ID

38973

Descrição

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

Palavras-chave

Versões (1)
  1. 17/11/2019 17/11/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

17 de novembro de 2019

DOI

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Licença

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

Inglês

Possible Suicidality-Related Adverse Event (PSRAE)

1 Formulários  
Section 1
Descrição

Section 1

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C3166387
Possible suicidality related AE
Descrição

Adverse Event, Suicidality

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
Start Date
Descrição

Adverse Event, Suicidality, Start Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0808070
Section 2: Brief Description of Possible Suicidality-Related Adverse Event
Descrição

Section 2: Brief Description of Possible Suicidality-Related Adverse Event

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C3166387
UMLS CUI-3
C0678257
Brief description of possible suicidality-related AE
Descrição

Adverse Event, Suicidality, Description

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0678257
Section 3: Possible Cause(s) of Possible Suicidality-Related Adverse Event
Descrição

Section 3: Possible Cause(s) of Possible Suicidality-Related Adverse Event

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C3166387
UMLS CUI-3
C0015127
Disease under study
Descrição

Adverse Event, Suicidality, Etiology aspects, Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0012634
Concomitant medication(s)
Descrição

Adverse Event, Suicidality, Etiology aspects, Concomitant Agent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C2347852
Comorbid psychiatric condition(s)
Descrição

Adverse Event, Suicidality, Etiology aspects, Mental disorders

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0004936
Medical condition(s)
Descrição

Adverse Event, Suicidality, Etiology aspects, Other medical condition

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C3843040
Psycho-social stressors
Descrição

Adverse Event, Suicidality, Etiology aspects, psychosocial stressor

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0748073
Withdrawal of investigational product(s)
Descrição

Adverse Event, Suicidality, Etiology aspects, Experimental drug, Withdraw

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C2349954
Investigational product dose change
Descrição

Adverse Event, Suicidality, Etiology aspects, Experimental drug, Medication dose changed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C1608430
Lack of efficacy
Descrição

Adverse Event, Suicidality, Etiology aspects, Lack of Efficacy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0235828
Investigational product(s)
Descrição

Adverse Event, Suicidality, Etiology aspects, Experimental drug

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0304229
Other
Descrição

Adverse Event, Suicidality, Etiology aspects, Other

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0205394
Yes, specify
Descrição

Adverse Event, Suicidality, Etiology aspects, Other

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0205394
Section 4: Provide Information
Descrição

Section 4: Provide Information

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C3166387
UMLS CUI-3
C1533716
Has the subject had any psychiatric conditions in the past?
Descrição

Adverse Event, Suicidality, Medical History, Mental disorders

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0262926
UMLS CUI [1,4]
C0004936
Has the subject had any suicidal ideation, behavior or self-harm in the past?
Descrição

Adverse Event, Suicidality, Medical History, Active suicidal ideation; Adverse Event, Suicidality, Medical History, Suicidal behavior; Adverse Event, Suicidality, Medical History, Self-injurious Behavior

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0262926
UMLS CUI [1,4]
C0749133
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C3166387
UMLS CUI [2,3]
C0262926
UMLS CUI [2,4]
C1760428
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C3166387
UMLS CUI [3,3]
C0262926
UMLS CUI [3,4]
C0085271
Subject's current use of illicit drugs?
Descrição

Adverse Event, Suicidality, Illicit medication use, Current

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0281875
UMLS CUI [1,4]
C0521116
Subject's current use of alcohol?
Descrição

Adverse Event, Suicidality, Alcohol consumption, Current

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0001948
UMLS CUI [1,4]
C0521116
Family history of suicidality?
Descrição

Adverse Event, Suicidality, Family history

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0241889
Family history of psychiatric disorders?
Descrição

Adverse Event, Suicidality, Family history, Mental disorders

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0241889
UMLS CUI [1,4]
C0004936
Section 5: Provide Information on the Subject's Current Psycho-social Stressors
Descrição

Section 5: Provide Information on the Subject's Current Psycho-social Stressors

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C3166387
UMLS CUI-3
C0748073
UMLS CUI-4
C0521116
Information of subject's current psycho-social stressors.
Descrição

Adverse event, Suicidality, Psychosocial stressor, Current

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0748073
UMLS CUI [1,4]
C0521116
Section 6: Relevant and/or Recent Suicidal Ideation
Descrição

Section 6: Relevant and/or Recent Suicidal Ideation

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C3166387
UMLS CUI-3
C0424000
Relevant/recent suicidal ideation
Descrição

Adverse Event, Suicidality, Feeling suicidal

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0424000
Section 7: Suicidal Behavior Present During Study
Descrição

Section 7: Suicidal Behavior Present During Study

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C3166387
UMLS CUI-3
C1760428
UMLS CUI-4
C0347984
UMLS CUI-5
C0008976
Suicide behavior present during study
Descrição

Adverse Event, Suicidality, Suicidal behavior, During, Clinical Trials

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C1760428
UMLS CUI [1,4]
C0347984
UMLS CUI [1,5]
C0008976
Section 8: Comments on Medical and Psychiatric Treatment
Descrição

Section 8: Comments on Medical and Psychiatric Treatment

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C3166387
UMLS CUI-3
C0087111
UMLS CUI-4
C0947611
Comments on medical/psych treatment
Descrição

Adverse Event, Suicidality, Therapeutic procedure, Comment

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3166387
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0947611
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Similar models

Possible Suicidality-Related Adverse Event (PSRAE)

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Section 1
C0877248 (UMLS CUI-1)
C3166387 (UMLS CUI-2)
Adverse Event, Suicidality
Item
Possible suicidality related AE
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
Adverse Event, Suicidality, Start Date
Item
Start Date
date
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Item Group
Section 2: Brief Description of Possible Suicidality-Related Adverse Event
C0877248 (UMLS CUI-1)
C3166387 (UMLS CUI-2)
C0678257 (UMLS CUI-3)
Adverse Event, Suicidality, Description
Item
Brief description of possible suicidality-related AE
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item Group
Section 3: Possible Cause(s) of Possible Suicidality-Related Adverse Event
C0877248 (UMLS CUI-1)
C3166387 (UMLS CUI-2)
C0015127 (UMLS CUI-3)
Adverse Event, Suicidality, Etiology aspects, Disease
Item
Disease under study
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
Adverse Event, Suicidality, Etiology aspects, Concomitant Agent
Item
Concomitant medication(s)
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,4])
Adverse Event, Suicidality, Etiology aspects, Mental disorders
Item
Comorbid psychiatric condition(s)
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0004936 (UMLS CUI [1,4])
Adverse Event, Suicidality, Etiology aspects, Other medical condition
Item
Medical condition(s)
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C3843040 (UMLS CUI [1,4])
Adverse Event, Suicidality, Etiology aspects, psychosocial stressor
Item
Psycho-social stressors
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0748073 (UMLS CUI [1,4])
Adverse Event, Suicidality, Etiology aspects, Experimental drug, Withdraw
Item
Withdrawal of investigational product(s)
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2349954 (UMLS CUI [1,5])
Adverse Event, Suicidality, Etiology aspects, Experimental drug, Medication dose changed
Item
Investigational product dose change
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C1608430 (UMLS CUI [1,5])
Adverse Event, Suicidality, Etiology aspects, Lack of Efficacy
Item
Lack of efficacy
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0235828 (UMLS CUI [1,4])
Adverse Event, Suicidality, Etiology aspects, Experimental drug
Item
Investigational product(s)
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
Adverse Event, Suicidality, Etiology aspects, Other
Item
Other
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Adverse Event, Suicidality, Etiology aspects, Other
Item
Yes, specify
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item Group
Section 4: Provide Information
C0877248 (UMLS CUI-1)
C3166387 (UMLS CUI-2)
C1533716 (UMLS CUI-3)
Adverse Event, Suicidality, Medical History, Mental disorders
Item
Has the subject had any psychiatric conditions in the past?
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0004936 (UMLS CUI [1,4])
Adverse Event, Suicidality, Medical History, Active suicidal ideation; Adverse Event, Suicidality, Medical History, Suicidal behavior; Adverse Event, Suicidality, Medical History, Self-injurious Behavior
Item
Has the subject had any suicidal ideation, behavior or self-harm in the past?
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0749133 (UMLS CUI [1,4])
C0877248 (UMLS CUI [2,1])
C3166387 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
C1760428 (UMLS CUI [2,4])
C0877248 (UMLS CUI [3,1])
C3166387 (UMLS CUI [3,2])
C0262926 (UMLS CUI [3,3])
C0085271 (UMLS CUI [3,4])
Adverse Event, Suicidality, Illicit medication use, Current
Item
Subject's current use of illicit drugs?
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0281875 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
Adverse Event, Suicidality, Alcohol consumption, Current
Item
Subject's current use of alcohol?
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0001948 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
Item
Family history of suicidality?
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
Adverse Event, Suicidality, Family history
Code List
Family history of suicidality?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item
Family history of psychiatric disorders?
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
C0004936 (UMLS CUI [1,4])
Adverse Event, Suicidality, Family history, Mental disorders
Code List
Family history of psychiatric disorders?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Item Group
Section 5: Provide Information on the Subject's Current Psycho-social Stressors
C0877248 (UMLS CUI-1)
C3166387 (UMLS CUI-2)
C0748073 (UMLS CUI-3)
C0521116 (UMLS CUI-4)
Adverse event, Suicidality, Psychosocial stressor, Current
Item
Information of subject's current psycho-social stressors.
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0748073 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
Item Group
Section 6: Relevant and/or Recent Suicidal Ideation
C0877248 (UMLS CUI-1)
C3166387 (UMLS CUI-2)
C0424000 (UMLS CUI-3)
Adverse Event, Suicidality, Feeling suicidal
Item
Relevant/recent suicidal ideation
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0424000 (UMLS CUI [1,3])
Item Group
Section 7: Suicidal Behavior Present During Study
C0877248 (UMLS CUI-1)
C3166387 (UMLS CUI-2)
C1760428 (UMLS CUI-3)
C0347984 (UMLS CUI-4)
C0008976 (UMLS CUI-5)
Adverse Event, Suicidality, Suicidal behavior, During, Clinical Trials
Item
Suicide behavior present during study
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C1760428 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,5])
Item Group
Section 8: Comments on Medical and Psychiatric Treatment
C0877248 (UMLS CUI-1)
C3166387 (UMLS CUI-2)
C0087111 (UMLS CUI-3)
C0947611 (UMLS CUI-4)
Adverse Event, Suicidality, Therapeutic procedure, Comment
Item
Comments on medical/psych treatment
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
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