ID

30780

Beschreibung

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

Stichworte

Versionen (1)
  1. 20.06.18 20.06.18 -
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GlaxoSmithKline

Hochgeladen am

20. Juni 2018

DOI

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

Deutsch Englisch

LOG Visit

1 Formulare  
  1. StudyEvent: ODM
    1. LOG Visit
Date of Visit/Assessment
Beschreibung

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Adverse event
Beschreibung

Adverse event

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

non-serious adverse events

Datentyp

boolean

Alias
UMLS CUI [1]
C1518404
Log status
Beschreibung

Log status

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

serious adverse events

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
concomitant medications
Beschreibung

concomitant medications

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Concomitant Medications
Beschreibung

Concomitant Medications

Alias
UMLS CUI-1
C2347852
Sequence number
Beschreibung

Sequence number

Datentyp

integer

Alias
UMLS CUI [1]
C2348184
Drug name
Beschreibung

Drug name

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Modified reported term
Beschreibung

Modified reported term

Datentyp

text

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

Unit Dose

Datentyp

float

Alias
UMLS CUI [1]
C0869039
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Beschreibung

Reason for Medication

Datentyp

text

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

Generic Dispensed

Datentyp

boolean

Alias
UMLS CUI [1]
C3242750
Prescription or OTC
Beschreibung

Prescription or OTC

Datentyp

text

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

Medication start datetime

Datentyp

datetime

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

Taken Prior to Study?

Datentyp

boolean

Alias
UMLS CUI [1]
C2826667
medication ongoing
Beschreibung

medication ongoing

Datentyp

boolean

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

Concomitant Medication End Date

Datentyp

date

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

Device used to administer medication

Datentyp

text

Alias
UMLS CUI [1]
C0699733
Total Daily Dose
Beschreibung

Total Daily Dose

Datentyp

integer

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

drug adminstered for an exacerbation

Datentyp

boolean

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

Rescue Medication

Datentyp

boolean

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

Total Dose

Datentyp

integer

Alias
UMLS CUI [1]
C2986497
drug use
Beschreibung

drug use

Datentyp

boolean

Alias
UMLS CUI [1]
C0242510
Total duration
Beschreibung

Total duration

Datentyp

integer

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

duration

Datentyp

text

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

Non-serious adverse event

Sequence Number
Beschreibung

Sequence Number

Datentyp

text

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

Non-serious adverse event

Datentyp

text

Alias
UMLS CUI [1]
C1518404
Modified term
Beschreibung

Modified term

Datentyp

text

Alias
UMLS CUI [1]
C2826302
MedDRA synonym
Beschreibung

MedDRA synonym

Datentyp

text

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

MedDRA lower level term code

Datentyp

text

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

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Outcome
Beschreibung

Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
End date
Beschreibung

End date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

text

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

Intensity at onset of event

Datentyp

text

Alias
UMLS CUI [1]
C1710066
Maximum Grade
Beschreibung

Maximum Grade

Datentyp

integer

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

Grade at onset of event

Datentyp

integer

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

Maximum Grade or Intensity

Datentyp

text

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

Grade or Intensity at onset of event

Datentyp

text

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

Action Taken with Investigational Product

Datentyp

text

Alias
UMLS CUI [1]
C1704758
Withdrawal from study
Beschreibung

Withdrawal from study

Datentyp

boolean

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

AE caused by investigational product

Datentyp

boolean

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

Duration of AE hours

Datentyp

integer

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

Duration of AE minutes

Datentyp

integer

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

Time to Onset Since Last Dose hours

Datentyp

integer

Maßeinheiten
  • 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
Beschreibung

Time to Onset Since Last Dose minutes

Datentyp

integer

Maßeinheiten
  • min
Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C1518404
min
Report
Beschreibung

Report

Initial report
Beschreibung

Initial report

Datentyp

boolean

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

Follow-up report

Datentyp

boolean

Alias
UMLS CUI [1]
C1704685
Randomisation
Beschreibung

Randomisation

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

SAE after initiation of study medication

Datentyp

boolean

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

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Sequence Number
Beschreibung

Sequence Number

Datentyp

text

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

Modified term

Datentyp

text

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

MedDRA synonym

Datentyp

text

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

MedDRA lower level term code

Datentyp

text

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

serious adverse event

Datentyp

boolean

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

Did SAE occur after initiation of study medication

Datentyp

boolean

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

Serious Adverse Event

Datentyp

text

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

Serious Adverse Event Start Date

Datentyp

date

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

Start Time Serious Adverse Event

Datentyp

time

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

Serious Adverse Event End Date

Datentyp

date

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

Serious Adverse Event End Time

Datentyp

time

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

Outcome

Datentyp

integer

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

Date of Death

Datentyp

date

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

Intensity (maximum)

Datentyp

text

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

Intensity at onset of event

Datentyp

text

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

Maximum Grade

Datentyp

integer

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

Grade at onset of event

Datentyp

integer

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

Maximum Grade or Intensity

Datentyp

text

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

Grade or Intensity at onset of event

Datentyp

text

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

Action Taken

Datentyp

integer

Alias
UMLS CUI [1]
C1547656
Relationship investigational product
Beschreibung

Relationship investigational product

Datentyp

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?
Beschreibung

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

Datentyp

boolean

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

Duration of AE if < 24 hours

Datentyp

integer

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

Time to Onset Since Last Dose

Datentyp

integer

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

SAE Causation

Datentyp

boolean

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

Serious Adverse Event

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
investigational product
Beschreibung

investigational product

Datentyp

text

Alias
UMLS CUI [1]
C0304229
Intensity changes
Beschreibung

Intensity changes

Serious Adverse Event Intensity changes
Beschreibung

Serious Adverse Event Intensity changes

Datentyp

text

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

Start Date of event segment

Datentyp

date

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

Start Time of event segment

Datentyp

time

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

Intensity of event segment

Datentyp

integer

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

Grade of event segment

Datentyp

integer

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

Grade or Intensity of event segment

Datentyp

text

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

Seriousness

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

Seriousness

Datentyp

integer

Alias
UMLS CUI [1]
C1710056
Seriousness Other
Beschreibung

Seriousness Other

Datentyp

text

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

Relevant concomitant/treatment medications

CM Sequence Number
Beschreibung

CM Sequence Number

Datentyp

text

Alias
UMLS CUI [1]
C2348184
Drug name
Beschreibung

Drug name

Datentyp

text

Alias
UMLS CUI [1]
C0013227
Modified reported term
Beschreibung

Modified reported term

Datentyp

text

Alias
UMLS CUI [1]
C2826819
Dose
Beschreibung

Dose

Datentyp

text

Alias
UMLS CUI [1]
C3174092
units of medication
Beschreibung

units of medication

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Frequency
Beschreibung

Frequency

Datentyp

text

Alias
UMLS CUI [1]
C3476109
Route of medication
Beschreibung

Route of medication

Datentyp

text

Alias
UMLS CUI [1]
C0013153
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Ongoing medication
Beschreibung

Ongoing medication

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
End date medication
Beschreibung

End date medication

Datentyp

date

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

Primary Indication

Datentyp

text

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

Modified reported term

Datentyp

text

Alias
UMLS CUI [1]
C2826819
Drug Type
Beschreibung

Drug Type

Datentyp

text

Alias
UMLS CUI [1]
C0457591
Relevant diagnostic results
Beschreibung

Relevant diagnostic results

Lab Sequence Number
Beschreibung

Lab Sequence Number

Datentyp

text

Alias
UMLS CUI [1]
C2348184
Test Name
Beschreibung

Test Name

Datentyp

text

Alias
UMLS CUI [1]
C0022885
Test Date
Beschreibung

Test Date

Datentyp

date

Alias
UMLS CUI [1]
C2826247
Test Result
Beschreibung

Test Result

Datentyp

text

Alias
UMLS CUI [1]
C0456984
Test Units
Beschreibung

Test Units

Datentyp

text

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

Normal Low Range

Datentyp

text

Alias
UMLS CUI [1]
C2700150
Normal High Range
Beschreibung

Normal High Range

Datentyp

text

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

Relevant diagnostic results not noted above

Datentyp

text

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

Rechallenge

Datentyp

text

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

investigational product

Alias
UMLS CUI-1
C0304229
Drug
Beschreibung

Drug

Datentyp

text

Alias
UMLS CUI [1]
C0013227
start date
Beschreibung

start date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
stop date
Beschreibung

stop date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Regimen
Beschreibung

Regimen

Datentyp

text

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

General narrative comments

General narrative comments
Beschreibung

General narrative comments

Datentyp

text

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

Non clinical

incomplete SAE data GSK Safety
Beschreibung

incomplete SAE data GSK Safety

Datentyp

boolean

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

Receipt by GSK date

Datentyp

date

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

Receipt by GSK date

Datentyp

date

Alias
UMLS CUI [1]
C2985846
serious SAE
Beschreibung

serious SAE

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
SAE Sequence Number
Beschreibung

SAE Sequence Number

Datentyp

text

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

Version Number

Datentyp

integer

Alias
UMLS CUI [1]
C2985700
Case ID
Beschreibung

Case ID

Datentyp

text

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

Randomisation Number

Datentyp

text

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

OCEANS Code

Datentyp

text

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

Email Flag

Datentyp

text

Alias
UMLS CUI [1]
C0013849
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Ähnliche Modelle

LOG Visit

1 Formulare
  1. StudyEvent: ODM
    1. LOG Visit
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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