ID

33846

Description

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

Mots-clés

Versions (1)
  1. 03/01/2019 03/01/2019 -
Détendeur de droits

GSK group of companies

Téléchargé le

3 janvier 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032

Anglais

Pregnancy Data

1 Formulaires  
  1. StudyEvent: ODM
    1. Pregnancy Data
Administrative data
Description

Administrative data

Site
Description

Site

Type de données

text

Subject
Description

Subject

Type de données

text

Visit Name
Description

Visit Name

Type de données

text

Status
Description

Status

Type de données

text

Document Number
Description

Document Number

Type de données

integer

Demography
Description

Demography

Subject ID Number
Description

Subject must discontinue study medication if pregnancy test is positive

Type de données

integer

Race
Description

Race

Type de données

text

Age
Description

Age

Type de données

float

Unités de mesure
  • years
years
Date of birth
Description

Date of birth

Type de données

date

Weight
Description

Weight

Type de données

float

Weight units
Description

Weight units

Type de données

text

Height
Description

Height

Type de données

float

Height units
Description

Height units

Type de données

text

Medical History
Description

Medical History

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, date:
Description

If Yes, date:

Type de données

date

Was termination elective or spontaneous?
Description

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 below
Description

If Yes, specify below

Type de données

text

Pregnancy Outcome Information
Description

Pregnancy Outcome Information

Subject ID Number
Description

Subject ID Number

Type de données

integer

Age
Description

Age

Type de données

float

Unités de mesure
  • years
years
Date of Birth
Description

Date of Birth

Type de données

date

Weight
Description

Weight

Type de données

float

Weight unit
Description

Weight unit

Type de données

text

Height
Description

Height

Type de données

float

Height units
Description

Height units

Type de données

text

Child Information
Description

Child Information

Baby #
Description

Baby #

Type de données

integer

Sex
Description

Sex

Type de données

text

Height
Description

Height

Type de données

float

Height units
Description

Height units

Type de données

text

Weight
Description

Weight

Type de données

float

Weight units
Description

Weight units

Type de données

text

Apgar score 1 min
Description

Apgar score 1 min

Type de données

integer

Apgar score 5 min
Description

Apgar score 5 min

Type de données

integer

Outcome of pregnancy
Description

Outcome of pregnancy

Type de données

text

Comment
Description

Comment

Type de données

text

If abortion, please record the date
Description

Date of abortion

Type de données

date

Date of congenital abnormality identified/diagnosed
Description

Date of congenital abnormality identified/diagnosed

Type de données

date

Pregnancy Outcome Details
Description

Pregnancy Outcome Details

Date of delivery
Description

Date of delivery

Type de données

date

Length of gestation
Description

Length of gestation

Type de données

float

Unités de mesure
  • weeks
weeks
Methods of delivery
Description

select one

Type de données

text

Number of births as a result of this pregnancy
Description

include live and stillbirth; if none enter a zero

Type de données

integer

Comments
Description

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

Type de données

text

Retour au début de la page

Similar models

Pregnancy Data

1 Formulaires
  1. StudyEvent: ODM
    1. Pregnancy Data
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial