Informatie:
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ID
33919
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
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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 - Death
- StudyEvent: ODM
Similar models
Adjudication Events - Death
- 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
AE / SAE Number
Item
AE / SAE Number
integer
Date and estimated time of death
Item
Date and estimated time of death
datetime
Cause of death as specified on Death Certificate or other documentation:
Item
Cause of death as specified on Death Certificate or other documentation:
text
Was an autopsy performed?
Item
Was an autopsy performed?
boolean
If Yes, was autopsy report available?
Item
If Yes, was autopsy report available?
boolean
CL Item
Non-cardiovascular death (1)
CL Item
Cardiovascular death (2)
Specify cause
Item
Specify cause
text
If a procedure / operation has been specified, please provide the date of procedure / operation:
Item
If a procedure / operation has been specified, please provide the date of procedure / operation:
date
1. Sudden death
Item
1. Sudden death
boolean
If Yes, record AE/SAE number
Item
If Yes, record AE/SAE number
integer
2. Death due to myocardial infraction
Item
2. Death due to myocardial infraction
boolean
If Yes, record AE/SAE number
Item
If Yes, record AE/SAE number
integer
3. Death due to stroke
Item
3. Death due to stroke
boolean
If Yes, record AE/SAE number
Item
If Yes, record AE/SAE number
integer
4. Death due to heart failure
Item
4. Death due to heart failure
boolean
If Yes, record AE/SAE number
Item
If Yes, record AE/SAE number
integer
5. Death due to a cordiovascular procedure/operation
Item
5. Death due to a cordiovascular procedure/operation
text
Date performed
Item
Date performed
date
6. Death due to pulmonary embolism
Item
6. Death due to pulmonary embolism
boolean
7. Death due to other cardiovascular event (e.g., ruptured aortic aneurysm)
Item
7. Death due to other cardiovascular event (e.g., ruptured aortic aneurysm)
text
8. Cause of death unknown
Item
8. Cause of death unknown
boolean
CL Item
Hospital (1)
CL Item
Home (2)
CL Item
Work (3)
CL Item
Other (e.g., ambulance) (4)
If Other, please specify
Item
If Other, please specify
text
Please complete any other appropriate event form(s) pertaining to the hospitalization and record the event number(s) from those forms below
Item
Please complete any other appropriate event form(s) pertaining to the hospitalization and record the event number(s) from those forms below
text
AE/SAE number
Item
AE/SAE number
integer
AE/SAE number
Item
AE/SAE number
integer
AE/SAE number
Item
AE/SAE number
integer
In the 14 days prior to death, had the subject been discharged from the hospital?
Item
In the 14 days prior to death, had the subject been discharged from the hospital?
boolean
If Yes, please specify
Item
If Yes, please specify
text
Reason for Hospitalization
Item
Reason for Hospitalization
text
AE/SAE Number
Item
AE/SAE Number
integer
Reason for Hospitalization 2
Item
Reason for Hospitalization 2
text
AE/SAE Number
Item
AE/SAE Number
integer
Reason for Hospitalization 3
Item
Reason for Hospitalization 3
text
AE/SAE Number
Item
AE/SAE Number
integer
Reason for Hospitalization 4
Item
Reason for Hospitalization 4
text
AE/SAE Number
Item
AE/SAE Number
integer
Item
Considering the subject's condition prior to death, was the death clinically expected?
text
Code List
Considering the subject's condition prior to death, was the death clinically expected?
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
Item
If No, how long since the subject had last been seen alive by anyone?
text
Code List
If No, how long since the subject had last been seen alive by anyone?
CL Item
≤ 1 hour (1)
CL Item
>1 hour and ≤ 24 hours (2)
CL Item
>24 hours (3)
CL Item
Unknown (4)
Item
When last seen, was the subject observed to be in his/her usual state of health?
text
Code List
When last seen, was the subject observed to be in his/her usual state of health?
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
In the 14 days prior to death, had the subject undergone any procedure(s)/operation(s)?
Item
In the 14 days prior to death, had the subject undergone any procedure(s)/operation(s)?
boolean
If Yes, specify
Item
If Yes, specify
text
Date
Item
Date
date
Further comment
Item
Further comment
text
Date
Item
Date
date
Item
What was the duration of new or worsening symptoms immediately before death?
text
Code List
What was the duration of new or worsening symptoms immediately before death?
CL Item
≤ 1 hour (1)
CL Item
>1 hour and ≤ 24 hours (2)
CL Item
>24 hours (3)
CL Item
Unknown (4)
Item
Was a life threatening arrhythmia or conduction disturbance identified?
text
Code List
Was a life threatening arrhythmia or conduction disturbance identified?
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
CL Item
Ventricular tachycardia (1)
CL Item
Ventricular fibrillation (2)
CL Item
Severe bradyarrhythmia (3)
CL Item
Asystole (4)
CL Item
Pulseless electrical activity (electromechanical dissociation) i.e. recordable cardiac electrical activity in the absence of a palpable pulse (5)
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
Date and Time of resuscitation attempt
Item
Date and Time of resuscitation attempt
datetime
CL Item
Cardiopulmonary resuscitation (1)
CL Item
Cardiac defibrillation (2)
CL Item
Emergency cardiac pacing (3)
CL Item
Other (4)
If Other, specify
Item
If Other, specify
text
Description of Event
Item
Briefly describe the events leading to the subject's death
text
Description of Event (Cont.)
Item
Description of Event (Cont.)
text
Description of Event (Cont.)
Item
Description of Event (Cont.)
text