ID

33812

Description

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

Keywords

  1. 12/28/18 12/28/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 28, 2018

DOI

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License

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,

Administrative data
Description

Administrative data

Site
Description

Site

Data type

text

Subject
Description

Subject

Data type

text

Visit Name
Description

Visit Name

Data type

text

Visit Number
Description

Visit Number

Data type

integer

Status
Description

Status

Data type

text

Document Number
Description

Document Number

Data type

text

Visit Date
Description

Visit Date

Data type

date

Vital Sign
Description

Vital Sign

Duplicate Number
Description

Duplicate Number

Data type

integer

Date of Vital Signs
Description

Date of Vital Signs

Data type

date

Visit Type
Description

Visit Type

Data type

text

If Repeat, please specify original visit
Description

If Repeat, please specify original visit

Data type

text

Blood Pressure
Description

Blood Pressure

Blood Pressure - Systolic
Description

Blood Pressure - Systolic

Data type

float

Measurement units
  • mmHg
mmHg
Blood Pressure - Diastolic
Description

Blood Pressure - Diastolic

Data type

float

Measurement units
  • mmHg
mmHg
Blood Pressure - Diastolic
Description

Blood Pressure - Diastolic

Data type

float

Measurement units
  • mmHg
mmHg
Body Position
Description

Body Position

Data type

text

Heart Rate
Description

Heart Rate

Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
Respiratory Rate
Description

Respiratory Rate

Respiratory Rate
Description

Respiratory Rate

Data type

integer

Measurement units
  • bpm
bpm
Temperature
Description

Temperature

Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
°C
Comment on Vital Signs
Description

Comment on Vital Signs

Data type

text

Physical Examination
Description

Physical Examination

Date of Physical Examination
Description

Date of Physical Examination

Data type

date

Visit Number
Description

Visit Number

Data type

integer

Assessment
Description

Assessment

Skin including Injection Site
Description

Skin including Injection Site

Data type

text

Specify Abnormality
Description

if applies

Data type

text

Head, Eyes, Ears, Nose, Throat
Description

Head, Eyes, Ears, Nose, Throat

Data type

text

Specify Abnormality
Description

if applies

Data type

text

Thyroid
Description

Thyroid

Data type

text

Specify Abnormality
Description

if applies

Data type

text

Lungs
Description

Lungs

Data type

text

Specify Abnormality
Description

if applies

Data type

text

Cardiovascular
Description

Cardiovascular

Data type

text

Specify Abnormality
Description

if applies

Data type

text

Abdomen (Liver and Spleen)
Description

Abdomen (Liver and Spleen)

Data type

text

Specify Abnormality
Description

if applies

Data type

text

Lymph Nodes
Description

Lymph Nodes

Data type

text

Specify Abnormality
Description

if applies

Data type

text

Neurological
Description

Neurological

Data type

text

Specify Abnormality
Description

if applies

Data type

text

Extremities
Description

Extremities

Data type

text

Specify Abnormality
Description

if applies

Data type

text

Other
Description

specify below

Data type

text

Specify other assessment and possible abnormality
Description

Specify other assessment and possible abnormality

Data type

text

Electrocardiogram
Description

Electrocardiogram

Visit Type
Description

Visit Type

Data type

text

If Repeated, please specify original visit
Description

If Repeated, please specify original visit

Data type

text

ECG Details
Description

ECG Details

Date of ECG performed
Description

Date of ECG performed

Data type

date

Time of ECG performed
Description

Time of ECG performed

Data type

time

Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
PR Interval
Description

PR Interval

Data type

float

Measurement units
  • msec
msec
QRS Duration
Description

QRS Duration

Data type

float

Measurement units
  • msec
msec
QT Interval
Description

QT Interval

Data type

float

Measurement units
  • msec
msec
Q-TcB Interval
Description

Q-TcB Interval

Data type

float

Measurement units
  • msec
msec
Q-TcF Interval
Description

Q-TcF Interval

Data type

float

Measurement units
  • msec
msec
RR Interval
Description

RR Interval

Data type

float

Measurement units
  • msec
msec
Normal Sinus Rhythm?
Description

Normal Sinus Rhythm?

Data type

boolean

Overall Interpretation of ECG
Description

Overall Interpretation of ECG

Check the result
Description

Check the result

Data type

text

If Abnormal, please specify
Description

If Abnormal, please specify

Data type

text

Central Laboratory Tests
Description

Central Laboratory Tests

Visit Number
Description

Visit Number

Data type

integer

Visit Date
Description

Visit Date

Data type

date

Blood
Description

Blood

Check all that apply
Description

Check all that apply

Data type

integer

Visit Type
Description

Visit Type

Data type

text

If Repeat, please specify original visit
Description

If Repeat, please specify original visit

Data type

text

Sample Date
Description

Sample Date

Data type

date

Sample Time
Description

Sample Time

Data type

time

Comment
Description

Comment

Data type

text

Urine
Description

Urine

Check all that apply
Description

Check all that apply

Data type

text

Visit Type
Description

Visit Type

Data type

text

If Repeat, please specify original visit
Description

If Repeat, please specify original visit

Data type

text

Sample Date
Description

Sample Date

Data type

date

Sample Time
Description

Sample Time

Data type

time

Comment
Description

Comment

Data type

text

Similar models

Unscheduled Visit: Vital Signs, Physical Examination,

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Site
Item
Site
text
Subject
Item
Subject
text
Item
Visit Name
text
Code List
Visit Name
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
Item Group
Vital Sign
Item
Duplicate Number
integer
Code List
Duplicate Number
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
Item
Visit Type
text
Code List
Visit Type
CL Item
Repeat (1)
CL Item
Unscheduled (2)
If Repeat, please specify original visit
Item
If Repeat, please specify original visit
text
Item Group
Blood Pressure
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
float
Item
Body Position
text
Code List
Body Position
CL Item
Sitting (1)
CL Item
Standing (2)
CL Item
Supine (3)
Item Group
Heart Rate
Heart Rate
Item
Heart Rate
integer
Item Group
Respiratory Rate
Respiratory Rate
Item
Respiratory Rate
integer
Item Group
Temperature
Temperature
Item
Temperature
float
Comment on Vital Signs
Item
Comment on Vital Signs
text
Item Group
Physical Examination
Date of Physical Examination
Item
Date of Physical Examination
date
Visit Number
Item
Visit Number
integer
Item Group
Assessment
Item
Skin including Injection Site
text
Code List
Skin including Injection Site
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality
Item
Specify Abnormality
text
Item
Head, Eyes, Ears, Nose, Throat
text
Code List
Head, Eyes, Ears, Nose, Throat
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality
Item
Specify Abnormality
text
Item
Thyroid
text
Code List
Thyroid
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality
Item
Specify Abnormality
text
Item
Lungs
text
Code List
Lungs
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality
Item
Specify Abnormality
text
Item
Cardiovascular
text
Code List
Cardiovascular
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality
Item
Specify Abnormality
text
Item
Abdomen (Liver and Spleen)
text
Code List
Abdomen (Liver and Spleen)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality
Item
Specify Abnormality
text
Item
Lymph Nodes
text
Code List
Lymph Nodes
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality
Item
Specify Abnormality
text
Item
Neurological
text
Code List
Neurological
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality
Item
Specify Abnormality
text
Item
Extremities
text
Code List
Extremities
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality
Item
Specify Abnormality
text
Item
Other
text
Code List
Other
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
Item Group
Electrocardiogram
Item
Visit Type
text
Code List
Visit Type
CL Item
Repeat (1)
CL Item
Unscheduled (2)
If Repeated, please specify original visit
Item
If Repeated, please specify original visit
text
Item Group
ECG Details
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
Item Group
Overall Interpretation of ECG
Item
Check the result
text
Code List
Check the result
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
Central Laboratory Tests
Visit Number
Item
Visit Number
integer
Visit Date
Item
Visit Date
date
Item Group
Blood
Item
Check all that apply
integer
Code List
Check all that apply
CL Item
Hematology (1)
CL Item
Chemistry (2)
CL Item
Serology (3)
CL Item
Serum HCG (4)
CL Item
SP Chem (5)
Item
Visit Type
text
Code List
Visit Type
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
Item Group
Urine
Item
Check all that apply
text
Code List
Check all that apply
CL Item
UA (1)
CL Item
ADS (2)
CL Item
Urine HCG (3)
CL Item
Urine Chem (4)
Item
Visit Type
text
Code List
Visit Type
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

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