ID

33708

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 (3)
  1. 12/12/18 12/12/18 -
  2. 20/12/18 20/12/18 -
  3. 20/12/18 20/12/18 -
Titular de derechos de autor

GSK group of companies

Subido en

20 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

Visit 20: Prior and Concomitant Medications + Gen-consent

1 formularios  
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

Doc №
Descripción

Doc №

Tipo de datos

integer

Is Page Blank?
Descripción

blank page?

Tipo de datos

boolean

Prior and Concomitant Medications/Non-Drug Therapies
Descripción

Prior and Concomitant Medications/Non-Drug Therapies

Concomitant Medication
Descripción

Concomitant Medication

Tipo de datos

boolean

Non-Drug Therapy
Descripción

including procedures and surgeries

Tipo de datos

boolean

Drug Name
Descripción

Trade name preferred

Tipo de datos

text

Unit Dose
Descripción

Unit Dose

Tipo de datos

text

Unit
Descripción

Unit

Tipo de datos

text

Frequency
Descripción

Frequency

Tipo de datos

text

Route
Descripción

Route

Tipo de datos

text

Indication
Descripción

If AE/SAE enter Event Term

Tipo de datos

text

AE/SAE Event Number
Descripción

AE/SAE Event Number

Tipo de datos

integer

Start date
Descripción

Start date

Tipo de datos

date

Stop date
Descripción

Stop date

Tipo de datos

date

Ongoing?
Descripción

Ongoing?

Tipo de datos

boolean

Taken prior to study?
Descripción

Taken prior to study?

Tipo de datos

boolean

PGx-Pharmacogenetic Research Consent
Descripción

PGx-Pharmacogenetic Research Consent

Has the informed consent been obtained for PGx-Pharmacogenetic Research?
Descripción

Has the informed consent been obtained for PGx-Pharmacogenetic Research?

Tipo de datos

boolean

Date informed consent obtained
Descripción

Date informed consent obtained

Tipo de datos

date

If no consent obtained, check the reason
Descripción

If no consent obtained, check the reason

Tipo de datos

text

If other, specify
Descripción

If other, specify

Tipo de datos

text

Blood Sample
Descripción

Blood Sample

Has a blood sample been collected for PGx research?
Descripción

Has a blood sample been collected for PGx research?

Tipo de datos

boolean

Record the date sample taken
Descripción

Record the date sample taken

Tipo de datos

date

If no, check the reason
Descripción

If no, check the reason

Tipo de datos

text

If Other, specify
Descripción

If Other, specify

Tipo de datos

text

PGx-Pharmacogenetic Research Consent Withdrawal
Descripción

PGx-Pharmacogenetic Research Consent Withdrawal

Has subject withdrawn consent for PGx-Pharmacogenetic research?
Descripción

Has subject withdrawn consent for PGx-Pharmacogenetic research?

Tipo de datos

boolean

Has a request been made for sample destruction?
Descripción

Has a request been made for sample destruction?

Tipo de datos

boolean

If Yes, enter the reason
Descripción

If Yes, enter the reason

Tipo de datos

text

If Other, specify
Descripción

If Other, specify

Tipo de datos

text

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Similar models

Visit 20: Prior and Concomitant Medications + Gen-consent

1 formularios
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
Adverse Events (1)
Status
Item
Status
text
Doc №
Item
Doc №
integer
blank page?
Item
Is Page Blank?
boolean
Item Group
Prior and Concomitant Medications/Non-Drug Therapies
Concomitant Medication
Item
Concomitant Medication
boolean
Non-Drug Therapy
Item
Non-Drug Therapy
boolean
Drug Name
Item
Drug Name
text
Unit Dose
Item
Unit Dose
text
Unit
Item
Unit
text
Frequency
Item
Frequency
text
Route
Item
Route
text
Indication
Item
Indication
text
AE/SAE Event Number
Item
AE/SAE Event Number
integer
Start date
Item
Start date
date
Stop date
Item
Stop date
date
Ongoing?
Item
Ongoing?
boolean
Taken prior to study?
Item
Taken prior to study?
boolean
Has the informed consent been obtained for PGx-Pharmacogenetic Research?
Item
Has the informed consent been obtained for PGx-Pharmacogenetic Research?
boolean
Date informed consent obtained
Item
Date informed consent obtained
date
Item
If no consent obtained, check the reason
text
If no consent obtained, check the reason
Code List
If no consent obtained, check the reason
CL Item
Subject declined (1)
CL Item
Subject not asked by investigator (2)
CL Item
Other (3)
If other, specify
Item
If other, specify
text
Item Group
Blood Sample
Has a blood sample been collected for PGx research?
Item
Has a blood sample been collected for PGx research?
boolean
Record the date sample taken
Item
Record the date sample taken
date
Item
If no, check the reason
text
If no, check the reason
Code List
If no, check the reason
CL Item
Subject declined (1)
CL Item
Subject not asked by investigator (2)
CL Item
Other (3)
If Other, specify
Item
If Other, specify
text
Item Group
PGx-Pharmacogenetic Research Consent Withdrawal
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
boolean
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
Item
If Yes, enter the reason
text
If Yes, enter the reason
Code List
If Yes, enter the reason
CL Item
Subject requested (1)
CL Item
Other (2)
If Other, specify
Item
If Other, specify
text
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