ID
28298
Beskrivning
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Liver biopsy - Repeating form (Unscheduled/Dynamic visit)
Nyckelord
Versioner (6)
- 2017-10-11 2017-10-11 -
- 2017-10-16 2017-10-16 -
- 2017-10-23 2017-10-23 -
- 2018-01-02 2018-01-02 -
- 2018-01-02 2018-01-02 -
- 2018-12-06 2018-12-06 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
2 januari 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Liver biopsy GSK study Chronic Coronary Heart Disease NCT00799903
Liver biopsy GSK study Chronic Coronary Heart Disease NCT00799903
Beskrivning
Biopsy size
Beskrivning
Final Diagnosis
Beskrivning
Final Diagnosis
Datatyp
text
Alias
- UMLS CUI [1]
- C0332144
Beskrivning
Acute hepatitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0267797
Beskrivning
Chronic hepatitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0019189
Beskrivning
Cholestatic hepatitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0149904
Beskrivning
Drug-induced cholestasis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2062350
Beskrivning
Acute viral hepatitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0276622
Beskrivning
Chronic viral hepatitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0276623
Beskrivning
Drug-induced hepatitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1262760
Beskrivning
Autoimmune hepatitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0241910
Beskrivning
Bridging necrosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0027540
Beskrivning
Submassive hepatic necrosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0151798
Beskrivning
Massive hepatic necrosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0151798
Beskrivning
Steatosis - microvesicular
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1850415
Beskrivning
Steatosis - macrovesicular
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1837256
Beskrivning
Steatosis - mixed
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2711227
Beskrivning
Non-alcoholic steatohepatitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3241937
Beskrivning
Alcoholic hepatitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0019187
Beskrivning
Hepatic granulomas
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0745754
Beskrivning
Sarcoidosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0036202
Beskrivning
Fibrosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0016059
Beskrivning
Cirrhosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0023890
Beskrivning
Primary biliary cirrhosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0008312
Beskrivning
Primary sclerosing cholangitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0008311
Beskrivning
Autoimmune overlap syndrome
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2702837
Beskrivning
Hemochromatosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0018995
Beskrivning
Alpha-1-antitrypsin deficiency
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0221757
Beskrivning
Wilson's disease
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0019202
Beskrivning
Veno-occlusive disease
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0948441
Beskrivning
Budd-Chiari syndrome
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0856761
Beskrivning
Neoplasia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1882062
Beskrivning
Other Final Diagnosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1546485
Beskrivning
Other Final Diagnosis specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C2348235
Beskrivning
Liver Architecture
Beskrivning
Liver Architecture
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0935919
- UMLS CUI [1,2]
- C0023884
Beskrivning
Bridging fibrosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0016059
Beskrivning
Diffuse fibrosis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205219
- UMLS CUI [1,2]
- C0016059
Beskrivning
Nodular regenerative hyperplasia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0020510
Beskrivning
Congenital hepatic fibrosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0009714
Beskrivning
Cirrhosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0023890
Beskrivning
Centrilobular congestion
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0700148
Beskrivning
Endophlebitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0014234
Beskrivning
Veno-occlusive disease
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0948441
Beskrivning
Canalicular cholestasis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0008370
Beskrivning
Apoptosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0162638
Beskrivning
Focal (or spotty or mild) hepatocellular necrosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1855038
Beskrivning
Interface hepatitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0333515
Beskrivning
Ischaemic necrosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3887513
Beskrivning
Centrolobular necrosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0027540
Beskrivning
Focal coagulative necrosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1522058
Beskrivning
Centrolobular coagulative necrosis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1522058
- UMLS CUI [1,2]
- C0682619
Beskrivning
Bridging hepatocellular necrosis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1855038
- UMLS CUI [1,2]
- C0333511
Beskrivning
Massive or panlobular hepatocellular necrosis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1855038
- UMLS CUI [1,2]
- C0442131
Beskrivning
Dysplasia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0334044
Beskrivning
Neoplasia
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1882062
Beskrivning
Other Liver Architecture
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0935919
- UMLS CUI [1,2]
- C0426686
Beskrivning
Other Liver Architecture specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0935919
- UMLS CUI [1,2]
- C0426686
- UMLS CUI [1,3]
- C2348235
- UMLS CUI [1,4]
- C0205394
Beskrivning
Description of Liver Cells or Hepatocytes
Beskrivning
Description of or Hepatocytes
Datatyp
text
Alias
- UMLS CUI [1]
- C0227525
Beskrivning
Ballooning Liver Cells or Hepatocytes
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0333445
- UMLS CUI [1,2]
- C0227525
Beskrivning
Acidophilic Liver Cells or Hepatocytes
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0333931
Beskrivning
Pseudoxanthomatous Liver Cells or Hepatocytes
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C3277905
Beskrivning
Multinucleated giant hepatocytes
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3550474
Beskrivning
Other Liver Cells or Hepatocytes
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0205394
Beskrivning
Other Liver Cells or Hepatocytes specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0227525
- UMLS CUI [1,4]
- C0205394
Beskrivning
Liver Cell or Hepatocyte Inclusions or Vacuoles
Beskrivning
Liver Cell or Hepatocyte Inclusions or Vacuoles
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0042219
- UMLS CUI [1,2]
- C0227525
- UMLS CUI [1,3]
- C1512693
Beskrivning
Macrovesicular steatosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1837256
Beskrivning
Microvesicular steatosis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1850415
Beskrivning
Bile accumulation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3686784
Beskrivning
Diastase-resistant, PAS-positive cytoplasmic inclusions
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0205708
Beskrivning
Alpha-1-antitrypsin inclusions
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0002191
Beskrivning
Megamitochondria
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0026237
Beskrivning
Mallory bodies
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0333744
Beskrivning
Ground Glass inclusions
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0598786
Beskrivning
Lipofuscin pigment
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0023789
Beskrivning
Hemosiderin granules
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0019113
Beskrivning
Orcein-positive cytoplasmin granules
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0069596
Beskrivning
Protoporphyrin crystals
Datatyp
boolean
Beskrivning
Uroporphyrin crystals
Datatyp
boolean
Beskrivning
Other Liver Cell or Hepatocyte Inclusions or Vacuoles
Datatyp
boolean
Beskrivning
Other Liver Cell or Hepatocyte Inclusions or Vacuoles specification
Datatyp
text
Beskrivning
Hepatocyte or Liver Cell Nuclear Abnormalities
Beskrivning
Hepatocyte or Liver Cell Nuclear Abnormalities
Datatyp
text
Beskrivning
Hepatocellular mitosis
Datatyp
boolean
Beskrivning
Binucleated or multinucleated hepatocytes
Datatyp
boolean
Beskrivning
CMV inclusion bodies
Datatyp
boolean
Beskrivning
HSV inclusions
Datatyp
boolean
Beskrivning
Varicella inclusions
Datatyp
boolean
Beskrivning
Other Hepatocyte or Liver Cell Nuclear Abnormalities
Datatyp
boolean
Beskrivning
Other Hepatocyte or Liver Cell Nuclear Abnormalities specification
Datatyp
text
Beskrivning
Liver or Lobular Infiltrates
Beskrivning
Liver or Lobular Infiltrates
Datatyp
text
Beskrivning
Liver or Lobular Infiltrates Eosinophils
Datatyp
boolean
Beskrivning
Liver or Lobular Infiltrates Lymphocytes
Datatyp
boolean
Beskrivning
Liver or Lobular Infiltrates Plasma cells
Datatyp
boolean
Beskrivning
Liver or Lobular Infiltrates Neutrophils
Datatyp
boolean
Beskrivning
Liver or Lobular Infiltrates Macrophages and proliferating Kupffer cells
Datatyp
boolean
Beskrivning
Liver or Lobular Infiltrates Granulomas
Datatyp
boolean
Beskrivning
Other Liver or Lobular Infiltrates
Datatyp
boolean
Beskrivning
Other Liver or Lobular Infiltrates specification
Datatyp
text
Beskrivning
Portal Tract Inflammation
Beskrivning
Portal Tract Inflammation
Datatyp
text
Beskrivning
Portal Tract Inflammation Eosinophils
Datatyp
boolean
Beskrivning
Portal Tract Inflammation Lymphoid aggregates and/or follicles
Datatyp
boolean
Beskrivning
Portal Tract Inflammation Plasma cells
Datatyp
boolean
Beskrivning
Portal Tract Inflammation Neutrophils
Datatyp
boolean
Beskrivning
Portal Tract Inflammation Histocytes and macrophages
Datatyp
boolean
Beskrivning
Other Portal Tract Inflammation
Datatyp
boolean
Beskrivning
Other Portal Tract Inflammation specification
Datatyp
text
Beskrivning
Bile Ducts
Beskrivning
Bile Ducts
Datatyp
text
Beskrivning
Proliferation of bile ducts
Datatyp
boolean
Beskrivning
Dilation, degeneration or disruption of portal bile ducts
Datatyp
boolean
Beskrivning
Paucity of bile ducts
Datatyp
boolean
Beskrivning
Periductal fibrosis
Datatyp
boolean
Beskrivning
Bile ducts Other
Datatyp
boolean
Beskrivning
Bile ducts Other specification
Datatyp
text
Beskrivning
Portal Veins
Beskrivning
Portal Veins
Datatyp
text
Beskrivning
Pyelophlebitis
Datatyp
boolean
Beskrivning
Thrombosis, sclerosis or occlusion of portal vein
Datatyp
boolean
Beskrivning
Neoplastic invasion of portal vein
Datatyp
boolean
Beskrivning
Granulomatous compression of portal vein
Datatyp
boolean
Beskrivning
Portal veins Other
Datatyp
boolean
Beskrivning
Portal veins Other specification
Datatyp
text
Beskrivning
Liver Infections
Beskrivning
Liver Infections
Datatyp
text
Beskrivning
Leishmaniasis donovani
Datatyp
boolean
Beskrivning
Plasmodium falciparum
Datatyp
boolean
Beskrivning
Toxoplasmosis
Datatyp
boolean
Beskrivning
Cryptococcus neoformans
Datatyp
boolean
Beskrivning
Histoplasma capsulatum
Datatyp
boolean
Beskrivning
Mycobacterium tuberculois
Datatyp
boolean
Beskrivning
Other mycobacterial species
Datatyp
boolean
Beskrivning
Other Liver Infections
Datatyp
boolean
Beskrivning
Other Liver Infections specification
Datatyp
text
Beskrivning
Parasites or Ova
Beskrivning
Parasites or Ova
Datatyp
text
Beskrivning
Schistosome and/or ova
Datatyp
boolean
Beskrivning
Ascaris and/or ova
Datatyp
boolean
Beskrivning
Toxocara and/or ova
Datatyp
boolean
Beskrivning
Echinococcus cysts
Datatyp
boolean
Beskrivning
Hepatic capillariasis worms and/or ova
Datatyp
boolean
Beskrivning
Other Parasites or Ova
Datatyp
boolean
Beskrivning
Other Parasites or Ova specification
Datatyp
text
Beskrivning
15. Histologic Staining or Additional Studies Obtained
Beskrivning
Haematoxylin and eosin
Datatyp
boolean
Beskrivning
Masson
Datatyp
boolean
Beskrivning
Toluidine blue or Giemsa
Datatyp
boolean
Beskrivning
Prussian blue
Datatyp
boolean
Beskrivning
Periodic Acidic Schiff with or without diastase
Datatyp
boolean
Beskrivning
Oil red O
Datatyp
boolean
Beskrivning
Congo red
Datatyp
boolean
Beskrivning
Hall's stain
Datatyp
boolean
Beskrivning
Gridley's stain
Datatyp
boolean
Beskrivning
Rhodanine
Datatyp
boolean
Beskrivning
Rubeanic acid
Datatyp
boolean
Beskrivning
Orcein, aldehyde fuchsin or Victoria blue
Datatyp
boolean
Beskrivning
Electron microscopy
Datatyp
boolean
Beskrivning
Hepatitis A immunostains positive
Datatyp
boolean
Beskrivning
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive
Datatyp
boolean
Beskrivning
Hepatitis D immunostains
Datatyp
boolean
Beskrivning
Other immunostains
Datatyp
boolean
Beskrivning
Other Histologic Staining or Additional Studies Obtained
Datatyp
boolean
Beskrivning
Other Histologic Staining or Additional Studies Obtained specification
Datatyp
text
Similar models
Liver biopsy GSK study Chronic Coronary Heart Disease NCT00799903
C0011008 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
C0016059 (UMLS CUI [1,2])
C0948441 (UMLS CUI [1,2])
C0682619 (UMLS CUI [1,2])
C0333511 (UMLS CUI [1,2])
C0442131 (UMLS CUI [1,2])
C0426686 (UMLS CUI [1,2])
C0426686 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0227525 (UMLS CUI [1,2])
C0333931 (UMLS CUI [1,2])
C3277905 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0227525 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0227525 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])