ID

32945

Beschreibung

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

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Versionen (1)
  1. 21.11.18 21.11.18 -
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GSK group of companies

Hochgeladen am

21. November 2018

DOI

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The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085

Englisch

Pregnancy Outcome Form

1 Formulare  
  1. StudyEvent: ODM
    1. Pregnancy Outcome Form
Administrative data
Beschreibung

Administrative data

Study Name
Beschreibung

Study Name

Datentyp

text

Site
Beschreibung

Site

Datentyp

text

Subject
Beschreibung

Subject

Datentyp

text

Visit Name
Beschreibung

Visit Name

Datentyp

text

DCI Name/Shortname
Beschreibung

DCI Name/Shortname

Datentyp

text

Status
Beschreibung

Status

Datentyp

text

Doc#
Beschreibung

Doc#

Datentyp

integer

Visit #
Beschreibung

Visit #

Datentyp

float

Demography
Beschreibung

Demography

Subject ID Number
Beschreibung

Subject ID Number

Datentyp

integer

Age
Beschreibung

Age

Datentyp

integer

Maßeinheiten
  • years
years
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Weight (kilogram)
Beschreibung

Weight (kilogram)

Datentyp

float

Maßeinheiten
  • kg
kg
Weight (pounds)
Beschreibung

Weight (pounds)

Datentyp

float

Maßeinheiten
  • pounds
pounds
Height (centimeters)
Beschreibung

Height (centimeters)

Datentyp

float

Maßeinheiten
  • cm
cm
Height (inches)
Beschreibung

Height (inches)

Datentyp

float

Maßeinheiten
  • inches
inches
Race
Beschreibung

Race

Datentyp

text

Child Information
Beschreibung

Child Information

Baby Number
Beschreibung

Baby Number

Datentyp

integer

Sex
Beschreibung

Sex

Datentyp

text

Height (centimeters)
Beschreibung

Height (centimeters)

Datentyp

float

Maßeinheiten
  • cm
cm
Height (inches)
Beschreibung

Height (inches)

Datentyp

float

Maßeinheiten
  • inches
inches
Weight (kilograms)
Beschreibung

Weight (kilograms)

Datentyp

float

Maßeinheiten
  • kg
kg
Weight (pounds)
Beschreibung

Weight (pounds)

Datentyp

float

Maßeinheiten
  • lbs/oz
lbs/oz
Apgar score 1 min
Beschreibung

Apgar score 1 min

Datentyp

integer

Apgar score 5 min
Beschreibung

Apgar score 5 min

Datentyp

integer

Outcome of pregnancy
Beschreibung

Outcome of pregnancy

Datentyp

text

If Spontaneous or Elective abortion, record the date
Beschreibung

If Spontaneous or Elective abortion, record the date

Datentyp

date

Specific information
Beschreibung

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

Datentyp

text

Date of congenital abnormality identified/diagnosed
Beschreibung

Date of congenital abnormality identified/diagnosed

Datentyp

date

Pregnancy Outcome Information
Beschreibung

Pregnancy Outcome Information

Baby number
Beschreibung

Baby number

Datentyp

integer

Date of delivery
Beschreibung

Date of delivery

Datentyp

date

Length of gestation (weeks)
Beschreibung

Length of gestation (weeks)

Datentyp

integer

Method of delivery
Beschreibung

select one

Datentyp

text

Number of births as a result of this pregnancy
Beschreibung

include live and stillbirth; if none, enter a zero

Datentyp

integer

Comments
Beschreibung

Comments

Datentyp

text

Important Note
Beschreibung

Important Note

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

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

Datentyp

text

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Pregnancy Outcome Form

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