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26357
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)
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- 06.12.18 06.12.18 - Sarah Riepenhausen
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GlaxoSmithKline
Hochgeladen am
16. Oktober 2017
DOI
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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
Ähnliche Modelle
Liver biopsy GSK study Chronic Coronary Heart Disease NCT00799903
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Date of liver biopsy
Item
1. Date of liver biopsy
date
Biopsy size
Item
2. Approximate size of liver biopsy
integer
Biopsy size unit
Item
3. Biopsy size unit
text
CL Item
Normal (A0)
CL Item
Check all that apply (AAA)
Acute hepatitis
Item
[A1] Acute hepatitis
boolean
Chronic hepatitis
Item
[A2] Chronic hepatitis
boolean
Cholestatic hepatitis
Item
[A3] Cholestatic hepatitis
boolean
Drug-induced cholestasis
Item
[A4] Drug-induced cholestasis
boolean
Acute viral hepatitis
Item
[A5] Acute viral hepatitis
boolean
Chronic viral hepatitis
Item
[A6] Chronic viral hepatitis
boolean
Drug-induced hepatitis
Item
[A7] Drug-induced hepatitis
boolean
Autoimmune hepatitis
Item
[A8] Autoimmune hepatitis
boolean
Bridging necrosis
Item
[A9] Bridging necrosis
boolean
Submassive hepatic necrosis
Item
[A10] Submassive hepatic necrosis
boolean
Massive hepatic necrosis
Item
[A11] Massive hepatic necrosis
boolean
Steatosis - microvesicular
Item
[A12] Steatosis - microvesicular
boolean
Steatosis - macrovesicular
Item
[A13] Steatosis - macrovesicular
boolean
Steatosis - mixed
Item
[A14] Steatosis - mixed
boolean
Non-alcoholic steatohepatitis
Item
[A15] Non-alcoholic steatohepatitis
boolean
Alcoholic hepatitis
Item
[A16] Alcoholic hepatitis
boolean
Hepatic granulomas
Item
[A17] Hepatic granulomas
boolean
Sarcoidosis
Item
[A18] Sarcoidosis
boolean
Fibrosis
Item
[A19] Fibrosis
boolean
Cirrhosis
Item
[A20] Cirrhosis
boolean
Primary biliary cirrhosis
Item
[A21] Primary biliary cirrhosis
boolean
Primary sclerosing cholangitis
Item
[A22] Primary sclerosing cholangitis
boolean
Autoimmune overlap syndrome
Item
[A23] Autoimmune overlap syndrome
boolean
Hemochromatosis
Item
[A24] Hemochromatosis
boolean
Alpha-1-antitrypsin deficiency
Item
[A25] Alpha-1-antitrypsin deficiency
boolean
Wilson's disease
Item
[A26] Wilson's disease
boolean
Veno-occlusive disease
Item
[A27] Veno-occlusive disease
boolean
Budd-Chiari syndrome
Item
[A28] Budd-Chiari syndrome
boolean
Neoplasia
Item
[A29] Neoplasia
boolean
Other Final Diagnosis
Item
[A99] Other
boolean
Other Final Diagnosis specification
Item
Other, specify:
text
CL Item
Normal (B1)
CL Item
Check all that apply (BBB)
Bridging fibrosis
Item
[B2] Bridging fibrosis
boolean
Diffuse fibrosis
Item
[B3] Diffuse fibrosis
boolean
Nodular regenerative hyperplasia
Item
[B4] Nodular regenerative hyperplasia
boolean
Congenital hepatic fibrosis
Item
[B5] Congenital hepatic fibrosis
boolean
Cirrhosis
Item
[B6] Cirrhosis
boolean
Centrilobular congestion
Item
[B7] Centrilobular congestion
boolean
Endophlebitis
Item
[B8] Endophlebitis
boolean
Veno-occlusive disease
Item
[B9] Veno-occlusive disease
boolean
Canalicular cholestasis
Item
[B10] Canalicular cholestasis
boolean
Apoptosis
Item
[B11] Apoptosis
boolean
Focal (or spotty or mild) hepatocellular necrosis
Item
[B12] Focal (or spotty or mild) hepatocellular necrosis
boolean
Interface hepatitis
Item
[B13] Interface hepatitis (periportal hepatitis or piecemeal necrosis)
boolean
Ischaemic necrosis
Item
[B14] Ischaemic necrosis
boolean
Centrolobular necrosis
Item
[B15] Centrolobular (Zone 3) necrosis
boolean
Focal coagulative necrosis
Item
[B16] Focal coagulative necrosis
boolean
Centrolobular coagulative necrosis
Item
[B17] Centrolobular (Zone 3) coagulative necrosis
boolean
Bridging hepatocellular necrosis
Item
[B18] Bridging hepatocellular necrosis
boolean
Massive or panlobular hepatocellular necrosis
Item
[B19] Massive or panlobular hepatocellular necrosis
boolean
Dysplasia
Item
[B20] Dysplasia
boolean
Neoplasia
Item
[B21] Neoplasia
boolean
Other Liver Architecture
Item
[B99] Other
boolean
Other Liver Architecture specification
Item
Other, specify:
text
CL Item
Normal (C0)
CL Item
Check all that apply (CCC)
Ballooning Liver Cells or Hepatocytes
Item
[C1] Ballooning
boolean
Acidophilic Liver Cells or Hepatocytes
Item
[C2] Acidophilic
boolean
Pseudoxanthomatous Liver Cells or Hepatocytes
Item
[C3] Pseudoxanthomatous
boolean
Multinucleated giant hepatocytes
Item
[C4] Multinucleated giant hepatocytes
boolean
Other Liver Cells or Hepatocytes
Item
[C99] Other
boolean
Other Liver Cells or Hepatocytes specification
Item
Other, specify:
text
Item Group
Liver Cell or Hepatocyte Inclusions or Vacuoles
Item
7. Liver Cell or Hepatocyte Inclusions or Vacuoles
text
Code List
7. Liver Cell or Hepatocyte Inclusions or Vacuoles
CL Item
No inclusions (D0)
CL Item
Check all that apply (DDD)
Macrovesicular steatosis
Item
[D1] Macrovesicular steatosis
boolean
Microvesicular steatosis
Item
D2] Microvesicular steatosis
boolean
Bile accumulation
Item
[D3] Bile accumulation
boolean
Diastase-resistant, PAS-positive cytoplasmic inclusions
Item
[D4] Diastase-resistant, PAS-positive cytoplasmic inclusions
boolean
Alpha-1-antitrypsin inclusions
Item
[D5] Alpha-1-antitrypsin inclusions
boolean
Megamitochondria
Item
[D6] Megamitochondria
boolean
Mallory bodies
Item
[D7] Mallory bodies
boolean
Ground Glass inclusions
Item
[D8] "Ground Glass" inclusions
boolean
Lipofuscin pigment
Item
[D9] Lipofuscin pigment
boolean
Hemosiderin granules
Item
[D10] Hemosiderin granules
boolean
Orcein-positive cytoplasmin granules
Item
[D11] Orcein-positive cytoplasmin granules
boolean
Protoporphyrin crystals
Item
[D12] Protoporphyrin crystals (birefringent under polarised light)
boolean
Uroporphyrin crystals
Item
[D13] Uroporphyrin crystals (red fluorescence under ultraviolet light)
boolean
Other Liver Cell or Hepatocyte Inclusions or Vacuoles
Item
[D99] Other
boolean
Other Liver Cell or Hepatocyte Inclusions or Vacuoles specification
Item
Other, specify:
text
Item Group
Hepatocyte or Liver Cell Nuclear Abnormalities
Item
8. Hepatocyte or Liver Cell Nuclear Abnormalities
text
Code List
8. Hepatocyte or Liver Cell Nuclear Abnormalities
CL Item
None (E0)
CL Item
Check all that apply (EEE)
Hepatocellular mitosis
Item
[E1] Hepatocellular mitosis
boolean
Binucleated or multinucleated hepatocytes
Item
[E2] Binucleated or multinucleated hepatocytes
boolean
CMV inclusion bodies
Item
[E3] CMV inclusion bodies
boolean
HSV inclusions
Item
[E4] HSV inclusions
boolean
Varicella inclusions
Item
[E5] Varicella inclusions
boolean
Other Hepatocyte or Liver Cell Nuclear Abnormalities
Item
[E99] Other
boolean
Other Hepatocyte or Liver Cell Nuclear Abnormalities specification
Item
Other, specify:
text
CL Item
None (F0)
CL Item
Check all that apply (FFF)
Liver or Lobular Infiltrates Eosinophils
Item
[F1] Eosinophils
boolean
Liver or Lobular Infiltrates Lymphocytes
Item
[F2] Lymphocytes
boolean
Liver or Lobular Infiltrates Plasma cells
Item
[F3] Plasma cells
boolean
Liver or Lobular Infiltrates Neutrophils
Item
[F4] Neutrophils
boolean
Liver or Lobular Infiltrates Macrophages and proliferating Kupffer cells
Item
[F5] Macrophages and proliferating Kupffer cells
boolean
Liver or Lobular Infiltrates Granulomas
Item
[F6] Granulomas
boolean
Other Liver or Lobular Infiltrates
Item
[F99] Other
boolean
Other Liver or Lobular Infiltrates specification
Item
Other, specify:
text
CL Item
None (G0)
CL Item
Check all that apply (GGG)
Portal Tract Inflammation Eosinophils
Item
[G1] Eosinophils
boolean
Portal Tract Inflammation Lymphoid aggregates and/or follicles
Item
[G2] Lymphoid aggregates and/or follicles
boolean
Portal Tract Inflammation Plasma cells
Item
[G3] Plasma cells
boolean
Portal Tract Inflammation Neutrophils
Item
[G4] Neutrophils
boolean
Portal Tract Inflammation Histocytes and macrophages
Item
[G5] Histocytes and macrophages
boolean
Other Portal Tract Inflammation
Item
[G99] Other
boolean
Other Portal Tract Inflammation specification
Item
Other, specify:
text
CL Item
Normal (H0)
CL Item
Check all that apply (HHH)
Proliferation of bile ducts
Item
[H1] Proliferation of bile ducts (bile ductular reaction)
boolean
Dilation, degeneration or disruption of portal bile ducts
Item
[H2] Dilation, degeneration or disruption of portal bile ducts
boolean
Paucity of bile ducts
Item
[H3] Paucity of bile ducts
boolean
Periductal fibrosis
Item
[H4] Periductal fibrosis
boolean
Bile ducts Other
Item
[H99] Other
boolean
Bile ducts Other specification
Item
Other, specify
text
CL Item
Normal (I0)
CL Item
Check all that apply (III)
Pyelophlebitis
Item
[I1] Pyelophlebitis
boolean
Thrombosis, sclerosis or occlusion of portal vein
Item
[I2] Thrombosis, sclerosis or occlusion of portal vein
boolean
Neoplastic invasion of portal vein
Item
[I3] Neoplastic invasion of portal vein
boolean
Granulomatous compression of portal vein
Item
[I4] Granulomatous compression of portal vein
boolean
Portal veins Other
Item
[I99] Other
boolean
Portal veins Other specification
Item
Other, specify:
text
CL Item
Normal (J0)
CL Item
Check all that apply (JJJ)
Leishmaniasis donovani
Item
[J1] Leishmaniasis donovani
boolean
Plasmodium falciparum
Item
[J2] Plasmodium falciparum
boolean
Toxoplasmosis
Item
[J3] Toxoplasmosis
boolean
Cryptococcus neoformans
Item
[J4] Cryptococcus neoformans
boolean
Histoplasma capsulatum
Item
[J5] Histoplasma capsulatum
boolean
Mycobacterium tuberculois
Item
[J6] Mycobacterium tuberculois
boolean
Other mycobacterial species
Item
[J7] Other mycobacterial species
boolean
Other Liver Infections
Item
[J99] Other
boolean
Other Liver Infections specification
Item
Other, specify:
text
CL Item
None (K0)
CL Item
Check all that apply (KKK)
Schistosome and/or ova
Item
[K1] Schistosome and/or ova
boolean
Ascaris and/or ova
Item
[K2] Ascaris and/or ova
boolean
Toxocara and/or ova
Item
[K3] Toxocara and/or ova
boolean
Echinococcus cysts
Item
[K4] Echinococcus cysts
boolean
Hepatic capillariasis worms and/or ova
Item
[K5] Hepatic capillariasis worms and/or ova
boolean
Other Parasites or Ova
Item
[K99] Other
boolean
Other Parasites or Ova specification
Item
Other, specify:
text
Item Group
15. Histologic Staining or Additional Studies Obtained
Haematoxylin and eosin
Item
[L1] Haematoxylin and eosin (or H & E)
boolean
Masson
Item
[L2] Masson
boolean
Toluidine blue or Giemsa
Item
[L3] Toluidine blue or Giemsa
boolean
Prussian blue
Item
[L4] Prussian blue
boolean
Periodic Acidic Schiff with or without diastase
Item
[L5] Periodic Acidic Schiff (PAS), with or without diastase
boolean
Oil red O
Item
[L6] Oil red O
boolean
Congo red
Item
[L7] Congo red
boolean
Hall's stain
Item
[L8] Hall's stain
boolean
Gridley's stain
Item
[L9] Gridley's stain
boolean
Rhodanine
Item
[L10] Rhodanine (copper)
boolean
Rubeanic acid
Item
[L11] Rubeanic acid (copper)
boolean
Orcein, aldehyde fuchsin or Victoria blue
Item
[L12] Orcein, aldehyde fuchsin or Victoria blue
boolean
Electron microscopy
Item
[L13] Electron microscopy
boolean
Hepatitis A immunostains positive
Item
[L14] Hepatitis A immunostains positive
boolean
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive
Item
[L15] Hepatitis B core antigen or hepatitis B surface antibody immunostains positive
boolean
Hepatitis D immunostains
Item
[L16] Hepatitis D immunostains
boolean
Other immunostains
Item
[L17] Other immunostains
boolean
Other Histologic Staining or Additional Studies Obtained
Item
[L99] Other
boolean
Other Histologic Staining or Additional Studies Obtained specification
Item
Other, specify:
text