Information:
Fel:
ID
41634
Beskrivning
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
Nyckelord
Versioner (2)
- 2020-11-09 2020-11-09 -
- 2020-11-29 2020-11-29 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
29 november 2020
DOI
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Licens
Creative Commons BY 4.0
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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692
Screening - Vital Signs; General Medical History; Physical Exam
- StudyEvent: ODM
Similar models
Screening - Vital Signs; General Medical History; Physical Exam
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
C0750479 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
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)
C0031809 (UMLS CUI-2)
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])
C2348235 (UMLS CUI [1,2])
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])
C0808070 (UMLS CUI [1,2])
Condition End Date
Item
Condition End Date
date
C0012634 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Date of Physical Exam
Item
Date of Physical Exam
date
C2826643 (UMLS CUI [1])
Item
Physical Exam - Assessment
integer
C0031809 (UMLS CUI [1])
C1516048 (UMLS CUI [2])
C1516048 (UMLS CUI [2])
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])
C1274040 (UMLS CUI [2])
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])
C1704258 (UMLS CUI [2])
C2348235 (UMLS CUI [3])