Information:
Fel:
ID
33784
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)
- 2018-12-27 2018-12-27 -
Rättsinnehavare
GSK group of companies
Uppladdad den
27 december 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032
Period 2 Day 18 + Day 19 + Day 20
- StudyEvent: ODM
Similar models
Period 2 Day 18 + Day 19 + Day 20
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Site
Item
Study Site
text
Subject
Item
Subject
text
CL Item
Period 2 Day 18 + Day 19 + Day 20 (1)
CL Item
Visit 240+250+260 (1)
Status
Item
Status
text
Document Number
Item
Document Number
integer
Visit Date
Item
Visit Date
date
Time of Vital Signs
Item
Time of Vital Signs
time
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Heart Rate
Item
Heart Rate
integer
Temperature
Item
Temperature
float
Body Position
Item
Body Position
text
Comment
Item
Comment
text
Time of Vital Signs
Item
Time of Vital Signs
time
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Heart Rate
Item
Heart Rate
integer
Body Position
Item
Body Position
text
Comment
Item
Comment
text
CL Item
Brevicon (1)
dose administered?
Item
Was the dose administered?
boolean
Dose Date
Item
Dose Date
date
Dose Time
Item
Dose Time
time
Dose
Item
Dose
text
Unit
Item
Unit
text
Comment
Item
Comment
text
Visit Date
Item
Visit Date
date
Time of Vital Signs
Item
Time of Vital Signs
time
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Heart Rate
Item
Heart Rate
integer
Temperature
Item
Temperature
float
Body Position
Item
Body Position
text
Comment
Item
Comment
text
Time of Vital Signs
Item
Time of Vital Signs
time
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Heart Rate
Item
Heart Rate
integer
Body Position
Item
Body Position
text
Comment
Item
Comment
text
CL Item
Brevicon (1)
Was the dose administered?
Item
Was the dose administered?
boolean
Dose Date
Item
Dose Date
date
Dose Time
Item
Dose Time
time
Dose
Item
Dose
text
Unit
Item
Unit
text
Comment
Item
Comment
text
CL Item
Albiglutide (1)
Was the dose administered?
Item
Was the dose administered?
boolean
Dose Date
Item
Dose Date
date
Dose Time
Item
Dose Time
time
Dose
Item
Dose
text
Unit
Item
Unit
text
CL Item
Right Abdomen (1)
CL Item
Left Abdomen (2)
Comment
Item
Comment
text
CL Item
Predose (1)
not done / not collected?
Item
Was the sample collected? / Was the test done?
boolean
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
Visit Date
Item
Visit Date
date
Time of Vital Signs
Item
Time of Vital Signs
time
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Heart Rate
Item
Heart Rate
integer
Temperature
Item
Temperature
float
Body Position
Item
Body Position
text
Comment
Item
Comment
text
Time of Vital Signs
Item
Time of Vital Signs
time
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Heart Rate
Item
Heart Rate
integer
Body Position
Item
Body Position
text
Comment
Item
Comment
text
Date of ECG performed
Item
Date of ECG performed
date
Time of ECG performed
Item
Time of ECG performed
time
Heart Rate
Item
Heart Rate
integer
PR Interval
Item
PR Interval
float
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
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
CL Item
Brevicon (1)
dose administered?
Item
Was the dose administered?
boolean
Dose Date
Item
Dose Date
date
Dose Time
Item
Dose Time
time
Dose
Item
Dose
text
Unit
Item
Unit
text
Comment
Item
Comment
text
Was the laboratory sample collected?
Item
Was the laboratory sample collected?
boolean
CL Item
Day 20 (1)
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
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
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