ID
38147
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
Mots-clés
Versions (2)
- 22/09/2019 22/09/2019 -
- 24/10/2019 24/10/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
22 septembre 2019
DOI
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Licence
Creative Commons BY-NC 3.0
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Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363
Unscheduled Visit
- StudyEvent: ODM
Description
Date of Visit/Assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Description
Status of ECG
Alias
- UMLS CUI-1
- C1623258
- UMLS CUI-2
- C0449438
Description
Status of Vital Signs
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0449438
Description
Status of Lab
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0449438
Description
Medications Recorded In-Clinic
Alias
- UMLS CUI-1
- C2347852
Description
Concomitant Agent
Type de données
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
Concomitant Agent, Sequence Number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348184
Description
Concomitant Agent, Medication name
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Description
Concomitant Agent, Medication name, Reported Term
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
- UMLS CUI [1,3]
- C2826302
Description
Concomitant Agent, Pharmaceutical Preparations, Synonym
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [1,3]
- C0871468
Description
Concomitant Agent, Code
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0805701
Description
Concomitant Agent, Code, Failed
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0805701
- UMLS CUI [1,3]
- C0231175
Description
Concomitant Agent, Date in time
Type de données
date
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0011008
Description
Concomitant Agent, Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0040223
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Body Height
Type de données
integer
Unités de mesure
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Body Weight
Type de données
float
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body mass index
Type de données
float
Unités de mesure
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Description
Systolic Pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Systolic Pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Systolic Pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Systolic Pressure, Low, Average
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0205251
- UMLS CUI [1,3]
- C1510992
Description
Diastolic blood pressure, Low, Average
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0205251
- UMLS CUI [1,3]
- C1510992
Description
Systolic Pressure, Low, Average, Screening procedure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0205251
- UMLS CUI [1,3]
- C1510992
- UMLS CUI [1,4]
- C0220908
Description
Diastolic blood pressure, Low, Average, Screening procedure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0205251
- UMLS CUI [1,3]
- C1510992C0220908
Description
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
12 lead ECG, Date in time
Type de données
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Description
12 lead ECG, Heart rate
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0018810
Description
12 lead ECG, P-R Interval
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Description
12 lead ECG, QRS complex duration
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Description
12 lead ECG, QT Interval
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Description
12 lead ECG, Electrocardiogram QT corrected interval
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Description
12 lead ECG, Repeat
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0205341
Description
12 lead ECG, Repeat, Reason and justification
Type de données
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0566251
Description
12 lead ECG, Result
Type de données
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Description
12 lead ECG, Result, Change status
Type de données
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0443172
Description
12 lead ECG, Result, Change status, Clinical Significance
Type de données
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0443172
- UMLS CUI [1,4]
- C2826293
Description
12 lead ECG, QRS Axis
Type de données
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429012
Description
12 lead ECG, RR interval
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0489636
Description
Liver Events Assessment
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0220825
Similar models
Unscheduled Visit
- StudyEvent: ODM
C1300638 (UMLS CUI [1,2])
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
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])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
C0205251 (UMLS CUI [1,2])
C1510992C0220908 (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])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
C0429012 (UMLS CUI [1,2])
C0489636 (UMLS CUI [1,2])
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0877248 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])