ID
31482
Beskrivning
Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram Study Indication: Depressive Disorder and Anxiety Disorders
Nyckelord
Versioner (1)
- 2018-08-27 2018-08-27 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
27 augusti 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384
Non- Serious and Serious Adverse Event
- StudyEvent: ODM
Beskrivning
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Report type
Datatyp
integer
Alias
- UMLS CUI [1]
- C0585733
Beskrivning
Serious Adverse Event; Experimental drug; Post
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0687676
Beskrivning
Serious Adverse Event; Diagnosis | Serious Adverse Event; Signs and Symptoms
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0037088
Beskrivning
Serious Adverse Event; Start Date | Serious Adverse Event; Start time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1301880
Beskrivning
Adverse Event Outcome; Serious Adverse Event
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beskrivning
Adverse Event Outcome | Adverse Event End Date Time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C1705586
- UMLS CUI [2]
- C2826793
Beskrivning
Severity of Adverse Event
Datatyp
integer
Alias
- UMLS CUI [1]
- C1710066
Beskrivning
Serious Adverse event; Grade
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
Beskrivning
Serious Adverse event; Grade | Severity of Adverse Event
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [2]
- C1710066
Beskrivning
Experimental drug; Treatment modification | Serious Adverse event
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1299575
- UMLS CUI [2]
- C1519255
Beskrivning
Study Withdrawn | Serious Adverse event
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348571
- UMLS CUI [2]
- C1519255
Beskrivning
Experimental drug; Serious Adverse event; Causations
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0085978
Beskrivning
Serious Adverse event; Duration (temporal concept)
Datatyp
durationDatetime
Alias
- UMLS CUI [1,1]
- C0449238
- UMLS CUI [1,2]
- C0449238
Beskrivning
Serious Adverse event; Time of onset; Date last dose
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449244
- UMLS CUI [1,3]
- C1762893
Beskrivning
Serious Adverse Event; Study Treatment Causality
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3641099
Beskrivning
Serious Adverse Event
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Seriousness of Adverse Event; Serious Adverse Event
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1519255
Beskrivning
Relevant Concomitant/ Tratment Medications
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C1707479
Beskrivning
Medication name
Datatyp
text
Alias
- UMLS CUI [1]
- C2360065
Beskrivning
Concomitant Therapy; Medication dose
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1707479
- UMLS CUI [1,2]
- C3174092
Beskrivning
Unit
Datatyp
text
Alias
- UMLS CUI [1]
- C0439148
Beskrivning
Medication frequency
Datatyp
integer
Alias
- UMLS CUI [1]
- C3476109
Beskrivning
Drug Administration Routes
Datatyp
integer
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
Concomitant Medication Start Date | Pharmaceutical Preparations; Concomitant Therapy; Start time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826734
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C1707479
- UMLS CUI [2,3]
- C1301880
Beskrivning
Concomitant Medication Ongoing
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
Concomitant Medication End Date | Pharmaceutical Preparations; Concomitant Therapy; End Time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826744
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C1707479
- UMLS CUI [2,3]
- C1522314
Beskrivning
Concomitant Medication Use Indication
Datatyp
text
Alias
- UMLS CUI [1]
- C2826696
Beskrivning
Types of drugs
Datatyp
text
Alias
- UMLS CUI [1]
- C0457591
Beskrivning
Relevant medical conditions/ risk factors
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0035648
Beskrivning
Disease; Specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beskrivning
Date of onset
Datatyp
date
Alias
- UMLS CUI [1]
- C0574845
Beskrivning
Disease; Continuous | risk factors; Continuous
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [2,1]
- C0035648
- UMLS CUI [2,2]
- C0549178
Beskrivning
Disease; Occurrence; Date in time | risk factors; Occurrence; Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2745955
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [2,1]
- C0035648
- UMLS CUI [2,2]
- C2745955
- UMLS CUI [2,3]
- C0011008
Beskrivning
Medical History | risk factors
Datatyp
text
Alias
- UMLS CUI [1]
- C0262926
- UMLS CUI [2]
- C0035648
Beskrivning
Relevant Diagnostic Results
Alias
- UMLS CUI-1
- C0430022
- UMLS CUI-2
- C1274040
Beskrivning
diagnostic procedure; Test Name
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C2826273
Beskrivning
Test Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826247
Beskrivning
Test Result
Datatyp
text
Alias
- UMLS CUI [1]
- C0456984
Beskrivning
diagnostic procedure; Result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C1274040
Beskrivning
Investigational Products
Alias
- UMLS CUI-1
- C0304229
Beskrivning
General Narrative Comments
Alias
- UMLS CUI-1
- C0947611
Similar models
Non- Serious and Serious Adverse Event
- StudyEvent: ODM
C0011900 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0037088 (UMLS CUI [2,2])
C1518404 (UMLS CUI [1,2])
C2826793 (UMLS CUI [2])
C0439603 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,2])
C1710066 (UMLS CUI [2])
C1299575 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])
C1518404 (UMLS CUI [2])
C1518404 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0037088 (UMLS CUI [2,2])
C0808070 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C1519255 (UMLS CUI [1,2])
C2826793 (UMLS CUI [2])
C0441800 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,2])
C1710066 (UMLS CUI [2])
C1299575 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
C1519255 (UMLS CUI [2])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,3])
C3641099 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1707479 (UMLS CUI-2)
C3174092 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C1707479 (UMLS CUI [2,2])
C1301880 (UMLS CUI [2,3])
C0013227 (UMLS CUI [2,1])
C1707479 (UMLS CUI [2,2])
C1522314 (UMLS CUI [2,3])
C0035648 (UMLS CUI-2)
C2348235 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C2745955 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0035648 (UMLS CUI [2,1])
C2745955 (UMLS CUI [2,2])
C0011008 (UMLS CUI [2,3])
C0035648 (UMLS CUI [2])
C1274040 (UMLS CUI-2)
C2826273 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,3])