ID

32923

Beskrivning

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 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)
  1. 2018-11-20 2018-11-20 -
Rättsinnehavare

GSK group of companies

Uppladdad den

20 november 2018

DOI

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Creative Commons BY-NC 3.0
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The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085

Engelsk

Liver Event Form: General Data

1 Formulär  
Administrative data
Beskrivning

Administrative data

Study Name
Beskrivning

Study Name

Datatyp

text

Site
Beskrivning

Site

Datatyp

text

Subject
Beskrivning

Subject

Datatyp

text

Visit Name
Beskrivning

Visit Name

Datatyp

text

DCI Name/Shortname
Beskrivning

DCI Name/Shortname

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Doc#
Beskrivning

Doc#

Datatyp

integer

Visit #
Beskrivning

Visit #

Datatyp

float

Liver Events Assessment
Beskrivning

Liver Events Assessment

Have liver chemistry results reached or exceeded protocol-defined stopping criteria?
Beskrivning

If YES, stop investigational product, complete date on Investigational Product form, contact GSK within 24 hours of occurrence, complete Liver Events Form and obtain the following test: -Blood sample for PK analysis, obtained within three half-lives (21 days) of last dose -Hepatitis A -Hepatitis B -Hepatitis C -Hepatitis E -Cytomegalovirus IgM antibody -EBV or if unavailabel, obtain heteropile antibody or monospot testing -CPK -LDH -Bilirubin fractionation, if bilirubin >=1.5xULN

Datatyp

boolean

Liver Event Description
Beskrivning

Liver Event Description

Date of assessment
Beskrivning

Date of assessment

Datatyp

date

AE/SAE reference number
Beskrivning

AE/SAE reference number

Datatyp

text

Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Beskrivning

check all that apply

Datatyp

text

Other, specify
Beskrivning

Other, specify

Datatyp

text

Is the subject age 55 or older?
Beskrivning

Is the subject age 55 or older?

Datatyp

boolean

If female, is the subject pregnant?
Beskrivning

If YES, ensure Pregnancy Notification Form has been completed.

Datatyp

text

Were any diagnostic tests of the liver or hepatobiliary system performed?
Beskrivning

Were any diagnostic tests of the liver or hepatobiliary system performed?

Datatyp

boolean

If Yes, were the results normal?
Beskrivning

If Yes, complete Liver Biopsy Form

Datatyp

boolean

Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Beskrivning

If Yes, record on the appropriate Concomitant Medication form

Datatyp

boolean

Did the subject fast or undergo significant dietary change in the past week?
Beskrivning

Did the subject fast or undergo significant dietary change in the past week?

Datatyp

boolean

Was a pharmacokinetic blood sample obtained?
Beskrivning

An unscheduled PK blood sample must be obtained within three half-lives

Datatyp

boolean

If Yes, date of sample taken
Beskrivning

If Yes, date of sample taken

Datatyp

date

If Yes, time of sample taken
Beskrivning

If Yes, time of sample taken

Datatyp

time

If Yes, date of last investigational product dose prior to PK sample
Beskrivning

If Yes, date of last investigational product dose prior to PK sample

Datatyp

date

If Yes, time of last investigational product dose prior to PK sample
Beskrivning

If Yes, time of last investigational product dose prior to PK sample

Datatyp

time

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Similar models

Liver Event Form: General Data

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Study Name
Item
Study Name
text
Site
Item
Site
text
Subject
Item
Subject
text
Visit Name
Item
Visit Name
text
DCI Name/Shortname
Item
DCI Name/Shortname
text
Status
Item
Status
text
Doc#
Item
Doc#
integer
Visit #
Item
Visit #
float
Item Group
Liver Events Assessment
Have liver chemistry results reached or exceeded protocol-defined stopping criteria?
Item
Have liver chemistry results reached or exceeded protocol-defined stopping criteria?
boolean
Item Group
Liver Event Description
Date of assessment
Item
Date of assessment
date
AE/SAE reference number
Item
AE/SAE reference number
text
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
text
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Code List
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
CL Item
ALT (alanine aminotransferase) (1)
CL Item
AST (aspartate aminotransferase) (2)
CL Item
Total bilirubin (3)
CL Item
Other (4)
Other, specify
Item
Other, specify
text
Is the subject age 55 or older?
Item
Is the subject age 55 or older?
boolean
Item
If female, is the subject pregnant?
text
If female, is the subject pregnant?
Code List
If female, is the subject pregnant?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (3)
Were any diagnostic tests of the liver or hepatobiliary system performed?
Item
Were any diagnostic tests of the liver or hepatobiliary system performed?
boolean
If Yes, were the results normal?
Item
If Yes, were the results normal?
boolean
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
Did the subject fast or undergo significant dietary change in the past week?
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
Was a pharmacokinetic blood sample obtained?
Item
Was a pharmacokinetic blood sample obtained?
boolean
If Yes, date of sample taken
Item
If Yes, date of sample taken
date
If Yes, time of sample taken
Item
If Yes, time of sample taken
time
If Yes, date of last investigational product dose prior to PK sample
Item
If Yes, date of last investigational product dose prior to PK sample
date
If Yes, time of last investigational product dose prior to PK sample
Item
If Yes, time of last investigational product dose prior to PK sample
time
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