ID

33716

Descripción

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

Palabras clave

Versiones (1)
  1. 20/12/18 20/12/18 -
Titular de derechos de autor

GSK group of companies

Subido en

20 de diciembre de 2018

DOI

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Licencia

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

Inglés

Visit 50

1 formularios  
  1. StudyEvent: ODM
    1. Visit 50
Administrative data
Descripción

Administrative data

Site
Descripción

Site

Tipo de datos

text

Subject
Descripción

Subject

Tipo de datos

text

Status
Descripción

Status

Tipo de datos

text

Doc №
Descripción

Doc №

Tipo de datos

integer

Is Page Blank?
Descripción

blank page?

Tipo de datos

boolean

Visit Date
Descripción

Visit Date

Tipo de datos

date

Informed Consent
Descripción

Informed Consent

Has the informed consent been obtained?
Descripción

Has the informed consent been obtained?

Tipo de datos

boolean

Date of consent obtained
Descripción

Date of consent

Tipo de datos

date

Admission Criteria
Descripción

Admission Criteria

Did the subject meet all eligibility criteria?
Descripción

Did the subject meet all eligibility criteria?

Tipo de datos

boolean

Failed Eligibility Criteria
Descripción

Failed Eligibility Criteria

Criteria Number
Descripción

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

Tipo de datos

integer

Check One Criteria Type
Descripción

Check One Criteria Type

Tipo de datos

integer

Waiver Granted?
Descripción

Waiver Granted?

Tipo de datos

boolean

Date of Sponsor Approval
Descripción

Date of Sponsor Approval

Tipo de datos

date

Comment
Descripción

Comment

Tipo de datos

text

Demographics
Descripción

Demographics

Date of Birth
Descripción

Date of Birth

Tipo de datos

date

Sex
Descripción

Sex

Tipo de datos

text

Ethnicity
Descripción

Ethnicity

Tipo de datos

text

Race
Descripción

Race

Check all that apply
Descripción

Check all that apply

Tipo de datos

integer

If Other, please specify
Descripción

If Other, please specify

Tipo de datos

text

Potentially Childbearing
Descripción

Potentially Childbearing

Is the subject of childbearing potential?
Descripción

Is the subject of childbearing potential?

Tipo de datos

boolean

Electrocardiogram
Descripción

Electrocardiogram

Date ECG performed
Descripción

Date ECG performed

Tipo de datos

date

Time ECG performed
Descripción

Time ECG performed

Tipo de datos

time

Heart Rate
Descripción

Heart Rate

Tipo de datos

integer

Unidades de medida
  • bpm
bpm
PR Interval
Descripción

PR Interval

Tipo de datos

integer

Unidades de medida
  • msec
msec
QRS Duration
Descripción

QRS Duration

Tipo de datos

float

Unidades de medida
  • msec
msec
QT Interval
Descripción

QT Interval

Tipo de datos

float

Unidades de medida
  • msec
msec
QTcB Interval
Descripción

QTcB Interval

Tipo de datos

float

Unidades de medida
  • msec
msec
QTcF Interval
Descripción

QTcF Interval

Tipo de datos

float

Unidades de medida
  • msec
msec
RR Interval
Descripción

RR Interval

Tipo de datos

float

Unidades de medida
  • msec
msec
Normal sinus rhythm?
Descripción

Normal sinus rhythm?

Tipo de datos

boolean

Overall interpretation of ECG
Descripción

Overall interpretation of ECG

Please mark the correct interpretation
Descripción

Please mark the correct interpretation

Tipo de datos

text

If Abnormal, please specify
Descripción

If Abnormal, please specify

Tipo de datos

text

Hematology Test
Descripción

Hematology Test

Was the laboratory sample collected?
Descripción

Was the laboratory sample collected?

Tipo de datos

boolean

Sample Date
Descripción

Sample Date

Tipo de datos

date

Sample Time
Descripción

Sample Time

Tipo de datos

time

Comment
Descripción

Comment

Tipo de datos

text

Chemistry / Serum HCG / SP Chemistry
Descripción

Chemistry / Serum HCG / SP Chemistry

Was the laboratory sample collected?
Descripción

Was the laboratory sample collected?

Tipo de datos

boolean

Sample Date
Descripción

Sample Date

Tipo de datos

date

Sample Time
Descripción

Sample Time

Tipo de datos

time

Comment
Descripción

Comment

Tipo de datos

text

Pregnancy test result
Descripción

Pregnancy test result

Tipo de datos

text

UA / UDS / Urine Chemistry
Descripción

UA / UDS / Urine Chemistry

Was the laboratory sample collected?
Descripción

Was the laboratory sample collected?

Tipo de datos

boolean

Sample Date
Descripción

Sample Date

Tipo de datos

date

Sample Time
Descripción

Sample Time

Tipo de datos

time

Comment
Descripción

Comment

Tipo de datos

text

Serology
Descripción

Serology

Was the laboratory sample collected?
Descripción

Was the laboratory sample collected?

Tipo de datos

boolean

Sample Date
Descripción

Sample Date

Tipo de datos

date

Sample Time
Descripción

Sample Time

Tipo de datos

time

Comment
Descripción

Comment

Tipo de datos

text

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Visit 50

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  1. StudyEvent: ODM
    1. Visit 50
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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