ID
38973
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 (1)
- 17/11/2019 17/11/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
17 novembre 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
Possible Suicidality-Related Adverse Event (PSRAE)
- StudyEvent: ODM
Description
Section 2: Brief Description of Possible Suicidality-Related Adverse Event
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C3166387
- UMLS CUI-3
- C0678257
Description
Section 3: Possible Cause(s) of Possible Suicidality-Related Adverse Event
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C3166387
- UMLS CUI-3
- C0015127
Description
Adverse Event, Suicidality, Etiology aspects, Disease
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3166387
- UMLS CUI [1,3]
- C0015127
- UMLS CUI [1,4]
- C0012634
Description
Adverse Event, Suicidality, Etiology aspects, Concomitant Agent
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3166387
- UMLS CUI [1,3]
- C0015127
- UMLS CUI [1,4]
- C2347852
Description
Adverse Event, Suicidality, Etiology aspects, Mental disorders
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3166387
- UMLS CUI [1,3]
- C0015127
- UMLS CUI [1,4]
- C0004936
Description
Adverse Event, Suicidality, Etiology aspects, Other medical condition
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3166387
- UMLS CUI [1,3]
- C0015127
- UMLS CUI [1,4]
- C3843040
Description
Adverse Event, Suicidality, Etiology aspects, psychosocial stressor
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3166387
- UMLS CUI [1,3]
- C0015127
- UMLS CUI [1,4]
- C0748073
Description
Adverse Event, Suicidality, Etiology aspects, Experimental drug, Withdraw
Type de données
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
Description
Adverse Event, Suicidality, Etiology aspects, Experimental drug, Medication dose changed
Type de données
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
Description
Adverse Event, Suicidality, Etiology aspects, Lack of Efficacy
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3166387
- UMLS CUI [1,3]
- C0015127
- UMLS CUI [1,4]
- C0235828
Description
Adverse Event, Suicidality, Etiology aspects, Experimental drug
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3166387
- UMLS CUI [1,3]
- C0015127
- UMLS CUI [1,4]
- C0304229
Description
Adverse Event, Suicidality, Etiology aspects, Other
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3166387
- UMLS CUI [1,3]
- C0015127
- UMLS CUI [1,4]
- C0205394
Description
Adverse Event, Suicidality, Etiology aspects, Other
Type de données
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3166387
- UMLS CUI [1,3]
- C0015127
- UMLS CUI [1,4]
- C0205394
Description
Section 4: Provide Information
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C3166387
- UMLS CUI-3
- C1533716
Description
Adverse Event, Suicidality, Medical History, Mental disorders
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3166387
- UMLS CUI [1,3]
- C0262926
- UMLS CUI [1,4]
- C0004936
Description
Adverse Event, Suicidality, Medical History, Active suicidal ideation; Adverse Event, Suicidality, Medical History, Suicidal behavior; Adverse Event, Suicidality, Medical History, Self-injurious Behavior
Type de données
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
Description
Adverse Event, Suicidality, Illicit medication use, Current
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3166387
- UMLS CUI [1,3]
- C0281875
- UMLS CUI [1,4]
- C0521116
Description
Adverse Event, Suicidality, Alcohol consumption, Current
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3166387
- UMLS CUI [1,3]
- C0001948
- UMLS CUI [1,4]
- C0521116
Description
Adverse Event, Suicidality, Family history
Type de données
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3166387
- UMLS CUI [1,3]
- C0241889
Description
Adverse Event, Suicidality, Family history, Mental disorders
Type de données
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C3166387
- UMLS CUI [1,3]
- C0241889
- UMLS CUI [1,4]
- C0004936
Description
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
Description
Section 6: Relevant and/or Recent Suicidal Ideation
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C3166387
- UMLS CUI-3
- C0424000
Description
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
Description
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
Similar models
Possible Suicidality-Related Adverse Event (PSRAE)
- StudyEvent: ODM
C3166387 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C3166387 (UMLS CUI-2)
C0678257 (UMLS CUI-3)
C3166387 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C3166387 (UMLS CUI-2)
C0015127 (UMLS CUI-3)
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,4])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0004936 (UMLS CUI [1,4])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C3843040 (UMLS CUI [1,4])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0748073 (UMLS CUI [1,4])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2349954 (UMLS CUI [1,5])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C1608430 (UMLS CUI [1,5])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0235828 (UMLS CUI [1,4])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C3166387 (UMLS CUI-2)
C1533716 (UMLS CUI-3)
C3166387 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0004936 (UMLS CUI [1,4])
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])
C3166387 (UMLS CUI [1,2])
C0281875 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
C3166387 (UMLS CUI [1,2])
C0001948 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
C3166387 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
C3166387 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
C0004936 (UMLS CUI [1,4])
C3166387 (UMLS CUI-2)
C0748073 (UMLS CUI-3)
C0521116 (UMLS CUI-4)
C3166387 (UMLS CUI [1,2])
C0748073 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
C3166387 (UMLS CUI-2)
C0424000 (UMLS CUI-3)
C3166387 (UMLS CUI [1,2])
C0424000 (UMLS CUI [1,3])
C3166387 (UMLS CUI-2)
C1760428 (UMLS CUI-3)
C0347984 (UMLS CUI-4)
C0008976 (UMLS CUI-5)
C3166387 (UMLS CUI [1,2])
C1760428 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,5])
C3166387 (UMLS CUI-2)
C0087111 (UMLS CUI-3)
C0947611 (UMLS CUI-4)
C3166387 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])