ID
33919
Beskrivning
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
Nyckelord
Versioner (1)
- 2019-01-07 2019-01-07 -
Rättsinnehavare
GSK group of companies
Uppladdad den
7 januari 2019
DOI
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Licens
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
Beskrivning
Death
Beskrivning
Cause of Death
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Cause of death as specified on Death Certificate or other documentation:
Datatyp
text
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Was an autopsy performed?
Datatyp
boolean
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If Yes, please provide a copy of the report. Every effort to obtain the report should be made.
Datatyp
boolean
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Classification of Primary Cause of Death
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Non-cardiovascular death
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Cardiovascular death
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1. Sudden death
Datatyp
boolean
Beskrivning
If Yes, record AE/SAE number
Datatyp
integer
Beskrivning
Please complete an Acute MI/Hospitalized Angina or Chest pain event form and record the event number from that form
Datatyp
boolean
Beskrivning
If Yes, record AE/SAE number
Datatyp
integer
Beskrivning
Please complete a Stroke/TIA event form and record the event number from that form
Datatyp
boolean
Beskrivning
If Yes, record AE/SAE number
Datatyp
integer
Beskrivning
If applicable, please complete a Hospitalization For Heart Failure event form and record the event number from that form.
Datatyp
boolean
Beskrivning
If Yes, record AE/SAE number
Datatyp
integer
Beskrivning
Specify
Datatyp
text
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Date performed
Datatyp
date
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6. Death due to pulmonary embolism
Datatyp
boolean
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Specify
Datatyp
text
Beskrivning
8. Cause of death unknown
Datatyp
boolean
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Place of Death
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Other data
Beskrivning
Please complete any other appropriate event form(s) pertaining to the hospitalization and record the event number(s) from those forms below
Datatyp
text
Beskrivning
AE/SAE number
Datatyp
integer
Beskrivning
AE/SAE number
Datatyp
integer
Beskrivning
AE/SAE number
Datatyp
integer
Beskrivning
In the 14 days prior to death, had the subject been discharged from the hospital?
Datatyp
boolean
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If Yes, please specify
Datatyp
text
Beskrivning
Reason for Hospitalization
Datatyp
text
Beskrivning
AE/SAE Number
Datatyp
integer
Beskrivning
Reason for Hospitalization 2
Datatyp
text
Beskrivning
AE/SAE Number
Datatyp
integer
Beskrivning
Reason for Hospitalization 3
Datatyp
text
Beskrivning
AE/SAE Number
Datatyp
integer
Beskrivning
Reason for Hospitalization 4
Datatyp
text
Beskrivning
AE/SAE Number
Datatyp
integer
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Circumstances of Death
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Considering the subject's condition prior to death, was the death clinically expected?
Datatyp
text
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Was the death witnessed?
Datatyp
text
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If No, how long since the subject had last been seen alive by anyone?
Datatyp
text
Beskrivning
When last seen, was the subject observed to be in his/her usual state of health?
Datatyp
text
Beskrivning
In the 14 days prior to death, had the subject undergone any procedure(s)/operation(s)?
Datatyp
boolean
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If Yes, specify
Datatyp
text
Beskrivning
Date
Datatyp
date
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Further comment
Datatyp
text
Beskrivning
Date
Datatyp
date
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What was the duration of new or worsening symptoms immediately before death?
Datatyp
text
Beskrivning
Was a life threatening arrhythmia or conduction disturbance identified?
Datatyp
text
Beskrivning
If Yes, check all that apply
Datatyp
text
Beskrivning
Was resuscitation attempted prior to death?
Datatyp
text
Beskrivning
Date and Time of resuscitation attempt
Datatyp
datetime
Beskrivning
If Yes, check all that apply
Datatyp
text
Beskrivning
If Other, specify
Datatyp
text
Beskrivning
Narrative
Beskrivning
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.
Datatyp
text
Beskrivning
Description of Event (Cont.)
Datatyp
text
Beskrivning
Description of Event (Cont.)
Datatyp
text
Similar models
Adjudication Events - Death
- StudyEvent: ODM