ID

33919

Description

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

Keywords

Versions (1)
  1. 1/7/19 1/7/19 -
Copyright Holder

GSK group of companies

Uploaded on

January 7, 2019

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License

Creative Commons BY-NC 3.0
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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032

English

Adjudication Events - Death

1 forms  
Administrative data
Description

Administrative data

Site
Description

Site

Data type

text

Subject
Description

Subject

Data type

text

Visit Name
Description

Visit Name

Data type

text

Status
Description

Status

Data type

text

Document Number
Description

Document Number

Data type

text

Death
Description

Death

AE / SAE Number
Description

AE / SAE Number

Data type

integer

Date and estimated time of death
Description

This form should be completed for all deaths that occur during the course of the study. Where applicable, a copy of the hospital discharge/death summary should be submitted.

Data type

datetime

Cause of Death
Description

Cause of Death

Cause of death as specified on Death Certificate or other documentation:
Description

Cause of death as specified on Death Certificate or other documentation:

Data type

text

Was an autopsy performed?
Description

Was an autopsy performed?

Data type

boolean

If Yes, was autopsy report available?
Description

If Yes, please provide a copy of the report. Every effort to obtain the report should be made.

Data type

boolean

Classification of Primary Cause of Death
Description

Classification of Primary Cause of Death

Specify cause of death
Description

Specify cause of death

Data type

text

Non-cardiovascular death
Description

Non-cardiovascular death

Specify cause
Description

if applies

Data type

text

If a procedure / operation has been specified, please provide the date of procedure / operation:
Description

If a procedure / operation has been specified, please provide the date of procedure / operation:

Data type

date

Cardiovascular death
Description

Cardiovascular death

1. Sudden death
Description

1. Sudden death

Data type

boolean

If Yes, record AE/SAE number
Description

If Yes, record AE/SAE number

Data type

integer

2. Death due to myocardial infraction
Description

Please complete an Acute MI/Hospitalized Angina or Chest pain event form and record the event number from that form

Data type

boolean

If Yes, record AE/SAE number
Description

If Yes, record AE/SAE number

Data type

integer

3. Death due to stroke
Description

Please complete a Stroke/TIA event form and record the event number from that form

Data type

boolean

If Yes, record AE/SAE number
Description

If Yes, record AE/SAE number

Data type

integer

4. Death due to heart failure
Description

If applicable, please complete a Hospitalization For Heart Failure event form and record the event number from that form.

Data type

boolean

If Yes, record AE/SAE number
Description

If Yes, record AE/SAE number

Data type

integer

5. Death due to a cordiovascular procedure/operation
Description

Specify

Data type

text

Date performed
Description

Date performed

Data type

date

6. Death due to pulmonary embolism
Description

6. Death due to pulmonary embolism

Data type

boolean

7. Death due to other cardiovascular event (e.g., ruptured aortic aneurysm)
Description

Specify

Data type

text

8. Cause of death unknown
Description

8. Cause of death unknown

Data type

boolean

Place of Death
Description

Place of Death

Check one
Description

Check one

Data type

text

If Other, please specify
Description

If Other, please specify

Data type

text

Other data
Description

Other data

Please complete any other appropriate event form(s) pertaining to the hospitalization and record the event number(s) from those forms below
Description

Please complete any other appropriate event form(s) pertaining to the hospitalization and record the event number(s) from those forms below

Data type

text

AE/SAE number
Description

AE/SAE number

Data type

integer

AE/SAE number
Description

AE/SAE number

Data type

integer

AE/SAE number
Description

AE/SAE number

Data type

integer

In the 14 days prior to death, had the subject been discharged from the hospital?
Description

In the 14 days prior to death, had the subject been discharged from the hospital?

Data type

boolean

If Yes, please specify
Description

If Yes, please specify

Data type

text

Reason for Hospitalization
Description

Reason for Hospitalization

Data type

text

AE/SAE Number
Description

AE/SAE Number

Data type

integer

Reason for Hospitalization 2
Description

Reason for Hospitalization 2

Data type

text

AE/SAE Number
Description

AE/SAE Number

Data type

integer

Reason for Hospitalization 3
Description

Reason for Hospitalization 3

Data type

text

AE/SAE Number
Description

AE/SAE Number

Data type

integer

Reason for Hospitalization 4
Description

Reason for Hospitalization 4

Data type

text

AE/SAE Number
Description

AE/SAE Number

Data type

integer

Circumstances of Death
Description

Circumstances of Death

Considering the subject's condition prior to death, was the death clinically expected?
Description

Considering the subject's condition prior to death, was the death clinically expected?

Data type

text

Was the death witnessed?
Description

Was the death witnessed?

Data type

text

If No, how long since the subject had last been seen alive by anyone?
Description

If No, how long since the subject had last been seen alive by anyone?

Data type

text

When last seen, was the subject observed to be in his/her usual state of health?
Description

When last seen, was the subject observed to be in his/her usual state of health?

Data type

text

In the 14 days prior to death, had the subject undergone any procedure(s)/operation(s)?
Description

In the 14 days prior to death, had the subject undergone any procedure(s)/operation(s)?

Data type

boolean

If Yes, specify
Description

If Yes, specify

Data type

text

Date
Description

Date

Data type

date

Further comment
Description

Further comment

Data type

text

Date
Description

Date

Data type

date

What was the duration of new or worsening symptoms immediately before death?
Description

What was the duration of new or worsening symptoms immediately before death?

Data type

text

Was a life threatening arrhythmia or conduction disturbance identified?
Description

Was a life threatening arrhythmia or conduction disturbance identified?

Data type

text

If Yes, check all that apply
Description

If Yes, check all that apply

Data type

text

Was resuscitation attempted prior to death?
Description

Was resuscitation attempted prior to death?

Data type

text

Date and Time of resuscitation attempt
Description

Date and Time of resuscitation attempt

Data type

datetime

If Yes, check all that apply
Description

If Yes, check all that apply

Data type

text

If Other, specify
Description

If Other, specify

Data type

text

Narrative
Description

Narrative

Briefly describe the events leading to the subject's death
Description

Include the subject's clinical condition prior to death, changes in signs and symptoms, changes in therapy, hospitalizations, and any procedures or operations that you feel may be relevant when considering the cause of this subject's death. Please describe the exact circumstances and place of death and any relevant autopsy findings. Please provide sufficient information to allow the Endpoint Committee to accurately classify the cause of death. A copy of the hospital discharge summary should be submitted.

Data type

text

Description of Event (Cont.)
Description

Description of Event (Cont.)

Data type

text

Description of Event (Cont.)
Description

Description of Event (Cont.)

Data type

text

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Similar models

Adjudication Events - Death

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Site
Item
Site
text
Subject
Item
Subject
text
Item
Visit Name
text
Visit Name
Code List
Visit Name
CL Item
Adjudication (1)
Status
Item
Status
text
Document Number
Item
Document Number
text
Item Group
Death
AE / SAE Number
Item
AE / SAE Number
integer
Date and estimated time of death
Item
Date and estimated time of death
datetime
Item Group
Cause of Death
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
Item Group
Classification of Primary Cause of Death
Item
Specify cause of death
text
Specify cause of death
Code List
Specify cause of death
CL Item
Non-cardiovascular death (1)
CL Item
Cardiovascular death (2)
Item Group
Non-cardiovascular death
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
Item Group
Cardiovascular death
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
Item Group
Place of Death
Item
Check one
text
Check one
Code List
Check one
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
Item Group
Other data
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 Group
Circumstances of Death
Item
Considering the subject's condition prior to death, was the death clinically expected?
text
Considering the subject's condition prior to death, was the death clinically expected?
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)
Item
Was the death witnessed?
text
Was the death witnessed?
Code List
Was the death witnessed?
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
If No, how long since the subject had last been seen alive by anyone?
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
When last seen, was the subject observed to be in his/her usual state of health?
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
What was the duration of new or worsening symptoms immediately before death?
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
Was a life threatening arrhythmia or conduction disturbance identified?
Code List
Was a life threatening arrhythmia or conduction disturbance identified?
CL Item
Unknown (1)
CL Item
Yes (2)
CL Item
No (3)
Item
If Yes, check all that apply
text
If Yes, check all that apply
Code List
If Yes, check all that apply
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)
Item
Was resuscitation attempted prior to death?
text
Was resuscitation attempted prior to death?
Code List
Was resuscitation attempted prior to death?
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
Item
If Yes, check all that apply
text
If Yes, check all that apply
Code List
If Yes, check all that apply
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
Item Group
Narrative
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
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