ID

32945

Beschrijving

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

Trefwoorden

Versies (1)
  1. 21-11-18 21-11-18 -
Houder van rechten

GSK group of companies

Geüploaded op

21 november 2018

DOI

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Licentie

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

Engels

Pregnancy Outcome Form

1 Formulieren  
  1. StudyEvent: ODM
    1. Pregnancy Outcome Form
Administrative data
Beschrijving

Administrative data

Study Name
Beschrijving

Study Name

Datatype

text

Site
Beschrijving

Site

Datatype

text

Subject
Beschrijving

Subject

Datatype

text

Visit Name
Beschrijving

Visit Name

Datatype

text

DCI Name/Shortname
Beschrijving

DCI Name/Shortname

Datatype

text

Status
Beschrijving

Status

Datatype

text

Doc#
Beschrijving

Doc#

Datatype

integer

Visit #
Beschrijving

Visit #

Datatype

float

Demography
Beschrijving

Demography

Subject ID Number
Beschrijving

Subject ID Number

Datatype

integer

Age
Beschrijving

Age

Datatype

integer

Maateenheden
  • years
years
Date of Birth
Beschrijving

Date of Birth

Datatype

date

Weight (kilogram)
Beschrijving

Weight (kilogram)

Datatype

float

Maateenheden
  • kg
kg
Weight (pounds)
Beschrijving

Weight (pounds)

Datatype

float

Maateenheden
  • pounds
pounds
Height (centimeters)
Beschrijving

Height (centimeters)

Datatype

float

Maateenheden
  • cm
cm
Height (inches)
Beschrijving

Height (inches)

Datatype

float

Maateenheden
  • inches
inches
Race
Beschrijving

Race

Datatype

text

Child Information
Beschrijving

Child Information

Baby Number
Beschrijving

Baby Number

Datatype

integer

Sex
Beschrijving

Sex

Datatype

text

Height (centimeters)
Beschrijving

Height (centimeters)

Datatype

float

Maateenheden
  • cm
cm
Height (inches)
Beschrijving

Height (inches)

Datatype

float

Maateenheden
  • inches
inches
Weight (kilograms)
Beschrijving

Weight (kilograms)

Datatype

float

Maateenheden
  • kg
kg
Weight (pounds)
Beschrijving

Weight (pounds)

Datatype

float

Maateenheden
  • lbs/oz
lbs/oz
Apgar score 1 min
Beschrijving

Apgar score 1 min

Datatype

integer

Apgar score 5 min
Beschrijving

Apgar score 5 min

Datatype

integer

Outcome of pregnancy
Beschrijving

Outcome of pregnancy

Datatype

text

If Spontaneous or Elective abortion, record the date
Beschrijving

If Spontaneous or Elective abortion, record the date

Datatype

date

Specific information
Beschrijving

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

Datatype

text

Date of congenital abnormality identified/diagnosed
Beschrijving

Date of congenital abnormality identified/diagnosed

Datatype

date

Pregnancy Outcome Information
Beschrijving

Pregnancy Outcome Information

Baby number
Beschrijving

Baby number

Datatype

integer

Date of delivery
Beschrijving

Date of delivery

Datatype

date

Length of gestation (weeks)
Beschrijving

Length of gestation (weeks)

Datatype

integer

Method of delivery
Beschrijving

select one

Datatype

text

Number of births as a result of this pregnancy
Beschrijving

include live and stillbirth; if none, enter a zero

Datatype

integer

Comments
Beschrijving

Comments

Datatype

text

Important Note
Beschrijving

Important Note

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

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

Datatype

text

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Similar models

Pregnancy Outcome Form

1 Formulieren
  1. StudyEvent: ODM
    1. Pregnancy Outcome Form
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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