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)
  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

English

Serious Adverse Event - Repeating Form

1 forms  
Type of Report
Description

Type of Report

Alias
UMLS CUI-1
C3897642
UMLS CUI-2
C0332307
Type of report
Description

Serious Adverse Event Report, Type

Data type

text

Alias
UMLS CUI [1,1]
C3897642
UMLS CUI [1,2]
C0332307
Randomisation
Description

Randomisation

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0034656
Did SAE occur after initiation of study medication?
Description

Serious Adverse Event, Experimental drug, Start Date

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0808070
Serious Adverse Event
Description

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
SAE Sequence Number
Description

Serious Adverse Event, Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Serious Adverse Event
Description

Serious Adverse Event

Data type

text

Alias
UMLS CUI [1]
C1519255
Modified term
Description

Serious Adverse Event, Adverse Event Modified Reported Term

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826798
MedDRA synonym
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
MedDRA lower level term code
Description

Serious Adverse Event, MedDRA Low Level Term Code

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3898442
Failed coding
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
Start Date and Time
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
Outcome
Description

Serious Adverse Event, Adverse Event Outcome

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
End Date and Time
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
Date and Time of Death
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
Frequency
Description

Non-serious Adverse Event, Frequencies

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439603
Maximum Intensity
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
Maximum Grade
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
Maximum Grade or Intensity
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
Action Taken with Investigational product(s) as a Result of the AE
Description

Serious Adverse Event, Action Taken with Study Treatment

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1704758
Did the subject withdraw from the study as a result of this AE?
Description

Serious Adverse Event, Withdraw

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2349954
Is there a reasonable possibility that the AE may have been caused by the investigational product?
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
Duration of AE if < 24 hours
Description

Serious Adverse Event, Duration

Data type

integer

Measurement units
  • hours
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2926735
hours
Time to Onset Since Last Dose
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
Was SAE caused by activities related to study participation
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
Was the event serious?
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Seriousness
Description

Seriousness

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710056
Seriousness?
Description

Serious Adverse Event, Seriousness of Adverse Event

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710056
Relevant Concomitant/Treatment Medications
Description

Relevant Concomitant/Treatment Medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
CM Sequence Number
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
Drug Name
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
Dose
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
Unit
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
Frequency
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
Route
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
Start Date
Description

Serious Adverse Event, Concomitant Medication Start Date

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826734
Ongoing?
Description

Serious Adverse Event, Concomitant Medication Ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826666
No, specify End Date
Description

Serious Adverse Event, Concomitant Medication End Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826744
Primary Indication
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
Drug Type
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
Relevant Medical Conditions/Risk Factors
Description

Relevant Medical Conditions/Risk Factors

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0012634
UMLS CUI-3
C0035648
MHx Sequence Number
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
Specific Condition Name
Description

Serious Adverse Event, Disease

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
Date of onset
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
Continuing?
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
No, specify date of last occurrence
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
Relevant Medical History/Risk Factors not noted above
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
Relevant Diagnostic Results
Description

Relevant Diagnostic Results

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0430022
UMLS CUI-3
C1274040
Lab Sequence Number
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
Test Name
Description

Serious Adverse Event, Diagnostic procedure

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0430022
Test Date
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
Test Result
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
Test Units
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
Normal Low Range
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
Normal High Range
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
Relevant diagnostic results not noted above
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
Investigational Products
Description

Investigational Products

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Description

Serious Adverse Event, Relationships, Experimental drugs

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
General Narrative Comments
Description

General Narrative Comments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
General narrative comments
Description

Serious Adverse Event, Comment

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0947611
Non Clinical
Description

Non Clinical

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2698490
Send incomplete SAE data to GSK Safety
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
Receipt by GSK date
Description

Serious Adverse Event, Receipt Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2985846
Receipt by GSK date
Description

Serious Adverse Event, Receipt Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2985846
Was the event serious?
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2985846
SAE Sequence Number
Description

Serious Adverse Event, Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
SAE Version Number
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
Case ID
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
Randomsation Number
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
OCEANS Code
Description

Serious Adverse Event, Code

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0805701
Email Flag
Description

Serious Adverse Event, Email

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013849
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Similar models

Serious Adverse Event - Repeating Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Type of Report
C3897642 (UMLS CUI-1)
C0332307 (UMLS CUI-2)
Item
Type of report
text
C3897642 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Serious Adverse Event Report, Type
Code List
Type of report
CL Item
Initial Report (1)
CL Item
Follow-Up Report (2)
Item Group
Randomisation
C1519255 (UMLS CUI-1)
C0034656 (UMLS CUI-2)
Serious Adverse Event, Experimental drug, Start Date
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
Serious Adverse Event, Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Serious Adverse Event, Adverse Event Modified Reported Term
Item
Modified term
text
C1519255 (UMLS CUI [1,1])
C2826798 (UMLS CUI [1,2])
Serious Adverse Event, Medical Dictionary for Regulatory Activities Terminology (MedDRA), Synonym
Item
MedDRA synonym
text
C1519255 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,3])
Serious Adverse Event, MedDRA Low Level Term Code
Item
MedDRA lower level term code
text
C1519255 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Serious Adverse Event, Code, Failed
Item
Failed coding
text
C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Serious Adverse Event, Start Date, Start time
Item
Start Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious Adverse Event, Adverse Event Outcome
Code List
Outcome
CL Item
Recovered/Resolved, provide End Date and Time (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (4)
CL Item
Fatal, record Date and Time of Death (5)
Serious Adverse Event, End date, End Time
Item
End Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Serious Adverse Event, Fatal, Date of death, Time of death
Item
Date and Time of Death
datetime
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C1148348 (UMLS CUI [1,3])
C1301931 (UMLS CUI [1,4])
Item
Frequency
text
C1518404 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Non-serious Adverse Event, Frequencies
Code List
Frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-serious Adverse Event, Frequencies
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Maximum Grade
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Non-serious Adverse Event, Grade, Maximum
Code List
Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 2 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Maximum Grade or Intensity
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
Non-serious Adverse Event, Grade, Symptom intensity, Maximum
Code List
Maximum Grade or Intensity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 2 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Action Taken with Investigational product(s) as a Result of the AE
text
C1519255 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Non-serious Adverse Event, Action Taken with Study Treatment
Code List
Action Taken with Investigational product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Serious Adverse Event, Withdraw
Item
Did the subject withdraw from the study as a result of this AE?
boolean
C1519255 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Serious Adverse Event, Relationships, Experimental drug
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event, Duration
Item
Duration of AE if < 24 hours
integer
C1519255 (UMLS CUI [1,1])
C2926735 (UMLS CUI [1,2])
Serious Adverse Event, Time of Onset, Time Last Dose
Item
Time to Onset Since Last Dose
time
C1519255 (UMLS CUI [1,1])
C0449244 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
Serious Adverse Event, Relationships, Study Subject Participation Status
Item
Was SAE caused by activities related to study participation
boolean
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Serious Adverse Event
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1])
Item Group
Seriousness
C1519255 (UMLS CUI-1)
C1710056 (UMLS CUI-2)
Item
Seriousness?
text
C1519255 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Serious Adverse Event, Seriousness of Adverse Event
Code List
Seriousness?
CL Item
Results in death (1)
CL Item
Is life-threatening  (2)
CL Item
Required hospitalization or prolongation of existing hospitalization  (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Other, specify within general narrative comment  (6)
Item Group
Relevant Concomitant/Treatment Medications
C1519255 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Serious Adverse Event, Concomitant Agent, Sequence Number
Item
CM Sequence Number
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Medication name
Item
Drug Name
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Dosage
Item
Dose
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Unit of Measure
Item
Unit
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Frequencies
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Agent, Drug Administration Routes
Item
Route
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Serious Adverse Event, Concomitant Medication Start Date
Item
Start Date
text
C1519255 (UMLS CUI [1,1])
C2826734 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Medication Ongoing
Item
Ongoing?
boolean
C1519255 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Medication End Date
Item
No, specify End Date
date
C1519255 (UMLS CUI [1,1])
C2826744 (UMLS CUI [1,2])
Serious Adverse Event, Concomitant Agent, Indication, Primary
Item
Primary Indication
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205225 (UMLS CUI [1,4])
Serious Adverse Event, Concomitant Agent, Type
Item
Drug Type
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Item Group
Relevant Medical Conditions/Risk Factors
C1519255 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
Serious Adverse Event, Disease, Risk factor, Sequence Number
Item
MHx Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,4])
Serious Adverse Event, Disease
Item
Specific Condition Name
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Serious Adverse Event, Disease, Start Date
Item
Date of onset
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Item
Continuing?
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Serious Adverse Event, Disease, Continuous
Code List
Continuing?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
Serious Adverse Event, Disease, End Date
Item
No, specify date of last occurrence
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Medical History, Relevance; Serious Adverse Event, Risk factor
Item
Relevant Medical History/Risk Factors not noted above
text
C1519255 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0035648 (UMLS CUI [2,2])
Item Group
Relevant Diagnostic Results
C1519255 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C1274040 (UMLS CUI-3)
Serious Adverse Event, Laboratory Procedures, Sequence Number
Item
Lab Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Serious Adverse Event, Diagnostic procedure
Item
Test Name
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
Serious Adverse Event, Diagnostic procedure, Date in time
Item
Test Date
date
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Serious Adverse Event, Diagnostic procedure, Result
Item
Test Result
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Serious Adverse Event, Diagnostic procedure, Unit of Measure
Item
Test Units
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Serious Adverse Event, Diagnostic procedure, Normal Range, Low
Item
Normal Low Range
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,4])
Serious Adverse Event, Diagnostic procedure, Normal Range, High
Item
Normal High Range
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
C0205250 (UMLS CUI [1,4])
Serious Adverse Event, Diagnostic procedure, Result, Other
Item
Relevant diagnostic results not noted above
text
C1519255 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item Group
Investigational Products
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Item
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Serious Adverse Event, Relationships, Experimental drugs
Code List
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item Group
General Narrative Comments
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Serious Adverse Event, Comment
Item
General narrative comments
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Non Clinical
C1519255 (UMLS CUI-1)
C2698490 (UMLS CUI-2)
Item
Send incomplete SAE data to GSK Safety
text
C1519255 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
Serious Adverse Event, Data, Incomplete
Code List
Send incomplete SAE data to GSK Safety
CL Item
Incomplete SAE (1)
Serious Adverse Event, Receipt Date
Item
Receipt by GSK date
date
C1519255 (UMLS CUI [1,1])
C2985846 (UMLS CUI [1,2])
Serious Adverse Event, Receipt Date
Item
Receipt by GSK date
date
C1519255 (UMLS CUI [1,1])
C2985846 (UMLS CUI [1,2])
Serious Adverse Event
Item
Was the event serious?
boolean
C1519255 (UMLS CUI [1,1])
C2985846 (UMLS CUI [1,2])
Serious Adverse Event, Sequence Number
Item
SAE Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Serious Adverse Event, Version, Numbers
Item
SAE Version Number
integer
C1519255 (UMLS CUI [1,1])
C0333052 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Serious Adverse Event, Case Subject, Identifier
Item
Case ID
integer
C1519255 (UMLS CUI [1,1])
C1698493 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Serious Adverse Event, Randomization, Numbers
Item
Randomsation Number
integer
C1519255 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Serious Adverse Event, Code
Item
OCEANS Code
integer
C1519255 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Serious Adverse Event, Email
Item
Email Flag
text
C1519255 (UMLS CUI [1,1])
C0013849 (UMLS CUI [1,2])
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