ID

32740

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. 14-11-18 14-11-18 -
Houder van rechten

GSK group of companies

Geüploaded op

14 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

Prior Concomitant Medications and Non-Drug Therapies

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

Prior Medications and Therapies
Beschrijving

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?
Beschrijving

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

Datatype

boolean

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

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

Drug Name
Beschrijving

Trade name peferred

Datatype

text

Unit Dose
Beschrijving

Unit Dose

Datatype

float

Unit
Beschrijving

Unit

Datatype

text

Frequency
Beschrijving

Frequency

Datatype

text

Route
Beschrijving

Route

Datatype

text

Reason for medication
Beschrijving

if SAE/AE enter Event Term

Datatype

text

AE/SAE Event Number
Beschrijving

If applicable

Datatype

integer

Start date
Beschrijving

Start date

Datatype

date

Stop Date
Beschrijving

Stop Date

Datatype

date

Mark if continuing
Beschrijving

Mark if continuing

Datatype

text

Taken prior to study
Beschrijving

Taken prior to study

Datatype

boolean

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Similar models

Prior Concomitant Medications and Non-Drug Therapies

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
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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