ID

32743

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

Screening Visit: Electrocardiogram

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

Visit Date
Description

Visit Date

Data type

date

ECG
Description

ECG

Date ECG Performed
Description

Date ECG Performed

Data type

date

Time ECG Performed
Description

Time ECG Performed

Data type

time

Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
PR Interval
Description

PR Interval

Data type

float

Measurement units
  • msec
msec
QRS Duration
Description

QRS Duration

Data type

float

Measurement units
  • msec
msec
QT Interval
Description

QT Interval

Data type

float

Measurement units
  • msec
msec
QTcF Interval
Description

QTcF Interval

Data type

float

Measurement units
  • msec
msec
QTcB Interval
Description

QTcB Interval

Data type

float

Measurement units
  • msec
msec
RR Interval
Description

RR Interval

Data type

float

Measurement units
  • msec
msec
Interpretation of ECG
Description

Interpretation of ECG

Normal sinus rhythm?
Description

Normal sinus rhythm?

Data type

boolean

Overall interpretation of ECG:
Description

Overall interpretation of ECG:

Data type

text

If Abnormal, please specify
Description

If Abnormal, please specify

Data type

text

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Similar models

Screening Visit: Electrocardiogram

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
Visit Date
Item
Visit Date
date
Item Group
ECG
Date ECG Performed
Item
Date ECG Performed
date
Time ECG Performed
Item
Time ECG Performed
time
Heart Rate
Item
Heart Rate
integer
PR Interval
Item
PR Interval
float
QRS Duration
Item
QRS Duration
float
QT Interval
Item
QT Interval
float
QTcF Interval
Item
QTcF Interval
float
QTcB Interval
Item
QTcB Interval
float
RR Interval
Item
RR Interval
float
Item Group
Interpretation of ECG
Normal sinus rhythm?
Item
Normal sinus rhythm?
boolean
Item
Overall interpretation of ECG:
text
Overall interpretation of ECG:
Code List
Overall interpretation of ECG:
CL Item
Normal (1)
CL Item
Abnormal, Not Clinically Significant (2)
CL Item
Abnormal, Clinically Significant (3)
If Abnormal, please specify
Item
If Abnormal, please specify
text
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