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)
- 1/7/19 1/7/19 -
Copyright Holder
GSK group of companies
Uploaded on
January 7, 2019
DOI
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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
Adjudication Events - Death
- StudyEvent: ODM
Description
Death
Description
Cause of Death
Description
Cause of death as specified on Death Certificate or other documentation:
Data type
text
Description
Was an autopsy performed?
Data type
boolean
Description
If Yes, please provide a copy of the report. Every effort to obtain the report should be made.
Data type
boolean
Description
Classification of Primary Cause of Death
Description
Non-cardiovascular death
Description
Cardiovascular death
Description
1. Sudden death
Data type
boolean
Description
If Yes, record AE/SAE number
Data type
integer
Description
Please complete an Acute MI/Hospitalized Angina or Chest pain event form and record the event number from that form
Data type
boolean
Description
If Yes, record AE/SAE number
Data type
integer
Description
Please complete a Stroke/TIA event form and record the event number from that form
Data type
boolean
Description
If Yes, record AE/SAE number
Data type
integer
Description
If applicable, please complete a Hospitalization For Heart Failure event form and record the event number from that form.
Data type
boolean
Description
If Yes, record AE/SAE number
Data type
integer
Description
Specify
Data type
text
Description
Date performed
Data type
date
Description
6. Death due to pulmonary embolism
Data type
boolean
Description
Specify
Data type
text
Description
8. Cause of death unknown
Data type
boolean
Description
Place of Death
Description
Other data
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
Description
AE/SAE number
Data type
integer
Description
AE/SAE number
Data type
integer
Description
AE/SAE number
Data type
integer
Description
In the 14 days prior to death, had the subject been discharged from the hospital?
Data type
boolean
Description
If Yes, please specify
Data type
text
Description
Reason for Hospitalization
Data type
text
Description
AE/SAE Number
Data type
integer
Description
Reason for Hospitalization 2
Data type
text
Description
AE/SAE Number
Data type
integer
Description
Reason for Hospitalization 3
Data type
text
Description
AE/SAE Number
Data type
integer
Description
Reason for Hospitalization 4
Data type
text
Description
AE/SAE Number
Data type
integer
Description
Circumstances of Death
Description
Considering the subject's condition prior to death, was the death clinically expected?
Data type
text
Description
Was the death witnessed?
Data type
text
Description
If No, how long since the subject had last been seen alive by anyone?
Data type
text
Description
When last seen, was the subject observed to be in his/her usual state of health?
Data type
text
Description
In the 14 days prior to death, had the subject undergone any procedure(s)/operation(s)?
Data type
boolean
Description
If Yes, specify
Data type
text
Description
Date
Data type
date
Description
Further comment
Data type
text
Description
Date
Data type
date
Description
What was the duration of new or worsening symptoms immediately before death?
Data type
text
Description
Was a life threatening arrhythmia or conduction disturbance identified?
Data type
text
Description
If Yes, check all that apply
Data type
text
Description
Was resuscitation attempted prior to death?
Data type
text
Description
Date and Time of resuscitation attempt
Data type
datetime
Description
If Yes, check all that apply
Data type
text
Description
If Other, specify
Data type
text
Description
Narrative
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
Description of Event (Cont.)
Data type
text
Description
Description of Event (Cont.)
Data type
text
Similar models
Adjudication Events - Death
- StudyEvent: ODM