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Informações:
Falhas:
ID
32577
Descrição
Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma
Palavras-chave
Versões (2)
- 07/11/2018 07/11/2018 -
- 07/12/2018 07/12/2018 -
Titular dos direitos
GSK group of companies
Transferido a
7 de novembro de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837
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Liver Biopsy Data
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Date
Item
Date
date
Approximate size of liver biopsy
Item
Approximate size of liver biopsy
integer
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, check YES for all that apply
Item
If ABNORMAL, check YES for all that apply
text
Acute hepatitis
Item
Acute hepatitis
boolean
Chronic hepatitis
Item
Chronic hepatitis
boolean
Cholestatic hepatitis
Item
Cholestatic hepatitis
boolean
Drug.induced cholestasis
Item
Drug.induced cholestasis
boolean
Acute viral hepatitis
Item
Acute viral hepatitis
boolean
Chronic viral hepatitis
Item
Chronic viral hepatitis
boolean
Drug-induced hepatitis
Item
Drug-induced hepatitis
boolean
Autoimmune hepatitis
Item
Autoimmune hepatitis
boolean
Bridging necrosis
Item
Bridging necrosis
boolean
Submassive hepatic necrosis
Item
Submassive hepatic necrosis
boolean
Massive hepatic necrosis
Item
Massive hepatic necrosis
boolean
Steatosis - microvesicular
Item
Steatosis - microvesicular
text
Steatosis - macrovesicular
Item
Steatosis - macrovesicular
boolean
Steatosis - mixed
Item
Steatosis - mixed
boolean
Non-alcoholic steatohepatitis
Item
Non-alcoholic steatohepatitis
boolean
Alcoholic hepatitis
Item
Alcoholic hepatitis
boolean
Hepatic granulomas
Item
Hepatic granulomas
boolean
Sarcoidosis
Item
Sarcoidosis
text
Fibrosis
Item
Fibrosis
boolean
Cirrhosis
Item
Cirrhosis
boolean
Primary biliary cirrhosis
Item
Primary biliary cirrhosis
boolean
Primary sclerosing cholangitis
Item
Primary sclerosing cholangitis
boolean
Autoimmune overlap syndrome
Item
Autoimmune overlap syndrome
boolean
Hemochromatosis
Item
Hemochromatosis
boolean
Alpha-1-antitrypsin deficiency
Item
Alpha-1-antitrypsin deficiency
boolean
Wilson's disease
Item
Wilson's disease
boolean
Veno-occlusive disease
Item
Veno-occlusive disease
boolean
Budd-Chiari syndrome
Item
Budd-Chiari syndrome
boolean
Neoplasia
Item
Neoplasia
boolean
Other, specify
Item
Other, specify
text
check YES for all that apply
Item
check YES for all that apply
text
Normal
Item
Normal
boolean
Bridging fibrosis
Item
Bridging fibrosis
boolean
Diffuse fibrosis
Item
Diffuse fibrosis
boolean
Nodular regenerative hyperplasia
Item
Nodular regenerative hyperplasia
boolean
Congenital hepatic fibrosis
Item
Congenital hepatic fibrosis
boolean
Cirrhosis
Item
Cirrhosis
boolean
Centrilobular congestion
Item
Centrilobular congestion
boolean
Endophlebitis
Item
Endophlebitis
boolean
Veno-occlusive disease
Item
Veno-occlusive disease
boolean
Canalicular cholestasis
Item
Canalicular cholestasis
boolean
Apoptosis
Item
Apoptosis
boolean
Focal (or spotty or mild) hepatocellular necrosis
Item
Focal (or spotty or mild) hepatocellular necrosis
boolean
Interface hepatitis (periportal hepatitis or piecemeal necrosis)
Item
Interface hepatitis (periportal hepatitis or piecemeal necrosis)
boolean
Ischaemic necrosis
Item
Ischaemic necrosis
boolean
Centroloular (Zone 3) necrosis
Item
Centroloular (Zone 3) necrosis
boolean
Focal coagulative necrosis
Item
Focal coagulative necrosis
boolean
Centrolobular (Zone 3) coagulative necrosis
Item
Centrolobular (Zone 3) coagulative necrosis
boolean
Bridging hepatocellular necrosis
Item
Bridging hepatocellular necrosis
boolean
Massive or panlobular hepatocellular necrosis
Item
Massive or panlobular hepatocellular necrosis
boolean
Dysplasia
Item
Dysplasia
boolean
Neoplasia
Item
Neoplasia
boolean
Other, specify
Item
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 Group
Liver Cell or Hepatocyte Inclusions or Vacuoles
check YES for all that apply
Item
check YES for all that apply
text
No inclusions
Item
No inclusions
boolean
Macrovesicular steatosis
Item
Macrovesicular steatosis
boolean
Microvesicular steatosis
Item
Microvesicular steatosis
boolean
Bile accumulation
Item
Bile accumulation
boolean
Diastase - resistant, PAS-positive cytoplasmic inclusions
Item
Diastase - resistant, PAS-positive cytoplasmic inclusions
boolean
Alpha-1-antitrypsin inclusions
Item
Alpha-1-antitrypsin inclusions
boolean
Megamitochondria
Item
Megamitochondria
boolean
Mallory bodies
Item
Mallory bodies
boolean
"Ground Glass" inclusions
Item
"Ground Glass" inclusions
boolean
Lipofuscin pigment
Item
Lipofuscin pigment
boolean
Hemosiderin granules
Item
Hemosiderin granules
boolean
Orcein - positive cytoplasmin granules
Item
Orcein - positive cytoplasmin granules
boolean
Protoporphyrin crystals (birefringend under polarised light)
Item
Protoporphyrin crystals (birefringend under polarised light)
boolean
Uroporchyrin crystals (red fluorescence under ultraviolet light)
Item
Uroporchyrin crystals (red fluorescence under ultraviolet light)
boolean
Other, specify
Item
Other, specify
text
Item Group
Hepatocyte or Liver Cell Nuclear Abnormalities
CL Item
None (1)
CL Item
Hepatocellular mitosis (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
boolean
CL Item
None (1)
CL Item
Eosinophils (2)
CL Item
Lymphosites (3)
CL Item
Plasma cells (4)
CL Item
Neutrophils (5)
CL Item
Macrophages and proliferating Kupffer 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
boolean
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
Toxooplasmosis (4)
CL Item
Cryptococcus neoformans (5)
CL Item
Histoplasma capsulatum (6)
CL Item
Mycobacterium 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 Group
Histologic Staining or Additional Studies Obtained
Check YES for all that apply
Item
Check YES for all that apply
text
Haematoxylin and eosin (or H & E)
Item
Haematoxylin and eosin (or H & E)
boolean
Masson
Item
Masson
boolean
Toluidine blue or Giemsa
Item
Toluidine blue or Giemsa
boolean
Prussian blue
Item
Prussian blue
boolean
Periodic Acidic Schiff (PAS), with or without diastase
Item
Periodic Acidic Schiff (PAS), with or without diastase
boolean
Oil red O
Item
Oil red O
boolean
Congo red
Item
Congo red
boolean
Hall's stain
Item
Hall's stain
boolean
Gridley's stain
Item
Gridley's stain
boolean
Rhodanine (copper)
Item
Rhodanine (copper)
boolean
Rubeanic acid (copper)
Item
Rubeanic acid (copper)
boolean
Orcein, aldehyde fuchsin or Victoria blue
Item
Orcein, aldehyde fuchsin or Victoria blue
boolean
Electron microscopy
Item
Electron microscopy
boolean
Hepatitis A immunistains positive
Item
Hepatitis A immunistains positive
boolean
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive
Item
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive
boolean
Hepatitis D immunostains
Item
Hepatitis D immunostains
boolean
Other immunostains
Item
Other immunostains
boolean
Other, specify
Item
Other, specify
text