ID

38275

Descripción

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

Palabras clave

Versiones (2)
  1. 6/10/19 6/10/19 -
  2. 24/10/19 24/10/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

6 de octubre de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363

Inglés

Treatment Period-T3

1 formularios  
  1. StudyEvent: ODM
    1. Treatment Period-T3
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Site
Descripción

Study Site

Tipo de datos

text

Alias
UMLS CUI [1]
C2825164
Patient
Descripción

Patient name

Tipo de datos

text

Alias
UMLS CUI [1]
C1299487
Patient No
Descripción

Patients, Identification number

Tipo de datos

integer

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

Date of Visit/Assessment

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

Date of visit; Assessment Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Blood pressure(1st Reading) - Systolic
Descripción

Systolic Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure(1st Reading) - Diastolic
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Blood pressure(2nd Reading) - Systolic
Descripción

Systolic Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure(2nd Reading) - Diastolic
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Blood pressure(3rd Reading) - Systolic
Descripción

Systolic Pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure(3rd Reading) - Diastolic
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Descripción

Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Average of the lowest two blood pressure readings - Systolic
Descripción

Systolic Pressure, Low, Average

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0205251
UMLS CUI [1,3]
C1510992
mmHg
Average of the lowest two blood pressure readings - Diastolic
Descripción

Diastolic blood pressure, Low, Average

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0205251
UMLS CUI [1,3]
C1510992
mmHg
Average of the lowest two blood pressure readings at Screening visit - Systolic
Descripción

Systolic Pressure, Screening procedure, Low, Average

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0220908
UMLS CUI [1,3]
C0205251
UMLS CUI [1,4]
C1510992
mmHg
Average of the lowest two blood pressure readings at Screening visit - Diastolic
Descripción

Diastolic blood pressure, Screening procedure, Low, Average

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0220908
UMLS CUI [1,3]
C0205251
UMLS CUI [1,4]
C1510992
mmHg
Liver, Adverse event, Evaluation
Descripción

Liver, Adverse event, Evaluation

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Descripción

Liver, Adverse event, Evaluation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0220825
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Similar models

Treatment Period-T3

1 formularios
  1. StudyEvent: ODM
    1. Treatment Period-T3
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
Vital Signs
C0518766 (UMLS CUI-1)
Systolic Pressure
Item
Blood pressure(1st Reading) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure(1st Reading) - Diastolic
integer
C0428883 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure(2nd Reading) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure(2nd Reading) - Diastolic
integer
C0428883 (UMLS CUI [1])
Systolic Pressure
Item
Blood pressure(3rd Reading) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure(3rd Reading) - Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Systolic Pressure, Low, Average
Item
Average of the lowest two blood pressure readings - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
Diastolic blood pressure, Low, Average
Item
Average of the lowest two blood pressure readings - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
Systolic Pressure, Screening procedure, Low, Average
Item
Average of the lowest two blood pressure readings at Screening visit - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C1510992 (UMLS CUI [1,4])
Diastolic blood pressure, Screening procedure, Low, Average
Item
Average of the lowest two blood pressure readings at Screening visit - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C1510992 (UMLS CUI [1,4])
Item Group
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Liver, Adverse event, Evaluation
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
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