ID

32944

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

Englisch

Pregnancy Notification Form

1 Formulare  
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

Race
Beschreibung

Race

Datentyp

text

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
Was the mother using a method of contraception?
Beschreibung

Was the mother using a method of contraception?

Datentyp

boolean

If Yes, specify
Beschreibung

If Yes, specify

Datentyp

text

Type of conception
Beschreibung

select one

Datentyp

text

Relevant laboratory tests and procedures
Beschreibung

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

Datentyp

text

Known allergies
Beschreibung

Known allergies

Datentyp

boolean

If Yes, specify
Beschreibung

If Yes, specify

Datentyp

text

Alcohol intake
Beschreibung

Alcohol intake

Datentyp

boolean

If Yes, specify
Beschreibung

If Yes, specify

Datentyp

text

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

Other significant prior or co-existent medical conditions or history

Datentyp

boolean

If Yes, specify
Beschreibung

If Yes, specify

Datentyp

text

Pregnancy Information
Beschreibung

Pregnancy Information

Start date of last menstrual period
Beschreibung

Start date of last menstrual period

Datentyp

date

Date of positive pregnancy test
Beschreibung

Date of positive pregnancy test

Datentyp

date

Date of last negative pregnancy test
Beschreibung

Date of last negative pregnancy test

Datentyp

date

Was pregnancy terminated?
Beschreibung

Was pregnancy terminated?

Datentyp

boolean

If Yes, record the date
Beschreibung

If Yes, record the date

Datentyp

date

If Yes, clarify if elective or spontaneous termination?
Beschreibung

If Yes, clarify if elective or spontaneous termination?

Datentyp

text

Date of expected delivery
Beschreibung

Date of expected delivery

Datentyp

date

Number of previous pregnancies
Beschreibung

If none, enter a zero

Datentyp

integer

Number of live births
Beschreibung

If none, enter a zero

Datentyp

integer

Has subject experienced complications during this or previous pregnancies?
Beschreibung

Has subject experienced complications during this or previous pregnancies?

Datentyp

boolean

If Yes, specify
Beschreibung

If Yes, specify

Datentyp

text

Important Note
Beschreibung

Important Note

Subject must discontinue study medication if pregnancy test is positive
Beschreibung

Subject must discontinue study medication if pregnancy test is positive

Datentyp

text

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Ähnliche Modelle

Pregnancy Notification Form

1 Formulare
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
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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