Informatie:
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ID
33913
Beschrijving
Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2
Trefwoorden
Versies (1)
- 07-01-19 07-01-19 -
Houder van rechten
GSK group of companies
Geüploaded op
7 januari 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032
Adjudication Events - Coronary Revascularization
- StudyEvent: ODM
Similar models
Adjudication Events - Coronary Revascularization
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Site
Item
Site
text
Subject
Item
Subject
text
CL Item
Adjudication (1)
Status
Item
Status
text
Document Number
Item
Document Number
text
Item
Please document all coronary revascularizations
text
Code List
Please document all coronary revascularizations
CL Item
Percutaneous coronary intervention (1)
CL Item
Coronary artery bypass graft procedure (2)
CL Item
Other coronary revascularization procedure (3)
Date
Item
Date
date
Time
Item
Time
time
Were stents placed?
Item
Were stents placed?
boolean
CL Item
Bare-metal (1)
CL Item
Drug-eluting (2)
Number of stents
Item
Number of stents
integer
Date
Item
Date
date
Time
Item
Time
time
Number of bypassed vessels
Item
Number of bypassed vessels
integer
Item Group
Specify other coronary revascularization procedure
Type
Item
Type
text
Date
Item
Date
date
Time
Item
Time
time
AE / SAE Number
Item
AE / SAE Number
integer
Item
Did the subject have this coronary revascularization procedure during a hospitalization for an acute myocardial infraction or angina or chest pain?
text
Code List
Did the subject have this coronary revascularization procedure during a hospitalization for an acute myocardial infraction or angina or chest pain?
CL Item
Yes (please complete this form and provide the AE/SAE event number) (1)
CL Item
No (2)
Was this an elective/non-emergency procedure?
Item
Was this an elective/non-emergency procedure?
boolean
Did the subject have this procedure as a result of another Adverse Event or Serious Adverse Event?
Item
Did the subject have this procedure as a result of another Adverse Event or Serious Adverse Event?
boolean
If Yes, please record AE/SAE number
Item
If Yes, please record AE/SAE number
integer
Item
Did myocardial infraction occur during or after the procedure?
text
Code List
Did myocardial infraction occur during or after the procedure?
CL Item
Yes (please record event on Acute Myocardial Infraction/Hospitalized Angina or Chest Pain form) (1)
CL Item
No (please fill in all the cardiac enzyme/marker measurements available. For a specific enzyme/marker both the peak value and the upper limit of normal should be stated in the same unit) (2)
Item
Did a cerebrovascular accident (CVA) occur after the procedure?
integer
Code List
Did a cerebrovascular accident (CVA) occur after the procedure?
CL Item
Yes (record event on the Stroke/TIA form) (1)
CL Item
No (2)
Item
Did the subject die as a direct consequence of the procedure?
text
Code List
Did the subject die as a direct consequence of the procedure?
CL Item
Yes, complete the Death form (1)
CL Item
No (2)
Was the value examination done?
Item
Was the value examination done?
boolean
Pre-Procedure value
Item
Pre-Procedure value
text
Date sample taken
Item
Date sample taken
date
Time
Item
Time
time
Post-Procedure peak value
Item
Post-Procedure peak value
text
Date sample taken
Item
Date sample taken
date
Time
Item
Time
time
Upper Limit of Normal
Item
Upper Limit of Normal
text
Enzyme Unit
Item
Enzyme Unit
text
Was the value examination done?
Item
Was the value examination done?
boolean
Pre-Procedure value
Item
Pre-Procedure value
text
Date sample taken
Item
Date sample taken
date
Time
Item
Time
time
Post-Procedure peak value
Item
Post-Procedure peak value
text
Date sample taken
Item
Date sample taken
date
Time
Item
Time
time
Upper Limit of Normal
Item
Upper Limit of Normal
text
Enzyme Unit
Item
Enzyme Unit
text
Was the value examination done?
Item
Was the value examination done?
boolean
Pre-Procedure value
Item
Pre-Procedure value
text
Date sample taken
Item
Date sample taken
date
Time
Item
Time
time
Post-Procedure peak value
Item
Post-Procedure peak value
text
Date sample taken
Item
Date sample taken
date
Time
Item
Time
time
Upper Limit of Normal
Item
Upper Limit of Normal
text
Enzyme Unit
Item
Enzyme Unit
text