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