ID

33719

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

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Versions (1)
  1. 12/20/18 12/20/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 20, 2018

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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

English

Visit 50: Physical Examination

1 forms  
Administrative data
Description

Administrative data

Site
Description

Site

Data type

text

Subject
Description

Subject

Data type

text

Status
Description

Status

Data type

text

Doc №
Description

Doc №

Data type

integer

Is Page Blank?
Description

blank page?

Data type

boolean

Visit Date
Description

Visit Date

Data type

date

Vital Signs
Description

Vital Signs

Duplicate
Description

Duplicate

Data type

integer

Date of Vital Signs
Description

Date of Vital Signs

Data type

date

Time
Description

Time

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
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

General Physical Examination
Description

General Physical Examination

Time
Description

Time

Data type

time

Height
Description

Height

Data type

integer

Measurement units
  • cm
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
kg
BMI
Description

BMI

Data type

float

Measurement units
  • kg / m2
kg / m2
General Medical History
Description

General Medical History

Body System Code
Description

Body System Code

Data type

text

Specific Condition
Description

Specific Condition

Data type

text

Status
Description

Check only one response for each condition

Data type

text

Start Date
Description

Start Date

Data type

date

End Date
Description

End Date

Data type

date

Detailed Physical Examination
Description

Detailed Physical Examination

Date of physical examination
Description

Date of physical examination

Data type

date

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

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Description

if applies

Data type

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Thyroid
Description

Thyroid

Data type

text

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Description

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Data type

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Lungs
Description

Lungs

Data type

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Description

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Data type

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Cardiovascular
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Cardiovascular

Data type

text

Specify Abnormality
Description

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Data type

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Abdomen (Liver and Spleen)
Description

Abdomen (Liver and Spleen)

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Description

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Data type

text

Lymph Nodes
Description

Lymph Nodes

Data type

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Description

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Data type

text

Neurological
Description

Neurological

Data type

text

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Description

if applies

Data type

text

Extremities
Description

Extremities

Data type

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Description

Specify Abnormality

Data type

text

Other
Description

Other

Data type

text

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Description

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Data type

text

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Visit 50: Physical Examination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Vital Signs
Item
Duplicate
integer
Duplicate
Code List
Duplicate
CL Item
Duplicate 1 (1)
CL Item
Duplicate 2 (2)
Date of Vital Signs
Item
Date of Vital Signs
date
Time
Item
Time
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
integer
Body Position
Item
Body Position
text
Comment
Item
Comment
text
Item Group
General Physical Examination
Time
Item
Time
time
Height
Item
Height
integer
Weight
Item
Weight
float
BMI
Item
BMI
float
Item Group
General Medical History
Item
Body System Code
text
Body System Code
Code List
Body System Code
CL Item
Blood and lymphatic system disorders (1)
CL Item
Ear and labyrinth disorders  (2)
CL Item
Endocrine disorders (excluding Thyroid and Pancreas) (3)
CL Item
Eye disorders (excluding diabetes-related disorders) (4)
CL Item
Immune system disorders (including allergies) (5)
CL Item
Metabolism and nutrition disorders (excluding diabetes) (6)
CL Item
Musculoskeletal and connective tissue disorders (7)
CL Item
Neoplasms benign, malignant and unspecified (including cysts and polyps) (8)
CL Item
Nervous system disorders (excluding diabetes-related disorders) (9)
CL Item
Psychiatric disorders (10)
CL Item
Renal ans urinary disorders (11)
CL Item
Reproductive system and breast disorders (12)
CL Item
Respiratory, thoracic, and mediastinal disorders (including asthma) (13)
CL Item
Infections and infestations (14)
CL Item
Congenital, familial and genetic disorders (15)
CL Item
General disorders ans administration site conditions (16)
CL Item
Injury, poisoning, and procedural complications (17)
CL Item
Other (18)
Specific Condition
Item
Specific Condition
text
Item
Status
text
Status
Code List
Status
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical condition (3)
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Item Group
Detailed Physical Examination
Date of physical examination
Item
Date of physical examination
date
Item Group
Assessment
Item
Skin including injection site
text
Skin including injection site
Code List
Skin including injection site
CL Item
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CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality
Item
Specify Abnormality
text
Item
Head, Eyes, Ears, Nose, Throat
text
Head, Eyes, Ears, Nose, Throat
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
Thyroid
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
Lungs
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
Cardiovascular
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
Abdomen (Liver and Spleen)
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
Lymph Nodes
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
Neurological
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
Extremities
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
Other
Code List
Other
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Specify Abnormality, if applies
Item
Specify Abnormality, if applies
text
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