ID

32740

Description

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

Keywords

Versions (1)
  1. 11/14/18 11/14/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 14, 2018

DOI

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License

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

English

Prior Concomitant Medications and Non-Drug Therapies

1 forms  
Administrative data
Description

Administrative data

Study Name
Description

Study Name

Data type

text

Site
Description

Site

Data type

text

Subject
Description

Subject

Data type

text

Visit Name
Description

Visit Name

Data type

text

DCI Name/Shortname
Description

DCI Name/Shortname

Data type

text

Status
Description

Status

Data type

text

Doc#
Description

Doc#

Data type

integer

Visit #
Description

Visit #

Data type

float

Prior Medications and Therapies
Description

Prior Medications and Therapies

Did the subject participate in any Non-Drug Therapies or take Concomitant medications within 30 days prior to screening and/or during the study?
Description

Did the subject participate in any Non-Drug Therapies or take Concomitant medications within 30 days prior to screening and/or during the study?

Data type

boolean

If Yes, add details on next page (includes over-the counter and prescription drugs) below
Description

If Yes, add details on next page (includes over-the counter and prescription drugs) below

Drug Name
Description

Trade name peferred

Data type

text

Unit Dose
Description

Unit Dose

Data type

float

Unit
Description

Unit

Data type

text

Frequency
Description

Frequency

Data type

text

Route
Description

Route

Data type

text

Reason for medication
Description

if SAE/AE enter Event Term

Data type

text

AE/SAE Event Number
Description

If applicable

Data type

integer

Start date
Description

Start date

Data type

date

Stop Date
Description

Stop Date

Data type

date

Mark if continuing
Description

Mark if continuing

Data type

text

Taken prior to study
Description

Taken prior to study

Data type

boolean

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Similar models

Prior Concomitant Medications and Non-Drug Therapies

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Prior Medications and Therapies
Did the subject participate in any Non-Drug Therapies or take Concomitant medications within 30 days prior to screening and/or during the study?
Item
Did the subject participate in any Non-Drug Therapies or take Concomitant medications within 30 days prior to screening and/or during the study?
boolean
Item Group
If Yes, add details on next page (includes over-the counter and prescription drugs) below
Drug Name
Item
Drug Name
text
Unit Dose
Item
Unit Dose
float
Unit
Item
Unit
text
Frequency
Item
Frequency
text
Route
Item
Route
text
Reason for medication
Item
Reason for medication
text
AE/SAE Event Number
Item
AE/SAE Event Number
integer
Start date
Item
Start date
date
Stop Date
Item
Stop Date
date
Item
Mark if continuing
text
Mark if continuing
Code List
Mark if continuing
CL Item
Yes (1)
Taken prior to study
Item
Taken prior to study
boolean
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