ID

33810

Beschrijving

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

Trefwoorden

Versies (1)
  1. 28-12-18 28-12-18 -
Houder van rechten

GSK group of companies

Geüploaded op

28 december 2018

DOI

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Licentie

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

Engels

Study Completion

1 Formulieren  
  1. StudyEvent: ODM
    1. Study Completion
Administrative data
Beschrijving

Administrative data

Site
Beschrijving

Site

Datatype

text

Subject
Beschrijving

Subject

Datatype

text

Visit Name
Beschrijving

Visit Name

Datatype

text

Visit Number
Beschrijving

Visit Number

Datatype

text

Status
Beschrijving

Status

Datatype

text

Document Number
Beschrijving

Document Number

Datatype

text

Visit Date
Beschrijving

Visit Date

Datatype

date

Study Termination
Beschrijving

Study Termination

Date of Final Contact
Beschrijving

Date of Final Contact

Datatype

date

Date of Last Dose
Beschrijving

Date of Last Dose

Datatype

date

Did subject complete the study?
Beschrijving

Did subject complete the study?

Datatype

boolean

Date of discontinuation
Beschrijving

Date of discontinuation

Datatype

date

If subject discontinued the study, mark one reason
Beschrijving

reason for study discontinuation

Datatype

text

If Other, please specify details
Beschrijving

If Other, specify

Datatype

text

AE Number in case of liver chemistry stopping criteria
Beschrijving

AE Number in case of liver chemistry stopping criteria

Datatype

integer

AE Number in case of adverse event
Beschrijving

AE Number in case of adverse event

Datatype

integer

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

AE Number in case of severe or repeated occurrences of hypoglycemia

Datatype

integer

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Study Completion

1 Formulieren
  1. StudyEvent: ODM
    1. Study Completion
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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