ID

33809

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

Early Term Data: Vital Signs, Physical Examination, ECG, Laboratory Tests

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

text

Status
Description

Status

Data type

text

Document Number
Description

Document Number

Data type

text

Visit Date
Description

Visit Date

Data type

date

Vital Signs - Duplicate 1
Description

Vital Signs - Duplicate 1

Date of Vital Signs
Description

Date of Vital Signs

Data type

date

Time of Vital Signs
Description

Time of Vital Signs

Data type

time

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
Temperature
Description

Temperature

Data type

integer

Measurement units
  • °C
°C
Body Position
Description

e.g., Sitting

Data type

text

Comment
Description

Comment

Data type

text

Vital Signs - Duplicate 2
Description

Vital Signs - Duplicate 2

Time of Vital Signs
Description

Time of Vital Signs

Data type

time

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
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
Body Position
Description

e.g., Sitting

Data type

text

Comment
Description

Comment

Data type

text

Physical Examination
Description

Physical Examination

Date of Physical Examination
Description

Date of Physical Examination

Data type

date

Skin including Injection Site
Description

Skin including Injection Site

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

Other
Description

specify below

Data type

text

Specify details and possible abnormalities
Description

Specify details and possible abnormalities

Data type

text

Electrocardiogram
Description

Electrocardiogram

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
QTcB Interval
Description

QTcB Interval

Data type

float

Measurement units
  • msec
msec
QTcF Interval
Description

QTcF 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

Hematologic Test
Description

Hematologic Test

Was the laboratory sample collected?
Description

sample collected?

Data type

boolean

Sample Date
Description

Date

Data type

date

Sample Time
Description

Time

Data type

time

Comment
Description

Comment

Data type

text

Chemistry Test
Description

Chemistry Test

Was the laboratory sample collected?
Description

sample collected?

Data type

boolean

Sample Date
Description

Date

Data type

date

Sample Time
Description

Time

Data type

time

Comment
Description

Comment

Data type

text

UA / Urine Chemistry Test
Description

UA / Urine Chemistry Test

Was the laboratory sample collected?
Description

sample collected?

Data type

boolean

Sample Date
Description

Date

Data type

date

Sample Time
Description

Time

Data type

time

Comment
Description

Comment

Data type

text

Similar models

Early Term Data: Vital Signs, Physical Examination, ECG, Laboratory Tests

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
Early Term (1)
Item
Visit Number
text
Code List
Visit Number
CL Item
295 (1)
Status
Item
Status
text
Document Number
Item
Document Number
text
Visit Date
Item
Visit Date
date
Item Group
Vital Signs - Duplicate 1
Date of Vital Signs
Item
Date of Vital Signs
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
Temperature
Item
Temperature
integer
Body Position
Item
Body Position
text
Comment
Item
Comment
text
Item Group
Vital Signs - Duplicate 2
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
Item Group
Physical Examination
Date of Physical Examination
Item
Date of Physical Examination
date
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
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
Other
text
Code List
Other
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify details and possible abnormalities
Item
Specify details and possible abnormalities
text
Item Group
Electrocardiogram
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
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
Hematologic Test
sample collected?
Item
Was the laboratory sample collected?
boolean
Date
Item
Sample Date
date
Time
Item
Sample Time
time
Comment
Item
Comment
text
Item Group
Chemistry Test
sample collected?
Item
Was the laboratory sample collected?
boolean
Date
Item
Sample Date
date
Time
Item
Sample Time
time
Comment
Item
Comment
text
Item Group
UA / Urine Chemistry Test
sample collected?
Item
Was the laboratory sample collected?
boolean
Date
Item
Sample Date
date
Time
Item
Sample Time
time
Comment
Item
Comment
text

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