ID

38542

Description

Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Keywords

Versions (2)
  1. 9/29/19 9/29/19 -
  2. 10/24/19 10/24/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 24, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636

English

Serious Adverse Events

1 forms  
  1. StudyEvent: ODM
    1. Serious Adverse Events
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Site
Description

Study Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient name

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient No
Description

Patients, Identification number

Data type

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Type of Report
Description

Type of Report

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0684224
UMLS CUI-3
C0332307
Type of Report
Description

Serious Adverse Event, Report, Type

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0684224
UMLS CUI [1,3]
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

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
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 Diagnosis Only (if known) Otherwise Sign/Symptom
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)

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1140263
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/Date of Death
Description

Serious Adverse Event, End Date; Serious Adverse Event, Date of death

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C1148348
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, Severity of Adverse Event

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710066
Intensity at onset of event
Description

Serious Adverse Event, Symptom intensity, Date of onset

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C0574845
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
Grade at onset of event
Description

Serious Adverse Event, Grade, Date of onset

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0574845
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
Grade or Intensity at onset of event
Description

Serious Adverse Event, Grade, Symptom intensity, Date of onset

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0518690
UMLS CUI [1,4]
C0574845
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 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

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2926735
Time to Onset Since Last Dose
Description

Serious Adverse Event, Time Last Dose

Data type

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0946444
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
Description

Serious Adverse Event, Relationship, 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
Related Investigational Product
Description

Serious Adverse Event, Relationship, Experimental drug

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0304229
Intensity Changes
Description

Intensity Changes

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0518690
UMLS CUI-3
C0392747
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/ Symptom
Description

Serious Adverse Event

Data type

text

Alias
UMLS CUI [1]
C1519255
Start Date and Time of event segment
Description

Serious Adverse Event, Part, Start Date, Start time

Data type

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0808070
UMLS CUI [1,4]
C1301880
Intensity of event segment
Description

Serious Adverse Event, Part, Symptom intensity

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0518690
Grade of event segment
Description

Serious Adverse Event, Part, Grade

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0441800
Grade or Intensity of event segment
Description

Serious Adverse Event, Part, Symptom intensity, Grade

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0518690
UMLS CUI [1,4]
C0441800
Seriousness
Description

Seriousness

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1710066
Seriousness?
Description

Serious Adverse Event, Severity of Adverse Event

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1710066
Relevant Concomitant/Treatment Medications
Description

Relevant Concomitant/Treatment Medications

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347852
CM Sequence Number
Description

Serous Adverse Event, Concomitant Agent, Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2348184
Drug name
Description

Serous 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
Modified reported term
Description

Serous Adverse Event, Concomitant Agent, Adverse Event Modified Reported Term

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2826819
Dose
Description

Serous Adverse Event, Concomitant Agent, Medication dose

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C3174092
Unit
Description

Serous Adverse Event, Concomitant Agent, Unit

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0439148
Frequency
Description

Serous 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

Serous 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

Serous Adverse Event, Concomitant Medication Start Date

Data type

date

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

Serous Adverse Event, Concomitant Medication Ongoing

Data type

boolean

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

Serous Adverse Event, Concomitant Medication Ongoing

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826744
Primary Indication
Description

Serous Adverse Event, Concomitant Agent, Indication

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0392360
Modified reported term
Description

Serous Adverse Event, Concomitant Agent, Adverse Event Modified Reported Term

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C2826798
Drug Type
Description

Serous 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, Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C2348184
Specific Condition Name
Description

Serious Adverse Event, Disease

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
Modified reported term
Description

Serious Adverse Event, Disease, Adverse Event Modified Reported Term

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C2826798
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

date

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, Disease, Risk factor

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
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
Rechallenge
Description

Rechallenge

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2347900
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
Description

Serious Adverse Event, Rechallenge

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2347900
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0304229
Study Drug
Description

Serious Adverse Event, Experimental drug

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Start Date
Description

Serious Adverse Event, Experimental drug, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0808070
Stop Date
Description

Serious Adverse Event, Experimental drug, End Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0806020
Dose
Description

Serious Adverse Event, Experimental drug, Dosage

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0178602
Cumulative Dose
Description

Serious Adverse Event, Experimental drug, Cumulative dose

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2986497
Regimen
Description

Serious Adverse Event, Experimental drug, Therapeutic regimen

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1276413
General Narrative Comments
Description

General Narrative Comments

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0947611
Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions) and details of the treatment.
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 in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2985846
UMLS CUI [1,3]
C1301880
Was the event serious?
Description

Serious Adverse Event

Data type

boolean

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
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
Randomisation 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

text

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 Events

1 forms
  1. StudyEvent: ODM
    1. Serious Adverse Events
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient name
Item
Patient
text
C1299487 (UMLS CUI [1])
Patients, Identification number
Item
Patient No
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item Group
Type of Report
C1519255 (UMLS CUI-1)
C0684224 (UMLS CUI-2)
C0332307 (UMLS CUI-3)
Item
Type of Report
text
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
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
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
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 Diagnosis Only (if known) Otherwise Sign/Symptom
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)
Item
MedDRA synonym
text
C1519255 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
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 (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae, provide End Date (4)
CL Item
Fatal, record Date of Death (5)
Serious Adverse Event, End Date; Serious Adverse Event, Date of death
Item
End Date/Date of Death
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1148348 (UMLS CUI [2,2])
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])
C1710066 (UMLS CUI [1,2])
Non-serious Adverse Event, Severity of Adverse Event
Code List
Maximum Intensity
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Intensity at onset of event
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
Non-serious Adverse Event, Symptom intensity, Date of onset
Code List
Intensity at onset of event
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 3  (3)
CL Item
Grade 4  (4)
CL Item
Grade 5 (5)
Item
Grade at onset of event
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,3])
Non-serious Adverse Event, Grade, Date of onset
Code List
Grade at onset of event
CL Item
Grade 1  (1)
CL Item
Grade 2  (2)
CL Item
Grade 3  (3)
CL Item
Grade 4  (4)
CL Item
Grade 5 (5)
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 3  (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (6)
Item
Grade or Intensity at onset of event
text
C1519255 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0574845 (UMLS CUI [1,4])
Non-serious Adverse Event, Grade, Symptom intensity, Date of onset
Code List
Grade or Intensity at onset of event
CL Item
Mild or Grade 1  (1)
CL Item
Moderate or Grade 2  (2)
CL Item
Severe or Grade 3  (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 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
time
C1519255 (UMLS CUI [1,1])
C2926735 (UMLS CUI [1,2])
Serious Adverse Event, Time Last Dose
Item
Time to Onset Since Last Dose
time
C1519255 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
Serious Adverse Event, Relationship, Study Subject Participation Status
Item
Was the SAE caused by activities related to study participation other than investigational product (e.g. procedures, blood draws, washout, etc)?
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])
Serious Adverse Event, Relationship, Experimental drug
Item
Related Investigational Product
text
C1519255 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item Group
Intensity Changes
C1519255 (UMLS CUI-1)
C0518690 (UMLS CUI-2)
C0392747 (UMLS CUI-3)
Serious Adverse Event
Item
Serious Adverse Event Diagnosis Only (if known) Otherwise Sign/ Symptom
text
C1519255 (UMLS CUI [1])
Serious Adverse Event, Part, Start Date, Start time
Item
Start Date and Time of event segment
datetime
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,4])
Item
Intensity of event segment
text
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
Non-serious Adverse Event, Part, Symptom intensity
Code List
Intensity of event segment
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
Item
Grade of event segment
text
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,3])
Non-serious Adverse Event, Part, Grade
Code List
Grade of event segment
CL Item
Grade 1  (1)
CL Item
Grade 2  (2)
CL Item
Grade 3  (3)
CL Item
Grade 4  (4)
CL Item
Grade 5 (5)
Item
Grade or Intensity of event segment
text
C1519255 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,4])
Non-serious Adverse Event, Part, Symptom intensity, Grade
Code List
Grade or Intensity of event segment
CL Item
Mild or Grade 1  (1)
CL Item
Moderate or Grade 2  (2)
CL Item
Severe or Grade 3  (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
Item Group
Seriousness
C1519255 (UMLS CUI-1)
C1710066 (UMLS CUI-2)
Item
Seriousness?
text
C1519255 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Serious Adverse Event, Severity of Adverse Event
Code List
Seriousness?
CL Item
Results in death  (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (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)
Serous Adverse Event, Concomitant Agent, Sequence Number
Item
CM Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Serous 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])
Serous Adverse Event, Concomitant Agent, Adverse Event Modified Reported Term
Item
Modified reported term
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826819 (UMLS CUI [1,3])
Serous Adverse Event, Concomitant Agent, Medication dose
Item
Dose
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
Serous Adverse Event, Concomitant Agent, Unit
Item
Unit
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439148 (UMLS CUI [1,3])
Serous Adverse Event, Concomitant Agent, Frequencies
Item
Frequency
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
Serous 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])
Serous Adverse Event, Concomitant Medication Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C2826734 (UMLS CUI [1,2])
Serous Adverse Event, Concomitant Medication Ongoing
Item
Ongoing?
boolean
C1519255 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
Serous Adverse Event, Concomitant Medication Ongoing
Item
No, specify End Date
date
C1519255 (UMLS CUI [1,1])
C2826744 (UMLS CUI [1,2])
Serous Adverse Event, Concomitant Agent, Indication
Item
Primary Indication
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Serous Adverse Event, Concomitant Agent, Adverse Event Modified Reported Term
Item
Modified reported term
text
C1519255 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2826798 (UMLS CUI [1,3])
Serous 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, Sequence Number
Item
MHx Sequence Number
integer
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,3])
Serious Adverse Event, Disease
Item
Specific Condition Name
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Serious Adverse Event, Disease, Adverse Event Modified Reported Term
Item
Modified reported term
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C2826798 (UMLS CUI [1,3])
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
date
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Disease, Risk factor
Item
Relevant Medical History / Risk Factors not noted above
text
C1519255 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,3])
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
Rechallenge
C1519255 (UMLS CUI-1)
C2347900 (UMLS CUI-2)
Item
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
text
C1519255 (UMLS CUI [1,1])
C2347900 (UMLS CUI [1,2])
Serious Adverse Event, Rechallenge
Code List
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown at this time  (3)
CL Item
Not applicable (4)
Item Group
Investigational Product
C1519255 (UMLS CUI-1)
C0304229 (UMLS CUI-2)
Serious Adverse Event, Experimental drug
Item
Study Drug
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Serious Adverse Event, Experimental drug, Start Date
Item
Start Date
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, End Date
Item
Stop Date
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, Dosage
Item
Dose
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, Cumulative dose
Item
Cumulative Dose
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,3])
Serious Adverse Event, Experimental drug, Therapeutic regimen
Item
Regimen
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1276413 (UMLS CUI [1,3])
Item Group
General Narrative Comments
C1519255 (UMLS CUI-1)
C0947611 (UMLS CUI-2)
Serious Adverse Event, Comment
Item
Provide a brief narrative description of SAE, possible other causes of the event (e.g. lack of efficacy, withdrawal of investigational product, the disease under study or other medical conditions) and details of the treatment.
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 in time, Time
Item
Receipt by GSK date
datetime
C1519255 (UMLS CUI [1,1])
C2985846 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Serious Adverse Event
Item
Was the event serious?
boolean
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, Version, Numbers
Item
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
Randomisation Number
integer
C1519255 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Serious Adverse Event, Code
Item
OCEANS Code
text
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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