUI-2)
C0005834 (UMLS CUI-3)
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C1706256 (UMLS CUI [1,3])
C2346576 (UMLS CUI [1,4])
C2348184 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,2])
C2826302 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
C0429012 (UMLS CUI [1,2])
C0489636 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,2])
C2346576 (UMLS CUI [1,2])