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ID
33916
Beschreibung
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
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- 07.01.19 07.01.19 -
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GSK group of companies
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7. Januar 2019
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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
Ähnliche Modelle
Adjudication Events - Acute Myocardial Infraction/Hospitalized Angina or Chest Pain
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Site
Item
Site
text
Subject
Item
Subject
text
CL Item
Adjudication (1)
Status
Item
Status
text
Document Number
Item
Document Number
text
Item Group
Acute Myocardial Infraction/Hospitalized Angina or Chest Pain
AE / SAE Number
Item
AE / SAE Number
integer
Date of event
Item
Date of event
date
Estimated time of event
Item
Estimated time of event
time
Was the subject hospitalized because of this event?
Item
Was the subject hospitalized because of this event?
boolean
Date of Hospitalization
Item
Date of hospitalization
date
Time of Hospitalization
Item
Time of Hospitalization
time
If Yes, was this event the primary reason for hospitalization?
Item
If Yes, was this event the primary reason for hospitalization?
boolean
If No, please specify primary reason for hospitalization:
Item
If No, please specify primary reason for hospitalization:
text
AE/SAE Number
Item
AE/SAE Number
integer
Did the event occur during an ongoing hospitalization?
Item
Did the event occur during an ongoing hospitalization?
boolean
If Yes, please specify primary reason for hospitalization
Item
If Yes, please specify primary reason for hospitalization
text
AE/SAE Number
Item
AE/SAE Number
integer
Did the subject die because of this event?
Item
Did the subject die because of this event?
boolean
Do you consider that this event occurred as a direct consequence of any procedure/operation?
Item
Do you consider that this event occurred as a direct consequence of any procedure/operation?
boolean
If Yes, please record AE/SAE Number
Item
If Yes, please record AE/SAE Number
integer
Date of procedure/operation
Item
Date of procedure/operation
date
Specify the procedure/operation
Item
Specify the procedure/operation
text
Did this even occur after a coronary revascularization procedure?
Item
Did this even occur after a coronary revascularization procedure?
boolean
Exercise related cardiac ischaemic-type chest pain/discomfort of new onset and duration of at least 10 minutes.
Item
Exercise related cardiac ischaemic-type chest pain/discomfort of new onset and duration of at least 10 minutes.
boolean
Exercise related cardiac ischaemic-type chest pain/discomfort increasing in frequency and/or severity and duration of at least 10 minutes.
Item
Exercise related cardiac ischaemic-type chest pain/discomfort increasing in frequency and/or severity and duration of at least 10 minutes.
boolean
Decreasing threshold for onset of exercise related cardiac ishaemic-type chest pain/discomfort.
Item
Decreasing threshold for onset of exercise related cardiac ishaemic-type chest pain/discomfort.
boolean
Cardiac ischaemic-type chest pain/discomfort at rest
Item
Cardiac ischaemic-type chest pain/discomfort at rest
boolean
Severe, prolonged cardiac ischaemic-type chest pain or discomfort.
Item
Severe, prolonged cardiac ischaemic-type chest pain or discomfort.
boolean
Other chest pain
Item
Other chest pain
text
Other possible manifestation of myocardial ischaemia.
Item
Other possible manifestation of myocardial ischaemia.
text
Were ECGs recorded in view of this event?
Item
Were ECGs recorded in view of this event?
boolean
Item
a. Are ECGs relating to this event (i.e during and/or after event) available?
text
Code List
a. Are ECGs relating to this event (i.e during and/or after event) available?
CL Item
Yes (please submit copies of these ECGs and ensure that the date and time of recording is clearly marked on each tracing) (1)
CL Item
No (2)
Dates of ECG
Item
Dates of ECG
integer
Times of ECG
Item
Times of ECG
time
b. Did the subject develop new ECG changes?
Item
b. Did the subject develop new ECG changes?
boolean
New pathologic Q waves (or new R waves in V1 and V2) in 2 or more contiguous leads
Item
New pathologic Q waves (or new R waves in V1 and V2) in 2 or more contiguous leads
boolean
CL Item
Anterior (1)
CL Item
Septal (2)
CL Item
Lateral (3)
CL Item
Inferior (4)
CL Item
Other (5)
If Other, specify
Item
If Other, specify
text
New ST segment elevation in 2 or more contiguous leads
Item
New ST segment elevation in 2 or more contiguous leads
boolean
CL Item
Anterior (1)
CL Item
Septal (2)
CL Item
Lateral (3)
CL Item
Inferior (4)
CL Item
Other (5)
Other, specify
Item
Other, specify
text
New ST segment depression
Item
New ST segment depression
boolean
CL Item
Anterior (1)
CL Item
Septal (2)
CL Item
Lateral (3)
CL Item
Inferior (4)
CL Item
Other (5)
Other, specify
Item
Other, specify
text
CL Item
Anterior (1)
CL Item
Septal (2)
CL Item
Lateral (3)
CL Item
Inferior (4)
CL Item
Other (5)
Other, specify
Item
Other, specify
text
New left bundle branch block
Item
New left bundle branch block
boolean
Other new ECG changes
Item
Other new ECG changes
boolean
Other, specify
Item
Other, specify
text
Were cardiac enzymes/markers measured in view of this event?
Item
Were cardiac enzymes/markers measured in view of this event?
boolean
Were the values taken?
Item
Were the values taken?
boolean
Peak Value
Item
Peak Value
text
Date sample taken
Item
Date sample taken
date
Time
Item
Time
time
Upper Limit of Normal
Item
Upper Limit of Normal
text
Enzyme Unit
Item
Enzyme Unit
text
Were the values taken?
Item
Were the values taken?
boolean
Peak Value
Item
Peak Value
text
Date sample taken
Item
Date sample taken
date
Time
Item
Time
time
Upper Limit of Normal
Item
Upper Limit of Normal
text
Enzyme Unit
Item
Enzyme Unit
text
Were the values taken?
Item
Were the values taken?
text
Peak Value
Item
Peak Value
text
Date sample taken
Item
Date sample taken
date
Time
Item
Time
time
Upper Limit of Normal
Item
Upper Limit of Normal
text
Enzyme Unit
Item
Enzyme Unit
text
Item Group
Treatment Given for Acute MI/Hospitalized Angina/Chest Pain Event
CL Item
Thrombolytic therapy (e.g., tenecteplase, reteplase, alteplase, streptokinase) (1)
CL Item
Primary or rescue percutaneous coronary intervention (PCI) for suspected acute myocardial infraction (e.g., primary angioplasty or rescue angioplasty) (2)
CL Item
Percutaneous coronary intervention for unstable angina (3)
CL Item
Other percutaneous coronary intervention (4)
CL Item
Coronary bypass surgery (5)
CL Item
Other revascularisation procedure/operation/mechanical intervention (6)
CL Item
Other therapy for this event (7)
If Primary or rescue percutaneous coronary intervention was prescribed, record the AE/SAE number:
Item
If Primary or rescue percutaneous coronary intervention was prescribed, record the AE/SAE number:
integer
If Percutaneous coronary intervention for unstable angina was prescribed, record the AE/SAE number:
Item
If Percutaneous coronary intervention for unstable angina was prescribed, record the AE/SAE number:
integer
For Other percutaneous coronary intervention record AE/SAE number
Item
For Other percutaneous coronary intervention record AE/SAE number
integer
Date
Item
Date
date
For Coronary bypass surgery record AE/SAE number
Item
For Coronary bypass surgery record AE/SAE number
integer
For Other revascularisation procedure/operation/mechanical intervention specify the treatment type:
Item
For Other revascularisation procedure/operation/mechanical intervention specify the treatment type:
text
AE/SAE number
Item
AE/SAE number
integer
Specify any additional therapies:
Item
Specify any additional therapies:
text
Item Group
Other Investigations Undertaken in View of this Event
1. Was coronary angiography performed in view of this event?
Item
1. Was coronary angiography performed in view of this event?
boolean
Date of coronary angiography performed
Item
Date of coronary angiography performed
date
Was invasive coronary angiography (i.e involving cardiac catheterization) performed?
Item
Was invasive coronary angiography (i.e involving cardiac catheterization) performed?
boolean
Date of invasive coronary angiography performed
Item
Date of invasive coronary angiography performed
date
Was this reported to demonstrate angiographycally significant coronary artery disease thought to be responsible for the subject's presentation?
Item
Was this reported to demonstrate angiographycally significant coronary artery disease thought to be responsible for the subject's presentation?
boolean
Was a stent previously placed prior to this hospitalization?
Item
Was a stent previously placed prior to this hospitalization?
boolean
Was there evidence of stent thrombosis?
Item
Was there evidence of stent thrombosis?
boolean
CT coronary angiography
Item
CT coronary angiography
boolean
If Yes, date of angiography performed
Item
If Yes, date of angiography performed
date
Was this reported to demonstrate angiographically significant coronary artery disease thought to be responsible for the subject's presentation?
Item
Was this reported to demonstrate angiographically significant coronary artery disease thought to be responsible for the subject's presentation?
boolean
2. Was echocardiography performed in view of this event?
Item
2. Was echocardiography performed in view of this event?
boolean
Date of echocardiography
Item
Date of echocardiography
date
Did this show evidence of a new regional wall motion abnormality?
Item
Did this show evidence of a new regional wall motion abnormality?
boolean
CL Item
Anterior (1)
CL Item
Septal (2)
CL Item
Lateral (3)
CL Item
Inferior (4)
CL Item
Other (5)
If Other, specify
Item
If Other, specify
text
3. Was an exercise ECG test undertaken?
Item
3. Was an exercise ECG test undertaken?
boolean
Date of ECG test
Item
Date of ECG test
date
Was the test positive for reversible myocardial ischaemia?
Item
Was the test positive for reversible myocardial ischaemia?
boolean
4. Was a stress myocardial perfusion scan undertaken?
Item
4. Was a stress myocardial perfusion scan undertaken?
boolean
If Yes, record the date
Item
If Yes, record the date
date
CL Item
Stress cardiac MRI (1)
CL Item
Stress nuclear perfusion imaging (2)
Was this test positive for reversible myocardial ischaemia?
Item
Was this test positive for reversible myocardial ischaemia?
boolean
5. Was any other investigation to test for the presence of reversible myocardial ischaemia undertaken (e.g. stress echocardiogram)?
Item
5. Was any other investigation to test for the presence of reversible myocardial ischaemia undertaken (e.g. stress echocardiogram)?
boolean
Specify type of test
Item
Specify type of test
text
Date of test
Item
Date of test
date
Was the test positive for reversible myocardial ischaemia?
Item
Was the test positive for reversible myocardial ischaemia?
boolean
Item
Was the final clinical diagnosis in relation to this event?
integer
Code List
Was the final clinical diagnosis in relation to this event?
CL Item
Acute myocardial infraction (1)
CL Item
Unstable angina (2)
CL Item
Other angina (3)
CL Item
Other chest pain (4)
CL Item
Other final clinical diagnosis (5)
Item
In case of acute myocardial infraction, choose the type of myocardial infraction
text
Code List
In case of acute myocardial infraction, choose the type of myocardial infraction
CL Item
ST segment elevation myocardial infraction (STEMI) (1)
CL Item
Non-ST segment elevation myocardial infraction (NSTEMI) (2)
CL Item
Acute myocardial infraction, type (i.e STEMI or NSTEMI) not specified (3)
In case of other chest pain, specify
Item
In case of other chest pain, specify
text
In case of other clinical diagnosis, specify
Item
In case of other clinical diagnosis, specify
text
Description of Event
Item
Briefly describe the event
text