Informatie:
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ID
33812
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)
- 28-12-18 28-12-18 -
Houder van rechten
GSK group of companies
Geüploaded op
28 december 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032
Unscheduled Visit: Vital Signs, Physical Examination,
- StudyEvent: ODM
Similar models
Unscheduled Visit: Vital Signs, Physical Examination,
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Site
Item
Site
text
Subject
Item
Subject
text
CL Item
Unscheduled Visit (1)
Visit Number
Item
Visit Number
integer
Status
Item
Status
text
Document Number
Item
Document Number
text
Visit Date
Item
Visit Date
date
CL Item
Duplicate 1 (1)
CL Item
Duplicate 2 (2)
CL Item
Duplicate 3 (3)
CL Item
Duplicate 4 (4)
Date of Vital Signs
Item
Date of Vital Signs
date
CL Item
Repeat (1)
CL Item
Unscheduled (2)
If Repeat, please specify original visit
Item
If Repeat, please specify original visit
text
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
CL Item
Sitting (1)
CL Item
Standing (2)
CL Item
Supine (3)
Heart Rate
Item
Heart Rate
integer
Respiratory Rate
Item
Respiratory Rate
integer
Temperature
Item
Temperature
float
Comment on Vital Signs
Item
Comment on Vital Signs
text
Date of Physical Examination
Item
Date of Physical Examination
date
Visit Number
Item
Visit Number
integer
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality
Item
Specify Abnormality
text
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality
Item
Specify Abnormality
text
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality
Item
Specify Abnormality
text
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality
Item
Specify Abnormality
text
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality
Item
Specify Abnormality
text
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality
Item
Specify Abnormality
text
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality
Item
Specify Abnormality
text
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality
Item
Specify Abnormality
text
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality
Item
Specify Abnormality
text
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify other assessment and possible abnormality
Item
Specify other assessment and possible abnormality
text
CL Item
Repeat (1)
CL Item
Unscheduled (2)
If Repeated, please specify original visit
Item
If Repeated, please specify original visit
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
Q-TcB Interval
Item
Q-TcB Interval
float
Q-TcF Interval
Item
Q-TcF 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
Visit Number
Item
Visit Number
integer
Visit Date
Item
Visit Date
date
CL Item
Hematology (1)
CL Item
Chemistry (2)
CL Item
Serology (3)
CL Item
Serum HCG (4)
CL Item
SP Chem (5)
CL Item
Repeat (1)
CL Item
Unscheduled (2)
If Repeat, please specify original visit
Item
If Repeat, please specify original visit
text
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text
CL Item
UA (1)
CL Item
ADS (2)
CL Item
Urine HCG (3)
CL Item
Urine Chem (4)
CL Item
Repeat (1)
CL Item
Unscheduled (2)
If Repeat, please specify original visit
Item
If Repeat, please specify original visit
text
Sample Date
Item
Sample Date
date
Sample Time
Item
Sample Time
time
Comment
Item
Comment
text