ID

33708

Beschreibung

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

Stichworte

Versionen (3)
  1. 12.12.18 12.12.18 -
  2. 20.12.18 20.12.18 -
  3. 20.12.18 20.12.18 -
Rechteinhaber

GSK group of companies

Hochgeladen am

20. Dezember 2018

DOI

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

Englisch

Visit 20: Prior and Concomitant Medications + Gen-consent

1 Formulare  
Administrative data
Beschreibung

Administrative data

Site
Beschreibung

Site

Datentyp

text

Subject
Beschreibung

Subject

Datentyp

text

Visit Name
Beschreibung

Visit Name

Datentyp

text

Status
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Status

Datentyp

text

Doc №
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Doc №

Datentyp

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blank page?

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Prior and Concomitant Medications/Non-Drug Therapies

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Beschreibung

Concomitant Medication

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Non-Drug Therapy
Beschreibung

including procedures and surgeries

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Drug Name
Beschreibung

Trade name preferred

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text

Unit Dose
Beschreibung

Unit Dose

Datentyp

text

Unit
Beschreibung

Unit

Datentyp

text

Frequency
Beschreibung

Frequency

Datentyp

text

Route
Beschreibung

Route

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Indication
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If AE/SAE enter Event Term

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text

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Beschreibung

AE/SAE Event Number

Datentyp

integer

Start date
Beschreibung

Start date

Datentyp

date

Stop date
Beschreibung

Stop date

Datentyp

date

Ongoing?
Beschreibung

Ongoing?

Datentyp

boolean

Taken prior to study?
Beschreibung

Taken prior to study?

Datentyp

boolean

PGx-Pharmacogenetic Research Consent
Beschreibung

PGx-Pharmacogenetic Research Consent

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

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

Datentyp

boolean

Date informed consent obtained
Beschreibung

Date informed consent obtained

Datentyp

date

If no consent obtained, check the reason
Beschreibung

If no consent obtained, check the reason

Datentyp

text

If other, specify
Beschreibung

If other, specify

Datentyp

text

Blood Sample
Beschreibung

Blood Sample

Has a blood sample been collected for PGx research?
Beschreibung

Has a blood sample been collected for PGx research?

Datentyp

boolean

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Beschreibung

Record the date sample taken

Datentyp

date

If no, check the reason
Beschreibung

If no, check the reason

Datentyp

text

If Other, specify
Beschreibung

If Other, specify

Datentyp

text

PGx-Pharmacogenetic Research Consent Withdrawal
Beschreibung

PGx-Pharmacogenetic Research Consent Withdrawal

Has subject withdrawn consent for PGx-Pharmacogenetic research?
Beschreibung

Has subject withdrawn consent for PGx-Pharmacogenetic research?

Datentyp

boolean

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Beschreibung

Has a request been made for sample destruction?

Datentyp

boolean

If Yes, enter the reason
Beschreibung

If Yes, enter the reason

Datentyp

text

If Other, specify
Beschreibung

If Other, specify

Datentyp

text

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Visit 20: Prior and Concomitant Medications + Gen-consent

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
Site
Item
Site
text
Subject
Item
Subject
text
Item
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text
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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
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Item
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Item
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text
Unit Dose
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Unit Dose
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Unit
Item
Unit
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Frequency
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Frequency
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Route
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AE/SAE Event Number
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Has a blood sample been collected for PGx research?
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Has a blood sample been collected for PGx research?
boolean
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text
If no, check the reason
Code List
If no, check the reason
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CL Item
Subject not asked by investigator (2)
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Other (3)
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If Other, specify
text
Item Group
PGx-Pharmacogenetic Research Consent Withdrawal
Has subject withdrawn consent for PGx-Pharmacogenetic research?
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Has subject withdrawn consent for PGx-Pharmacogenetic research?
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Has a request been made for sample destruction?
boolean
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text
If Yes, enter the reason
Code List
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CL Item
Subject requested (1)
CL Item
Other (2)
If Other, specify
Item
If Other, specify
text
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