Information:
Fel:
ID
33859
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)
- 2019-01-04 2019-01-04 -
Rättsinnehavare
GSK group of companies
Uppladdad den
4 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 - Heart Failure
- StudyEvent: ODM
Similar models
Adjudication Events - Heart Failure
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Site
Item
Site
text
Subject
Item
Subject
text
CL Item
Adjudication (1)
Status
Item
Status
text
Document Number
Item
Document Number
text
AE / SAE Number
Item
AE / SAE Number
integer
Was the subject hospitalized for this event?
Item
Was the subject hospitalized for this event?
boolean
Date of hospitalization
Item
Date of hospitalization
date
Was the event primary reason for hospitalization?
Item
Was the event primary reason for hospitalization?
boolean
If No, specify the primary reason for hospitalization:
Item
If No, specify the primary reason for hospitalization:
text
Record corresponding AE/SAE number
Item
Record corresponding AE/SAE number
integer
Did the subject die due to this event?
Item
Did the subject die due to this event?
boolean
Date of Onset
Item
Date of Onset
date
Time of Onset
Item
Time of Onset
time
New or worsening dyspnoea at rest
Item
New or worsening dyspnoea at rest
boolean
New or worsening dyspnoea on exertion
Item
New or worsening dyspnoea on exertion
boolean
New or worsening orthopnoea
Item
New or worsening orthopnoea
boolean
New or worsening PND (paroxymal nocturnal dyspnoea)
Item
New or worsening PND (paroxymal nocturnal dyspnoea)
boolean
New or worsening peripheral oedema
Item
New or worsening peripheral oedema
boolean
New or worsening pulmonary crackles / crepitations
Item
New or worsening pulmonary crackles / crepitations
boolean
New or worsening elevated JVP (jugular venous pressure)
Item
New or worsening elevated JVP (jugular venous pressure)
boolean
New or worsening third heart sounds ("S3") or gallop rhythm
Item
New or worsening third heart sounds ("S3") or gallop rhythm
boolean
New or worsening peripheral oedema
Item
New or worsening peripheral oedema
boolean
New or worsening other clinical evidence of heart failure
Item
New or worsening other clinical evidence of heart failure
boolean
Specify
Item
Specify
text
Item Group
Investigative Evidence of Structural or Functional Heart Disease
Please record the details in the following section
Item
Please record the details in the following section
text
Was a chest x-ray performed?
Item
Was a chest x-ray performed?
boolean
Date of chest x-ray?
Item
Date of chest x-ray?
date
Cardiomegaly, i.e cardiothoracic ratio
Item
Cardiomegaly, i.e cardiothoracic ratio
boolean
Upper zone flow redistribution (cephalisation of pulmonary veins)
Item
Upper zone flow redistribution (cephalisation of pulmonary veins)
boolean
Interstitial pulmanory oedema
Item
Interstitial pulmanory oedema
boolean
Alveolar pulmonary oedema
Item
Alveolar pulmonary oedema
boolean
Pleural effusion(s)
Item
Pleural effusion(s)
boolean
CL Item
Unilateral (1)
CL Item
Bilateral (2)
CL Item
Unknown (3)
Other x-ray features consistent with heart failure
Item
Other x-ray features consistent with heart failure
boolean
If Yes, specify
Item
If Yes, specify
text
Was an echocardiogram performed?
Item
Was an echocardiogram performed?
date
Was Left ventricular end diastolic diameter (LVEDD) documented?
Item
Was Left ventricular end diastolic diameter (LVEDD) documented?
boolean
(LVEDD)
Item
(LVEDD)
float
Dilated left ventricle
Item
Dilated left ventricle
boolean
Left ventricular hypertrophy
Item
Left ventricular hypertrophy
boolean
Was intraventricular septal thickness during diastole (IVSd) documented?
Item
Was intraventricular septal thickness during diastole (IVSd) documented?
boolean
IVSd
Item
IVSd
float
Was left posterior wall thickness during diastole (LVPWd) documented?
Item
Was left posterior wall thickness during diastole (LVPWd) documented?
boolean
LVPWd
Item
LVPWd
float
Was ejection fraction (EF) documented?
Item
Was ejection fraction (EF) documented?
boolean
EF
Item
EF
float
Item Group
Left ventricular systolic dysfunction / impairment
Was the echocardiogram reported as showing left ventricular systolic dysfunction / impairment?
Item
Was the echocardiogram reported as showing left ventricular systolic dysfunction / impairment?
boolean
Item
If Yes, was this systolic dysfunction / impairment reported to be:
text
Code List
If Yes, was this systolic dysfunction / impairment reported to be:
CL Item
Mild (1)
CL Item
Mild to moderate (2)
CL Item
Moderate (3)
CL Item
Moderate to severe (4)
CL Item
Severe (5)
CL Item
Other (6)
If Other, specify
Item
If Other, specify
text
Was left atrial diameter documented?
Item
Was left atrial diameter documented?
boolean
Left atrial diameter
Item
Left atrial diameter
float
Dilated left atrium
Item
Dilated left atrium
boolean
Significant valvular heart disease
Item
Significant valvular heart disease
boolean
Mitral stenosis
Item
Mitral stenosis
boolean
Mitral regurgitation
Item
Mitral regurgitation
boolean
Tricuspid stenosis
Item
Tricuspid stenosis
boolean
Tricuspid regurgitation
Item
Tricuspid regurgitation
boolean
Aortic stenosis
Item
Aortic stenosis
boolean
Aortic regurgitation
Item
Aortic regurgitation
boolean
Other
Item
Other
boolean
Specify
Item
Specify
text
Evidence of diastolic dysfunction
Item
Evidence of diastolic dysfunction
boolean
Specify
Item
Specify
text
Other relevant echocardiogram findings
Item
Other relevant echocardiogram findings
boolean
Specify
Item
Specify
text
Item Group
BNP (B-type natriuretic peptide) or NT-proBNP (N-terminal proBNP)
Was BNP/NT-proBNP measured in view of this event?
Item
Was BNP/NT-proBNP measured in view of this event?
boolean
Item Group
Peak BNP/NT-proBNP value + the laboratory upper reference limit
Please provide the peak BNP/NT-proBNP value that obtained during this event along with the laboratory upper reference limit.
Item
Please provide the peak BNP/NT-proBNP value that obtained during this event along with the laboratory upper reference limit.
text
Was peak value recorded?
Item
Was peak value recorded?
boolean
Peak Value
Item
Peak Value
float
Date sample taken
Item
Date sample taken
date
Upper limit of normal
Item
Upper limit of normal
float
CL Item
pg/mol (1)
CL Item
ng/L (2)
Was peak value recorded?
Item
Was peak value recorded?
boolean
Peak Value
Item
Peak Value
float
Date sample taken
Item
Date sample taken
date
Upper limit of normal
Item
Upper limit of normal
float
CL Item
pg/mol (1)
CL Item
ng/L (2)
Were any other investigations undertaken in view of possible heart failure?
Item
Were any other investigations undertaken in view of possible heart failure?
boolean
Please specify the type of investigation(s) performed and briefly describe the result(s) or any relevant findings
Item
Please specify the type of investigation(s) performed and briefly describe the result(s) or any relevant findings
text
Date of Investigation
Item
Date of Investigation
date
During this event, did the subject receive any of the following specifically for the treatment of heart failure?
Item
During this event, did the subject receive any of the following specifically for the treatment of heart failure?
boolean
CL Item
Cardiac resynchronization therapy (biventricular or multisite pacing) (1)
CL Item
CPAP or BiPAP ventilation (2)
CL Item
Mechanical circulatory support (e.g., intra-aortic balloon pump, ventricular assist device) (3)
CL Item
Haemofiltration / ultrafiltration / haemodialysis / peritoneal dialysis (specifically directed at heart failure) (4)
CL Item
Other non-pharmacological treatment for this event (5)
If Other, specify
Item
If Other, specify
text
Date of Treatment
Item
Date of Treatment
date
Please provide sufficient description of event to allow the Endpoint Committee to accurately classify this event.
Item
Please provide sufficient description of event to allow the Endpoint Committee to accurately classify this event.
text