ID

33716

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2018-12-20 2018-12-20 -
Rättsinnehavare

GSK group of companies

Uppladdad den

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

Engelsk

Visit 50

1 Formulär  
  1. StudyEvent: ODM
    1. Visit 50
Administrative data
Beskrivning

Administrative data

Site
Beskrivning

Site

Datatyp

text

Subject
Beskrivning

Subject

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Doc №
Beskrivning

Doc №

Datatyp

integer

Is Page Blank?
Beskrivning

blank page?

Datatyp

boolean

Visit Date
Beskrivning

Visit Date

Datatyp

date

Informed Consent
Beskrivning

Informed Consent

Has the informed consent been obtained?
Beskrivning

Has the informed consent been obtained?

Datatyp

boolean

Date of consent obtained
Beskrivning

Date of consent

Datatyp

date

Admission Criteria
Beskrivning

Admission Criteria

Did the subject meet all eligibility criteria?
Beskrivning

Did the subject meet all eligibility criteria?

Datatyp

boolean

Failed Eligibility Criteria
Beskrivning

Failed Eligibility Criteria

Criteria Number
Beskrivning

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

Datatyp

integer

Check One Criteria Type
Beskrivning

Check One Criteria Type

Datatyp

integer

Waiver Granted?
Beskrivning

Waiver Granted?

Datatyp

boolean

Date of Sponsor Approval
Beskrivning

Date of Sponsor Approval

Datatyp

date

Comment
Beskrivning

Comment

Datatyp

text

Demographics
Beskrivning

Demographics

Date of Birth
Beskrivning

Date of Birth

Datatyp

date

Sex
Beskrivning

Sex

Datatyp

text

Ethnicity
Beskrivning

Ethnicity

Datatyp

text

Race
Beskrivning

Race

Check all that apply
Beskrivning

Check all that apply

Datatyp

integer

If Other, please specify
Beskrivning

If Other, please specify

Datatyp

text

Potentially Childbearing
Beskrivning

Potentially Childbearing

Is the subject of childbearing potential?
Beskrivning

Is the subject of childbearing potential?

Datatyp

boolean

Electrocardiogram
Beskrivning

Electrocardiogram

Date ECG performed
Beskrivning

Date ECG performed

Datatyp

date

Time ECG performed
Beskrivning

Time ECG performed

Datatyp

time

Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • bpm
bpm
PR Interval
Beskrivning

PR Interval

Datatyp

integer

Måttenheter
  • msec
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

float

Måttenheter
  • msec
msec
QT Interval
Beskrivning

QT Interval

Datatyp

float

Måttenheter
  • msec
msec
QTcB Interval
Beskrivning

QTcB Interval

Datatyp

float

Måttenheter
  • msec
msec
QTcF Interval
Beskrivning

QTcF Interval

Datatyp

float

Måttenheter
  • msec
msec
RR Interval
Beskrivning

RR Interval

Datatyp

float

Måttenheter
  • msec
msec
Normal sinus rhythm?
Beskrivning

Normal sinus rhythm?

Datatyp

boolean

Overall interpretation of ECG
Beskrivning

Overall interpretation of ECG

Please mark the correct interpretation
Beskrivning

Please mark the correct interpretation

Datatyp

text

If Abnormal, please specify
Beskrivning

If Abnormal, please specify

Datatyp

text

Hematology Test
Beskrivning

Hematology Test

Was the laboratory sample collected?
Beskrivning

Was the laboratory sample collected?

Datatyp

boolean

Sample Date
Beskrivning

Sample Date

Datatyp

date

Sample Time
Beskrivning

Sample Time

Datatyp

time

Comment
Beskrivning

Comment

Datatyp

text

Chemistry / Serum HCG / SP Chemistry
Beskrivning

Chemistry / Serum HCG / SP Chemistry

Was the laboratory sample collected?
Beskrivning

Was the laboratory sample collected?

Datatyp

boolean

Sample Date
Beskrivning

Sample Date

Datatyp

date

Sample Time
Beskrivning

Sample Time

Datatyp

time

Comment
Beskrivning

Comment

Datatyp

text

Pregnancy test result
Beskrivning

Pregnancy test result

Datatyp

text

UA / UDS / Urine Chemistry
Beskrivning

UA / UDS / Urine Chemistry

Was the laboratory sample collected?
Beskrivning

Was the laboratory sample collected?

Datatyp

boolean

Sample Date
Beskrivning

Sample Date

Datatyp

date

Sample Time
Beskrivning

Sample Time

Datatyp

time

Comment
Beskrivning

Comment

Datatyp

text

Serology
Beskrivning

Serology

Was the laboratory sample collected?
Beskrivning

Was the laboratory sample collected?

Datatyp

boolean

Sample Date
Beskrivning

Sample Date

Datatyp

date

Sample Time
Beskrivning

Sample Time

Datatyp

time

Comment
Beskrivning

Comment

Datatyp

text

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Similar models

Visit 50

1 Formulär
  1. StudyEvent: ODM
    1. Visit 50
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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