ID

33708

Description

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

Versions (3)
  1. 12/12/18 12/12/18 -
  2. 12/20/18 12/20/18 -
  3. 12/20/18 12/20/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 20, 2018

DOI

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License

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

English

Visit 20: Prior and Concomitant Medications + Gen-consent

1 forms  
Administrative data
Description

Administrative data

Site
Description

Site

Data type

text

Subject
Description

Subject

Data type

text

Visit Name
Description

Visit Name

Data type

text

Status
Description

Status

Data type

text

Doc №
Description

Doc №

Data type

integer

Is Page Blank?
Description

blank page?

Data type

boolean

Prior and Concomitant Medications/Non-Drug Therapies
Description

Prior and Concomitant Medications/Non-Drug Therapies

Concomitant Medication
Description

Concomitant Medication

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boolean

Non-Drug Therapy
Description

including procedures and surgeries

Data type

boolean

Drug Name
Description

Trade name preferred

Data type

text

Unit Dose
Description

Unit Dose

Data type

text

Unit
Description

Unit

Data type

text

Frequency
Description

Frequency

Data type

text

Route
Description

Route

Data type

text

Indication
Description

If AE/SAE enter Event Term

Data type

text

AE/SAE Event Number
Description

AE/SAE Event Number

Data type

integer

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Description

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date

Stop date
Description

Stop date

Data type

date

Ongoing?
Description

Ongoing?

Data type

boolean

Taken prior to study?
Description

Taken prior to study?

Data type

boolean

PGx-Pharmacogenetic Research Consent
Description

PGx-Pharmacogenetic Research Consent

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

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

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boolean

Date informed consent obtained
Description

Date informed consent obtained

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date

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If no consent obtained, check the reason

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text

If other, specify
Description

If other, specify

Data type

text

Blood Sample
Description

Blood Sample

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Description

Has a blood sample been collected for PGx research?

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boolean

Record the date sample taken
Description

Record the date sample taken

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date

If no, check the reason
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If no, check the reason

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text

If Other, specify
Description

If Other, specify

Data type

text

PGx-Pharmacogenetic Research Consent Withdrawal
Description

PGx-Pharmacogenetic Research Consent Withdrawal

Has subject withdrawn consent for PGx-Pharmacogenetic research?
Description

Has subject withdrawn consent for PGx-Pharmacogenetic research?

Data type

boolean

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Description

Has a request been made for sample destruction?

Data type

boolean

If Yes, enter the reason
Description

If Yes, enter the reason

Data type

text

If Other, specify
Description

If Other, specify

Data type

text

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Visit 20: Prior and Concomitant Medications + Gen-consent

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
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Doc №
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Is Page Blank?
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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
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Item
Date informed consent obtained
date
Item
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text
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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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