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ID
33836
Descrição
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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Versões (1)
- 02/01/2019 02/01/2019 -
Titular dos direitos
GSK group of companies
Transferido a
2 de janeiro de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032
Similar models
Liver Biopsy
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Site
Item
Site
text
Subject
Item
Subject
text
CL Item
Liver Biopsy (1)
Status
Item
Status
text
Document Number
Item
Document Number
text
Date of Liver Biopsy
Item
Date of Liver Biopsy
date
Approximate size of liver biopsy
Item
Approximate size of liver biopsy
float
CL Item
Normal (1)
CL Item
Acute Hepatitis (2)
CL Item
Chronic Hepatitis (3)
CL Item
Cholestatic Hepatitis (4)
CL Item
Drug-induced cholestasis (5)
CL Item
Acute viral hepatitis (6)
CL Item
Chronic viral hepatitis (7)
CL Item
Drug-induced hepatitis (8)
CL Item
Autoimmune hepatitis (9)
CL Item
Bridging necrosis (10)
CL Item
Submassive hepatic necrosis (11)
CL Item
Massive hepatic necrosis (12)
CL Item
Steatosis - microvesicular (13)
CL Item
Steatosis - macrovesicular (14)
CL Item
Steatosis - mixed (15)
CL Item
Non-alcoholic steatohepatitis (16)
CL Item
Alcoholic hepatitis (17)
CL Item
Hepatic granulomas (18)
CL Item
Sarcoidosis (19)
CL Item
Fibrosis (20)
CL Item
Cirrhosis (21)
CL Item
Primary biliary cirrhosis (22)
CL Item
Primary sclerosing cholangitis (23)
CL Item
Autoimmune overlap syndrome (24)
CL Item
Hemochromatosis (25)
CL Item
Alpha - 1 - antitrypsin deficiency (26)
CL Item
Wilson's disease (27)
CL Item
Veno-occlusive disease (28)
CL Item
Budd-Chiari syndrome (29)
CL Item
Neoplasia (30)
CL Item
Other (31)
If Other, specify
Item
If Other, specify
text
CL Item
Normal (1)
CL Item
Bridging fibrosis (2)
CL Item
Diffuse fibrosis (3)
CL Item
Nodular regenerative hyperplasia (4)
CL Item
Congenital hepatic fibrosis (5)
CL Item
Cirrhosis (6)
CL Item
Centrilobular congestion (7)
CL Item
Endophlebitis (8)
CL Item
Veno-Occlusive disease (9)
CL Item
Canalicular cholestatis (10)
CL Item
Apoptosis (11)
CL Item
Focal ( or spotty or mild) hepatocellular necrosis (12)
CL Item
Interface hepatitis (periportal hepatitis or piecemeal necrosis) (13)
CL Item
Ischaemic necrosis (14)
CL Item
Centrolobular (Zone 3) necrosis (15)
CL Item
Focal coagulative necrosis (16)
CL Item
Centrolobular (Zone 3) coagulative necrosis (17)
CL Item
Bridging hepatocellular necrosis (18)
CL Item
Massive or panlobular hepatocellular necrosis (19)
CL Item
Dycplasia (20)
CL Item
Neoplasia (21)
CL Item
Other (22)
If Other, specify
Item
If Other, specify
text
CL Item
Normal (1)
CL Item
Ballooning (2)
CL Item
Acidophilic (3)
CL Item
Pseudoxanthomatous (4)
CL Item
Multinucleated giant hepatocytes (5)
CL Item
Other (6)
If Other, specify
Item
If Other, specify
text
Item
D. Liver Cell or Hepatocyte Inclusions or Vacuoles
text
Code List
D. Liver Cell or Hepatocyte Inclusions or Vacuoles
CL Item
No inclusions (1)
CL Item
Macrovesicular steatosis (2)
CL Item
Microvesicular ateatosis (3)
CL Item
Bile accumulation (4)
CL Item
Diastase - resistant, Pas-positive cytoplasmic inclusion (5)
CL Item
Alphy-1-Antitrypsin inclusions (6)
CL Item
Megamitochondria (7)
CL Item
Mallory bodies (8)
CL Item
"Ground Glass" inclusions (9)
CL Item
Lipofuchsin pigment (10)
CL Item
Hemosiderin Granules (11)
CL Item
Orcein-Positive Cytoplasmin Granules (12)
CL Item
Protoporphyrin Crystals (Birefringent under polarised light) (13)
CL Item
Uroporphyrin crystals (Red fluorescence under ultraviolet light) (14)
CL Item
Other (15)
If Other, specify
Item
If Other, specify
text
Item
E. Hepatocyte or Liver Cell Nuclear Abnormalities
text
Code List
E. Hepatocyte or Liver Cell Nuclear Abnormalities
CL Item
None (1)
CL Item
Hepatocellular mitoses (2)
CL Item
Binucleated or multinucleated hepatocytes (3)
CL Item
CMV Inclusion bodies (4)
CL Item
HSV Inclusions (5)
CL Item
Varicella Inclusions (6)
CL Item
Other (7)
If Other, specify
Item
If Other, specify
text
CL Item
None (1)
CL Item
Eosinophils (2)
CL Item
Lymphocytes (3)
CL Item
Plasma cells (4)
CL Item
Neutrophils (5)
CL Item
Macrophages and proliferating Kupfer cells (6)
CL Item
Granulomas (7)
CL Item
Other (8)
If Other, specify
Item
If Other, specify
text
CL Item
None (1)
CL Item
Eosinophils (2)
CL Item
Lymphoid aggregates and / or follicles (3)
CL Item
Plasma cells (4)
CL Item
Neutrophils (5)
CL Item
Histocytes and macrophages (6)
CL Item
Other (7)
If Other, specify
Item
If Other, specify
text
CL Item
Normal (1)
CL Item
Proliferation of bile ducts (bile ductular reaction) (2)
CL Item
Dilation, degeneration or disruption of portal bile ducts (3)
CL Item
Paucity of bile ducts (4)
CL Item
Periductal fibrosis (5)
CL Item
Other (6)
If Other, specify
Item
If Other, specify
text
CL Item
Normal (1)
CL Item
Pyelophlebitis (2)
CL Item
Thrombosis, sclerosis or occlusion of portal vein (3)
CL Item
Neoplastic invasion of portal vein (4)
CL Item
Granulomatous compression of portal vein (5)
CL Item
Other (6)
If Other, specify
Item
If Other, specify
text
CL Item
Normal (1)
CL Item
Leishmaniasis Donovani (2)
CL Item
Plasmodium Falciparum (3)
CL Item
Toxoplasmosis (4)
CL Item
Cryptococcus Neoformans (5)
CL Item
Histoplasma Capsulatum (6)
CL Item
Mycobacterioum Tuberculosis (7)
CL Item
Other mycrobacterial Species (8)
CL Item
Other (9)
If Other, specify
Item
If Other, specify
text
CL Item
None (1)
CL Item
Schistosome and/or Ova (2)
CL Item
Ascaris and/or Ova (3)
CL Item
Toxocara and/or Ova (4)
CL Item
Echinococcus cysts (5)
CL Item
Hepatic Capillariasis worms and/or Ova (6)
CL Item
Other (7)
If Other, specify
Item
If Other, specify
text
Item
L. Histologic Staining or Additional Studies Obtained
text
Code List
L. Histologic Staining or Additional Studies Obtained
CL Item
Haematoxylin and Eosin (or H&E) (1)
CL Item
Masson (2)
CL Item
Toluidine Blue or Giemsa (3)
CL Item
Prussian Blue (4)
CL Item
Periodic Acidic Schiff (PAS), with or without diastase (5)
CL Item
Oil Red O (6)
CL Item
Congo Red (7)
CL Item
Hall's Stain (8)
CL Item
Gridley's Stain (9)
CL Item
Rhodanine (Copper) (10)
CL Item
Rubeanic Acid (Copper) (11)
CL Item
Orcein, Aldehyde Fuchsin or Victoria Blue (12)
CL Item
Electron Microscopy (13)
CL Item
Hepatitis A Immunostains Positive (14)
CL Item
Hepatitis B Core Antigen or Hepatitis B Surface Antibody Immunostains Positive (15)
CL Item
Hepatitis D Immunostains (16)
CL Item
Other Immunostains (17)
CL Item
Other (18)
If Other, specify
Item
If Other, specify
text