ID

38973

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 (1)
  1. 17.11.19 17.11.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

17. November 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

Possible Suicidality-Related Adverse Event (PSRAE)

1 Formulare  
Section 1
Beschreibung

Section 1

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

Adverse Event, Suicidality

Datentyp

text

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

Adverse Event, Suicidality, Start Date

Datentyp

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
Beschreibung

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
Beschreibung

Adverse Event, Suicidality, Description

Datentyp

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
Beschreibung

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
Beschreibung

Adverse Event, Suicidality, Etiology aspects, Disease

Datentyp

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)
Beschreibung

Adverse Event, Suicidality, Etiology aspects, Concomitant Agent

Datentyp

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)
Beschreibung

Adverse Event, Suicidality, Etiology aspects, Mental disorders

Datentyp

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)
Beschreibung

Adverse Event, Suicidality, Etiology aspects, Other medical condition

Datentyp

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
Beschreibung

Adverse Event, Suicidality, Etiology aspects, psychosocial stressor

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Adverse Event, Suicidality, Etiology aspects, Lack of Efficacy

Datentyp

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)
Beschreibung

Adverse Event, Suicidality, Etiology aspects, Experimental drug

Datentyp

boolean

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

Adverse Event, Suicidality, Etiology aspects, Other

Datentyp

boolean

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

Adverse Event, Suicidality, Etiology aspects, Other

Datentyp

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
Beschreibung

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?
Beschreibung

Adverse Event, Suicidality, Medical History, Mental disorders

Datentyp

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?
Beschreibung

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

Datentyp

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?
Beschreibung

Adverse Event, Suicidality, Illicit medication use, Current

Datentyp

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?
Beschreibung

Adverse Event, Suicidality, Alcohol consumption, Current

Datentyp

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?
Beschreibung

Adverse Event, Suicidality, Family history

Datentyp

text

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

Adverse Event, Suicidality, Family history, Mental disorders

Datentyp

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
Beschreibung

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.
Beschreibung

Adverse event, Suicidality, Psychosocial stressor, Current

Datentyp

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
Beschreibung

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
Beschreibung

Adverse Event, Suicidality, Feeling suicidal

Datentyp

text

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

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
Beschreibung

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

Datentyp

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
Beschreibung

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
Beschreibung

Adverse Event, Suicidality, Therapeutic procedure, Comment

Datentyp

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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Ähnliche Modelle

Possible Suicidality-Related Adverse Event (PSRAE)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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