ID

33716

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 (1)
  1. 12/20/18 12/20/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 20, 2018

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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 50

1 forms  
  1. StudyEvent: ODM
    1. Visit 50
Administrative data
Description

Administrative data

Site
Description

Site

Data type

text

Subject
Description

Subject

Data type

text

Status
Description

Status

Data type

text

Doc №
Description

Doc №

Data type

integer

Is Page Blank?
Description

blank page?

Data type

boolean

Visit Date
Description

Visit Date

Data type

date

Informed Consent
Description

Informed Consent

Has the informed consent been obtained?
Description

Has the informed consent been obtained?

Data type

boolean

Date of consent obtained
Description

Date of consent

Data type

date

Admission Criteria
Description

Admission Criteria

Did the subject meet all eligibility criteria?
Description

Did the subject meet all eligibility criteria?

Data type

boolean

Failed Eligibility Criteria
Description

Failed Eligibility Criteria

Criteria Number
Description

If the subject did not meet all eligibility criteria, please specify criteria number and explain below

Data type

integer

Check One Criteria Type
Description

Check One Criteria Type

Data type

integer

Waiver Granted?
Description

Waiver Granted?

Data type

boolean

Date of Sponsor Approval
Description

Date of Sponsor Approval

Data type

date

Comment
Description

Comment

Data type

text

Demographics
Description

Demographics

Date of Birth
Description

Date of Birth

Data type

date

Sex
Description

Sex

Data type

text

Ethnicity
Description

Ethnicity

Data type

text

Race
Description

Race

Check all that apply
Description

Check all that apply

Data type

integer

If Other, please specify
Description

If Other, please specify

Data type

text

Potentially Childbearing
Description

Potentially Childbearing

Is the subject of childbearing potential?
Description

Is the subject of childbearing potential?

Data type

boolean

Electrocardiogram
Description

Electrocardiogram

Date ECG performed
Description

Date ECG performed

Data type

date

Time ECG performed
Description

Time ECG performed

Data type

time

Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
PR Interval
Description

PR Interval

Data type

integer

Measurement units
  • msec
msec
QRS Duration
Description

QRS Duration

Data type

float

Measurement units
  • msec
msec
QT Interval
Description

QT Interval

Data type

float

Measurement units
  • msec
msec
QTcB Interval
Description

QTcB Interval

Data type

float

Measurement units
  • msec
msec
QTcF Interval
Description

QTcF Interval

Data type

float

Measurement units
  • msec
msec
RR Interval
Description

RR Interval

Data type

float

Measurement units
  • msec
msec
Normal sinus rhythm?
Description

Normal sinus rhythm?

Data type

boolean

Overall interpretation of ECG
Description

Overall interpretation of ECG

Please mark the correct interpretation
Description

Please mark the correct interpretation

Data type

text

If Abnormal, please specify
Description

If Abnormal, please specify

Data type

text

Hematology Test
Description

Hematology Test

Was the laboratory sample collected?
Description

Was the laboratory sample collected?

Data type

boolean

Sample Date
Description

Sample Date

Data type

date

Sample Time
Description

Sample Time

Data type

time

Comment
Description

Comment

Data type

text

Chemistry / Serum HCG / SP Chemistry
Description

Chemistry / Serum HCG / SP Chemistry

Was the laboratory sample collected?
Description

Was the laboratory sample collected?

Data type

boolean

Sample Date
Description

Sample Date

Data type

date

Sample Time
Description

Sample Time

Data type

time

Comment
Description

Comment

Data type

text

Pregnancy test result
Description

Pregnancy test result

Data type

text

UA / UDS / Urine Chemistry
Description

UA / UDS / Urine Chemistry

Was the laboratory sample collected?
Description

Was the laboratory sample collected?

Data type

boolean

Sample Date
Description

Sample Date

Data type

date

Sample Time
Description

Sample Time

Data type

time

Comment
Description

Comment

Data type

text

Serology
Description

Serology

Was the laboratory sample collected?
Description

Was the laboratory sample collected?

Data type

boolean

Sample Date
Description

Sample Date

Data type

date

Sample Time
Description

Sample Time

Data type

time

Comment
Description

Comment

Data type

text

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Visit 50

1 forms
  1. StudyEvent: ODM
    1. Visit 50
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Site
Item
Site
text
Subject
Item
Subject
text
Status
Item
Status
text
Doc №
Item
Doc №
integer
blank page?
Item
Is Page Blank?
boolean
Visit Date
Item
Visit Date
date
Item Group
Informed Consent
Has the informed consent been obtained?
Item
Has the informed consent been obtained?
boolean
Date of consent
Item
Date of consent obtained
date
Item Group
Admission Criteria
Did the subject meet all eligibility criteria?
Item
Did the subject meet all eligibility criteria?
boolean
Item Group
Failed Eligibility Criteria
Item
Criteria Number
integer
Criteria Number
Code List
Criteria Number
CL Item
Criterion 1 (1)
CL Item
Criterion 2 (2)
CL Item
Criterion 3 (3)
CL Item
Criterion 4 (4)
Item
Check One Criteria Type
integer
Check One Criteria Type
Code List
Check One Criteria Type
CL Item
Inclusion (1)
CL Item
Exclusion (2)
Waiver Granted?
Item
Waiver Granted?
boolean
Date of Sponsor Approval
Item
Date of Sponsor Approval
date
Comment
Item
Comment
text
Item Group
Demographics
Date of Birth
Item
Date of Birth
date
Item
Sex
text
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity
text
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item Group
Race
Item
Check all that apply
integer
Check all that apply
Code List
Check all that apply
CL Item
African-American/African Heritage (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic/North African Heritage (8)
CL Item
White - White/Caucasian/European Heritage (9)
CL Item
Other (10)
If Other, please specify
Item
If Other, please specify
text
Item Group
Potentially Childbearing
Is the subject of childbearing potential?
Item
Is the subject of childbearing potential?
boolean
Item Group
Electrocardiogram
Date ECG performed
Item
Date ECG performed
date
Time ECG performed
Item
Time ECG performed
time
Heart Rate
Item
Heart Rate
integer
PR Interval
Item
PR Interval
integer
QRS Duration
Item
QRS Duration
float
QT Interval
Item
QT Interval
float
QTcB Interval
Item
QTcB Interval
float
QTcF Interval
Item
QTcF Interval
float
RR Interval
Item
RR Interval
float
Normal sinus rhythm?
Item
Normal sinus rhythm?
boolean
Item Group
Overall interpretation of ECG
Item
Please mark the correct interpretation
text
Please mark the correct interpretation
Code List
Please mark the correct interpretation
CL Item
Normal (1)
CL Item
Abnormal; Not clinically significant (2)
CL Item
Abnormal; Clinically Significant (3)
If Abnormal, please specify
Item
If Abnormal, please specify
text
Item Group
Hematology Test
Was the laboratory sample collected?
Item
Was the laboratory sample collected?
boolean
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
Item Group
Chemistry / Serum HCG / SP Chemistry
Was the laboratory sample collected?
Item
Was the laboratory sample collected?
boolean
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
Item
Pregnancy test result
text
Pregnancy test result
Code List
Pregnancy test result
CL Item
Positive (P)
CL Item
Negative (N)
Item Group
UA / UDS / Urine Chemistry
Was the laboratory sample collected?
Item
Was the laboratory sample collected?
boolean
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
Item Group
Serology
Was the laboratory sample collected?
Item
Was the laboratory sample collected?
boolean
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
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