ID

33716

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 (1)
  1. 20.12.18 20.12.18 -
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GSK group of companies

Hochgeladen am

20. Dezember 2018

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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 50

1 Formulare  
  1. StudyEvent: ODM
    1. Visit 50
Administrative data
Beschreibung

Administrative data

Site
Beschreibung

Site

Datentyp

text

Subject
Beschreibung

Subject

Datentyp

text

Status
Beschreibung

Status

Datentyp

text

Doc №
Beschreibung

Doc №

Datentyp

integer

Is Page Blank?
Beschreibung

blank page?

Datentyp

boolean

Visit Date
Beschreibung

Visit Date

Datentyp

date

Informed Consent
Beschreibung

Informed Consent

Has the informed consent been obtained?
Beschreibung

Has the informed consent been obtained?

Datentyp

boolean

Date of consent obtained
Beschreibung

Date of consent

Datentyp

date

Admission Criteria
Beschreibung

Admission Criteria

Did the subject meet all eligibility criteria?
Beschreibung

Did the subject meet all eligibility criteria?

Datentyp

boolean

Failed Eligibility Criteria
Beschreibung

Failed Eligibility Criteria

Criteria Number
Beschreibung

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

Datentyp

integer

Check One Criteria Type
Beschreibung

Check One Criteria Type

Datentyp

integer

Waiver Granted?
Beschreibung

Waiver Granted?

Datentyp

boolean

Date of Sponsor Approval
Beschreibung

Date of Sponsor Approval

Datentyp

date

Comment
Beschreibung

Comment

Datentyp

text

Demographics
Beschreibung

Demographics

Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Sex
Beschreibung

Sex

Datentyp

text

Ethnicity
Beschreibung

Ethnicity

Datentyp

text

Race
Beschreibung

Race

Check all that apply
Beschreibung

Check all that apply

Datentyp

integer

If Other, please specify
Beschreibung

If Other, please specify

Datentyp

text

Potentially Childbearing
Beschreibung

Potentially Childbearing

Is the subject of childbearing potential?
Beschreibung

Is the subject of childbearing potential?

Datentyp

boolean

Electrocardiogram
Beschreibung

Electrocardiogram

Date ECG performed
Beschreibung

Date ECG performed

Datentyp

date

Time ECG performed
Beschreibung

Time ECG performed

Datentyp

time

Heart Rate
Beschreibung

Heart Rate

Datentyp

integer

Maßeinheiten
  • bpm
bpm
PR Interval
Beschreibung

PR Interval

Datentyp

integer

Maßeinheiten
  • msec
msec
QRS Duration
Beschreibung

QRS Duration

Datentyp

float

Maßeinheiten
  • msec
msec
QT Interval
Beschreibung

QT Interval

Datentyp

float

Maßeinheiten
  • msec
msec
QTcB Interval
Beschreibung

QTcB Interval

Datentyp

float

Maßeinheiten
  • msec
msec
QTcF Interval
Beschreibung

QTcF Interval

Datentyp

float

Maßeinheiten
  • msec
msec
RR Interval
Beschreibung

RR Interval

Datentyp

float

Maßeinheiten
  • msec
msec
Normal sinus rhythm?
Beschreibung

Normal sinus rhythm?

Datentyp

boolean

Overall interpretation of ECG
Beschreibung

Overall interpretation of ECG

Please mark the correct interpretation
Beschreibung

Please mark the correct interpretation

Datentyp

text

If Abnormal, please specify
Beschreibung

If Abnormal, please specify

Datentyp

text

Hematology Test
Beschreibung

Hematology Test

Was the laboratory sample collected?
Beschreibung

Was the laboratory sample collected?

Datentyp

boolean

Sample Date
Beschreibung

Sample Date

Datentyp

date

Sample Time
Beschreibung

Sample Time

Datentyp

time

Comment
Beschreibung

Comment

Datentyp

text

Chemistry / Serum HCG / SP Chemistry
Beschreibung

Chemistry / Serum HCG / SP Chemistry

Was the laboratory sample collected?
Beschreibung

Was the laboratory sample collected?

Datentyp

boolean

Sample Date
Beschreibung

Sample Date

Datentyp

date

Sample Time
Beschreibung

Sample Time

Datentyp

time

Comment
Beschreibung

Comment

Datentyp

text

Pregnancy test result
Beschreibung

Pregnancy test result

Datentyp

text

UA / UDS / Urine Chemistry
Beschreibung

UA / UDS / Urine Chemistry

Was the laboratory sample collected?
Beschreibung

Was the laboratory sample collected?

Datentyp

boolean

Sample Date
Beschreibung

Sample Date

Datentyp

date

Sample Time
Beschreibung

Sample Time

Datentyp

time

Comment
Beschreibung

Comment

Datentyp

text

Serology
Beschreibung

Serology

Was the laboratory sample collected?
Beschreibung

Was the laboratory sample collected?

Datentyp

boolean

Sample Date
Beschreibung

Sample Date

Datentyp

date

Sample Time
Beschreibung

Sample Time

Datentyp

time

Comment
Beschreibung

Comment

Datentyp

text

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Visit 50

1 Formulare
  1. StudyEvent: ODM
    1. Visit 50
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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?
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Item Group
Informed Consent
Has the informed consent been obtained?
Item
Has the informed consent been obtained?
boolean
Date of consent
Item
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Item Group
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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
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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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