ID
28298
Beschrijving
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)
Trefwoorden
Versies (6)
- 11-10-17 11-10-17 -
- 16-10-17 16-10-17 -
- 23-10-17 23-10-17 -
- 02-01-18 02-01-18 -
- 02-01-18 02-01-18 -
- 06-12-18 06-12-18 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
2 januari 2018
DOI
Voor een aanvraag inloggen.
Licentie
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
Beschrijving
Biopsy size
Beschrijving
Final Diagnosis
Beschrijving
Final Diagnosis
Datatype
text
Alias
- UMLS CUI [1]
- C0332144
Beschrijving
Acute hepatitis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0267797
Beschrijving
Chronic hepatitis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0019189
Beschrijving
Cholestatic hepatitis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0149904
Beschrijving
Drug-induced cholestasis
Datatype
boolean
Alias
- UMLS CUI [1]
- C2062350
Beschrijving
Acute viral hepatitis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0276622
Beschrijving
Chronic viral hepatitis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0276623
Beschrijving
Drug-induced hepatitis
Datatype
boolean
Alias
- UMLS CUI [1]
- C1262760
Beschrijving
Autoimmune hepatitis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0241910
Beschrijving
Bridging necrosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0027540
Beschrijving
Submassive hepatic necrosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0151798
Beschrijving
Massive hepatic necrosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0151798
Beschrijving
Steatosis - microvesicular
Datatype
boolean
Alias
- UMLS CUI [1]
- C1850415
Beschrijving
Steatosis - macrovesicular
Datatype
boolean
Alias
- UMLS CUI [1]
- C1837256
Beschrijving
Steatosis - mixed
Datatype
boolean
Alias
- UMLS CUI [1]
- C2711227
Beschrijving
Non-alcoholic steatohepatitis
Datatype
boolean
Alias
- UMLS CUI [1]
- C3241937
Beschrijving
Alcoholic hepatitis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0019187
Beschrijving
Hepatic granulomas
Datatype
boolean
Alias
- UMLS CUI [1]
- C0745754
Beschrijving
Sarcoidosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0036202
Beschrijving
Fibrosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0016059
Beschrijving
Cirrhosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0023890
Beschrijving
Primary biliary cirrhosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0008312
Beschrijving
Primary sclerosing cholangitis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0008311
Beschrijving
Autoimmune overlap syndrome
Datatype
boolean
Alias
- UMLS CUI [1]
- C2702837
Beschrijving
Hemochromatosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0018995
Beschrijving
Alpha-1-antitrypsin deficiency
Datatype
boolean
Alias
- UMLS CUI [1]
- C0221757
Beschrijving
Wilson's disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C0019202
Beschrijving
Veno-occlusive disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C0948441
Beschrijving
Budd-Chiari syndrome
Datatype
boolean
Alias
- UMLS CUI [1]
- C0856761
Beschrijving
Neoplasia
Datatype
boolean
Alias
- UMLS CUI [1]
- C1882062
Beschrijving
Other Final Diagnosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C1546485
Beschrijving
Other Final Diagnosis specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C2348235
Beschrijving
Liver Architecture
Beschrijving
Liver Architecture
Datatype
text
Alias
- UMLS CUI [1,1]
- C0935919
- UMLS CUI [1,2]
- C0023884
Beschrijving
Bridging fibrosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0016059
Beschrijving
Diffuse fibrosis
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205219
- UMLS CUI [1,2]
- C0016059
Beschrijving
Nodular regenerative hyperplasia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0020510
Beschrijving
Congenital hepatic fibrosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0009714
Beschrijving
Cirrhosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0023890
Beschrijving
Centrilobular congestion
Datatype
boolean
Alias
- UMLS CUI [1]
- C0700148
Beschrijving
Endophlebitis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0014234
Beschrijving
Veno-occlusive disease
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0948441
Beschrijving
Canalicular cholestasis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0008370
Beschrijving
Apoptosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0162638
Beschrijving
Focal (or spotty or mild) hepatocellular necrosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C1855038
Beschrijving
Interface hepatitis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0333515
Beschrijving
Ischaemic necrosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C3887513
Beschrijving
Centrolobular necrosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0027540
Beschrijving
Focal coagulative necrosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C1522058
Beschrijving
Centrolobular coagulative necrosis
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1522058
- UMLS CUI [1,2]
- C0682619
Beschrijving
Bridging hepatocellular necrosis
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1855038
- UMLS CUI [1,2]
- C0333511
Beschrijving
Massive or panlobular hepatocellular necrosis
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1855038
- UMLS CUI [1,2]
- C0442131
Beschrijving
Dysplasia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0334044
Beschrijving
Neoplasia
Datatype
boolean
Alias
- UMLS CUI [1]
- C1882062
Beschrijving
Other Liver Architecture
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0935919
- UMLS CUI [1,2]
- C0426686
Beschrijving
Other Liver Architecture specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0935919
- UMLS CUI [1,2]
- C0426686
- UMLS CUI [1,3]
- C2348235
- UMLS CUI [1,4]
- C0205394
Beschrijving
Description of Liver Cells or Hepatocytes
Beschrijving
Description of or Hepatocytes
Datatype
text
Alias
- UMLS CUI [1]
- C0227525
Beschrijving
Ballooning Liver Cells or Hepatocytes
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0333445
- UMLS CUI [1,2]
- C0227525
Beschrijving
Acidophilic Liver Cells or Hepatocytes
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0333931
Beschrijving
Pseudoxanthomatous Liver Cells or Hepatocytes
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C3277905
Beschrijving
Multinucleated giant hepatocytes
Datatype
boolean
Alias
- UMLS CUI [1]
- C3550474
Beschrijving
Other Liver Cells or Hepatocytes
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0205394
Beschrijving
Other Liver Cells or Hepatocytes specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0227525
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0227525
- UMLS CUI [1,4]
- C0205394
Beschrijving
Liver Cell or Hepatocyte Inclusions or Vacuoles
Beschrijving
Liver Cell or Hepatocyte Inclusions or Vacuoles
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042219
- UMLS CUI [1,2]
- C0227525
- UMLS CUI [1,3]
- C1512693
Beschrijving
Macrovesicular steatosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C1837256
Beschrijving
Microvesicular steatosis
Datatype
boolean
Alias
- UMLS CUI [1]
- C1850415
Beschrijving
Bile accumulation
Datatype
boolean
Alias
- UMLS CUI [1]
- C3686784
Beschrijving
Diastase-resistant, PAS-positive cytoplasmic inclusions
Datatype
boolean
Alias
- UMLS CUI [1]
- C0205708
Beschrijving
Alpha-1-antitrypsin inclusions
Datatype
boolean
Alias
- UMLS CUI [1]
- C0002191
Beschrijving
Megamitochondria
Datatype
boolean
Alias
- UMLS CUI [1]
- C0026237
Beschrijving
Mallory bodies
Datatype
boolean
Alias
- UMLS CUI [1]
- C0333744
Beschrijving
Ground Glass inclusions
Datatype
boolean
Alias
- UMLS CUI [1]
- C0598786
Beschrijving
Lipofuscin pigment
Datatype
boolean
Alias
- UMLS CUI [1]
- C0023789
Beschrijving
Hemosiderin granules
Datatype
boolean
Alias
- UMLS CUI [1]
- C0019113
Beschrijving
Orcein-positive cytoplasmin granules
Datatype
boolean
Alias
- UMLS CUI [1]
- C0069596
Beschrijving
Protoporphyrin crystals
Datatype
boolean
Beschrijving
Uroporphyrin crystals
Datatype
boolean
Beschrijving
Other Liver Cell or Hepatocyte Inclusions or Vacuoles
Datatype
boolean
Beschrijving
Other Liver Cell or Hepatocyte Inclusions or Vacuoles specification
Datatype
text
Beschrijving
Hepatocyte or Liver Cell Nuclear Abnormalities
Beschrijving
Hepatocyte or Liver Cell Nuclear Abnormalities
Datatype
text
Beschrijving
Hepatocellular mitosis
Datatype
boolean
Beschrijving
Binucleated or multinucleated hepatocytes
Datatype
boolean
Beschrijving
CMV inclusion bodies
Datatype
boolean
Beschrijving
HSV inclusions
Datatype
boolean
Beschrijving
Varicella inclusions
Datatype
boolean
Beschrijving
Other Hepatocyte or Liver Cell Nuclear Abnormalities
Datatype
boolean
Beschrijving
Other Hepatocyte or Liver Cell Nuclear Abnormalities specification
Datatype
text
Beschrijving
Liver or Lobular Infiltrates
Beschrijving
Liver or Lobular Infiltrates
Datatype
text
Beschrijving
Liver or Lobular Infiltrates Eosinophils
Datatype
boolean
Beschrijving
Liver or Lobular Infiltrates Lymphocytes
Datatype
boolean
Beschrijving
Liver or Lobular Infiltrates Plasma cells
Datatype
boolean
Beschrijving
Liver or Lobular Infiltrates Neutrophils
Datatype
boolean
Beschrijving
Liver or Lobular Infiltrates Macrophages and proliferating Kupffer cells
Datatype
boolean
Beschrijving
Liver or Lobular Infiltrates Granulomas
Datatype
boolean
Beschrijving
Other Liver or Lobular Infiltrates
Datatype
boolean
Beschrijving
Other Liver or Lobular Infiltrates specification
Datatype
text
Beschrijving
Portal Tract Inflammation
Beschrijving
Portal Tract Inflammation
Datatype
text
Beschrijving
Portal Tract Inflammation Eosinophils
Datatype
boolean
Beschrijving
Portal Tract Inflammation Lymphoid aggregates and/or follicles
Datatype
boolean
Beschrijving
Portal Tract Inflammation Plasma cells
Datatype
boolean
Beschrijving
Portal Tract Inflammation Neutrophils
Datatype
boolean
Beschrijving
Portal Tract Inflammation Histocytes and macrophages
Datatype
boolean
Beschrijving
Other Portal Tract Inflammation
Datatype
boolean
Beschrijving
Other Portal Tract Inflammation specification
Datatype
text
Beschrijving
Bile Ducts
Beschrijving
Bile Ducts
Datatype
text
Beschrijving
Proliferation of bile ducts
Datatype
boolean
Beschrijving
Dilation, degeneration or disruption of portal bile ducts
Datatype
boolean
Beschrijving
Paucity of bile ducts
Datatype
boolean
Beschrijving
Periductal fibrosis
Datatype
boolean
Beschrijving
Bile ducts Other
Datatype
boolean
Beschrijving
Bile ducts Other specification
Datatype
text
Beschrijving
Portal Veins
Beschrijving
Portal Veins
Datatype
text
Beschrijving
Pyelophlebitis
Datatype
boolean
Beschrijving
Thrombosis, sclerosis or occlusion of portal vein
Datatype
boolean
Beschrijving
Neoplastic invasion of portal vein
Datatype
boolean
Beschrijving
Granulomatous compression of portal vein
Datatype
boolean
Beschrijving
Portal veins Other
Datatype
boolean
Beschrijving
Portal veins Other specification
Datatype
text
Beschrijving
Liver Infections
Beschrijving
Liver Infections
Datatype
text
Beschrijving
Leishmaniasis donovani
Datatype
boolean
Beschrijving
Plasmodium falciparum
Datatype
boolean
Beschrijving
Toxoplasmosis
Datatype
boolean
Beschrijving
Cryptococcus neoformans
Datatype
boolean
Beschrijving
Histoplasma capsulatum
Datatype
boolean
Beschrijving
Mycobacterium tuberculois
Datatype
boolean
Beschrijving
Other mycobacterial species
Datatype
boolean
Beschrijving
Other Liver Infections
Datatype
boolean
Beschrijving
Other Liver Infections specification
Datatype
text
Beschrijving
Parasites or Ova
Beschrijving
Parasites or Ova
Datatype
text
Beschrijving
Schistosome and/or ova
Datatype
boolean
Beschrijving
Ascaris and/or ova
Datatype
boolean
Beschrijving
Toxocara and/or ova
Datatype
boolean
Beschrijving
Echinococcus cysts
Datatype
boolean
Beschrijving
Hepatic capillariasis worms and/or ova
Datatype
boolean
Beschrijving
Other Parasites or Ova
Datatype
boolean
Beschrijving
Other Parasites or Ova specification
Datatype
text
Beschrijving
15. Histologic Staining or Additional Studies Obtained
Beschrijving
Haematoxylin and eosin
Datatype
boolean
Beschrijving
Masson
Datatype
boolean
Beschrijving
Toluidine blue or Giemsa
Datatype
boolean
Beschrijving
Prussian blue
Datatype
boolean
Beschrijving
Periodic Acidic Schiff with or without diastase
Datatype
boolean
Beschrijving
Oil red O
Datatype
boolean
Beschrijving
Congo red
Datatype
boolean
Beschrijving
Hall's stain
Datatype
boolean
Beschrijving
Gridley's stain
Datatype
boolean
Beschrijving
Rhodanine
Datatype
boolean
Beschrijving
Rubeanic acid
Datatype
boolean
Beschrijving
Orcein, aldehyde fuchsin or Victoria blue
Datatype
boolean
Beschrijving
Electron microscopy
Datatype
boolean
Beschrijving
Hepatitis A immunostains positive
Datatype
boolean
Beschrijving
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive
Datatype
boolean
Beschrijving
Hepatitis D immunostains
Datatype
boolean
Beschrijving
Other immunostains
Datatype
boolean
Beschrijving
Other Histologic Staining or Additional Studies Obtained
Datatype
boolean
Beschrijving
Other Histologic Staining or Additional Studies Obtained specification
Datatype
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])