ID

33846

Descripción

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

Palabras clave

Versiones (1)
  1. 3/1/19 3/1/19 -
Titular de derechos de autor

GSK group of companies

Subido en

3 de enero de 2019

DOI

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Licencia

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

Inglés

Pregnancy Data

1 formularios  
  1. StudyEvent: ODM
    1. Pregnancy Data
Administrative data
Descripción

Administrative data

Site
Descripción

Site

Tipo de datos

text

Subject
Descripción

Subject

Tipo de datos

text

Visit Name
Descripción

Visit Name

Tipo de datos

text

Status
Descripción

Status

Tipo de datos

text

Document Number
Descripción

Document Number

Tipo de datos

integer

Demography
Descripción

Demography

Subject ID Number
Descripción

Subject must discontinue study medication if pregnancy test is positive

Tipo de datos

integer

Race
Descripción

Race

Tipo de datos

text

Age
Descripción

Age

Tipo de datos

float

Unidades de medida
  • years
years
Date of birth
Descripción

Date of birth

Tipo de datos

date

Weight
Descripción

Weight

Tipo de datos

float

Weight units
Descripción

Weight units

Tipo de datos

text

Height
Descripción

Height

Tipo de datos

float

Height units
Descripción

Height units

Tipo de datos

text

Medical History
Descripción

Medical History

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, date:
Descripción

If Yes, date:

Tipo de datos

date

Was termination elective or spontaneous?
Descripción

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 below
Descripción

If Yes, specify below

Tipo de datos

text

Pregnancy Outcome Information
Descripción

Pregnancy Outcome Information

Subject ID Number
Descripción

Subject ID Number

Tipo de datos

integer

Age
Descripción

Age

Tipo de datos

float

Unidades de medida
  • years
years
Date of Birth
Descripción

Date of Birth

Tipo de datos

date

Weight
Descripción

Weight

Tipo de datos

float

Weight unit
Descripción

Weight unit

Tipo de datos

text

Height
Descripción

Height

Tipo de datos

float

Height units
Descripción

Height units

Tipo de datos

text

Child Information
Descripción

Child Information

Baby #
Descripción

Baby #

Tipo de datos

integer

Sex
Descripción

Sex

Tipo de datos

text

Height
Descripción

Height

Tipo de datos

float

Height units
Descripción

Height units

Tipo de datos

text

Weight
Descripción

Weight

Tipo de datos

float

Weight units
Descripción

Weight units

Tipo de datos

text

Apgar score 1 min
Descripción

Apgar score 1 min

Tipo de datos

integer

Apgar score 5 min
Descripción

Apgar score 5 min

Tipo de datos

integer

Outcome of pregnancy
Descripción

Outcome of pregnancy

Tipo de datos

text

Comment
Descripción

Comment

Tipo de datos

text

If abortion, please record the date
Descripción

Date of abortion

Tipo de datos

date

Date of congenital abnormality identified/diagnosed
Descripción

Date of congenital abnormality identified/diagnosed

Tipo de datos

date

Pregnancy Outcome Details
Descripción

Pregnancy Outcome Details

Date of delivery
Descripción

Date of delivery

Tipo de datos

date

Length of gestation
Descripción

Length of gestation

Tipo de datos

float

Unidades de medida
  • weeks
weeks
Methods of delivery
Descripción

select one

Tipo de datos

text

Number of births as a result of this pregnancy
Descripción

include live and stillbirth; if none enter a zero

Tipo de datos

integer

Comments
Descripción

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

Tipo de datos

text

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Similar models

Pregnancy Data

1 formularios
  1. StudyEvent: ODM
    1. Pregnancy Data
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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