ID

32944

Beschrijving

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

Trefwoorden

Versies (1)
  1. 21-11-18 21-11-18 -
Houder van rechten

GSK group of companies

Geüploaded op

21 november 2018

DOI

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Licentie

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

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Pregnancy Notification Form

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Study Name
Beschrijving

Study Name

Datatype

text

Site
Beschrijving

Site

Datatype

text

Subject
Beschrijving

Subject

Datatype

text

Visit Name
Beschrijving

Visit Name

Datatype

text

DCI Name/Shortname
Beschrijving

DCI Name/Shortname

Datatype

text

Status
Beschrijving

Status

Datatype

text

Doc#
Beschrijving

Doc#

Datatype

integer

Visit #
Beschrijving

Visit #

Datatype

float

Demography
Beschrijving

Demography

Subject ID Number
Beschrijving

Subject ID Number

Datatype

integer

Race
Beschrijving

Race

Datatype

text

Age
Beschrijving

Age

Datatype

integer

Maateenheden
  • years
years
Date of Birth
Beschrijving

Date of Birth

Datatype

date

Weight (kilogram)
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Weight (kilogram)

Datatype

float

Maateenheden
  • kg
kg
Weight (pounds)
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Weight (pounds)

Datatype

float

Maateenheden
  • pounds
pounds
Height (centimeters)
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Height (centimeters)

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float

Maateenheden
  • cm
cm
Height (inches)
Beschrijving

Height (inches)

Datatype

float

Maateenheden
  • inches
inches
Was the mother using a method of contraception?
Beschrijving

Was the mother using a method of contraception?

Datatype

boolean

If Yes, specify
Beschrijving

If Yes, specify

Datatype

text

Type of conception
Beschrijving

select one

Datatype

text

Relevant laboratory tests and procedures
Beschrijving

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

Datatype

text

Known allergies
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Known allergies

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boolean

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If Yes, specify

Datatype

text

Alcohol intake
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Alcohol intake

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boolean

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If Yes, specify

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text

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

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boolean

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Beschrijving

If Yes, specify

Datatype

text

Pregnancy Information
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Pregnancy Information

Start date of last menstrual period
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Start date of last menstrual period

Datatype

date

Date of positive pregnancy test
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Date of positive pregnancy test

Datatype

date

Date of last negative pregnancy test
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Date of last negative pregnancy test

Datatype

date

Was pregnancy terminated?
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Was pregnancy terminated?

Datatype

boolean

If Yes, record the date
Beschrijving

If Yes, record the date

Datatype

date

If Yes, clarify if elective or spontaneous termination?
Beschrijving

If Yes, clarify if elective or spontaneous termination?

Datatype

text

Date of expected delivery
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Date of expected delivery

Datatype

date

Number of previous pregnancies
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If none, enter a zero

Datatype

integer

Number of live births
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If none, enter a zero

Datatype

integer

Has subject experienced complications during this or previous pregnancies?
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Has subject experienced complications during this or previous pregnancies?

Datatype

boolean

If Yes, specify
Beschrijving

If Yes, specify

Datatype

text

Important Note
Beschrijving

Important Note

Subject must discontinue study medication if pregnancy test is positive
Beschrijving

Subject must discontinue study medication if pregnancy test is positive

Datatype

text

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Similar models

Pregnancy Notification Form

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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