ID

33716

Beschrijving

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

Trefwoorden

Versies (1)
  1. 20-12-18 20-12-18 -
Houder van rechten

GSK group of companies

Geüploaded op

20 december 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

Engels

Visit 50

1 Formulieren  
  1. StudyEvent: ODM
    1. Visit 50
Administrative data
Beschrijving

Administrative data

Site
Beschrijving

Site

Datatype

text

Subject
Beschrijving

Subject

Datatype

text

Status
Beschrijving

Status

Datatype

text

Doc №
Beschrijving

Doc №

Datatype

integer

Is Page Blank?
Beschrijving

blank page?

Datatype

boolean

Visit Date
Beschrijving

Visit Date

Datatype

date

Informed Consent
Beschrijving

Informed Consent

Has the informed consent been obtained?
Beschrijving

Has the informed consent been obtained?

Datatype

boolean

Date of consent obtained
Beschrijving

Date of consent

Datatype

date

Admission Criteria
Beschrijving

Admission Criteria

Did the subject meet all eligibility criteria?
Beschrijving

Did the subject meet all eligibility criteria?

Datatype

boolean

Failed Eligibility Criteria
Beschrijving

Failed Eligibility Criteria

Criteria Number
Beschrijving

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

Datatype

integer

Check One Criteria Type
Beschrijving

Check One Criteria Type

Datatype

integer

Waiver Granted?
Beschrijving

Waiver Granted?

Datatype

boolean

Date of Sponsor Approval
Beschrijving

Date of Sponsor Approval

Datatype

date

Comment
Beschrijving

Comment

Datatype

text

Demographics
Beschrijving

Demographics

Date of Birth
Beschrijving

Date of Birth

Datatype

date

Sex
Beschrijving

Sex

Datatype

text

Ethnicity
Beschrijving

Ethnicity

Datatype

text

Race
Beschrijving

Race

Check all that apply
Beschrijving

Check all that apply

Datatype

integer

If Other, please specify
Beschrijving

If Other, please specify

Datatype

text

Potentially Childbearing
Beschrijving

Potentially Childbearing

Is the subject of childbearing potential?
Beschrijving

Is the subject of childbearing potential?

Datatype

boolean

Electrocardiogram
Beschrijving

Electrocardiogram

Date ECG performed
Beschrijving

Date ECG performed

Datatype

date

Time ECG performed
Beschrijving

Time ECG performed

Datatype

time

Heart Rate
Beschrijving

Heart Rate

Datatype

integer

Maateenheden
  • bpm
bpm
PR Interval
Beschrijving

PR Interval

Datatype

integer

Maateenheden
  • msec
msec
QRS Duration
Beschrijving

QRS Duration

Datatype

float

Maateenheden
  • msec
msec
QT Interval
Beschrijving

QT Interval

Datatype

float

Maateenheden
  • msec
msec
QTcB Interval
Beschrijving

QTcB Interval

Datatype

float

Maateenheden
  • msec
msec
QTcF Interval
Beschrijving

QTcF Interval

Datatype

float

Maateenheden
  • msec
msec
RR Interval
Beschrijving

RR Interval

Datatype

float

Maateenheden
  • msec
msec
Normal sinus rhythm?
Beschrijving

Normal sinus rhythm?

Datatype

boolean

Overall interpretation of ECG
Beschrijving

Overall interpretation of ECG

Please mark the correct interpretation
Beschrijving

Please mark the correct interpretation

Datatype

text

If Abnormal, please specify
Beschrijving

If Abnormal, please specify

Datatype

text

Hematology Test
Beschrijving

Hematology Test

Was the laboratory sample collected?
Beschrijving

Was the laboratory sample collected?

Datatype

boolean

Sample Date
Beschrijving

Sample Date

Datatype

date

Sample Time
Beschrijving

Sample Time

Datatype

time

Comment
Beschrijving

Comment

Datatype

text

Chemistry / Serum HCG / SP Chemistry
Beschrijving

Chemistry / Serum HCG / SP Chemistry

Was the laboratory sample collected?
Beschrijving

Was the laboratory sample collected?

Datatype

boolean

Sample Date
Beschrijving

Sample Date

Datatype

date

Sample Time
Beschrijving

Sample Time

Datatype

time

Comment
Beschrijving

Comment

Datatype

text

Pregnancy test result
Beschrijving

Pregnancy test result

Datatype

text

UA / UDS / Urine Chemistry
Beschrijving

UA / UDS / Urine Chemistry

Was the laboratory sample collected?
Beschrijving

Was the laboratory sample collected?

Datatype

boolean

Sample Date
Beschrijving

Sample Date

Datatype

date

Sample Time
Beschrijving

Sample Time

Datatype

time

Comment
Beschrijving

Comment

Datatype

text

Serology
Beschrijving

Serology

Was the laboratory sample collected?
Beschrijving

Was the laboratory sample collected?

Datatype

boolean

Sample Date
Beschrijving

Sample Date

Datatype

date

Sample Time
Beschrijving

Sample Time

Datatype

time

Comment
Beschrijving

Comment

Datatype

text

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Visit 50

1 Formulieren
  1. StudyEvent: ODM
    1. Visit 50
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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