ID

32923

Beschrijving

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

Trefwoorden

Versies (1)
  1. 20-11-18 20-11-18 -
Houder van rechten

GSK group of companies

Geüploaded op

20 november 2018

DOI

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Licentie

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

Engels

Liver Event Form: General Data

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Study Name
Beschrijving

Study Name

Datatype

text

Site
Beschrijving

Site

Datatype

text

Subject
Beschrijving

Subject

Datatype

text

Visit Name
Beschrijving

Visit Name

Datatype

text

DCI Name/Shortname
Beschrijving

DCI Name/Shortname

Datatype

text

Status
Beschrijving

Status

Datatype

text

Doc#
Beschrijving

Doc#

Datatype

integer

Visit #
Beschrijving

Visit #

Datatype

float

Liver Events Assessment
Beschrijving

Liver Events Assessment

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

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

Datatype

boolean

Liver Event Description
Beschrijving

Liver Event Description

Date of assessment
Beschrijving

Date of assessment

Datatype

date

AE/SAE reference number
Beschrijving

AE/SAE reference number

Datatype

text

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

check all that apply

Datatype

text

Other, specify
Beschrijving

Other, specify

Datatype

text

Is the subject age 55 or older?
Beschrijving

Is the subject age 55 or older?

Datatype

boolean

If female, is the subject pregnant?
Beschrijving

If YES, ensure Pregnancy Notification Form has been completed.

Datatype

text

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

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

Datatype

boolean

If Yes, were the results normal?
Beschrijving

If Yes, complete Liver Biopsy Form

Datatype

boolean

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

If Yes, record on the appropriate Concomitant Medication form

Datatype

boolean

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

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

Datatype

boolean

Was a pharmacokinetic blood sample obtained?
Beschrijving

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

Datatype

boolean

If Yes, date of sample taken
Beschrijving

If Yes, date of sample taken

Datatype

date

If Yes, time of sample taken
Beschrijving

If Yes, time of sample taken

Datatype

time

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

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

Datatype

date

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

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

Datatype

time

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Similar models

Liver Event Form: General Data

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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