ID

30780

Beschrijving

Study ID: 107979 Clinical Study ID: TXA107979 Study Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00843024 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan/naproxen Trade Name: Treximet Study Indication: Migraine Disorders CRF Seiten: 879-993

Trefwoorden

Versies (1)
  1. 20-06-18 20-06-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

20 juni 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
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TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024

Duits Engels

LOG Visit

1 Formulieren  
  1. StudyEvent: ODM
    1. LOG Visit
Date of Visit/Assessment
Beschrijving

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
Date of Visit
Beschrijving

Date of Visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Adverse event
Beschrijving

Adverse event

Alias
UMLS CUI-1
C0877248
non-serious adverse events
Beschrijving

non-serious adverse events

Datatype

boolean

Alias
UMLS CUI [1]
C1518404
Log status
Beschrijving

Log status

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0449438
serious adverse events
Beschrijving

serious adverse events

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
concomitant medications
Beschrijving

concomitant medications

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
Concomitant Medications
Beschrijving

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Sequence number
Beschrijving

Sequence number

Datatype

integer

Alias
UMLS CUI [1]
C2348184
Drug name
Beschrijving

Drug name

Datatype

text

Alias
UMLS CUI [1]
C0013227
Modified reported term
Beschrijving

Modified reported term

Datatype

text

Alias
UMLS CUI [1]
C2826302
UMLS CUI [2]
C2347852
Unit Dose
Beschrijving

Unit Dose

Datatype

float

Alias
UMLS CUI [1]
C0869039
Units
Beschrijving

Units

Datatype

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beschrijving

Frequency

Datatype

text

Alias
UMLS CUI [1]
C3476109
Route
Beschrijving

Route

Datatype

text

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Beschrijving

Reason for Medication

Datatype

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0013227
Generic Dispensed
Beschrijving

Generic Dispensed

Datatype

boolean

Alias
UMLS CUI [1]
C3242750
Prescription or OTC
Beschrijving

Prescription or OTC

Datatype

text

Alias
UMLS CUI [1]
C3166216
UMLS CUI [2]
C0013231
Medication start datetime
Beschrijving

Medication start datetime

Datatype

datetime

Alias
UMLS CUI [1]
C3173309
Taken Prior to Study?
Beschrijving

Taken Prior to Study?

Datatype

boolean

Alias
UMLS CUI [1]
C2826667
medication ongoing
Beschrijving

medication ongoing

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
Concomitant Medication End Date
Beschrijving

Concomitant Medication End Date

Datatype

date

Alias
UMLS CUI [1]
C2826744
Device used to administer medication
Beschrijving

Device used to administer medication

Datatype

text

Alias
UMLS CUI [1]
C0699733
Total Daily Dose
Beschrijving

Total Daily Dose

Datatype

integer

Alias
UMLS CUI [1]
C2348070
drug adminstered for an exacerbation
Beschrijving

drug adminstered for an exacerbation

Datatype

boolean

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C4086268
Rescue Medication
Beschrijving

Rescue Medication

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0884980
kumulative Dosis
Beschrijving

Total Dose

Datatype

integer

Alias
UMLS CUI [1]
C2986497
drug use
Beschrijving

drug use

Datatype

boolean

Alias
UMLS CUI [1]
C0242510
Total duration
Beschrijving

Total duration

Datatype

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0449238
duration
Beschrijving

duration

Datatype

text

Alias
UMLS CUI [1]
C0449238
Non-serious adverse event
Beschrijving

Non-serious adverse event

Sequence Number
Beschrijving

Sequence Number

Datatype

text

Alias
UMLS CUI [1]
C2348184
Non-serious adverse event
Beschrijving

Non-serious adverse event

Datatype

text

Alias
UMLS CUI [1]
C1518404
Modified term
Beschrijving

Modified term

Datatype

text

Alias
UMLS CUI [1]
C2826302
MedDRA synonym
Beschrijving

MedDRA synonym

Datatype

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Beschrijving

MedDRA lower level term code

Datatype

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C1518404
Start Date
Beschrijving

Start Date

Datatype

date

Alias
UMLS CUI [1]
C0808070
Outcome
Beschrijving

Outcome

Datatype

integer

Alias
UMLS CUI [1]
C1705586
End date
Beschrijving

End date

Datatype

date

Alias
UMLS CUI [1]
C0806020
Maximum Intensity
Beschrijving

Maximum Intensity

Datatype

text

Alias
UMLS CUI [1]
C1710066
Intensity at onset of event
Beschrijving

Intensity at onset of event

Datatype

text

Alias
UMLS CUI [1]
C1710066
Maximum Grade
Beschrijving

Maximum Grade

Datatype

integer

Alias
UMLS CUI [1]
C0441799
Grade at onset of event
Beschrijving

Grade at onset of event

Datatype

integer

Alias
UMLS CUI [1,1]
C2985916
UMLS CUI [1,2]
C0441799
Maximum Grade or Intensity
Beschrijving

Maximum Grade or Intensity

Datatype

text

Alias
UMLS CUI [1,1]
C0441799
UMLS CUI [1,2]
C1710066
Grade or Intensity at onset of event
Beschrijving

Grade or Intensity at onset of event

Datatype

text

Alias
UMLS CUI [1]
C1710066
Action Taken with Investigational Product
Beschrijving

Action Taken with Investigational Product

Datatype

text

Alias
UMLS CUI [1]
C1704758
Withdrawal from study
Beschrijving

Withdrawal from study

Datatype

boolean

Alias
UMLS CUI [1]
C0422727
AE caused by investigational product
Beschrijving

AE caused by investigational product

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1518404
Duration of AE hours
Beschrijving

Duration of AE hours

Datatype

integer

Maateenheden
  • h
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1519255
h
Duration of AE minutes
Beschrijving

Duration of AE minutes

Datatype

integer

Maateenheden
  • min
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1518404
min
Time to Onset Since Last Dose hours
Beschrijving

Time to Onset Since Last Dose hours

Datatype

integer

Maateenheden
  • h
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
h
Time to Onset Since Last Dose minutes
Beschrijving

Time to Onset Since Last Dose minutes

Datatype

integer

Maateenheden
  • min
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
min
Report
Beschrijving

Report

Initial report
Beschrijving

Initial report

Datatype

boolean

Alias
UMLS CUI [1]
C0684224
Follow-up report
Beschrijving

Follow-up report

Datatype

boolean

Alias
UMLS CUI [1]
C1704685
Randomisation
Beschrijving

Randomisation

Alias
UMLS CUI-1
C0034656
SAE after initiation of study medication
Beschrijving

SAE after initiation of study medication

Datatype

boolean

Alias
UMLS CUI [1,1]
C2826666
UMLS CUI [1,2]
C1519255
Serious Adverse Event
Beschrijving

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Sequence Number
Beschrijving

Sequence Number

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Modified term
Beschrijving

Modified term

Datatype

text

Alias
UMLS CUI [1,1]
C2826302
UMLS CUI [1,2]
C1519255
MedDRA synonym
Beschrijving

MedDRA synonym

Datatype

text

Alias
UMLS CUI [1,1]
C1140263
UMLS CUI [1,2]
C1519255
MedDRA lower level term code
Beschrijving

MedDRA lower level term code

Datatype

text

Alias
UMLS CUI [1,1]
C3898442
UMLS CUI [1,2]
C1519255
serious adverse event
Beschrijving

serious adverse event

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Did SAE occur after initiation of study medication
Beschrijving

Did SAE occur after initiation of study medication

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
Serious Adverse Event
Beschrijving

Serious Adverse Event

Datatype

text

Alias
UMLS CUI [1]
C1519255
Serious Adverse Event Start Date
Beschrijving

Serious Adverse Event Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697888
Start Time Serious Adverse Event
Beschrijving

Start Time Serious Adverse Event

Datatype

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697889
Serious Adverse Event End Date
Beschrijving

Serious Adverse Event End Date

Datatype

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697886
Serious Adverse Event End Time
Beschrijving

Serious Adverse Event End Time

Datatype

time

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826658
Outcome
Beschrijving

Outcome

Datatype

integer

Alias
UMLS CUI [1,1]
C1624730
UMLS CUI [1,2]
C1519255
Date of Death
Beschrijving

Date of Death

Datatype

date

Alias
UMLS CUI [1]
C1148348
Intensity (maximum)
Beschrijving

Intensity (maximum)

Datatype

text

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Intensity at onset of event
Beschrijving

Intensity at onset of event

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
Maximum Grade
Beschrijving

Maximum Grade

Datatype

integer

Alias
UMLS CUI [1]
C0441799
Grade at onset of event
Beschrijving

Grade at onset of event

Datatype

integer

Alias
UMLS CUI [1]
C2985911
Maximum Grade or Intensity
Beschrijving

Maximum Grade or Intensity

Datatype

text

Alias
UMLS CUI [1,1]
C0441799
UMLS CUI [1,2]
C1710066
Grade or Intensity at onset of event
Beschrijving

Grade or Intensity at onset of event

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
Action Taken
Beschrijving

Action Taken

Datatype

integer

Alias
UMLS CUI [1]
C1547656
Relationship investigational product
Beschrijving

Relationship investigational product

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1519255
Did the subject withdraw from study as a result of this AE?
Beschrijving

Did the subject withdraw from study as a result of this AE?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1519255
Duration of AE if < 24 hours
Beschrijving

Duration of AE if < 24 hours

Datatype

integer

Maateenheden
  • Hr(s)
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449238
Hr(s)
Time to Onset Since Last Dose
Beschrijving

Time to Onset Since Last Dose

Datatype

integer

Maateenheden
  • Min(s)
Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0946444
UMLS CUI [1,3]
C0449244
Min(s)
SAE Causation
Beschrijving

SAE Causation

Datatype

boolean

Alias
UMLS CUI [1,1]
C3641099
UMLS CUI [1,2]
C1519255
Serious Adverse Event
Beschrijving

Serious Adverse Event

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
investigational product
Beschrijving

investigational product

Datatype

text

Alias
UMLS CUI [1]
C0304229
Intensity changes
Beschrijving

Intensity changes

Serious Adverse Event Intensity changes
Beschrijving

Serious Adverse Event Intensity changes

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
Start Date of event segment
Beschrijving

Start Date of event segment

Datatype

date

Alias
UMLS CUI [1]
C2697888
Start Time of event segment
Beschrijving

Start Time of event segment

Datatype

time

Alias
UMLS CUI [1]
C2697889
Intensity of event segment
Beschrijving

Intensity of event segment

Datatype

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
Grade of event segment
Beschrijving

Grade of event segment

Datatype

integer

Alias
UMLS CUI [1]
C2985911
Grade or Intensity of event segment
Beschrijving

Grade or Intensity of event segment

Datatype

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0518690
Seriousness
Beschrijving

Seriousness

Alias
UMLS CUI-1
C0871902
UMLS CUI-2
C1519255
Seriousness
Beschrijving

Seriousness

Datatype

integer

Alias
UMLS CUI [1]
C1710056
Seriousness Other
Beschrijving

Seriousness Other

Datatype

text

Alias
UMLS CUI [1]
C1710056
Relevant concomitant/treatment medications
Beschrijving

Relevant concomitant/treatment medications

CM Sequence Number
Beschrijving

CM Sequence Number

Datatype

text

Alias
UMLS CUI [1]
C2348184
Drug name
Beschrijving

Drug name

Datatype

text

Alias
UMLS CUI [1]
C0013227
Modified reported term
Beschrijving

Modified reported term

Datatype

text

Alias
UMLS CUI [1]
C2826819
Dose
Beschrijving

Dose

Datatype

text

Alias
UMLS CUI [1]
C3174092
units of medication
Beschrijving

units of medication

Datatype

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beschrijving

Frequency

Datatype

text

Alias
UMLS CUI [1]
C3476109
Route of medication
Beschrijving

Route of medication

Datatype

text

Alias
UMLS CUI [1]
C0013153
Start Date
Beschrijving

Start Date

Datatype

date

Alias
UMLS CUI [1]
C0808070
Ongoing medication
Beschrijving

Ongoing medication

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
End date medication
Beschrijving

End date medication

Datatype

date

Alias
UMLS CUI [1,1]
C1521826
UMLS CUI [1,2]
C0806020
Primary Indication
Beschrijving

Primary Indication

Datatype

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C1519255
Modified reported term
Beschrijving

Modified reported term

Datatype

text

Alias
UMLS CUI [1]
C2826819
Drug Type
Beschrijving

Drug Type

Datatype

text

Alias
UMLS CUI [1]
C0457591
Relevant diagnostic results
Beschrijving

Relevant diagnostic results

Lab Sequence Number
Beschrijving

Lab Sequence Number

Datatype

text

Alias
UMLS CUI [1]
C2348184
Test Name
Beschrijving

Test Name

Datatype

text

Alias
UMLS CUI [1]
C0022885
Test Date
Beschrijving

Test Date

Datatype

date

Alias
UMLS CUI [1]
C2826247
Test Result
Beschrijving

Test Result

Datatype

text

Alias
UMLS CUI [1]
C0456984
Test Units
Beschrijving

Test Units

Datatype

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0587081
Normal Low Range
Beschrijving

Normal Low Range

Datatype

text

Alias
UMLS CUI [1]
C2700150
Normal High Range
Beschrijving

Normal High Range

Datatype

text

Alias
UMLS CUI [1]
C2700149
Relevant diagnostic results not noted above
Beschrijving

Relevant diagnostic results not noted above

Datatype

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C1274040
Rechallenge
Beschrijving

Rechallenge

Datatype

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C0877248
investigational product
Beschrijving

investigational product

Alias
UMLS CUI-1
C0304229
Drug
Beschrijving

Drug

Datatype

text

Alias
UMLS CUI [1]
C0013227
start date
Beschrijving

start date

Datatype

date

Alias
UMLS CUI [1]
C0808070
stop date
Beschrijving

stop date

Datatype

date

Alias
UMLS CUI [1]
C0806020
Regimen
Beschrijving

Regimen

Datatype

text

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C0013227
General narrative comments
Beschrijving

General narrative comments

General narrative comments
Beschrijving

General narrative comments

Datatype

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1519255
Non clinical
Beschrijving

Non clinical

incomplete SAE data GSK Safety
Beschrijving

incomplete SAE data GSK Safety

Datatype

boolean

Alias
UMLS CUI [1]
C1710056
Receipt by GSK date
Beschrijving

Receipt by GSK date

Datatype

date

Alias
UMLS CUI [1]
C2985846
Receipt by GSK date
Beschrijving

Receipt by GSK date

Datatype

date

Alias
UMLS CUI [1]
C2985846
serious SAE
Beschrijving

serious SAE

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
SAE Sequence Number
Beschrijving

SAE Sequence Number

Datatype

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348184
Version Number
Beschrijving

Version Number

Datatype

integer

Alias
UMLS CUI [1]
C2985700
Case ID
Beschrijving

Case ID

Datatype

text

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C0600091
Randomisation Number
Beschrijving

Randomisation Number

Datatype

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
OCEANS Code
Beschrijving

OCEANS Code

Datatype

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C1516728
Email Flag
Beschrijving

Email Flag

Datatype

text

Alias
UMLS CUI [1]
C0013849
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Similar models

LOG Visit

1 Formulieren
  1. StudyEvent: ODM
    1. LOG Visit
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1320303 (UMLS CUI-1)
Date of Visit
Item
date
C1320303 (UMLS CUI [1])
Item Group
C0877248 (UMLS CUI-1)
non-serious adverse events
Item
boolean
C1518404 (UMLS CUI [1])
Item Group
C1708728 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
serious adverse events
Item
boolean
C1519255 (UMLS CUI [1])
concomitant medications
Item
boolean
C2347852 (UMLS CUI [1])
Item Group
C2347852 (UMLS CUI-1)
Sequence number
Item
integer
C2348184 (UMLS CUI [1])
Drug name
Item
text
C0013227 (UMLS CUI [1])
Modified reported term
Item
text
C2826302 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
Unit Dose
Item
float
C0869039 (UMLS CUI [1])
Units
Item
text
C1519795 (UMLS CUI [1])
Frequency
Item
text
C3476109 (UMLS CUI [1])
Route
Item
text
C0013153 (UMLS CUI [1])
Reason for Medication
Item
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Generic Dispensed
Item
boolean
C3242750 (UMLS CUI [1])
Item
text
C3166216 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
Prescription or OTC
Code List
Prescription or OTC
CL Item
 (1)
CL Item
 (2)
Medication start datetime
Item
datetime
C3173309 (UMLS CUI [1])
Taken Prior to Study?
Item
boolean
C2826667 (UMLS CUI [1])
medication ongoing
Item
boolean
C2826666 (UMLS CUI [1])
Concomitant Medication End Date
Item
date
C2826744 (UMLS CUI [1])
Device used to administer medication
Item
text
C0699733 (UMLS CUI [1])
Total Daily Dose
Item
integer
C2348070 (UMLS CUI [1])
drug adminstered for an exacerbation
Item
boolean
C3469597 (UMLS CUI [1,1])
C4086268 (UMLS CUI [1,2])
Rescue Medication
Item
boolean
C0013227 (UMLS CUI [1,1])
C0884980 (UMLS CUI [1,2])
Total Dose
Item
kumulative Dosis
integer
C2986497 (UMLS CUI [1])
drug use
Item
boolean
C0242510 (UMLS CUI [1])
Total duration
Item
integer
C2347852 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
duration
Item
text
C0449238 (UMLS CUI [1])
Sequence Number
Item
text
C2348184 (UMLS CUI [1])
Non-serious adverse event
Item
text
C1518404 (UMLS CUI [1])
Modified term
Item
text
C2826302 (UMLS CUI [1])
MedDRA synonym
Item
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
text
C2826302 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Start Date
Item
date
C0808070 (UMLS CUI [1])
Item
integer
C1705586 (UMLS CUI [1])
Outcome / End Date
Code List
Outcome
CL Item
 (1)
C1709863 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1709864 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C1709277 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C1709862 (UMLS CUI-1)
(Comment:en)
End date
Item
date
C0806020 (UMLS CUI [1])
Item
text
C1710066 (UMLS CUI [1])
Maximum Intensity
Code List
Maximum Intensity
CL Item
 (1)
C2945599 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C0205081 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0205082 (UMLS CUI-1)
(Comment:en)
CL Item
 (X)
C1272460 (UMLS CUI-1)
(Comment:en)
Item
text
C1710066 (UMLS CUI [1])
Maximum Intensity
Code List
Intensity at onset of event
CL Item
 (1)
C2945599 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C0205081 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0205082 (UMLS CUI-1)
(Comment:en)
CL Item
 (X)
C1272460 (UMLS CUI-1)
(Comment:en)
Item
integer
C0441799 (UMLS CUI [1])
Maximum Grade
Code List
Maximum Grade
CL Item
 (1)
C0687695 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1522446 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0450094 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C0547054 (UMLS CUI-1)
(Comment:en)
CL Item
 (5)
C2985911 (UMLS CUI-1)
(Comment:en)
Item
integer
C2985916 (UMLS CUI [1,1])
C0441799 (UMLS CUI [1,2])
Maximum Grade
Code List
Grade at onset of event
CL Item
 (1)
C0687695 (UMLS CUI-1)
(Comment:en)
CL Item
 (2)
C1522446 (UMLS CUI-1)
(Comment:en)
CL Item
 (3)
C0450094 (UMLS CUI-1)
(Comment:en)
CL Item
 (4)
C0547054 (UMLS CUI-1)
(Comment:en)
CL Item
 (5)
C2985911 (UMLS CUI-1)
(Comment:en)
Item
text
C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Maximum Grade or Intensity
Code List
Maximum Grade or Intensity
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
CL Item
 (X)
Item
text
C1710066 (UMLS CUI [1])
Maximum Grade or Intensity
Code List
Grade or Intensity at onset of event
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
CL Item
 (X)
Item
text
C1704758 (UMLS CUI [1])
Action Taken with Investigational Product
Code List
Action Taken with Investigational Product
CL Item
 (1)
C0304229 (UMLS CUI-1)
(Comment:en)
CL Item
 (X)
C1272460 (UMLS CUI-1)
(Comment:en)
Withdrawal from study
Item
boolean
C0422727 (UMLS CUI [1])
AE caused by investigational product
Item
boolean
C0013230 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Duration of AE hours
Item
integer
C0449238 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Duration of AE minutes
Item
integer
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Time to Onset Since Last Dose hours
Item
integer
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Time to Onset Since Last Dose minutes
Item
integer
C0449244 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item Group
Initial report
Item
boolean
C0684224 (UMLS CUI [1])
Follow-up report
Item
boolean
C1704685 (UMLS CUI [1])
Item Group
C0034656 (UMLS CUI-1)
SAE after initiation of study medication
Item
boolean
C2826666 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
C1519255 (UMLS CUI-1)
Sequence Number
Item
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Modified term
Item
text
C2826302 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
MedDRA synonym
Item
text
C1140263 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
MedDRA lower level term code
Item
text
C3898442 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
serious adverse event
Item
boolean
C1519255 (UMLS CUI [1])
Did SAE occur after initiation of study medication
Item
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Serious Adverse Event
Item
text
C1519255 (UMLS CUI [1])
Serious Adverse Event Start Date
Item
date
C1519255 (UMLS CUI [1,1])
C2697888 (UMLS CUI [1,2])
Start Time Serious Adverse Event
Item
time
C1519255 (UMLS CUI [1,1])
C2697889 (UMLS CUI [1,2])
Serious Adverse Event End Date
Item
date
C1519255 (UMLS CUI [1,1])
C2697886 (UMLS CUI [1,2])
Serious Adverse Event End Time
Item
time
C1519255 (UMLS CUI [1,1])
C2826658 (UMLS CUI [1,2])
Item
integer
C1624730 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
Date of Death
Item
date
C1148348 (UMLS CUI [1])
Item
text
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Intensity (maximum)
Code List
Intensity (maximum)
CL Item
 (1)
(Comment:en)
CL Item
 (2)
(Comment:en)
CL Item
 (3)
(Comment:en)
CL Item
 (X)
(Comment:en)
Item
text
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity (maximum)
Code List
Intensity at onset of event
CL Item
 (1)
(Comment:en)
CL Item
 (2)
(Comment:en)
CL Item
 (3)
(Comment:en)
CL Item
 (X)
(Comment:en)
Item
integer
C0441799 (UMLS CUI [1])
Serious Adverse Event Maximum Grade
Code List
Maximum Grade
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
Item
integer
C2985911 (UMLS CUI [1])
Serious Adverse Event Maximum Grade
Code List
Grade at onset of event
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
Item
text
C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Serious Adverse Event Maximum Grade
Code List
Maximum Grade or Intensity
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
CL Item
 (X)
Item
text
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Serious Adverse Event Maximum Grade
Code List
Grade or Intensity at onset of event
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
CL Item
 (X)
Item
integer
C1547656 (UMLS CUI [1])
Action Taken
Code List
Action Taken
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
CL Item
 (6)
Relationship investigational product
Item
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Did the subject withdraw from study as a result of this AE?
Item
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Duration of AE if < 24 hours
Item
integer
C1519255 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Time to Onset Since Last Dose
Item
integer
C1519255 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
SAE Causation
Item
boolean
C3641099 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event
Item
boolean
C1519255 (UMLS CUI [1])
investigational product
Item
text
C0304229 (UMLS CUI [1])
Serious Adverse Event Intensity changes
Item
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Start Date of event segment
Item
date
C2697888 (UMLS CUI [1])
Start Time of event segment
Item
time
C2697889 (UMLS CUI [1])
Item
integer
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Maximum Intensity
Code List
Intensity of event segment
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
Item
integer
C2985911 (UMLS CUI [1])
Grade at onset of event
Code List
Grade of event segment
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
Item
text
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Grade or Intensity at onset of event
Code List
Grade or Intensity of event segment
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
Item Group
C0871902 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Item
integer
C1710056 (UMLS CUI [1])
Seriousness
Code List
Seriousness
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
CL Item
 (6)
Seriousness Other
Item
text
C1710056 (UMLS CUI [1])
CM Sequence Number
Item
text
C2348184 (UMLS CUI [1])
Drug name
Item
text
C0013227 (UMLS CUI [1])
Modified reported term
Item
text
C2826819 (UMLS CUI [1])
Dose
Item
text
C3174092 (UMLS CUI [1])
Item
text
C1519795 (UMLS CUI [1])
units of medication
Code List
units of medication
CL Item
 (ACTU)
CL Item
 (AMP)
CL Item
 (AP)
CL Item
 (BT)
CL Item
 (CAP)
CL Item
 (CC)
CL Item
 (031)
CL Item
 (002)
CL Item
 (025)
CL Item
 (028)
CL Item
 (IUML)
CL Item
 (011)
CL Item
 (LM)
CL Item
 (LOZ)
CL Item
 (MEGU)
CL Item
 (004)
CL Item
 (004)
CL Item
 (008)
CL Item
 (MCG/KG/MIN)
CL Item
 (MCG/MIN)
CL Item
 (013)
CL Item
 (029)
CL Item
 (MEQ24)
CL Item
 (003)
CL Item
 (MGPER)
CL Item
 (MGH)
CL Item
 (007)
CL Item
 (MGKH)
CL Item
 (MGKM)
CL Item
 (009)
CL Item
 (MGML)
CL Item
 (012)
CL Item
 (MLH)
CL Item
 (MLM)
CL Item
 (023)
CL Item
 (027)
CL Item
 (MAC)
CL Item
 (NEB)
CL Item
 (PAT)
CL Item
 (030)
CL Item
 (PUFF)
CL Item
 (SAC)
CL Item
 (SPR)
CL Item
 (SUP)
CL Item
 (TBS)
CL Item
 (TAB)
CL Item
 (TSP)
CL Item
 (UNT)
CL Item
 (U)
CL Item
 (VIA)
Item
text
C3476109 (UMLS CUI [1])
Frequency
Code List
Frequency
CL Item
 (2W)
CL Item
 (2W)
CL Item
 (4W)
CL Item
 (5D)
CL Item
 (5W)
CL Item
 (AC)
CL Item
 (2D)
CL Item
 (CO)
CL Item
 (FO)
CL Item
 (Q3W)
CL Item
 (Q3M)
CL Item
 (AD)
CL Item
 (1N)
CL Item
 (MO)
CL Item
 (WE)
CL Item
 (1D)
CL Item
 (1S)
CL Item
 (PC)
CL Item
 (PRN)
CL Item
 (12D)
CL Item
 (Q3D)
CL Item
 (Q4D)
CL Item
 (6D)
CL Item
 (4D)
CL Item
 (3D)
CL Item
 (2D)
CL Item
 (1M)
CL Item
 (24D)
CL Item
 (4D)
CL Item
 (1N)
CL Item
 (3D)
CL Item
 (U)
Item
text
C0013153 (UMLS CUI [1])
Route of medication
Code List
Route of medication
CL Item
 (047)
C0229118 (UMLS CUI-1)
(Comment:en)
CL Item
 (008)
C0014537 (UMLS CUI-1)
(Comment:en)
CL Item
 (GT)
C0017196 (UMLS CUI-1)
C0041281 (UMLS CUI-2)
(Comment:en)
CL Item
 (055)
C0004048 (UMLS CUI-1)
(Comment:en)
CL Item
 (INJ)
C1272883 (UMLS CUI-1)
(Comment:en)
CL Item
 (013)
C0694634 (UMLS CUI-1)
(Comment:en)
CL Item
 (IBU)
C0230212 (UMLS CUI-1)
(Comment:en)
CL Item
 (026)
C1512954 (UMLS CUI-1)
(Comment:en)
CL Item
 (030)
C0442117 (UMLS CUI-1)
(Comment:en)
CL Item
 (045)
C0442118 (UMLS CUI-1)
(Comment:en)
CL Item
 (031)
CL Item
 (IOS)
CL Item
 (033)
CL Item
 (037)
CL Item
 (015)
CL Item
 (042)
CL Item
 (045)
CL Item
 (048)
CL Item
 (054)
CL Item
 (058)
CL Item
 (060)
CL Item
 (061)
CL Item
 (062)
CL Item
 (065)
CL Item
 (067)
Start Date
Item
date
C0808070 (UMLS CUI [1])
Ongoing medication
Item
boolean
C2826666 (UMLS CUI [1])
End date medication
Item
date
C1521826 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Primary Indication
Item
text
C3146298 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Modified reported term
Item
text
C2826819 (UMLS CUI [1])
Item
text
C0457591 (UMLS CUI [1])
Drug Type
Code List
Drug Type
CL Item
 (2)
CL Item
 (T)
CL Item
 (1)
Lab Sequence Number
Item
text
C2348184 (UMLS CUI [1])
Item
text
C0022885 (UMLS CUI [1])
Test Name
Code List
Test Name
CL Item
 (Activated partial thromboplastin time)
C0030605 (UMLS CUI-1)
(Comment:en)
CL Item
 (Alanine aminotransferase)
C0201899 (UMLS CUI-1)
C0201836 (UMLS CUI-2)
(Comment:en)
CL Item
 (Albumin)
C0201838 (UMLS CUI-1)
(Comment:en)
CL Item
 (Alkaline phosphatase)
C0201850 (UMLS CUI-1)
(Comment:en)
CL Item
 (Amylase)
C0201883 (UMLS CUI-1)
(Comment:en)
CL Item
 (Aspartate aminotransferase)
C0201899 (UMLS CUI-1)
C0201836 (UMLS CUI-2)
(Comment:en)
CL Item
 (Basophils)
C0004827 (UMLS CUI-1)
(Comment:en)
CL Item
 (Bicarbonate)
C0202059 (UMLS CUI-1)
(Comment:en)
CL Item
 (Bilirubin)
C1278039 (UMLS CUI-1)
(Comment:en)
CL Item
 (Bilirubin direct)
C0201916 (UMLS CUI-1)
(Comment:en)
CL Item
 (Bilirubin total)
CL Item
 (Blood myoglobin)
CL Item
 (Blood pH)
CL Item
 (Blood pressure)
CL Item
 (Blood urea nitrogen)
CL Item
 (Body temperature)
CL Item
 (Calcium)
CL Item
 (CD4 lymphocytes)
CL Item
 (CD8 lymphocytes)
CL Item
 (Chloride)
CL Item
 (Cholesterol total)
CL Item
 (C-reactive protein)
CL Item
 (Creatine)
CL Item
 (Creatine phosphokinase)
CL Item
 (Creatine phosphokinase MB)
CL Item
 (Creatinine)
CL Item
 (Creatinine clearance)
CL Item
 (Diastolic blood pressure)
CL Item
 (Eosinophils)
CL Item
 (Erythrocyte sedimentation rate)
CL Item
 (Fasting blood glucose)
CL Item
 (FEV 1)
CL Item
 (Gamma-glutamyltransferase)
CL Item
 (HbA1c)
CL Item
 (HBV-DNA decreased)
CL Item
 (HBV-DNA increased)
CL Item
 (Heart rate)
CL Item
 (Hematocrit)
CL Item
 (Hemoglobin)
CL Item
 (High density lipoprotein)
CL Item
 (HIV viral load)
CL Item
 (INR)
CL Item
 (Lactic dehydrogenase)
CL Item
 (Lipase)
CL Item
 (Low density lipoprotein)
CL Item
 (Lymphocytes)
CL Item
 (Magnesium)
CL Item
 (Mean cell hemoglobin concentration)
CL Item
 (Mean corpuscular hemoglobin)
CL Item
 (Mean corpuscular volume)
CL Item
 (Monocytes)
CL Item
 (Neutrophils)
CL Item
 (Oxygen saturation)
CL Item
 (pCO2)
CL Item
 (pH)
CL Item
 (Phosphate)
CL Item
 (Platelet count)
CL Item
 (pO2)
CL Item
 (Potassium)
CL Item
 (Protein total)
CL Item
 (Prothrombin time)
CL Item
 (Red blood cell count)
CL Item
 (Respiratory rate)
CL Item
 (Reticulocyte count)
CL Item
 (Serum glucose)
CL Item
 (Serum uric acid)
CL Item
 (Sodium)
CL Item
 (Systolic blood pressure)
CL Item
 (Thrombin time)
CL Item
 (Total lung capacity)
CL Item
 (Triglycerides)
CL Item
 (Troponin)
CL Item
 (Troponin I)
CL Item
 (Troponin T)
CL Item
 (Urine myoglobin)
CL Item
 (Urine pH)
CL Item
 (Vital capacity)
CL Item
 (White blood cell count)
Test Date
Item
date
C2826247 (UMLS CUI [1])
Test Result
Item
text
C0456984 (UMLS CUI [1])
Test Units
Item
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Normal Low Range
Item
text
C2700150 (UMLS CUI [1])
Normal High Range
Item
text
C2700149 (UMLS CUI [1])
Relevant diagnostic results not noted above
Item
text
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
text
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Rechallenge
Code List
Rechallenge
CL Item
 (N)
CL Item
 (Y)
CL Item
 (U)
CL Item
 (X)
Item Group
C0304229 (UMLS CUI-1)
Drug
Item
text
C0013227 (UMLS CUI [1])
start date
Item
date
C0808070 (UMLS CUI [1])
stop date
Item
date
C0806020 (UMLS CUI [1])
Regimen
Item
text
C1276413 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
General narrative comments
Item
text
C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
incomplete SAE data GSK Safety
Item
boolean
C1710056 (UMLS CUI [1])
Receipt by GSK date
Item
date
C2985846 (UMLS CUI [1])
Receipt by GSK date
Item
date
C2985846 (UMLS CUI [1])
serious SAE
Item
boolean
C1519255 (UMLS CUI [1])
SAE Sequence Number
Item
text
C1519255 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Version Number
Item
integer
C2985700 (UMLS CUI [1])
Case ID
Item
text
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Randomisation Number
Item
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
OCEANS Code
Item
text
C0805701 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Email Flag
Item
text
C0013849 (UMLS CUI [1])
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