ID

38272

Beschreibung

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

Stichworte

Versionen (2)
  1. 06.10.19 06.10.19 -
  2. 24.10.19 24.10.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

6. Oktober 2019

DOI

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Lizenz

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

Englisch

Baseline Diaries

1 Formulare  
  1. StudyEvent: ODM
    1. Baseline Diaries
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Site
Beschreibung

Study Site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschreibung

Patient name

Datentyp

text

Alias
UMLS CUI [1]
C1299487
Patient No
Beschreibung

Patients, Identification number

Datentyp

integer

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

Date of Visit/Assessment

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

Date of visit; Assessment Date

Datentyp

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Status of Medications
Beschreibung

Status of Medications

Alias
UMLS CUI-1
C2347852
Were any medications recorded on the In-Clinic Medications Taken Diary?
Beschreibung

Concomitant Agent, Clinic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442592
Were any medications recorded on the At Home Medications Taken Diary?
Beschreibung

Concomitant Agent, Home environment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442519
Meds Recorded In-Clinic
Beschreibung

Meds Recorded In-Clinic

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0442592
Sequence Number
Beschreibung

Concomitant Agent, Clinic, Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C2348184
Drug Name (Trade Name preferred)
Beschreibung

Concomitant Agent, Clinic, Medication name

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C2360065
Modified reported term
Beschreibung

Concomitant Agent, Clinic, Medication name, Reported Term

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C2360065
UMLS CUI [1,4]
C2826302
GSK Drug synonym
Beschreibung

Concomitant Agent, Clinic, Pharmaceutical Preparations, Synonym

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0871468
GSK Drug Collection code
Beschreibung

Concomitant Agent, Clinic, Code

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C0805701
Date Taken
Beschreibung

Concomitant Agent, Clinic, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C0011008
Time Taken
Beschreibung

Concomitant Agent, Clinic, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442592
UMLS CUI [1,3]
C0040223
Meds Recorded at Home
Beschreibung

Meds Recorded at Home

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0442519
Sequence Number
Beschreibung

Concomitant Agent, Home environment, Sequence Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442519
UMLS CUI [1,3]
C2348184
Drug Name (Trade Name preferred)
Beschreibung

Concomitant Agent, Home environment, Medication name

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442519
UMLS CUI [1,3]
C2360065
Modified reported term
Beschreibung

Concomitant Agent, Home environment, Medication name, Reported Term

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442519
UMLS CUI [1,3]
C2360065
UMLS CUI [1,4]
C2826302
GSK Drug synonym
Beschreibung

Concomitant Agent, Home environment, Pharmaceutical Preparations, Synonym

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442519
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0871468
GSK Drug Collection code
Beschreibung

Concomitant Agent, Home environment, Code

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442519
UMLS CUI [1,3]
C0805701
Failed coding
Beschreibung

Concomitant Agent, Home environment, Code, Failed

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442519
UMLS CUI [1,3]
C0805701
UMLS CUI [1,4]
C0231175
Date Taken
Beschreibung

Concomitant Agent, Home environment, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442519
UMLS CUI [1,3]
C0011008
Time Taken
Beschreibung

Concomitant Agent, Home environment, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0442519
UMLS CUI [1,3]
C0040223
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Ähnliche Modelle

Baseline Diaries

1 Formulare
  1. StudyEvent: ODM
    1. Baseline Diaries
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
Status of Medications
C2347852 (UMLS CUI-1)
Concomitant Agent, Clinic
Item
Were any medications recorded on the In-Clinic Medications Taken Diary?
boolean
C2347852 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
Concomitant Agent, Home environment
Item
Were any medications recorded on the At Home Medications Taken Diary?
boolean
C2347852 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
Item Group
Meds Recorded In-Clinic
C2347852 (UMLS CUI-1)
C0442592 (UMLS CUI-2)
Concomitant Agent, Clinic, Sequence Number
Item
Sequence Number
integer
C2347852 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Concomitant Agent, Clinic, Medication name
Item
Drug Name (Trade Name preferred)
text
C2347852 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Concomitant Agent, Clinic, Medication name, Reported Term
Item
Modified reported term
text
C2347852 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
C2826302 (UMLS CUI [1,4])
Concomitant Agent, Clinic, Pharmaceutical Preparations, Synonym
Item
GSK Drug synonym
text
C2347852 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0871468 (UMLS CUI [1,4])
Concomitant Agent, Clinic, Code
Item
GSK Drug Collection code
text
C2347852 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Concomitant Agent, Clinic, Date in time
Item
Date Taken
date
C2347852 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Concomitant Agent, Clinic, Time
Item
Time Taken
time
C2347852 (UMLS CUI [1,1])
C0442592 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Meds Recorded at Home
C2347852 (UMLS CUI-1)
C0442519 (UMLS CUI-2)
Concomitant Agent, Home environment, Sequence Number
Item
Sequence Number
integer
C2347852 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Concomitant Agent, Home environment, Medication name
Item
Drug Name (Trade Name preferred)
text
C2347852 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Concomitant Agent, Home environment, Medication name, Reported Term
Item
Modified reported term
text
C2347852 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
C2826302 (UMLS CUI [1,4])
Concomitant Agent, Home environment, Pharmaceutical Preparations, Synonym
Item
GSK Drug synonym
text
C2347852 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0871468 (UMLS CUI [1,4])
Concomitant Agent, Home environment, Code
Item
GSK Drug Collection code
text
C2347852 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
Concomitant Agent, Home environment, Code, Failed
Item
Failed coding
text
C2347852 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
Concomitant Agent, Home environment, Date in time
Item
Date Taken
date
C2347852 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Concomitant Agent, Home environment, Time
Item
Time Taken
time
C2347852 (UMLS CUI [1,1])
C0442519 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
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