ID

32945

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2018-11-21 2018-11-21 -
Rättsinnehavare

GSK group of companies

Uppladdad den

21 november 2018

DOI

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

Engelsk

Pregnancy Outcome Form

1 Formulär  
  1. StudyEvent: ODM
    1. Pregnancy Outcome Form
Administrative data
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Administrative data

Study Name
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Study Name

Datatyp

text

Site
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Site

Datatyp

text

Subject
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Subject

Datatyp

text

Visit Name
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Visit Name

Datatyp

text

DCI Name/Shortname
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DCI Name/Shortname

Datatyp

text

Status
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Status

Datatyp

text

Doc#
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Doc#

Datatyp

integer

Visit #
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Visit #

Datatyp

float

Demography
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Demography

Subject ID Number
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Subject ID Number

Datatyp

integer

Age
Beskrivning

Age

Datatyp

integer

Måttenheter
  • years
years
Date of Birth
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Date of Birth

Datatyp

date

Weight (kilogram)
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Weight (kilogram)

Datatyp

float

Måttenheter
  • kg
kg
Weight (pounds)
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Weight (pounds)

Datatyp

float

Måttenheter
  • pounds
pounds
Height (centimeters)
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Height (centimeters)

Datatyp

float

Måttenheter
  • cm
cm
Height (inches)
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Height (inches)

Datatyp

float

Måttenheter
  • inches
inches
Race
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Race

Datatyp

text

Child Information
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Child Information

Baby Number
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Baby Number

Datatyp

integer

Sex
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Sex

Datatyp

text

Height (centimeters)
Beskrivning

Height (centimeters)

Datatyp

float

Måttenheter
  • cm
cm
Height (inches)
Beskrivning

Height (inches)

Datatyp

float

Måttenheter
  • inches
inches
Weight (kilograms)
Beskrivning

Weight (kilograms)

Datatyp

float

Måttenheter
  • kg
kg
Weight (pounds)
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Weight (pounds)

Datatyp

float

Måttenheter
  • lbs/oz
lbs/oz
Apgar score 1 min
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Apgar score 1 min

Datatyp

integer

Apgar score 5 min
Beskrivning

Apgar score 5 min

Datatyp

integer

Outcome of pregnancy
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Outcome of pregnancy

Datatyp

text

If Spontaneous or Elective abortion, record the date
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If Spontaneous or Elective abortion, record the date

Datatyp

date

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

Datatyp

text

Date of congenital abnormality identified/diagnosed
Beskrivning

Date of congenital abnormality identified/diagnosed

Datatyp

date

Pregnancy Outcome Information
Beskrivning

Pregnancy Outcome Information

Baby number
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Baby number

Datatyp

integer

Date of delivery
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Date of delivery

Datatyp

date

Length of gestation (weeks)
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Length of gestation (weeks)

Datatyp

integer

Method of delivery
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select one

Datatyp

text

Number of births as a result of this pregnancy
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include live and stillbirth; if none, enter a zero

Datatyp

integer

Comments
Beskrivning

Comments

Datatyp

text

Important Note
Beskrivning

Important Note

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

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

Datatyp

text

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Similar models

Pregnancy Outcome Form

1 Formulär
  1. StudyEvent: ODM
    1. Pregnancy Outcome Form
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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