ID
38816
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
Keywords
Versions (1)
- 11/6/19 11/6/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
November 6, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder; NCT00896363
Serious Adverse Event - Repeating Form
- StudyEvent: ODM
Description
Randomisation
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0034656
Description
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Description
Serious Adverse Event, Sequence Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
Serious Adverse Event
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
Serious Adverse Event, Adverse Event Modified Reported Term
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826798
Description
Serious Adverse Event, Medical Dictionary for Regulatory Activities Terminology (MedDRA), Synonym
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1140263
- UMLS CUI [1,3]
- C0871468
Description
Serious Adverse Event, MedDRA Low Level Term Code
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3898442
Description
Serious Adverse Event, Code, Failed
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0805701
- UMLS CUI [1,3]
- C0231175
Description
Serious Adverse Event, Start Date, Start time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [1,3]
- C1301880
Description
Serious Adverse Event, Adverse Event Outcome
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Description
Serious Adverse Event, End date, End Time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [1,3]
- C1522314
Description
Serious Adverse Event, Fatal, Date of death, Time of death
Data type
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1302234
- UMLS CUI [1,3]
- C1148348
- UMLS CUI [1,4]
- C1301931
Description
Non-serious Adverse Event, Frequencies
Data type
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Description
Serious Adverse Event, Symptom intensity, Maximum
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Description
Serious Adverse Event, Grade, Maximum
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Description
Serious Adverse Event, Grade, Symptom intensity, Maximum
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0518690
- UMLS CUI [1,4]
- C0806909
Description
Serious Adverse Event, Action Taken with Study Treatment
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1704758
Description
Serious Adverse Event, Withdraw
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2349954
Description
Serious Adverse Event, Relationships, Experimental drug
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C0304229
Description
Serious Adverse Event, Duration
Data type
integer
Measurement units
- hours
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2926735
Description
Serious Adverse Event, Time of Onset, Time Last Dose
Data type
time
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449244
- UMLS CUI [1,3]
- C0946444
Description
Serious Adverse Event, Relationships, Study Subject Participation Status
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0439849
- UMLS CUI [1,3]
- C2348568
Description
Serious Adverse Event
Data type
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
Seriousness
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C1710056
Description
Relevant Concomitant/Treatment Medications
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Description
Serious Adverse Event, Concomitant Agent, Sequence Number
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2348184
Description
Serious Adverse Event, Concomitant Agent, Medication name
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C2360065
Description
Serious Adverse Event, Concomitant Agent, Dosage
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0178602
Description
Serious Adverse Event, Concomitant Agent, Unit of Measure
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C1519795
Description
Serious Adverse Event, Concomitant Agent, Frequencies
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0439603
Description
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0013153
Description
Serious Adverse Event, Concomitant Medication Start Date
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826734
Description
Serious Adverse Event, Concomitant Medication Ongoing
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826666
Description
Serious Adverse Event, Concomitant Medication End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2826744
Description
Serious Adverse Event, Concomitant Agent, Indication, Primary
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0392360
- UMLS CUI [1,4]
- C0205225
Description
Serious Adverse Event, Concomitant Agent, Type
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [1,3]
- C0332307
Description
Relevant Medical Conditions/Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0035648
Description
Serious Adverse Event, Disease, Risk factor, Sequence Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0035648
- UMLS CUI [1,4]
- C2348184
Description
Serious Adverse Event, Disease
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
Description
Serious Adverse Event, Disease, Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0808070
Description
Serious Adverse Event, Disease, Continuous
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0549178
Description
Serious Adverse Event, Disease, End Date
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0806020
Description
Serious Adverse Event, Medical History, Relevance; Serious Adverse Event, Risk factor
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C2347946
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0035648
Description
Relevant Diagnostic Results
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0430022
- UMLS CUI-3
- C1274040
Description
Serious Adverse Event, Laboratory Procedures, Sequence Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0022885
- UMLS CUI [1,3]
- C2348184
Description
Serious Adverse Event, Diagnostic procedure
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0430022
Description
Serious Adverse Event, Diagnostic procedure, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0011008
Description
Serious Adverse Event, Diagnostic procedure, Result
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C1274040
Description
Serious Adverse Event, Diagnostic procedure, Unit of Measure
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C1519795
Description
Serious Adverse Event, Diagnostic procedure, Normal Range, Low
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0086715
- UMLS CUI [1,4]
- C0205251
Description
Serious Adverse Event, Diagnostic procedure, Normal Range, High
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0086715
- UMLS CUI [1,4]
- C0205250
Description
Serious Adverse Event, Diagnostic procedure, Result, Other
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C1274040
- UMLS CUI [1,4]
- C0205394
Description
Investigational Products
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0304229
Description
General Narrative Comments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Description
Non Clinical
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2698490
Description
Serious Adverse Event, Data, Incomplete
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0205257
Description
Serious Adverse Event, Receipt Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2985846
Description
Serious Adverse Event, Receipt Date
Data type
date
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2985846
Description
Serious Adverse Event
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2985846
Description
Serious Adverse Event, Sequence Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Description
Serious Adverse Event, Version, Numbers
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0333052
- UMLS CUI [1,3]
- C0237753
Description
Serious Adverse Event, Case Subject, Identifier
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1698493
- UMLS CUI [1,3]
- C0600091
Description
Serious Adverse Event, Randomization, Numbers
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034656
- UMLS CUI [1,3]
- C0237753
Description
Serious Adverse Event, Code
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0805701
Description
Serious Adverse Event, Email
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013849
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- StudyEvent: ODM
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C1301931 (UMLS CUI [1,4])
C0439603 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
C1704758 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
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C0449244 (UMLS CUI [1,2])
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C1710056 (UMLS CUI-2)
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C2347852 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C2826734 (UMLS CUI [1,2])
C2826666 (UMLS CUI [1,2])
C2826744 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205225 (UMLS CUI [1,4])
C2347852 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0012634 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
C0012634 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,4])
C0012634 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0035648 (UMLS CUI [2,2])
C0430022 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
C0022885 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
C0430022 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0430022 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C0430022 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,4])
C0430022 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0205250 (UMLS CUI [1,4])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0304229 (UMLS CUI-2)
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0947611 (UMLS CUI-2)
C0947611 (UMLS CUI [1,2])
C2698490 (UMLS CUI-2)
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
C2985846 (UMLS CUI [1,2])
C2985846 (UMLS CUI [1,2])
C2985846 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C0333052 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0034656 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
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