ID

32944

Description

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

Mots-clés

Versions (1)
  1. 21/11/2018 21/11/2018 -
Détendeur de droits

GSK group of companies

Téléchargé le

21 novembre 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

Anglais

Pregnancy Notification Form

1 Formulaires  
Administrative data
Description

Administrative data

Study Name
Description

Study Name

Type de données

text

Site
Description

Site

Type de données

text

Subject
Description

Subject

Type de données

text

Visit Name
Description

Visit Name

Type de données

text

DCI Name/Shortname
Description

DCI Name/Shortname

Type de données

text

Status
Description

Status

Type de données

text

Doc#
Description

Doc#

Type de données

integer

Visit #
Description

Visit #

Type de données

float

Demography
Description

Demography

Subject ID Number
Description

Subject ID Number

Type de données

integer

Race
Description

Race

Type de données

text

Age
Description

Age

Type de données

integer

Unités de mesure
  • years
years
Date of Birth
Description

Date of Birth

Type de données

date

Weight (kilogram)
Description

Weight (kilogram)

Type de données

float

Unités de mesure
  • kg
kg
Weight (pounds)
Description

Weight (pounds)

Type de données

float

Unités de mesure
  • pounds
pounds
Height (centimeters)
Description

Height (centimeters)

Type de données

float

Unités de mesure
  • cm
cm
Height (inches)
Description

Height (inches)

Type de données

float

Unités de mesure
  • inches
inches
Was the mother using a method of contraception?
Description

Was the mother using a method of contraception?

Type de données

boolean

If Yes, specify
Description

If Yes, specify

Type de données

text

Type of conception
Description

select one

Type de données

text

Relevant laboratory tests and procedures
Description

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

Type de données

text

Known allergies
Description

Known allergies

Type de données

boolean

If Yes, specify
Description

If Yes, specify

Type de données

text

Alcohol intake
Description

Alcohol intake

Type de données

boolean

If Yes, specify
Description

If Yes, specify

Type de données

text

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

Other significant prior or co-existent medical conditions or history

Type de données

boolean

If Yes, specify
Description

If Yes, specify

Type de données

text

Pregnancy Information
Description

Pregnancy Information

Start date of last menstrual period
Description

Start date of last menstrual period

Type de données

date

Date of positive pregnancy test
Description

Date of positive pregnancy test

Type de données

date

Date of last negative pregnancy test
Description

Date of last negative pregnancy test

Type de données

date

Was pregnancy terminated?
Description

Was pregnancy terminated?

Type de données

boolean

If Yes, record the date
Description

If Yes, record the date

Type de données

date

If Yes, clarify if elective or spontaneous termination?
Description

If Yes, clarify if elective or spontaneous termination?

Type de données

text

Date of expected delivery
Description

Date of expected delivery

Type de données

date

Number of previous pregnancies
Description

If none, enter a zero

Type de données

integer

Number of live births
Description

If none, enter a zero

Type de données

integer

Has subject experienced complications during this or previous pregnancies?
Description

Has subject experienced complications during this or previous pregnancies?

Type de données

boolean

If Yes, specify
Description

If Yes, specify

Type de données

text

Important Note
Description

Important Note

Subject must discontinue study medication if pregnancy test is positive
Description

Subject must discontinue study medication if pregnancy test is positive

Type de données

text

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Pregnancy Notification Form

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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