ID

32944

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

  1. 11/21/18 11/21/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 21, 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

Pregnancy Notification Form

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

Demography
Description

Demography

Subject ID Number
Description

Subject ID Number

Data type

integer

Race
Description

Race

Data type

text

Age
Description

Age

Data type

integer

Measurement units
  • years
years
Date of Birth
Description

Date of Birth

Data type

date

Weight (kilogram)
Description

Weight (kilogram)

Data type

float

Measurement units
  • kg
kg
Weight (pounds)
Description

Weight (pounds)

Data type

float

Measurement units
  • pounds
pounds
Height (centimeters)
Description

Height (centimeters)

Data type

float

Measurement units
  • cm
cm
Height (inches)
Description

Height (inches)

Data type

float

Measurement units
  • inches
inches
Was the mother using a method of contraception?
Description

Was the mother using a method of contraception?

Data type

boolean

If Yes, specify
Description

If Yes, specify

Data type

text

Type of conception
Description

select one

Data type

text

Relevant laboratory tests and procedures
Description

e.g., ultrasound, amniocentesis, chronic villi sampling, including dates of test and procedures

Data type

text

Known allergies
Description

Known allergies

Data type

boolean

If Yes, specify
Description

If Yes, specify

Data type

text

Alcohol intake
Description

Alcohol intake

Data type

boolean

If Yes, specify
Description

If Yes, specify

Data type

text

Other significant prior or co-existent medical conditions or history
Description

Other significant prior or co-existent medical conditions or history

Data type

boolean

If Yes, specify
Description

If Yes, specify

Data type

text

Pregnancy Information
Description

Pregnancy Information

Start date of last menstrual period
Description

Start date of last menstrual period

Data type

date

Date of positive pregnancy test
Description

Date of positive pregnancy test

Data type

date

Date of last negative pregnancy test
Description

Date of last negative pregnancy test

Data type

date

Was pregnancy terminated?
Description

Was pregnancy terminated?

Data type

boolean

If Yes, record the date
Description

If Yes, record the date

Data type

date

If Yes, clarify if elective or spontaneous termination?
Description

If Yes, clarify if elective or spontaneous termination?

Data type

text

Date of expected delivery
Description

Date of expected delivery

Data type

date

Number of previous pregnancies
Description

If none, enter a zero

Data type

integer

Number of live births
Description

If none, enter a zero

Data type

integer

Has subject experienced complications during this or previous pregnancies?
Description

Has subject experienced complications during this or previous pregnancies?

Data type

boolean

If Yes, specify
Description

If Yes, specify

Data type

text

Important Note
Description

Important Note

Subject must discontinue study medication if pregnancy test is positive
Description

Subject must discontinue study medication if pregnancy test is positive

Data type

text

Similar models

Pregnancy Notification Form

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
Demography
Subject ID Number
Item
Subject ID Number
integer
Race
Item
Race
text
Age
Item
Age
integer
Date of Birth
Item
Date of Birth
date
Weight (kilogram)
Item
Weight (kilogram)
float
Weight (pounds)
Item
Weight (pounds)
float
Height (centimeters)
Item
Height (centimeters)
float
Height (inches)
Item
Height (inches)
float
Was the mother using a method of contraception?
Item
Was the mother using a method of contraception?
boolean
If Yes, specify
Item
If Yes, specify
text
Item
Type of conception
text
Code List
Type of conception
CL Item
Normal (includes use of fertility drugs) (1)
CL Item
IVF (in vitro fertilization) (2)
Relevant laboratory tests and procedures
Item
Relevant laboratory tests and procedures
text
Known allergies
Item
Known allergies
boolean
If Yes, specify
Item
If Yes, specify
text
Alcohol intake
Item
Alcohol intake
boolean
If Yes, specify
Item
If Yes, specify
text
Other significant prior or co-existent medical conditions or history
Item
Other significant prior or co-existent medical conditions or history
boolean
If Yes, specify
Item
If Yes, specify
text
Item Group
Pregnancy Information
Start date of last menstrual period
Item
Start date of last menstrual period
date
Date of positive pregnancy test
Item
Date of positive pregnancy test
date
Date of last negative pregnancy test
Item
Date of last negative pregnancy test
date
Was pregnancy terminated?
Item
Was pregnancy terminated?
boolean
If Yes, record the date
Item
If Yes, record the date
date
Item
If Yes, clarify if elective or spontaneous termination?
text
Code List
If Yes, clarify if elective or spontaneous termination?
CL Item
Elective (1)
CL Item
Spontaneous (2)
Date of expected delivery
Item
Date of expected delivery
date
Number of previous pregnancies
Item
Number of previous pregnancies
integer
Number of live births
Item
Number of live births
integer
Has subject experienced complications during this or previous pregnancies?
Item
Has subject experienced complications during this or previous pregnancies?
boolean
If Yes, specify
Item
If Yes, specify
text
Item Group
Important Note
Subject must discontinue study medication if pregnancy test is positive
Item
Subject must discontinue study medication if pregnancy test is positive
text

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