Informações:
Falhas:
ID
33413
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 dezembro 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 ofvliver biopsy
date
C0193388 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Approximate size of liver biopsy
Item
Approximate size of liver biopsy
integer
C1299482 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0332232 (UMLS CUI [1,3])
C0193388 (UMLS CUI [1,2])
C0332232 (UMLS CUI [1,3])
Item Group
Final diagnosis of biopsy
C0011900 (UMLS CUI-1)
C0193388 (UMLS CUI-2)
C0193388 (UMLS CUI-2)
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
C0011900 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0193388 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Acute hepatitis
Item
Acute hepatitis
boolean
C0267797 (UMLS CUI [1])
Chronic hepatitis
Item
Chronic hepatitis
boolean
C0524910 (UMLS CUI [1])
Cholestatic hepatitis
Item
Cholestatic hepatitis
boolean
C0149904 (UMLS CUI [1])
Drug-induced cholestasis
Item
Drug-induced cholestasis
boolean
C2062350 (UMLS CUI [1])
Acute viral hepatitis
Item
Acute viral hepatitis
boolean
C0276622 (UMLS CUI [1])
Chronic viral hepatitis
Item
Chronic viral hepatitis
boolean
C0276623 (UMLS CUI [1])
Drug-induced hepatitis
Item
Drug-induced hepatitis
boolean
C1262760 (UMLS CUI [1])
Autoimmune hepatitis
Item
Autoimmune hepatitis
boolean
C0241910 (UMLS CUI [1])
Bridging necrosis
Item
Bridging necrosis
boolean
C0333511 (UMLS CUI [1])
Submassive hepatic necrosis
Item
Submassive hepatic necrosis
boolean
C0151798 (UMLS CUI [1])
Massive hepatic necrosis
Item
Massive hepatic necrosis
boolean
C0001364 (UMLS CUI [1])
Steatosis - microvesicular
Item
Steatosis - microvesicular
text
C1850415 (UMLS CUI [1])
Steatosis - macrovesicular
Item
Steatosis - macrovesicular
boolean
C1837256 (UMLS CUI [1])
Steatosis - mixed
Item
Steatosis - mixed
boolean
C2711227 (UMLS CUI [1,1])
C0205430 (UMLS CUI [1,2])
C0205430 (UMLS CUI [1,2])
Non-alcoholic steatohepatitis
Item
Non-alcoholic steatohepatitis
boolean
C3241937 (UMLS CUI [1])
Alcoholic hepatitis
Item
Alcoholic hepatitis
boolean
C0019187 (UMLS CUI [1])
Hepatic granulomas
Item
Hepatic granulomas
boolean
C0745754 (UMLS CUI [1])
Sarcoidosis
Item
Sarcoidosis
text
C0036202 (UMLS CUI [1])
Fibrosis
Item
Fibrosis
boolean
C0016059 (UMLS CUI [1])
Cirrhosis
Item
Cirrhosis
boolean
C0023890 (UMLS CUI [1])
Primary biliary cirrhosis
Item
Primary biliary cirrhosis
boolean
C0008312 (UMLS CUI [1])
Primary sclerosing cholangitis
Item
Primary sclerosing cholangitis
boolean
C0566602 (UMLS CUI [1])
Autoimmune overlap syndrome
Item
Autoimmune overlap syndrome
boolean
C2702837 (UMLS CUI [1])
Hemochromatosis
Item
Hemochromatosis
boolean
C0018995 (UMLS CUI [1])
Alpha-1-antitrypsin deficiency
Item
Alpha-1-antitrypsin deficiency
boolean
C0221757 (UMLS CUI [1])
Wilson's disease
Item
Wilson's disease
boolean
C0019202 (UMLS CUI [1])
Veno-occlusive disease
Item
Veno-occlusive disease
boolean
C0948441 (UMLS CUI [1])
Budd-Chiari syndrome
Item
Budd-Chiari syndrome
boolean
C0856761 (UMLS CUI [1])
Neoplasia
Item
Neoplasia
boolean
C1882062 (UMLS CUI [1])
Other, specify
Item
Other, specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
check YES for all that apply
Item
check YES for all that apply
text
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0935919 (UMLS CUI [1,2])
Normal
Item
liver architecture Normal
boolean
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
C0935919 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
Bridging fibrosis
Item
Bridging fibrosis
boolean
C0334160 (UMLS CUI [1])
Diffuse fibrosis
Item
Diffuse fibrosis
boolean
C0016059 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C0205219 (UMLS CUI [1,2])
Nodular regenerative hyperplasia
Item
Nodular regenerative hyperplasia
boolean
C0020510 (UMLS CUI [1])
Congenital hepatic fibrosis
Item
Congenital hepatic fibrosis
boolean
C0009714 (UMLS CUI [1])
Cirrhosis
Item
Cirrhosis
boolean
C0023890 (UMLS CUI [1])
Centrilobular congestion
Item
Centrilobular congestion
boolean
C0267821 (UMLS CUI [1,1])
C0442080 (UMLS CUI [1,2])
C0442080 (UMLS CUI [1,2])
Endophlebitis
Item
Endophlebitis
boolean
C0014234 (UMLS CUI [1])
Veno-occlusive disease
Item
Veno-occlusive disease
boolean
C0948441 (UMLS CUI [1])
Canalicular cholestasis
Item
Canalicular cholestasis
boolean
C3150342 (UMLS CUI [1])
Apoptosis
Item
Apoptosis
boolean
C0162638 (UMLS CUI [1])
Focal (or spotty or mild) hepatocellular necrosis
Item
Focal (or spotty or mild) hepatocellular necrosis
boolean
C0267800 (UMLS CUI [1])
Interface hepatitis (periportal hepatitis or piecemeal necrosis)
Item
Interface hepatitis (periportal hepatitis or piecemeal necrosis)
boolean
C0333515 (UMLS CUI [1])
Ischaemic necrosis
Item
Ischaemic necrosis
boolean
C3887513 (UMLS CUI [1])
Centroloular (Zone 3) necrosis
Item
Centrolobular (Zone 3) necrosis
boolean
C0027540 (UMLS CUI [1,1])
C0205417 (UMLS CUI [1,2])
C0305578 (UMLS CUI [1,3])
C0205417 (UMLS CUI [1,2])
C0305578 (UMLS CUI [1,3])
Focal coagulative necrosis
Item
Focal coagulative necrosis
boolean
C1522058 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205234 (UMLS CUI [1,2])
Centrolobular (Zone 3) coagulative necrosis
Item
Centrolobular (Zone 3) coagulative necrosis
boolean
C1522058 (UMLS CUI [1,1])
C0205417 (UMLS CUI [1,2])
C0305578 (UMLS CUI [1,3])
C0205417 (UMLS CUI [1,2])
C0305578 (UMLS CUI [1,3])
Bridging hepatocellular necrosis
Item
Bridging hepatocellular necrosis
boolean
C1855038 (UMLS CUI [1,1])
C0333511 (UMLS CUI [1,2])
C0333511 (UMLS CUI [1,2])
Massive or panlobular hepatocellular necrosis
Item
Massive or panlobular hepatocellular necrosis
boolean
C1855038 (UMLS CUI [1,1])
C0442131 (UMLS CUI [1,2])
C0442131 (UMLS CUI [1,2])
Dysplasia
Item
Dysplasia
boolean
C0334044 (UMLS CUI [1])
Neoplasia
Item
Neoplasia
boolean
C1882062 (UMLS CUI [1])
Other, specify
Item
Other liver architecture, specify
text
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0935919 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Description of Liver Cells or Hepatocytes
C0227525 (UMLS CUI-1)
C0678257 (UMLS CUI-2)
C0678257 (UMLS CUI-2)
Item
Check all that apply
text
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
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
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
Item Group
Liver Cell or Hepatocyte Inclusions or Vacuoles
C0227525 (UMLS CUI-1)
C0042219 (UMLS CUI-2)
C1512693 (UMLS CUI-3)
C0042219 (UMLS CUI-2)
C1512693 (UMLS CUI-3)
check YES for all that apply
Item
check YES for all that apply
text
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
No inclusions
Item
No inclusions
boolean
C0227525 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,2])
Macrovesicular steatosis
Item
Macrovesicular steatosis
boolean
C1837256 (UMLS CUI [1])
Microvesicular steatosis
Item
Microvesicular steatosis
boolean
C1850415 (UMLS CUI [1])
Bile accumulation
Item
Bile accumulation
boolean
C3686784 (UMLS CUI [1])
Diastase - resistant, PAS-positive cytoplasmic inclusions
Item
Diastase - resistant, PAS-positive cytoplasmic inclusions
boolean
C0205708 (UMLS CUI [1])
Alpha-1-antitrypsin inclusions
Item
Alpha-1-antitrypsin inclusions
boolean
C0002191 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C0227525 (UMLS CUI [1,3])
C1512693 (UMLS CUI [1,2])
C0227525 (UMLS CUI [1,3])
Megamitochondria
Item
Megamitochondria
boolean
C0544931 (UMLS CUI [1])
Mallory bodies
Item
Mallory bodies
boolean
C0333744 (UMLS CUI [1])
"Ground Glass" inclusions
Item
"Ground Glass" inclusions
boolean
C0598786 (UMLS CUI [1])
Lipofuscin pigment
Item
Lipofuscin pigment
boolean
C0023789 (UMLS CUI [1])
Hemosiderin granules
Item
Hemosiderin granules
boolean
C0019113 (UMLS CUI [1])
Orcein - positive cytoplasmin granules
Item
Orcein - positive cytoplasmin granules
boolean
C0069596 (UMLS CUI [1])
Protoporphyrin crystals (birefringend under polarised light)
Item
Protoporphyrin crystals (birefringend under polarised light)
boolean
C0033733 (UMLS CUI [1])
Uroporchyrin crystals (red fluorescence under ultraviolet light)
Item
Uroporchyrin crystals (red fluorescence under ultraviolet light)
boolean
C0042093 (UMLS CUI [1,1])
C1378554 (UMLS CUI [1,2])
C1378554 (UMLS CUI [1,2])
Other, specify
Item
If Other Liver Cell or Hepatocyte Inclusions or Vacuoles, specify
text
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item Group
Hepatocyte or Liver Cell Nuclear Abnormalities
C0227525 (UMLS CUI-1)
C1849376 (UMLS CUI-2)
C1849376 (UMLS CUI-2)
Item
check all that apply
text
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,2])
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
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C1849376 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Liver or Lobular Infiltrates
C1400896 (UMLS CUI-1)
C0205417 (UMLS CUI-2)
C0205417 (UMLS CUI-2)
Item
check all that apply
text
C1400896 (UMLS CUI [1,1])
C0205417 (UMLS CUI [1,2])
C0205417 (UMLS CUI [1,2])
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
C1400896 (UMLS CUI [1,1])
C0205417 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0205417 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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
C3854488 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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
C0005400 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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
C0032718 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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
C1112211 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Parasites or Ova
C0030498 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C0555117 (UMLS CUI-3)
C0023884 (UMLS CUI-2)
C0555117 (UMLS CUI-3)
Item
check all that apply
text
C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [1,3])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [1,3])
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
C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item Group
Histologic Staining or Additional Studies Obtained
C0487602 (UMLS CUI-1)
C0205462 (UMLS CUI-2)
C0023884 (UMLS CUI-3)
C0205462 (UMLS CUI-2)
C0023884 (UMLS CUI-3)
Check YES for all that apply
Item
Check YES for all that apply
text
C0487602 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
Haematoxylin and eosin (or H & E)
Item
Haematoxylin and eosin (or H & E)
boolean
C0523207 (UMLS CUI [1])
Masson
Item
Masson
boolean
C1294297 (UMLS CUI [1])
Toluidine blue or Giemsa
Item
Toluidine blue or Giemsa
boolean
C0523203 (UMLS CUI [1,1])
C0017542 (UMLS CUI [1,2])
C0017542 (UMLS CUI [1,2])
Prussian blue
Item
Prussian blue
boolean
C0060234 (UMLS CUI [1])
Periodic Acidic Schiff (PAS), with or without diastase
Item
Periodic Acidic Schiff (PAS), with or without diastase
boolean
C0440048 (UMLS CUI [1,1])
C0596624 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0596624 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
Oil red O
Item
Oil red O
boolean
C1294000 (UMLS CUI [1])
Congo red
Item
Congo red
boolean
C0009742 (UMLS CUI [1])
Hall's stain
Item
Hall's stain
boolean
C1720394 (UMLS CUI [1])
Gridley's stain
Item
Gridley's stain
boolean
C1293978 (UMLS CUI [1])
Rhodanine (copper)
Item
Rhodanine (copper)
boolean
C0035486 (UMLS CUI [1])
Rubeanic acid (copper)
Item
Rubeanic acid (copper)
boolean
C0073680 (UMLS CUI [1])
Orcein, aldehyde fuchsin or Victoria blue
Item
Orcein, aldehyde fuchsin or Victoria blue
boolean
C0491984 (UMLS CUI [1,1])
C0078232 (UMLS CUI [1,2])
C0069596 (UMLS CUI [1,3])
C0078232 (UMLS CUI [1,2])
C0069596 (UMLS CUI [1,3])
Electron microscopy
Item
Electron microscopy
boolean
C0026019 (UMLS CUI [1])
Hepatitis A immunostains positive
Item
Hepatitis A immunostains positive
boolean
C0560226 (UMLS CUI [1,1])
C3687908 (UMLS CUI [1,2])
C3687908 (UMLS CUI [1,2])
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive
Item
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive
boolean
C0201479 (UMLS CUI [1,1])
C3687908 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,3])
C0201478 (UMLS CUI [2,1])
C3687908 (UMLS CUI [2,2])
C1446409 (UMLS CUI [2,3])
C3687908 (UMLS CUI [1,2])
C1446409 (UMLS CUI [1,3])
C0201478 (UMLS CUI [2,1])
C3687908 (UMLS CUI [2,2])
C1446409 (UMLS CUI [2,3])
Hepatitis D immunostains
Item
Hepatitis D immunostains
boolean
C0011226 (UMLS CUI [1,1])
C3687908 (UMLS CUI [1,2])
C3687908 (UMLS CUI [1,2])
Other immunostains
Item
Other immunostains
boolean
C3687908 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Other, specify
Item
Other histological staining, specify
text
C0487602 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0205462 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])