ID

33708

Descrizione

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

Keywords

  1. 12/12/18 12/12/18 -
  2. 20/12/18 20/12/18 -
  3. 20/12/18 20/12/18 -
Titolare del copyright

GSK group of companies

Caricato su

20 dicembre 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0

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

Visit 20: Prior and Concomitant Medications + Gen-consent

Administrative data
Descrizione

Administrative data

Site
Descrizione

Site

Tipo di dati

text

Subject
Descrizione

Subject

Tipo di dati

text

Visit Name
Descrizione

Visit Name

Tipo di dati

text

Status
Descrizione

Status

Tipo di dati

text

Doc №
Descrizione

Doc №

Tipo di dati

integer

Is Page Blank?
Descrizione

blank page?

Tipo di dati

boolean

Prior and Concomitant Medications/Non-Drug Therapies
Descrizione

Prior and Concomitant Medications/Non-Drug Therapies

Concomitant Medication
Descrizione

Concomitant Medication

Tipo di dati

boolean

Non-Drug Therapy
Descrizione

including procedures and surgeries

Tipo di dati

boolean

Drug Name
Descrizione

Trade name preferred

Tipo di dati

text

Unit Dose
Descrizione

Unit Dose

Tipo di dati

text

Unit
Descrizione

Unit

Tipo di dati

text

Frequency
Descrizione

Frequency

Tipo di dati

text

Route
Descrizione

Route

Tipo di dati

text

Indication
Descrizione

If AE/SAE enter Event Term

Tipo di dati

text

AE/SAE Event Number
Descrizione

AE/SAE Event Number

Tipo di dati

integer

Start date
Descrizione

Start date

Tipo di dati

date

Stop date
Descrizione

Stop date

Tipo di dati

date

Ongoing?
Descrizione

Ongoing?

Tipo di dati

boolean

Taken prior to study?
Descrizione

Taken prior to study?

Tipo di dati

boolean

PGx-Pharmacogenetic Research Consent
Descrizione

PGx-Pharmacogenetic Research Consent

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

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

Tipo di dati

boolean

Date informed consent obtained
Descrizione

Date informed consent obtained

Tipo di dati

date

If no consent obtained, check the reason
Descrizione

If no consent obtained, check the reason

Tipo di dati

text

If other, specify
Descrizione

If other, specify

Tipo di dati

text

Blood Sample
Descrizione

Blood Sample

Has a blood sample been collected for PGx research?
Descrizione

Has a blood sample been collected for PGx research?

Tipo di dati

boolean

Record the date sample taken
Descrizione

Record the date sample taken

Tipo di dati

date

If no, check the reason
Descrizione

If no, check the reason

Tipo di dati

text

If Other, specify
Descrizione

If Other, specify

Tipo di dati

text

PGx-Pharmacogenetic Research Consent Withdrawal
Descrizione

PGx-Pharmacogenetic Research Consent Withdrawal

Has subject withdrawn consent for PGx-Pharmacogenetic research?
Descrizione

Has subject withdrawn consent for PGx-Pharmacogenetic research?

Tipo di dati

boolean

Has a request been made for sample destruction?
Descrizione

Has a request been made for sample destruction?

Tipo di dati

boolean

If Yes, enter the reason
Descrizione

If Yes, enter the reason

Tipo di dati

text

If Other, specify
Descrizione

If Other, specify

Tipo di dati

text

Similar models

Visit 20: Prior and Concomitant Medications + Gen-consent

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative data
Site
Item
Site
text
Subject
Item
Subject
text
Item
Visit Name
text
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
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
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
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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