ID

32945

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 Outcome Form

  1. StudyEvent: ODM
    1. Pregnancy Outcome 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

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
Race
Description

Race

Data type

text

Child Information
Description

Child Information

Baby Number
Description

Baby Number

Data type

integer

Sex
Description

Sex

Data type

text

Height (centimeters)
Description

Height (centimeters)

Data type

float

Measurement units
  • cm
cm
Height (inches)
Description

Height (inches)

Data type

float

Measurement units
  • inches
inches
Weight (kilograms)
Description

Weight (kilograms)

Data type

float

Measurement units
  • kg
kg
Weight (pounds)
Description

Weight (pounds)

Data type

float

Measurement units
  • lbs/oz
lbs/oz
Apgar score 1 min
Description

Apgar score 1 min

Data type

integer

Apgar score 5 min
Description

Apgar score 5 min

Data type

integer

Outcome of pregnancy
Description

Outcome of pregnancy

Data type

text

If Spontaneous or Elective abortion, record the date
Description

If Spontaneous or Elective abortion, record the date

Data type

date

Specific information
Description

if Abnormal baby, congenital abnormality, stillborn, died at birth

Data type

text

Date of congenital abnormality identified/diagnosed
Description

Date of congenital abnormality identified/diagnosed

Data type

date

Pregnancy Outcome Information
Description

Pregnancy Outcome Information

Baby number
Description

Baby number

Data type

integer

Date of delivery
Description

Date of delivery

Data type

date

Length of gestation (weeks)
Description

Length of gestation (weeks)

Data type

integer

Method of delivery
Description

select one

Data type

text

Number of births as a result of this pregnancy
Description

include live and stillbirth; if none, enter a zero

Data type

integer

Comments
Description

Comments

Data type

text

Important Note
Description

Important Note

If pregnancy outcome is serious (spontaneous abortion, congenital abnormality, stillbirth, prolonged hospitalization, etc.) please submit the SAE report.
Description

If pregnancy outcome is serious (spontaneous abortion, congenital abnormality, stillbirth, prolonged hospitalization, etc.) please submit the SAE report.

Data type

text

Similar models

Pregnancy Outcome Form

  1. StudyEvent: ODM
    1. Pregnancy Outcome 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
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
Race
Item
Race
text
Item Group
Child Information
Baby Number
Item
Baby Number
integer
Item
Sex
text
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Height (centimeters)
Item
Height (centimeters)
float
Height (inches)
Item
Height (inches)
float
Weight (kilograms)
Item
Weight (kilograms)
float
Weight (pounds)
Item
Weight (pounds)
float
Apgar score 1 min
Item
Apgar score 1 min
integer
Apgar score 5 min
Item
Apgar score 5 min
integer
Item
Outcome of pregnancy
text
Code List
Outcome of pregnancy
CL Item
Spontaneous abortion (1)
CL Item
Elective abortion (2)
CL Item
Normal (3)
CL Item
Abnormal baby (specify below) (4)
CL Item
Congenital abnormality (specify below) (5)
CL Item
Stillborn (specify below) (6)
CL Item
Died at birth (specify below) (7)
If Spontaneous or Elective abortion, record the date
Item
If Spontaneous or Elective abortion, record the date
date
Specific information
Item
Specific information
text
Date of congenital abnormality identified/diagnosed
Item
Date of congenital abnormality identified/diagnosed
date
Item Group
Pregnancy Outcome Information
Baby number
Item
Baby number
integer
Date of delivery
Item
Date of delivery
date
Length of gestation (weeks)
Item
Length of gestation (weeks)
integer
Item
Method of delivery
text
Code List
Method of delivery
CL Item
Vaginal (1)
CL Item
Cesarean section (2)
Number of births as a result of this pregnancy
Item
Number of births as a result of this pregnancy
integer
Comments
Item
Comments
text
Item Group
Important Note
If pregnancy outcome is serious (spontaneous abortion, congenital abnormality, stillbirth, prolonged hospitalization, etc.) please submit the SAE report.
Item
If pregnancy outcome is serious (spontaneous abortion, congenital abnormality, stillbirth, prolonged hospitalization, etc.) please submit the SAE report.
text

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