ID

32944

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

Versiones (1)
  1. 21/11/18 21/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

21 de noviembre de 2018

DOI

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Licencia

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

Inglés

Pregnancy Notification Form

1 formularios  
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

Race
Descripción

Race

Tipo de datos

text

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
Was the mother using a method of contraception?
Descripción

Was the mother using a method of contraception?

Tipo de datos

boolean

If Yes, specify
Descripción

If Yes, specify

Tipo de datos

text

Type of conception
Descripción

select one

Tipo de datos

text

Relevant laboratory tests and procedures
Descripción

e.g., ultrasound, amniocentesis, chronic villi sampling, including dates of test and procedures

Tipo de datos

text

Known allergies
Descripción

Known allergies

Tipo de datos

boolean

If Yes, specify
Descripción

If Yes, specify

Tipo de datos

text

Alcohol intake
Descripción

Alcohol intake

Tipo de datos

boolean

If Yes, specify
Descripción

If Yes, specify

Tipo de datos

text

Other significant prior or co-existent medical conditions or history
Descripción

Other significant prior or co-existent medical conditions or history

Tipo de datos

boolean

If Yes, specify
Descripción

If Yes, specify

Tipo de datos

text

Pregnancy Information
Descripción

Pregnancy Information

Start date of last menstrual period
Descripción

Start date of last menstrual period

Tipo de datos

date

Date of positive pregnancy test
Descripción

Date of positive pregnancy test

Tipo de datos

date

Date of last negative pregnancy test
Descripción

Date of last negative pregnancy test

Tipo de datos

date

Was pregnancy terminated?
Descripción

Was pregnancy terminated?

Tipo de datos

boolean

If Yes, record the date
Descripción

If Yes, record the date

Tipo de datos

date

If Yes, clarify if elective or spontaneous termination?
Descripción

If Yes, clarify if elective or spontaneous termination?

Tipo de datos

text

Date of expected delivery
Descripción

Date of expected delivery

Tipo de datos

date

Number of previous pregnancies
Descripción

If none, enter a zero

Tipo de datos

integer

Number of live births
Descripción

If none, enter a zero

Tipo de datos

integer

Has subject experienced complications during this or previous pregnancies?
Descripción

Has subject experienced complications during this or previous pregnancies?

Tipo de datos

boolean

If Yes, specify
Descripción

If Yes, specify

Tipo de datos

text

Important Note
Descripción

Important Note

Subject must discontinue study medication if pregnancy test is positive
Descripción

Subject must discontinue study medication if pregnancy test is positive

Tipo de datos

text

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Similar models

Pregnancy Notification Form

1 formularios
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
Race
Item
Race
text
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
Was the mother using a method of contraception?
Item
Was the mother using a method of contraception?
boolean
If Yes, specify
Item
If Yes, specify
text
Item
Type of conception
text
Type of conception
Code List
Type of conception
CL Item
Normal (includes use of fertility drugs) (1)
CL Item
IVF (in vitro fertilization) (2)
Relevant laboratory tests and procedures
Item
Relevant laboratory tests and procedures
text
Known allergies
Item
Known allergies
boolean
If Yes, specify
Item
If Yes, specify
text
Alcohol intake
Item
Alcohol intake
boolean
If Yes, specify
Item
If Yes, specify
text
Other significant prior or co-existent medical conditions or history
Item
Other significant prior or co-existent medical conditions or history
boolean
If Yes, specify
Item
If Yes, specify
text
Item Group
Pregnancy Information
Start date of last menstrual period
Item
Start date of last menstrual period
date
Date of positive pregnancy test
Item
Date of positive pregnancy test
date
Date of last negative pregnancy test
Item
Date of last negative pregnancy test
date
Was pregnancy terminated?
Item
Was pregnancy terminated?
boolean
If Yes, record the date
Item
If Yes, record the date
date
Item
If Yes, clarify if elective or spontaneous termination?
text
If Yes, clarify if elective or spontaneous termination?
Code List
If Yes, clarify if elective or spontaneous termination?
CL Item
Elective (1)
CL Item
Spontaneous (2)
Date of expected delivery
Item
Date of expected delivery
date
Number of previous pregnancies
Item
Number of previous pregnancies
integer
Number of live births
Item
Number of live births
integer
Has subject experienced complications during this or previous pregnancies?
Item
Has subject experienced complications during this or previous pregnancies?
boolean
If Yes, specify
Item
If Yes, specify
text
Item Group
Important Note
Subject must discontinue study medication if pregnancy test is positive
Item
Subject must discontinue study medication if pregnancy test is positive
text
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