ID

41634

Description

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Keywords

Versions (2)
  1. 11/9/20 11/9/20 -
  2. 11/29/20 11/29/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 29, 2020

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692

English

Screening - Vital Signs; General Medical History; Physical Exam

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Site
Description

Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Subject
Description

Subject

Data type

text

Alias
UMLS CUI [1]
C2348585
Status
Description

Status

Data type

text

Alias
UMLS CUI [1]
C0449438
Doc #
Description

Doc #

Data type

text

Alias
UMLS CUI [1]
C1301746
Is Page Blank?
Description

Is Page Blank?

Data type

boolean

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0750479
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Vital Signs (sitting)
Description

Vital Signs (sitting)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0277814
Vital Signs Date
Description

Vital Signs Date

Data type

date

Alias
UMLS CUI [1]
C2826644
Vital Signs Time
Description

Vital Signs Time

Data type

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

integer

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
BMI
Description

BMI

Data type

integer

Measurement units
  • kg/m^2
Alias
UMLS CUI [1]
C1305855
kg/m^2
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
General Medical History
Description

General Medical History

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Body System
Description

Body System

Data type

text

Alias
UMLS CUI [1]
C0460002
Specific Condition
Description

Specific Condition

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Condition Status
Description

Condition Status

Data type

integer

Alias
UMLS CUI [1]
C3176928
Condition Start Date
Description

Condition Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0808070
Condition End Date
Description

Condition End Date

Data type

date

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0806020
Physical Exam
Description

Physical Exam

Alias
UMLS CUI-1
C0031809
Date of Physical Exam
Description

Date of Physical Exam

Data type

date

Alias
UMLS CUI [1]
C2826643
Physical Exam
Description

Physical Exam

Alias
UMLS CUI-1
C0031809
Physical Exam - Assessment
Description

Physical Exam - Assessment

Data type

integer

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C1516048
Physical Exam - Result
Description

Physical Exam - Result

Data type

integer

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C1274040
Physical Exam - Only Specify Abnormality
Description

Physical Exam - Only Specify Abnormality

Data type

text

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C1704258
UMLS CUI [3]
C2348235
Back to the top of the page

Similar models

Screening - Vital Signs; General Medical History; Physical Exam

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Subject
Item
Subject
text
C2348585 (UMLS CUI [1])
Status
Item
Status
text
C0449438 (UMLS CUI [1])
Doc #
Item
Doc #
text
C1301746 (UMLS CUI [1])
Is Page Blank?
Item
Is Page Blank?
boolean
C1704732 (UMLS CUI [1,1])
C0750479 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Vital Signs (sitting)
C0518766 (UMLS CUI-1)
C0277814 (UMLS CUI-2)
Vital Signs Date
Item
Vital Signs Date
date
C2826644 (UMLS CUI [1])
Vital Signs Time
Item
Vital Signs Time
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1])
BMI
Item
BMI
integer
C1305855 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
General Medical History
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Item
Body System
text
C0460002 (UMLS CUI [1])
Body System
Code List
Body System
CL Item
Blood and lymphatic system disorders (1)
CL Item
Ear and labyrinth disorders (2)
CL Item
Endocrine disorders (3)
CL Item
Eye disorders (4)
CL Item
Immune system disorders (including allergies) (5)
CL Item
Metabolism and nutrition disorders (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 (9)
CL Item
Psychiatric disorders (10)
CL Item
Renal and 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 and administration site conditions (16)
CL Item
Injury, poisoning, and procedural complications (17)
CL Item
Cardiovascular disorder (18)
CL Item
Gastrointestinal disorder (19)
CL Item
Hepatobiliary disorders (20)
CL Item
Skin and subcutaneous tissue disorders (21)
CL Item
Vascular disorders (22)
CL Item
Other (Z)
Specific Condition
Item
Specific Condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Condition Status
integer
C3176928 (UMLS CUI [1])
Condition Status
Code List
Condition Status
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical condition (3)
Condition Start Date
Item
Condition Start Date
date
C0012634 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Condition End Date
Item
Condition End Date
date
C0012634 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Physical Exam
C0031809 (UMLS CUI-1)
Date of Physical Exam
Item
Date of Physical Exam
date
C2826643 (UMLS CUI [1])
Item Group
Physical Exam
C0031809 (UMLS CUI-1)
Item
Physical Exam - Assessment
integer
C0031809 (UMLS CUI [1])
C1516048 (UMLS CUI [2])
Physical Exam - Assessment
Code List
Physical Exam - Assessment
CL Item
Skin including Injection Site (1)
CL Item
Head, Eyes, Ears, Nose, Throat (2)
CL Item
Thyroid (3)
CL Item
Central Nervous System (4)
CL Item
Resoiratory System (5)
CL Item
Cardiovascular System (6)
CL Item
Abdomen (Liver and Spleen) (7)
Item
Physical Exam - Result
integer
C0031809 (UMLS CUI [1])
C1274040 (UMLS CUI [2])
Physical Exam - Result
Code List
Physical Exam - Result
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Physical Exam - Only Specify Abnormality
Item
Physical Exam - Only Specify Abnormality
text
C0031809 (UMLS CUI [1])
C1704258 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial