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

Mots-clés

Versions (1)
  1. 21/11/2018 21/11/2018 -
Détendeur de droits

GSK group of companies

Téléchargé le

21 novembre 2018

DOI

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Licence

Creative Commons BY-NC 3.0
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The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085

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Pregnancy Outcome Form

1 Formulaires  
  1. StudyEvent: ODM
    1. Pregnancy Outcome Form
Administrative data
Description

Administrative data

Study Name
Description

Study Name

Type de données

text

Site
Description

Site

Type de données

text

Subject
Description

Subject

Type de données

text

Visit Name
Description

Visit Name

Type de données

text

DCI Name/Shortname
Description

DCI Name/Shortname

Type de données

text

Status
Description

Status

Type de données

text

Doc#
Description

Doc#

Type de données

integer

Visit #
Description

Visit #

Type de données

float

Demography
Description

Demography

Subject ID Number
Description

Subject ID Number

Type de données

integer

Age
Description

Age

Type de données

integer

Unités de mesure
  • years
years
Date of Birth
Description

Date of Birth

Type de données

date

Weight (kilogram)
Description

Weight (kilogram)

Type de données

float

Unités de mesure
  • kg
kg
Weight (pounds)
Description

Weight (pounds)

Type de données

float

Unités de mesure
  • pounds
pounds
Height (centimeters)
Description

Height (centimeters)

Type de données

float

Unités de mesure
  • cm
cm
Height (inches)
Description

Height (inches)

Type de données

float

Unités de mesure
  • inches
inches
Race
Description

Race

Type de données

text

Child Information
Description

Child Information

Baby Number
Description

Baby Number

Type de données

integer

Sex
Description

Sex

Type de données

text

Height (centimeters)
Description

Height (centimeters)

Type de données

float

Unités de mesure
  • cm
cm
Height (inches)
Description

Height (inches)

Type de données

float

Unités de mesure
  • inches
inches
Weight (kilograms)
Description

Weight (kilograms)

Type de données

float

Unités de mesure
  • kg
kg
Weight (pounds)
Description

Weight (pounds)

Type de données

float

Unités de mesure
  • lbs/oz
lbs/oz
Apgar score 1 min
Description

Apgar score 1 min

Type de données

integer

Apgar score 5 min
Description

Apgar score 5 min

Type de données

integer

Outcome of pregnancy
Description

Outcome of pregnancy

Type de données

text

If Spontaneous or Elective abortion, record the date
Description

If Spontaneous or Elective abortion, record the date

Type de données

date

Specific information
Description

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

Type de données

text

Date of congenital abnormality identified/diagnosed
Description

Date of congenital abnormality identified/diagnosed

Type de données

date

Pregnancy Outcome Information
Description

Pregnancy Outcome Information

Baby number
Description

Baby number

Type de données

integer

Date of delivery
Description

Date of delivery

Type de données

date

Length of gestation (weeks)
Description

Length of gestation (weeks)

Type de données

integer

Method of delivery
Description

select one

Type de données

text

Number of births as a result of this pregnancy
Description

include live and stillbirth; if none, enter a zero

Type de données

integer

Comments
Description

Comments

Type de données

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.

Type de données

text

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Similar models

Pregnancy Outcome Form

1 Formulaires
  1. StudyEvent: ODM
    1. Pregnancy Outcome Form
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
Sex
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
Outcome of pregnancy
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
Method of delivery
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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