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