ID

32740

Descripción

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

Palabras clave

  1. 14/11/18 14/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

14 de noviembre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0

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The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085

Prior Concomitant Medications and Non-Drug Therapies

Administrative data
Descripción

Administrative data

Study Name
Descripción

Study Name

Tipo de datos

text

Site
Descripción

Site

Tipo de datos

text

Subject
Descripción

Subject

Tipo de datos

text

Visit Name
Descripción

Visit Name

Tipo de datos

text

DCI Name/Shortname
Descripción

DCI Name/Shortname

Tipo de datos

text

Status
Descripción

Status

Tipo de datos

text

Doc#
Descripción

Doc#

Tipo de datos

integer

Visit #
Descripción

Visit #

Tipo de datos

float

Prior Medications and Therapies
Descripción

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?
Descripción

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

Tipo de datos

boolean

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

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

Drug Name
Descripción

Trade name peferred

Tipo de datos

text

Unit Dose
Descripción

Unit Dose

Tipo de datos

float

Unit
Descripción

Unit

Tipo de datos

text

Frequency
Descripción

Frequency

Tipo de datos

text

Route
Descripción

Route

Tipo de datos

text

Reason for medication
Descripción

if SAE/AE enter Event Term

Tipo de datos

text

AE/SAE Event Number
Descripción

If applicable

Tipo de datos

integer

Start date
Descripción

Start date

Tipo de datos

date

Stop Date
Descripción

Stop Date

Tipo de datos

date

Mark if continuing
Descripción

Mark if continuing

Tipo de datos

text

Taken prior to study
Descripción

Taken prior to study

Tipo de datos

boolean

Similar models

Prior Concomitant Medications and Non-Drug Therapies

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
Code List
Mark if continuing
CL Item
Yes (1)
Taken prior to study
Item
Taken prior to study
boolean

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