ID
33859
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)
- 1/4/19 1/4/19 -
Copyright Holder
GSK group of companies
Uploaded on
January 4, 2019
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032
Adjudication Events - Heart Failure
- StudyEvent: ODM
Description
Hospitalization for Heart Failure
Description
AE / SAE Number
Data type
integer
Description
Was the subject hospitalized for this event?
Data type
boolean
Description
Date of hospitalization
Data type
date
Description
Was the event primary reason for hospitalization?
Data type
boolean
Description
If No, specify the primary reason for hospitalization:
Data type
text
Description
Record corresponding AE/SAE number
Data type
integer
Description
If Yes, please record details on the Death Form
Data type
boolean
Description
Clinical Symptoms of Heart Failure
Description
Date of Onset
Data type
date
Description
Time of Onset
Data type
time
Description
New or worsening dyspnoea at rest
Data type
boolean
Description
New or worsening dyspnoea on exertion
Data type
boolean
Description
New or worsening orthopnoea
Data type
boolean
Description
New or worsening PND (paroxymal nocturnal dyspnoea)
Data type
boolean
Description
New or worsening peripheral oedema
Data type
boolean
Description
New or worsening pulmonary crackles / crepitations
Data type
boolean
Description
New or worsening elevated JVP (jugular venous pressure)
Data type
boolean
Description
New or worsening third heart sounds ("S3") or gallop rhythm
Data type
boolean
Description
New or worsening peripheral oedema
Data type
boolean
Description
Please, specify below
Data type
boolean
Description
Specify
Data type
text
Description
Investigative Evidence of Structural or Functional Heart Disease
Description
Chest X-Ray
Description
Was a chest x-ray performed?
Data type
boolean
Description
Please submit a copy of the chest x-ray report, if available
Data type
date
Description
CTR >=0.5; If Yes, provide CTR, if available
Data type
boolean
Description
Upper zone flow redistribution (cephalisation of pulmonary veins)
Data type
boolean
Description
Interstitial pulmanory oedema
Data type
boolean
Description
Alveolar pulmonary oedema
Data type
boolean
Description
Pleural effusion(s)
Data type
boolean
Description
If Yes, specify here
Data type
text
Description
Other x-ray features consistent with heart failure
Data type
boolean
Description
If Yes, specify
Data type
text
Description
Echocardiography
Description
Please submit a copy of the electrocardiogram report, if available
Data type
date
Description
Was Left ventricular end diastolic diameter (LVEDD) documented?
Data type
boolean
Description
(LVEDD)
Data type
float
Measurement units
- cm
Description
Dilated left ventricle
Data type
boolean
Description
Left ventricular hypertrophy
Data type
boolean
Description
Was intraventricular septal thickness during diastole (IVSd) documented?
Data type
boolean
Description
IVSd
Data type
float
Measurement units
- cm
Description
Was left posterior wall thickness during diastole (LVPWd) documented?
Data type
boolean
Description
LVPWd
Data type
float
Measurement units
- cm
Description
Was ejection fraction (EF) documented?
Data type
boolean
Description
EF
Data type
float
Measurement units
- %
Description
Left ventricular systolic dysfunction / impairment
Description
Was the echocardiogram reported as showing left ventricular systolic dysfunction / impairment?
Data type
boolean
Description
If Yes, was this systolic dysfunction / impairment reported to be:
Data type
text
Description
If Other, specify
Data type
text
Description
Was left atrial diameter documented?
Data type
boolean
Description
Left atrial diameter
Data type
float
Measurement units
- cm
Description
Dilated left atrium
Data type
boolean
Description
Significant valvular heart disease
Description
Significant valvular heart disease
Data type
boolean
Description
Mitral stenosis
Data type
boolean
Description
Mitral regurgitation
Data type
boolean
Description
Tricuspid stenosis
Data type
boolean
Description
Tricuspid regurgitation
Data type
boolean
Description
Aortic stenosis
Data type
boolean
Description
Aortic regurgitation
Data type
boolean
Description
Other
Data type
boolean
Description
Specify
Data type
text
Description
Evidence of diastolic dysfunction
Data type
boolean
Description
Specify
Data type
text
Description
Other relevant echocardiogram findings
Data type
boolean
Description
Specify
Data type
text
Description
BNP (B-type natriuretic peptide) or NT-proBNP (N-terminal proBNP)
Description
Peak BNP/NT-proBNP value + the laboratory upper reference limit
Description
BNP
Description
Was peak value recorded?
Data type
boolean
Description
Peak Value
Data type
float
Description
Date sample taken
Data type
date
Description
Upper limit of normal
Data type
float
Description
Unit
Data type
text
Description
NT-proBNP
Description
Was peak value recorded?
Data type
boolean
Description
Peak Value
Data type
float
Description
Date sample taken
Data type
date
Description
Upper limit of normal
Data type
float
Description
Unit
Data type
text
Description
Other Investigations
Description
e.g., cardiac magnetic resonance imaging (CMRI), radionuclide ventriculogram scan (RNVG), pulmonary artery catheterization
Data type
boolean
Description
Please specify the type of investigation(s) performed and briefly describe the result(s) or any relevant findings
Data type
text
Description
Date of Investigation
Data type
date
Description
Treatment
Description
During this event, did the subject receive any of the following specifically for the treatment of heart failure?
Data type
boolean
Description
If Yes, please check all that apply
Data type
integer
Description
If Other, specify
Data type
text
Description
Date of Treatment
Data type
date
Description
Description of Event
Description
Describe signs and symptoms, results of investigations that provided evidence for a diagnosis of heart failure, treatment and outcome, including autopsy if appropriate. If you have already provided an adequate summary of the event on another accompanying event form or Adverse Event form, the information need not be duplicated here. A copy of the hospital discharge summary should be submitted.
Data type
text
Similar models
Adjudication Events - Heart Failure
- StudyEvent: ODM