ID

33810

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

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Versiones (1)
  1. 28/12/18 28/12/18 -
Titular de derechos de autor

GSK group of companies

Subido en

28 de diciembre de 2018

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

Study Completion

1 formularios  
  1. StudyEvent: ODM
    1. Study Completion
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

Visit Number
Descripción

Visit Number

Tipo de datos

text

Status
Descripción

Status

Tipo de datos

text

Document Number
Descripción

Document Number

Tipo de datos

text

Visit Date
Descripción

Visit Date

Tipo de datos

date

Study Termination
Descripción

Study Termination

Date of Final Contact
Descripción

Date of Final Contact

Tipo de datos

date

Date of Last Dose
Descripción

Date of Last Dose

Tipo de datos

date

Did subject complete the study?
Descripción

Did subject complete the study?

Tipo de datos

boolean

Date of discontinuation
Descripción

Date of discontinuation

Tipo de datos

date

If subject discontinued the study, mark one reason
Descripción

reason for study discontinuation

Tipo de datos

text

If Other, please specify details
Descripción

If Other, specify

Tipo de datos

text

AE Number in case of liver chemistry stopping criteria
Descripción

AE Number in case of liver chemistry stopping criteria

Tipo de datos

integer

AE Number in case of adverse event
Descripción

AE Number in case of adverse event

Tipo de datos

integer

AE Number in case of severe or repeated occurrences of hypoglycemia
Descripción

AE Number in case of severe or repeated occurrences of hypoglycemia

Tipo de datos

integer

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Similar models

Study Completion

1 formularios
  1. StudyEvent: ODM
    1. Study Completion
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
Completion (1)
Item
Visit Number
text
Visit Number
Code List
Visit Number
CL Item
300 (1)
Status
Item
Status
text
Document Number
Item
Document Number
text
Visit Date
Item
Visit Date
date
Item Group
Study Termination
Date of Final Contact
Item
Date of Final Contact
date
Date of Last Dose
Item
Date of Last Dose
date
Did subject complete the study?
Item
Did subject complete the study?
boolean
Date of discontinuation
Item
Date of discontinuation
date
Item
If subject discontinued the study, mark one reason
text
reason for study discontinuation
Code List
If subject discontinued the study, mark one reason
CL Item
Liver chemistry stopping criteria (record AE Number below in a corresponding line) (1)
CL Item
Adverse Event (record AE number below in a corresponding line) (2)
CL Item
Severe or repeated occurrences of hypoglycemia (record AE number below in a corresponding line) (3)
CL Item
Consent withdrawal (4)
CL Item
Lost to Follow-Up (5)
CL Item
Protocol violation (6)
CL Item
Noncompliance with study visit schedule (7)
CL Item
Termination of study by sponsor (8)
CL Item
Pregnancy (9)
CL Item
Other (10)
If Other, specify
Item
If Other, please specify details
text
AE Number in case of liver chemistry stopping criteria
Item
AE Number in case of liver chemistry stopping criteria
integer
AE Number in case of adverse event
Item
AE Number in case of adverse event
integer
AE Number in case of severe or repeated occurrences of hypoglycemia
Item
AE Number in case of severe or repeated occurrences of hypoglycemia
integer
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