ID
33916
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 - Acute Myocardial Infraction/Hospitalized Angina or Chest Pain
Description
Acute Myocardial Infraction/Hospitalized Angina or Chest Pain
Description
AE / SAE Number
Data type
integer
Description
Date of event
Data type
date
Description
Estimated time of event
Data type
time
Description
Was the subject hospitalized because of this event?
Data type
boolean
Description
Date of Hospitalization
Data type
date
Description
Time of Hospitalization
Data type
time
Description
If Yes, was this event the primary reason for hospitalization?
Data type
boolean
Description
If No, please specify primary reason for hospitalization:
Data type
text
Description
AE/SAE Number
Data type
integer
Description
Did the event occur during an ongoing hospitalization?
Data type
boolean
Description
If Yes, please specify primary reason for hospitalization
Data type
text
Description
AE/SAE Number
Data type
integer
Description
if Yes, please complete the Death form
Data type
boolean
Description
Do you consider that this event occurred as a direct consequence of any procedure/operation?
Data type
boolean
Description
If Yes, please record AE/SAE Number
Data type
integer
Description
Date of procedure/operation
Data type
date
Description
Specify the procedure/operation
Data type
text
Description
If Yes, please complete a Coronary Revascularization form
Data type
boolean
Description
Clinical Presentation
Description
Exercise related cardiac ischaemic-type chest pain/discomfort of new onset and duration of at least 10 minutes.
Data type
boolean
Description
Exercise related cardiac ischaemic-type chest pain/discomfort increasing in frequency and/or severity and duration of at least 10 minutes.
Data type
boolean
Description
Decreasing threshold for onset of exercise related cardiac ishaemic-type chest pain/discomfort.
Data type
boolean
Description
Cardiac ischaemic-type chest pain/discomfort at rest
Data type
boolean
Description
Severe, prolonged cardiac ischaemic-type chest pain or discomfort.
Data type
boolean
Description
e.g., non-cardiac-type chest pain or discomfort
Data type
text
Description
e.g., arm, throat or jaw pain/discomfort
Data type
text
Description
Electrocardiographic Details
Description
Were ECGs recorded in view of this event?
Data type
boolean
Description
a. Are ECGs relating to this event (i.e during and/or after event) available?
Data type
text
Description
record all dates here
Data type
integer
Description
record all times here
Data type
time
Description
if Yes, please ensure that you have provided copies of any ECG tracings that show these new changes.
Data type
boolean
Description
New pathologic Q waves (or new R waves in V1 and V2) in 2 or more contiguous leads
Data type
boolean
Description
If Yes, mark all that apply
Data type
text
Description
If Other, specify
Data type
text
Description
New ST segment elevation in 2 or more contiguous leads
Data type
boolean
Description
If Yes, mark all that apply
Data type
text
Description
Other, specify
Data type
text
Description
New ST segment depression
Data type
boolean
Description
If Yes, mark all that apply
Data type
text
Description
Other, specify
Data type
text
Description
New T wave changes
Data type
text
Description
Other, specify
Data type
text
Description
New left bundle branch block
Data type
boolean
Description
Other new ECG changes
Data type
boolean
Description
Other, specify
Data type
text
Description
Cardiac Enzymes/Markers
Description
CK-MB
Description
Were the values taken?
Data type
boolean
Description
Peak Value
Data type
text
Description
Date sample taken
Data type
date
Description
Time
Data type
time
Description
Upper Limit of Normal
Data type
text
Description
Enzyme Unit
Data type
text
Description
Troponin I
Description
Were the values taken?
Data type
boolean
Description
Peak Value
Data type
text
Description
Date sample taken
Data type
date
Description
Time
Data type
time
Description
Upper Limit of Normal
Data type
text
Description
Enzyme Unit
Data type
text
Description
Troponin T
Description
Were the values taken?
Data type
text
Description
Peak Value
Data type
text
Description
Date sample taken
Data type
date
Description
Time
Data type
time
Description
Upper Limit of Normal
Data type
text
Description
Enzyme Unit
Data type
text
Description
Treatment Given for Acute MI/Hospitalized Angina/Chest Pain Event
Description
check all that apply
Data type
text
Description
If Primary or rescue percutaneous coronary intervention was prescribed, record the AE/SAE number:
Data type
integer
Description
If Percutaneous coronary intervention for unstable angina was prescribed, record the AE/SAE number:
Data type
integer
Description
For Other percutaneous coronary intervention record AE/SAE number
Data type
integer
Description
Date
Data type
date
Description
For Coronary bypass surgery record AE/SAE number
Data type
integer
Description
For Other revascularisation procedure/operation/mechanical intervention specify the treatment type:
Data type
text
Description
AE/SAE number
Data type
integer
Description
Specify any additional therapies:
Data type
text
Description
Other Investigations Undertaken in View of this Event
Description
1. Was coronary angiography performed in view of this event?
Data type
boolean
Description
Date of coronary angiography performed
Data type
date
Description
Was invasive coronary angiography (i.e involving cardiac catheterization) performed?
Data type
boolean
Description
Date of invasive coronary angiography performed
Data type
date
Description
Was this reported to demonstrate angiographycally significant coronary artery disease thought to be responsible for the subject's presentation?
Data type
boolean
Description
Was a stent previously placed prior to this hospitalization?
Data type
boolean
Description
Was there evidence of stent thrombosis?
Data type
boolean
Description
CT coronary angiography
Data type
boolean
Description
Please submit a copy of the report, if available
Data type
date
Description
Was this reported to demonstrate angiographically significant coronary artery disease thought to be responsible for the subject's presentation?
Data type
boolean
Description
2. Was echocardiography performed in view of this event?
Data type
boolean
Description
Date of echocardiography
Data type
date
Description
Did this show evidence of a new regional wall motion abnormality?
Data type
boolean
Description
If Yes, mark all that apply
Data type
text
Description
If Other, specify
Data type
text
Description
3. Was an exercise ECG test undertaken?
Data type
boolean
Description
please submit a copy of the echocardiogram report, if available
Data type
date
Description
Was the test positive for reversible myocardial ischaemia?
Data type
boolean
Description
4. Was a stress myocardial perfusion scan undertaken?
Data type
boolean
Description
please submit a copy of the stress myocardial perfusion scan report, if available
Data type
date
Description
Test type
Data type
text
Description
Was this test positive for reversible myocardial ischaemia?
Data type
boolean
Description
5. Was any other investigation to test for the presence of reversible myocardial ischaemia undertaken (e.g. stress echocardiogram)?
Data type
boolean
Description
Specify type of test
Data type
text
Description
Please submit a copy of the other investigation report, if available
Data type
date
Description
Was the test positive for reversible myocardial ischaemia?
Data type
boolean
Description
Final Clinical Diagnosis
Description
Was the final clinical diagnosis in relation to this event?
Data type
integer
Description
mark one only
Data type
text
Description
In case of other chest pain, specify
Data type
text
Description
In case of other clinical diagnosis, specify
Data type
text
Description
Narrative
Description
include clinical presentation, treatment (including procedures or operations), results of investigations (e.g., ECGs and whether cardiac enzymes/biomarkers were elevated), and outcome, including autopsy if appropriate. Please provide sufficient information to allow the Endpoint Committee to accurately classify this event. A copy of the hospital discharge summary should be submitted.
Data type
text