ID

33919

Descrizione

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

versioni (1)
  1. 07/01/19 07/01/19 -
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GSK group of companies

Caricato su

7 gennaio 2019

DOI

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Licenza

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

Inglese

Adjudication Events - Death

1 moduli  
Administrative data
Descrizione

Administrative data

Site
Descrizione

Site

Tipo di dati

text

Subject
Descrizione

Subject

Tipo di dati

text

Visit Name
Descrizione

Visit Name

Tipo di dati

text

Status
Descrizione

Status

Tipo di dati

text

Document Number
Descrizione

Document Number

Tipo di dati

text

Death
Descrizione

Death

AE / SAE Number
Descrizione

AE / SAE Number

Tipo di dati

integer

Date and estimated time of death
Descrizione

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.

Tipo di dati

datetime

Cause of Death
Descrizione

Cause of Death

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

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

Tipo di dati

text

Was an autopsy performed?
Descrizione

Was an autopsy performed?

Tipo di dati

boolean

If Yes, was autopsy report available?
Descrizione

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

Tipo di dati

boolean

Classification of Primary Cause of Death
Descrizione

Classification of Primary Cause of Death

Specify cause of death
Descrizione

Specify cause of death

Tipo di dati

text

Non-cardiovascular death
Descrizione

Non-cardiovascular death

Specify cause
Descrizione

if applies

Tipo di dati

text

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

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

Tipo di dati

date

Cardiovascular death
Descrizione

Cardiovascular death

1. Sudden death
Descrizione

1. Sudden death

Tipo di dati

boolean

If Yes, record AE/SAE number
Descrizione

If Yes, record AE/SAE number

Tipo di dati

integer

2. Death due to myocardial infraction
Descrizione

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

Tipo di dati

boolean

If Yes, record AE/SAE number
Descrizione

If Yes, record AE/SAE number

Tipo di dati

integer

3. Death due to stroke
Descrizione

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

Tipo di dati

boolean

If Yes, record AE/SAE number
Descrizione

If Yes, record AE/SAE number

Tipo di dati

integer

4. Death due to heart failure
Descrizione

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

Tipo di dati

boolean

If Yes, record AE/SAE number
Descrizione

If Yes, record AE/SAE number

Tipo di dati

integer

5. Death due to a cordiovascular procedure/operation
Descrizione

Specify

Tipo di dati

text

Date performed
Descrizione

Date performed

Tipo di dati

date

6. Death due to pulmonary embolism
Descrizione

6. Death due to pulmonary embolism

Tipo di dati

boolean

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

Specify

Tipo di dati

text

8. Cause of death unknown
Descrizione

8. Cause of death unknown

Tipo di dati

boolean

Place of Death
Descrizione

Place of Death

Check one
Descrizione

Check one

Tipo di dati

text

If Other, please specify
Descrizione

If Other, please specify

Tipo di dati

text

Other data
Descrizione

Other data

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

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

Tipo di dati

text

AE/SAE number
Descrizione

AE/SAE number

Tipo di dati

integer

AE/SAE number
Descrizione

AE/SAE number

Tipo di dati

integer

AE/SAE number
Descrizione

AE/SAE number

Tipo di dati

integer

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

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

Tipo di dati

boolean

If Yes, please specify
Descrizione

If Yes, please specify

Tipo di dati

text

Reason for Hospitalization
Descrizione

Reason for Hospitalization

Tipo di dati

text

AE/SAE Number
Descrizione

AE/SAE Number

Tipo di dati

integer

Reason for Hospitalization 2
Descrizione

Reason for Hospitalization 2

Tipo di dati

text

AE/SAE Number
Descrizione

AE/SAE Number

Tipo di dati

integer

Reason for Hospitalization 3
Descrizione

Reason for Hospitalization 3

Tipo di dati

text

AE/SAE Number
Descrizione

AE/SAE Number

Tipo di dati

integer

Reason for Hospitalization 4
Descrizione

Reason for Hospitalization 4

Tipo di dati

text

AE/SAE Number
Descrizione

AE/SAE Number

Tipo di dati

integer

Circumstances of Death
Descrizione

Circumstances of Death

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

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

Tipo di dati

text

Was the death witnessed?
Descrizione

Was the death witnessed?

Tipo di dati

text

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

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

Tipo di dati

text

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

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

Tipo di dati

text

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

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

Tipo di dati

boolean

If Yes, specify
Descrizione

If Yes, specify

Tipo di dati

text

Date
Descrizione

Date

Tipo di dati

date

Further comment
Descrizione

Further comment

Tipo di dati

text

Date
Descrizione

Date

Tipo di dati

date

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

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

Tipo di dati

text

Was a life threatening arrhythmia or conduction disturbance identified?
Descrizione

Was a life threatening arrhythmia or conduction disturbance identified?

Tipo di dati

text

If Yes, check all that apply
Descrizione

If Yes, check all that apply

Tipo di dati

text

Was resuscitation attempted prior to death?
Descrizione

Was resuscitation attempted prior to death?

Tipo di dati

text

Date and Time of resuscitation attempt
Descrizione

Date and Time of resuscitation attempt

Tipo di dati

datetime

If Yes, check all that apply
Descrizione

If Yes, check all that apply

Tipo di dati

text

If Other, specify
Descrizione

If Other, specify

Tipo di dati

text

Narrative
Descrizione

Narrative

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

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.

Tipo di dati

text

Description of Event (Cont.)
Descrizione

Description of Event (Cont.)

Tipo di dati

text

Description of Event (Cont.)
Descrizione

Description of Event (Cont.)

Tipo di dati

text

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Similar models

Adjudication Events - Death

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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