Information:
Fel:
ID
33844
Beskrivning
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
Nyckelord
Versioner (1)
- 2019-01-03 2019-01-03 -
Rättsinnehavare
GSK group of companies
Uppladdad den
3 januari 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032
Liver Imaging Form + Liver Chemistries Follow-Up
- StudyEvent: ODM
Similar models
Liver Imaging Form + Liver Chemistries Follow-Up
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Site
Item
Site
text
Subject
Item
Subject
text
CL Item
Liver Imaging (1)
Status
Item
Status
text
Document Number
Item
Document Number
text
Date of hepatic or liver imaging test
Item
Date of hepatic or liver imaging test
date
CL Item
Ultrasound - transdominal (1)
CL Item
Ultrasound - endoscopic (2)
CL Item
Magnetic Resonance Imaging (MRI) (3)
CL Item
Computerised Tomography (CT) (4)
CL Item
Endoscopic Retrograde CHolangiopancreatography (ERCP) (5)
CL Item
Positron Emission Tomography (PET) (6)
CL Item
Positron Emission Tomography/Computed Tomography (PET/CT) (7)
CL Item
Other (8)
If Other, specify
Item
If Other, specify
text
CL Item
Optimal (1)
CL Item
Readable, but not optimal (2)
CL Item
Not readable (3)
CL Item
Other (4)
If Other, specify
Item
If Other, specify
text
CL Item
Normal size (1)
CL Item
Hypertrophy (or enlarged) (2)
CL Item
Atrophy (or smaller than normal) (3)
CL Item
Segmental hypertrophy (4)
CL Item
Other (5)
If Other, specify
Item
If Other, specify
text
CL Item
Normal (1)
CL Item
Heterogeneous (2)
CL Item
Suggestive of fibrosis (3)
CL Item
Nodular or suggestive of cirrhosis (4)
CL Item
Other (5)
If Other, specify
Item
If Other, specify
text
Item
C. Grade the diffuse and/or geographic fatty infiltrate of the liver
text
Code List
C. Grade the diffuse and/or geographic fatty infiltrate of the liver
CL Item
Not applicable - no fatty infiltration (1)
CL Item
Mild (>=25%) (2)
CL Item
Moderate (>25% to <75%) (3)
CL Item
Severe (>=75%) (4)
CL Item
Other (5)
If Other, specify
Item
If Other, specify
text
CL Item
None present (1)
CL Item
Yes - small amount (2)
CL Item
Yes - moderate or severe amount (3)
CL Item
Other (4)
If Other, specify
Item
If Other, specify
text
Item
E. Are Focal Hepatic Lesions characterisable?
text
Code List
E. Are Focal Hepatic Lesions characterisable?
CL Item
Not applicable - no hepatic lesions (1)
CL Item
Solid (2)
CL Item
Cystic (3)
CL Item
Hemangioma (4)
CL Item
Focal nodular hyperplasia (5)
CL Item
Other (6)
If Other, specify
Item
If Other, specify
text
CL Item
None (1)
CL Item
Gallstones (2)
CL Item
Gallbladder polyps (3)
CL Item
Sludge (4)
CL Item
Gallbladder wall thickening/Oedema (5)
CL Item
Gallbladder wall gas (6)
CL Item
Cholecystitis (7)
CL Item
Gallbladder wall calcification (8)
CL Item
Gallbladder mass (9)
CL Item
Other (10)
If Other, specify
Item
If Other, specify
text
CL Item
None (1)
CL Item
Intrahepatic ductal dilation (focal involving the right hepatic lobe) (2)
CL Item
Intrahepatic ductal dilation (focal involving the left hepatic lobe) (3)
CL Item
Intrahepatic ductal dilation (involving both right and left hepatic lobes) (4)
CL Item
Extrahepatic ductal dilation (5)
CL Item
Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts) (6)
CL Item
Acute cholangitis (7)
CL Item
Primary sclerosing cholangitis (8)
CL Item
Choledocholitiasis (gullstone in duct) (9)
CL Item
Ductal filling defect(s), other than gallstone (10)
CL Item
Ductal wall thickening or oedema (11)
CL Item
Choledochal cyst (12)
CL Item
Ductal mass (13)
CL Item
Extrinsic mass compressing bile duct(s) (14)
CL Item
Other (15)
If Other, specify
Item
If Other, specify
text
CL Item
None (1)
CL Item
Portal vein enlargement (2)
CL Item
Hepatic vein enlargement (3)
CL Item
Nonocclusive portal vein thrombosis (4)
CL Item
Occlusive portal vein thrombosis - bland (5)
CL Item
Hepatic vein thrombosis - bland (6)
CL Item
Occlusive portal vein thrombosis - malignant (7)
CL Item
Hepatic vein thrombosis - malignant (8)
CL Item
Involvement of the main portal vein (9)
CL Item
Involvement of the right portal vein (10)
CL Item
Involvement of the left portal vein (11)
CL Item
Budd-Chiari syndrome (12)
CL Item
Other (13)
If Other, specify
Item
If Other, specify
text
Date sample taken
Item
Date sample taken
date
Were liver chemistries (ALT, AST, ALP, bilirubin) performed?
Item
Were liver chemistries (ALT, AST, ALP, bilirubin) performed?
boolean
Did liver chemistries (ALT, AST, ALP, bilirubin) resolve, stabilize, or return to within Baseline values?
Item
Did liver chemistries (ALT, AST, ALP, bilirubin) resolve, stabilize, or return to within Baseline values?
boolean