ID

32945

Descripción

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

Palabras clave

  1. 21/11/18 21/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

21 de noviembre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0

Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085

Pregnancy Outcome Form

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

Administrative data

Study Name
Descripción

Study Name

Tipo de datos

text

Site
Descripción

Site

Tipo de datos

text

Subject
Descripción

Subject

Tipo de datos

text

Visit Name
Descripción

Visit Name

Tipo de datos

text

DCI Name/Shortname
Descripción

DCI Name/Shortname

Tipo de datos

text

Status
Descripción

Status

Tipo de datos

text

Doc#
Descripción

Doc#

Tipo de datos

integer

Visit #
Descripción

Visit #

Tipo de datos

float

Demography
Descripción

Demography

Subject ID Number
Descripción

Subject ID Number

Tipo de datos

integer

Age
Descripción

Age

Tipo de datos

integer

Unidades de medida
  • years
years
Date of Birth
Descripción

Date of Birth

Tipo de datos

date

Weight (kilogram)
Descripción

Weight (kilogram)

Tipo de datos

float

Unidades de medida
  • kg
kg
Weight (pounds)
Descripción

Weight (pounds)

Tipo de datos

float

Unidades de medida
  • pounds
pounds
Height (centimeters)
Descripción

Height (centimeters)

Tipo de datos

float

Unidades de medida
  • cm
cm
Height (inches)
Descripción

Height (inches)

Tipo de datos

float

Unidades de medida
  • inches
inches
Race
Descripción

Race

Tipo de datos

text

Child Information
Descripción

Child Information

Baby Number
Descripción

Baby Number

Tipo de datos

integer

Sex
Descripción

Sex

Tipo de datos

text

Height (centimeters)
Descripción

Height (centimeters)

Tipo de datos

float

Unidades de medida
  • cm
cm
Height (inches)
Descripción

Height (inches)

Tipo de datos

float

Unidades de medida
  • inches
inches
Weight (kilograms)
Descripción

Weight (kilograms)

Tipo de datos

float

Unidades de medida
  • kg
kg
Weight (pounds)
Descripción

Weight (pounds)

Tipo de datos

float

Unidades de medida
  • lbs/oz
lbs/oz
Apgar score 1 min
Descripción

Apgar score 1 min

Tipo de datos

integer

Apgar score 5 min
Descripción

Apgar score 5 min

Tipo de datos

integer

Outcome of pregnancy
Descripción

Outcome of pregnancy

Tipo de datos

text

If Spontaneous or Elective abortion, record the date
Descripción

If Spontaneous or Elective abortion, record the date

Tipo de datos

date

Specific information
Descripción

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

Tipo de datos

text

Date of congenital abnormality identified/diagnosed
Descripción

Date of congenital abnormality identified/diagnosed

Tipo de datos

date

Pregnancy Outcome Information
Descripción

Pregnancy Outcome Information

Baby number
Descripción

Baby number

Tipo de datos

integer

Date of delivery
Descripción

Date of delivery

Tipo de datos

date

Length of gestation (weeks)
Descripción

Length of gestation (weeks)

Tipo de datos

integer

Method of delivery
Descripción

select one

Tipo de datos

text

Number of births as a result of this pregnancy
Descripción

include live and stillbirth; if none, enter a zero

Tipo de datos

integer

Comments
Descripción

Comments

Tipo de datos

text

Important Note
Descripción

Important Note

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

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

Tipo de datos

text

Similar models

Pregnancy Outcome Form

  1. StudyEvent: ODM
    1. Pregnancy Outcome Form
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial