ID

33846

Beskrivning

Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 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

Nyckelord

Versioner (1)
  1. 2019-01-03 2019-01-03 -
Rättsinnehavare

GSK group of companies

Uppladdad den

3 januari 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032

Engelsk

Pregnancy Data

1 Formulär  
  1. StudyEvent: ODM
    1. Pregnancy Data
Administrative data
Beskrivning

Administrative data

Site
Beskrivning

Site

Datatyp

text

Subject
Beskrivning

Subject

Datatyp

text

Visit Name
Beskrivning

Visit Name

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Document Number
Beskrivning

Document Number

Datatyp

integer

Demography
Beskrivning

Demography

Subject ID Number
Beskrivning

Subject must discontinue study medication if pregnancy test is positive

Datatyp

integer

Race
Beskrivning

Race

Datatyp

text

Age
Beskrivning

Age

Datatyp

float

Måttenheter
  • years
years
Date of birth
Beskrivning

Date of birth

Datatyp

date

Weight
Beskrivning

Weight

Datatyp

float

Weight units
Beskrivning

Weight units

Datatyp

text

Height
Beskrivning

Height

Datatyp

float

Height units
Beskrivning

Height units

Datatyp

text

Medical History
Beskrivning

Medical History

Was the mother using a method of contraception?
Beskrivning

Was the mother using a method of contraception?

Datatyp

boolean

If Yes, specify
Beskrivning

If Yes, specify

Datatyp

text

Type of conception
Beskrivning

select one

Datatyp

text

Relevant laboratory tests and procedures
Beskrivning

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

Datatyp

text

Known allergies
Beskrivning

Known allergies

Datatyp

boolean

If Yes, specify
Beskrivning

If Yes, specify

Datatyp

text

Alcohol intake
Beskrivning

Alcohol intake

Datatyp

boolean

If Yes, specify
Beskrivning

If Yes, specify

Datatyp

text

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

Other significant prior or co-existent medical conditions or history

Datatyp

boolean

If Yes, specify
Beskrivning

If Yes, specify

Datatyp

text

Pregnancy Information
Beskrivning

Pregnancy Information

Start date of last menstrual period
Beskrivning

Start date of last menstrual period

Datatyp

date

Date of positive pregnancy test
Beskrivning

Date of positive pregnancy test

Datatyp

date

Date of last negative pregnancy test
Beskrivning

Date of last negative pregnancy test

Datatyp

date

Was pregnancy terminated?
Beskrivning

Was pregnancy terminated?

Datatyp

boolean

If Yes, date:
Beskrivning

If Yes, date:

Datatyp

date

Was termination elective or spontaneous?
Beskrivning

elective or spontaneous termination?

Datatyp

text

Date of expected delivery
Beskrivning

Date of expected delivery

Datatyp

date

Number of previous pregnancies
Beskrivning

If none, enter a zero

Datatyp

integer

Number of live births
Beskrivning

if none, enter a zero

Datatyp

integer

Has subject experienced complications during this or previous pregnancies?
Beskrivning

Has subject experienced complications during this or previous pregnancies?

Datatyp

boolean

If Yes, specify below
Beskrivning

If Yes, specify below

Datatyp

text

Pregnancy Outcome Information
Beskrivning

Pregnancy Outcome Information

Subject ID Number
Beskrivning

Subject ID Number

Datatyp

integer

Age
Beskrivning

Age

Datatyp

float

Måttenheter
  • years
years
Date of Birth
Beskrivning

Date of Birth

Datatyp

date

Weight
Beskrivning

Weight

Datatyp

float

Weight unit
Beskrivning

Weight unit

Datatyp

text

Height
Beskrivning

Height

Datatyp

float

Height units
Beskrivning

Height units

Datatyp

text

Child Information
Beskrivning

Child Information

Baby #
Beskrivning

Baby #

Datatyp

integer

Sex
Beskrivning

Sex

Datatyp

text

Height
Beskrivning

Height

Datatyp

float

Height units
Beskrivning

Height units

Datatyp

text

Weight
Beskrivning

Weight

Datatyp

float

Weight units
Beskrivning

Weight units

Datatyp

text

Apgar score 1 min
Beskrivning

Apgar score 1 min

Datatyp

integer

Apgar score 5 min
Beskrivning

Apgar score 5 min

Datatyp

integer

Outcome of pregnancy
Beskrivning

Outcome of pregnancy

Datatyp

text

Comment
Beskrivning

Comment

Datatyp

text

If abortion, please record the date
Beskrivning

Date of abortion

Datatyp

date

Date of congenital abnormality identified/diagnosed
Beskrivning

Date of congenital abnormality identified/diagnosed

Datatyp

date

Pregnancy Outcome Details
Beskrivning

Pregnancy Outcome Details

Date of delivery
Beskrivning

Date of delivery

Datatyp

date

Length of gestation
Beskrivning

Length of gestation

Datatyp

float

Måttenheter
  • weeks
weeks
Methods of delivery
Beskrivning

select one

Datatyp

text

Number of births as a result of this pregnancy
Beskrivning

include live and stillbirth; if none enter a zero

Datatyp

integer

Comments
Beskrivning

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

Datatyp

text

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Pregnancy Data

1 Formulär
  1. StudyEvent: ODM
    1. Pregnancy Data
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Site
Item
Site
text
Subject
Item
Subject
text
Item
Visit Name
text
Visit Name
Code List
Visit Name
CL Item
Pregnancy Info (1)
Status
Item
Status
text
Document Number
Item
Document Number
integer
Item Group
Demography
Subject ID Number
Item
Subject ID Number
integer
Race
Item
Race
text
Age
Item
float
Date of birth
Item
Date of birth
date
Weight
Item
Weight
float
Item
Weight units
text
Weight units
Code List
Weight units
CL Item
kg (1)
CL Item
pounds (2)
Height
Item
Height
float
Item
Height units
text
Height units
Code List
Height units
CL Item
cm (1)
CL Item
inches (2)
Item Group
Medical History
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 (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, date:
Item
If Yes, date:
date
Item
Was termination elective or spontaneous?
text
elective or spontaneous termination?
Code List
Was termination elective or spontaneous?
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 below
Item
If Yes, specify below
text
Item Group
Pregnancy Outcome Information
Subject ID Number
Item
Subject ID Number
integer
Age
Item
Age
float
Date of Birth
Item
Date of Birth
date
Weight
Item
Weight
float
Item
Weight unit
text
Weight unit
Code List
Weight unit
CL Item
kg (1)
CL Item
pounds (2)
Height
Item
Height
float
Item
Height units
text
Height units
Code List
Height units
CL Item
cm (1)
CL Item
inches (2)
Item Group
Child Information
Baby #
Item
Baby #
integer
Item
Sex
text
Sex
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Height
Item
Height
float
Item
Height units
text
Height units
Code List
Height units
CL Item
cm (1)
CL Item
inches (2)
Weight
Item
Weight
float
Item
Weight units
text
Weight units
Code List
Weight units
CL Item
kg (1)
CL Item
lbs/oz (2)
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
Outcome of pregnancy
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)
Comment
Item
Comment
text
Date of abortion
Item
If abortion, please record the date
date
Date of congenital abnormality identified/diagnosed
Item
Date of congenital abnormality identified/diagnosed
date
Item Group
Pregnancy Outcome Details
Date of delivery
Item
Date of delivery
date
Length of gestation
Item
Length of gestation
float
Item
Methods of delivery
text
Methods of delivery
Code List
Methods 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
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