ID

33919

Beschreibung

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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  1. 07.01.19 07.01.19 -
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GSK group of companies

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7. Januar 2019

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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032

Englisch

Adjudication Events - Death

1 Formulare  
Administrative data
Beschreibung

Administrative data

Site
Beschreibung

Site

Datentyp

text

Subject
Beschreibung

Subject

Datentyp

text

Visit Name
Beschreibung

Visit Name

Datentyp

text

Status
Beschreibung

Status

Datentyp

text

Document Number
Beschreibung

Document Number

Datentyp

text

Death
Beschreibung

Death

AE / SAE Number
Beschreibung

AE / SAE Number

Datentyp

integer

Date and estimated time of death
Beschreibung

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.

Datentyp

datetime

Cause of Death
Beschreibung

Cause of Death

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

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

Datentyp

text

Was an autopsy performed?
Beschreibung

Was an autopsy performed?

Datentyp

boolean

If Yes, was autopsy report available?
Beschreibung

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

Datentyp

boolean

Classification of Primary Cause of Death
Beschreibung

Classification of Primary Cause of Death

Specify cause of death
Beschreibung

Specify cause of death

Datentyp

text

Non-cardiovascular death
Beschreibung

Non-cardiovascular death

Specify cause
Beschreibung

if applies

Datentyp

text

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

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

Datentyp

date

Cardiovascular death
Beschreibung

Cardiovascular death

1. Sudden death
Beschreibung

1. Sudden death

Datentyp

boolean

If Yes, record AE/SAE number
Beschreibung

If Yes, record AE/SAE number

Datentyp

integer

2. Death due to myocardial infraction
Beschreibung

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

Datentyp

boolean

If Yes, record AE/SAE number
Beschreibung

If Yes, record AE/SAE number

Datentyp

integer

3. Death due to stroke
Beschreibung

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

Datentyp

boolean

If Yes, record AE/SAE number
Beschreibung

If Yes, record AE/SAE number

Datentyp

integer

4. Death due to heart failure
Beschreibung

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

Datentyp

boolean

If Yes, record AE/SAE number
Beschreibung

If Yes, record AE/SAE number

Datentyp

integer

5. Death due to a cordiovascular procedure/operation
Beschreibung

Specify

Datentyp

text

Date performed
Beschreibung

Date performed

Datentyp

date

6. Death due to pulmonary embolism
Beschreibung

6. Death due to pulmonary embolism

Datentyp

boolean

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

Specify

Datentyp

text

8. Cause of death unknown
Beschreibung

8. Cause of death unknown

Datentyp

boolean

Place of Death
Beschreibung

Place of Death

Check one
Beschreibung

Check one

Datentyp

text

If Other, please specify
Beschreibung

If Other, please specify

Datentyp

text

Other data
Beschreibung

Other data

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

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

Datentyp

text

AE/SAE number
Beschreibung

AE/SAE number

Datentyp

integer

AE/SAE number
Beschreibung

AE/SAE number

Datentyp

integer

AE/SAE number
Beschreibung

AE/SAE number

Datentyp

integer

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

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

Datentyp

boolean

If Yes, please specify
Beschreibung

If Yes, please specify

Datentyp

text

Reason for Hospitalization
Beschreibung

Reason for Hospitalization

Datentyp

text

AE/SAE Number
Beschreibung

AE/SAE Number

Datentyp

integer

Reason for Hospitalization 2
Beschreibung

Reason for Hospitalization 2

Datentyp

text

AE/SAE Number
Beschreibung

AE/SAE Number

Datentyp

integer

Reason for Hospitalization 3
Beschreibung

Reason for Hospitalization 3

Datentyp

text

AE/SAE Number
Beschreibung

AE/SAE Number

Datentyp

integer

Reason for Hospitalization 4
Beschreibung

Reason for Hospitalization 4

Datentyp

text

AE/SAE Number
Beschreibung

AE/SAE Number

Datentyp

integer

Circumstances of Death
Beschreibung

Circumstances of Death

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

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

Datentyp

text

Was the death witnessed?
Beschreibung

Was the death witnessed?

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

boolean

If Yes, specify
Beschreibung

If Yes, specify

Datentyp

text

Date
Beschreibung

Date

Datentyp

date

Further comment
Beschreibung

Further comment

Datentyp

text

Date
Beschreibung

Date

Datentyp

date

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

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

Datentyp

text

Was a life threatening arrhythmia or conduction disturbance identified?
Beschreibung

Was a life threatening arrhythmia or conduction disturbance identified?

Datentyp

text

If Yes, check all that apply
Beschreibung

If Yes, check all that apply

Datentyp

text

Was resuscitation attempted prior to death?
Beschreibung

Was resuscitation attempted prior to death?

Datentyp

text

Date and Time of resuscitation attempt
Beschreibung

Date and Time of resuscitation attempt

Datentyp

datetime

If Yes, check all that apply
Beschreibung

If Yes, check all that apply

Datentyp

text

If Other, specify
Beschreibung

If Other, specify

Datentyp

text

Narrative
Beschreibung

Narrative

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

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.

Datentyp

text

Description of Event (Cont.)
Beschreibung

Description of Event (Cont.)

Datentyp

text

Description of Event (Cont.)
Beschreibung

Description of Event (Cont.)

Datentyp

text

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Ähnliche Modelle

Adjudication Events - Death

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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