ID
33919
Beschrijving
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
Trefwoorden
Versies (1)
- 07-01-19 07-01-19 -
Houder van rechten
GSK group of companies
Geüploaded op
7 januari 2019
DOI
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Licentie
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
Beschrijving
Death
Beschrijving
Cause of Death
Beschrijving
Cause of death as specified on Death Certificate or other documentation:
Datatype
text
Beschrijving
Was an autopsy performed?
Datatype
boolean
Beschrijving
If Yes, please provide a copy of the report. Every effort to obtain the report should be made.
Datatype
boolean
Beschrijving
Classification of Primary Cause of Death
Beschrijving
Non-cardiovascular death
Beschrijving
Cardiovascular death
Beschrijving
1. Sudden death
Datatype
boolean
Beschrijving
If Yes, record AE/SAE number
Datatype
integer
Beschrijving
Please complete an Acute MI/Hospitalized Angina or Chest pain event form and record the event number from that form
Datatype
boolean
Beschrijving
If Yes, record AE/SAE number
Datatype
integer
Beschrijving
Please complete a Stroke/TIA event form and record the event number from that form
Datatype
boolean
Beschrijving
If Yes, record AE/SAE number
Datatype
integer
Beschrijving
If applicable, please complete a Hospitalization For Heart Failure event form and record the event number from that form.
Datatype
boolean
Beschrijving
If Yes, record AE/SAE number
Datatype
integer
Beschrijving
Specify
Datatype
text
Beschrijving
Date performed
Datatype
date
Beschrijving
6. Death due to pulmonary embolism
Datatype
boolean
Beschrijving
Specify
Datatype
text
Beschrijving
8. Cause of death unknown
Datatype
boolean
Beschrijving
Place of Death
Beschrijving
Other data
Beschrijving
Please complete any other appropriate event form(s) pertaining to the hospitalization and record the event number(s) from those forms below
Datatype
text
Beschrijving
AE/SAE number
Datatype
integer
Beschrijving
AE/SAE number
Datatype
integer
Beschrijving
AE/SAE number
Datatype
integer
Beschrijving
In the 14 days prior to death, had the subject been discharged from the hospital?
Datatype
boolean
Beschrijving
If Yes, please specify
Datatype
text
Beschrijving
Reason for Hospitalization
Datatype
text
Beschrijving
AE/SAE Number
Datatype
integer
Beschrijving
Reason for Hospitalization 2
Datatype
text
Beschrijving
AE/SAE Number
Datatype
integer
Beschrijving
Reason for Hospitalization 3
Datatype
text
Beschrijving
AE/SAE Number
Datatype
integer
Beschrijving
Reason for Hospitalization 4
Datatype
text
Beschrijving
AE/SAE Number
Datatype
integer
Beschrijving
Circumstances of Death
Beschrijving
Considering the subject's condition prior to death, was the death clinically expected?
Datatype
text
Beschrijving
Was the death witnessed?
Datatype
text
Beschrijving
If No, how long since the subject had last been seen alive by anyone?
Datatype
text
Beschrijving
When last seen, was the subject observed to be in his/her usual state of health?
Datatype
text
Beschrijving
In the 14 days prior to death, had the subject undergone any procedure(s)/operation(s)?
Datatype
boolean
Beschrijving
If Yes, specify
Datatype
text
Beschrijving
Date
Datatype
date
Beschrijving
Further comment
Datatype
text
Beschrijving
Date
Datatype
date
Beschrijving
What was the duration of new or worsening symptoms immediately before death?
Datatype
text
Beschrijving
Was a life threatening arrhythmia or conduction disturbance identified?
Datatype
text
Beschrijving
If Yes, check all that apply
Datatype
text
Beschrijving
Was resuscitation attempted prior to death?
Datatype
text
Beschrijving
Date and Time of resuscitation attempt
Datatype
datetime
Beschrijving
If Yes, check all that apply
Datatype
text
Beschrijving
If Other, specify
Datatype
text
Beschrijving
Narrative
Beschrijving
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.
Datatype
text
Beschrijving
Description of Event (Cont.)
Datatype
text
Beschrijving
Description of Event (Cont.)
Datatype
text
Similar models
Adjudication Events - Death
- StudyEvent: ODM