ID

29286

Beschreibung

Study ID: 102871 Clinical Study ID: HZC102871 Study Title:HZC102871: A 52-week efficacy and safety study to compare the effect of three dosage strengths of Fluticasone Furoate/GW642444 Inhalation Powder with GW642444 on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01009463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Pulmonary Disease, Chronic Obstructive Documentation part: Liver Biopsy

Stichworte

Versionen (1)
  1. 15.03.18 15.03.18 -
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GlaxoSmithKline

Hochgeladen am

15. März 2018

DOI

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Efficacy and safety of Fluticasone on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) GSK102871

Englisch

Liver Biopsy

1 Formulare  
  1. StudyEvent: ODM
    1. Liver Biopsy
Liver Biopsy
Beschreibung

Liver Biopsy

Alias
UMLS CUI-1
C0193388
Date of Liver Biopsy
Beschreibung

Date of Liver Biopsy

Datentyp

date

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0011008
Approximate size of liver biopsy
Beschreibung

Approximate size of liver biopsy

Datentyp

float

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C1299482
UMLS CUI [1,2]
C0193388
mm
Final Diagnosis Liver Biopsy
Beschreibung

Final Diagnosis Liver Biopsy

Datentyp

integer

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0193388
Final Diagnosis Liver Biopsy, if abnormal specify
Beschreibung

Final Diagnosis Liver Biopsy

Datentyp

integer

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0193388
UMLS CUI [1,3]
C0205161
Final Diagnosis Liver Biopsy, if Other specify
Beschreibung

Final Diagnosis Liver Biopsy

Datentyp

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0193388
Liver Architecture
Beschreibung

Liver Architecture

Datentyp

integer

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0935919
Liver Architecture, if abnormal specify
Beschreibung

Liver Architecture

Datentyp

integer

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0935919
UMLS CUI [1,3]
C0205161
Liver Architecture, if Other specify
Beschreibung

Liver Architecture

Datentyp

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0935919
Description of Liver Cells or Hepatocytes
Beschreibung

Description of Liver Cells or Hepatocytes

Datentyp

integer

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0678257
Description of Liver Cells or Hepatocytes, if abnormal, specify
Beschreibung

Description of Liver Cells or Hepatocytes

Datentyp

integer

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C0678257
Description of Liver Cells or Hepatocytes, if Other, specify
Beschreibung

Description of Liver Cells or Hepatocytes

Datentyp

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0678257
Liver Cell or Hepatocyte Inclusions or Vacuoles
Beschreibung

Liver Cell or Hepatocyte Inclusions or Vacuoles

Datentyp

integer

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0042219
UMLS CUI [2]
C1512693
Liver Cell or Hepatocyte Inclusions or Vacuoles, if abnormal, specify
Beschreibung

Liver Cell or Hepatocyte Inclusions or Vacuoles

Datentyp

integer

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0042219
UMLS CUI [2]
C1512693
Liver Cell or Hepatocyte Inclusions or Vacuoles, if Other, specify
Beschreibung

Liver Cell or Hepatocyte Inclusions or Vacuoles

Datentyp

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0042219
UMLS CUI [2]
C1512693
Hepatocyte or Liver Cell Nuclear Abnormalities
Beschreibung

Hepatocyte or Liver Cell Nuclear Abnormalities

Datentyp

integer

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C1849376
Hepatocyte or Liver Cell Nuclear Abnormalities, if abnormal, specify
Beschreibung

Hepatocyte or Liver Cell Nuclear Abnormalities

Datentyp

integer

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C1849376
Hepatocyte or Liver Cell Nuclear Abnormalities, if Other, specify
Beschreibung

Hepatocyte or Liver Cell Nuclear Abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C1849376
Liver or Lobular Infiltrates
Beschreibung

Liver or Lobular Infiltrates

Datentyp

boolean

Alias
UMLS CUI [1]
C1400896
If Liver or Lobular Infiltrates, specify
Beschreibung

Liver or Lobular Infiltrates

Datentyp

integer

Alias
UMLS CUI [1]
C1400896
If Other Liver or Lobular Infiltrates, specify
Beschreibung

Liver or Lobular Infiltrates

Datentyp

text

Alias
UMLS CUI [1]
C1400896
Portal Tract Inflammation
Beschreibung

Portal Tract Inflammation

Datentyp

boolean

Alias
UMLS CUI [1]
C3854488
If Portal Tract Inflammation, specify
Beschreibung

Portal Tract Inflammation

Datentyp

integer

Alias
UMLS CUI [1]
C3854488
If Other Portal Tract Inflammation, specify
Beschreibung

Portal Tract Inflammation

Datentyp

text

Alias
UMLS CUI [1]
C3854488
Bile Ducts
Beschreibung

Bile Ducts

Datentyp

integer

Alias
UMLS CUI [1]
C0005400
Bile Ducts, if abnormal, specify
Beschreibung

Bile Ducts

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005400
UMLS CUI [1,2]
C0205161
Bile Ducts, if Other, specify
Beschreibung

Bile Ducts

Datentyp

text

Alias
UMLS CUI [1,1]
C0005400
UMLS CUI [1,2]
C0205161
Portal Veins
Beschreibung

Portal Veins

Datentyp

integer

Alias
UMLS CUI [1]
C0032718
Portal Veins, if abnormal, specify
Beschreibung

Portal Veins

Datentyp

integer

Alias
UMLS CUI [1,1]
C0032718
UMLS CUI [1,2]
C0205161
Portal Veins, if other, specify
Beschreibung

Portal Veins

Datentyp

text

Alias
UMLS CUI [1,1]
C0032718
UMLS CUI [1,2]
C0205161
Liver Infections
Beschreibung

Liver Infections

Datentyp

integer

Alias
UMLS CUI [1]
C1112211
If Liver Infections, specify
Beschreibung

Liver Infections

Datentyp

integer

Alias
UMLS CUI [1]
C1112211
If Other Liver Infections, specify
Beschreibung

Liver Infections

Datentyp

text

Alias
UMLS CUI [1]
C1112211
Parasites or ova
Beschreibung

Parasites or ova

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030498
UMLS CUI [1,2]
C0023884
UMLS CUI [2]
C0555117
If Parasites or ova, specify
Beschreibung

Parasites or ova

Datentyp

integer

Alias
UMLS CUI [1,1]
C0030498
UMLS CUI [1,2]
C0023884
UMLS CUI [2]
C0555117
If Other Parasites or ova, specify
Beschreibung

Parasites or ova

Datentyp

text

Alias
UMLS CUI [1,1]
C0030498
UMLS CUI [1,2]
C0023884
UMLS CUI [2]
C0555117
Histologic Staining or Additional Studies Obtained
Beschreibung

Histologic Staining or Additional Studies Obtained

Datentyp

integer

Alias
UMLS CUI [1,1]
C0487602
UMLS CUI [1,2]
C0023884
If Other Histologic Staining or Additional Studies Obtained, specify
Beschreibung

Histologic Staining or Additional Studies Obtained

Datentyp

text

Alias
UMLS CUI [1,1]
C0487602
UMLS CUI [1,2]
C0023884
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Ähnliche Modelle

Liver Biopsy

1 Formulare
  1. StudyEvent: ODM
    1. Liver Biopsy
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Liver Biopsy
C0193388 (UMLS CUI-1)
Date of Liver Biopsy
Item
Date of Liver Biopsy
date
C0193388 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Approximate size of liver biopsy
Item
Approximate size of liver biopsy
float
C1299482 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Item
Final Diagnosis Liver Biopsy
integer
C0011900 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Final Diagnosis Liver Biopsy
Code List
Final Diagnosis Liver Biopsy
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Final Diagnosis Liver Biopsy, if abnormal specify
integer
C0011900 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Final Diagnosis Liver Biopsy
Code List
Final Diagnosis Liver Biopsy, if abnormal specify
CL Item
Acute hepatitis (1)
CL Item
Chronic hepatitis (2)
CL Item
Cholestatic hepatitis (3)
CL Item
Drug-induced cholestasis (4)
CL Item
Acute viral hepatitis (5)
CL Item
Chronic viral hepatitis (6)
CL Item
Drug-induced hepatitis (7)
CL Item
Autoimmune hepatitis (8)
CL Item
Bridging necrosis (9)
CL Item
Submassive hepatic necrosis (10)
CL Item
Massive hepatic necrosis (11)
CL Item
Steatosis - microvesicular (12)
CL Item
Steatosis - macrovesicular (13)
CL Item
Steatosis - mixed (14)
CL Item
Non alcoholic steatohepatitis (15)
CL Item
Alcoholic hepatitis (16)
CL Item
Hepatic granutomas (17)
CL Item
Sarcoidosis (18)
CL Item
Fibrosis (19)
CL Item
Cirrhosis (20)
CL Item
Primacy biliary cirrhosis (21)
CL Item
Primary sclerosing cholangitis (22)
CL Item
Autoimmune overlap syndrome (23)
CL Item
Hemoch5omatosis (24)
CL Item
Alpha-1-antitcypsin deficiency (25)
CL Item
Wilson's disease (26)
CL Item
Veno-occlusive disease (27)
CL Item
Budd-Chiari syndrome (28)
CL Item
Neoplasia (29)
CL Item
Other, specify (30)
Final Diagnosis Liver Biopsy
Item
Final Diagnosis Liver Biopsy, if Other specify
text
C0011900 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Item
Liver Architecture
integer
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
Final Diagnosis Liver Biopsy
Code List
Liver Architecture
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Liver Architecture, if abnormal specify
integer
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Liver Architecture
Code List
Liver Architecture, if abnormal specify
CL Item
Bridging fibrosis (1)
CL Item
Diffuse fibrosis (2)
CL Item
Nodular regenerative hyperplasia (3)
CL Item
Congenital hepatic fibrosis (4)
CL Item
Cirrhosis  (5)
CL Item
Centrilobular congestion (6)
CL Item
Endophlebitis (7)
CL Item
Veno-occlusive disease (8)
CL Item
Canalicular cholestasis (9)
CL Item
Apoptosis (10)
CL Item
Focal (or spottyor mild ) hepatocellular necrosis (11)
CL Item
lnterface hepatitis (periportal hepatitis or piecemealnecrosis) (12)
CL Item
lschaemic necrosis (13)
CL Item
Centrolobular (Zone 3) necrosis (14)
CL Item
Foca l coagulative necrosis (15)
CL Item
Centrolobular (Zone 3) coagulative necrosis (16)
CL Item
Bridging hepatocellular necrosis (17)
CL Item
Massive or panlobular hepatoceltular necrosis (18)
CL Item
Dysplasia (19)
CL Item
Neoplasia (20)
CL Item
Other, specify (21)
Liver Architecture
Item
Liver Architecture, if Other specify
text
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
Item
Description of Liver Cells or Hepatocytes
integer
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Final Diagnosis Liver Biopsy
Code List
Description of Liver Cells or Hepatocytes
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Description of Liver Cells or Hepatocytes, if abnormal, specify
integer
C0227525 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Description of Liver Cells or Hepatocytes
Code List
Description of Liver Cells or Hepatocytes, if abnormal, specify
CL Item
Ballooning (1)
CL Item
Acidophilic (2)
CL Item
Pseudoxanthomatous (3)
CL Item
Multinucleated giant hepatocytes (4)
CL Item
Other, specify (5)
Description of Liver Cells or Hepatocytes
Item
Description of Liver Cells or Hepatocytes, if Other, specify
text
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Liver Cell or Hepatocyte Inclusions or Vacuoles
integer
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [2])
Final Diagnosis Liver Biopsy
Code List
Liver Cell or Hepatocyte Inclusions or Vacuoles
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Liver Cell or Hepatocyte Inclusions or Vacuoles, if abnormal, specify
integer
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [2])
Liver Cell or Hepatocyte Inclusions or Vacuoles
Code List
Liver Cell or Hepatocyte Inclusions or Vacuoles, if abnormal, specify
CL Item
Macrovesicular steatosis (1)
CL Item
Microvesicular steatosis (2)
CL Item
Bile accumulation (3)
CL Item
Diastase-resistant, PAS-positive cytoplasmic inclusions (4)
CL Item
Alpha-1-antitrypsininclusions (5)
CL Item
Megamitochondria (6)
CL Item
Mallory bodies (7)
CL Item
"Ground Glass inclusions (8)
CL Item
Lipofuscinpigment (9)
CL Item
Hemosiderin granules (10)
CL Item
Orcein positive cytoplasmin granules (11)
CL Item
Protoporphyrin crystals (birefringent under polarised light) (12)
CL Item
Uroporphyrin crystals (red fluorescence under ultraviolet light) (13)
CL Item
Other, specify (14)
Liver Cell or Hepatocyte Inclusions or Vacuoles
Item
Liver Cell or Hepatocyte Inclusions or Vacuoles, if Other, specify
text
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [2])
Item
Hepatocyte or Liver Cell Nuclear Abnormalities
integer
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
Final Diagnosis Liver Biopsy
Code List
Hepatocyte or Liver Cell Nuclear Abnormalities
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Hepatocyte or Liver Cell Nuclear Abnormalities, if abnormal, specify
integer
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
Hepatocyte or Liver Cell Nuclear Abnormalities
Code List
Hepatocyte or Liver Cell Nuclear Abnormalities, if abnormal, specify
CL Item
Hepatocellular mitosis (1)
CL Item
Binucleated or multinucleated hepatocytes (2)
CL Item
CMV inclusion bodies (3)
CL Item
HSV inclusions (4)
CL Item
Varicella inclusions (5)
CL Item
Other, specify (6)
Hepatocyte or Liver Cell Nuclear Abnormalities
Item
Hepatocyte or Liver Cell Nuclear Abnormalities, if Other, specify
text
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
Liver or Lobular Infiltrates
Item
Liver or Lobular Infiltrates
boolean
C1400896 (UMLS CUI [1])
Item
If Liver or Lobular Infiltrates, specify
integer
C1400896 (UMLS CUI [1])
Liver or Lobular Infiltrates
Code List
If Liver or Lobular Infiltrates, specify
CL Item
Eosinophils (1)
CL Item
Lymphocytes (2)
CL Item
Plasma cells  (3)
CL Item
Neutrophils (4)
CL Item
Macrophages and proliferating Kupffer cells (5)
CL Item
Granulomas (6)
CL Item
Other, specify (7)
Liver or Lobular Infiltrates
Item
If Other Liver or Lobular Infiltrates, specify
text
C1400896 (UMLS CUI [1])
Portal Tract Inflammation
Item
Portal Tract Inflammation
boolean
C3854488 (UMLS CUI [1])
Item
If Portal Tract Inflammation, specify
integer
C3854488 (UMLS CUI [1])
Portal Tract Inflammation
Code List
If Portal Tract Inflammation, specify
CL Item
Eosinophils (1)
CL Item
Lymphoid aggregates and/or follicles (2)
CL Item
Plasma cells (3)
CL Item
Neutrophils (4)
CL Item
Histocytes and macrophages (5)
CL Item
Other, specify (6)
Portal Tract Inflammation
Item
If Other Portal Tract Inflammation, specify
text
C3854488 (UMLS CUI [1])
Item
Bile Ducts
integer
C0005400 (UMLS CUI [1])
Final Diagnosis Liver Biopsy
Code List
Bile Ducts
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Bile Ducts, if abnormal, specify
integer
C0005400 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Bile Ducts
Code List
Bile Ducts, if abnormal, specify
CL Item
Proliferation of bile ducts (bile ductular reaction) (1)
CL Item
Dilation, degeneration or disruption of portal bile ducts (2)
CL Item
Paucity of bile ducts (3)
CL Item
Periductal fibrosis (4)
CL Item
Other, specify (5)
Bile Ducts
Item
Bile Ducts, if Other, specify
text
C0005400 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Item
Portal Veins
integer
C0032718 (UMLS CUI [1])
Final Diagnosis Liver Biopsy
Code List
Portal Veins
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Portal Veins, if abnormal, specify
integer
C0032718 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Portal Veins
Code List
Portal Veins, if abnormal, specify
CL Item
Pyelophlebitis (1)
CL Item
Thrombosis, sclerosis or occlusion of portal vein (2)
CL Item
Neoplastic Invasion of portal vein (3)
CL Item
Granulomatous compression of portal vein (4)
CL Item
Other, specify (5)
Portal Veins
Item
Portal Veins, if other, specify
text
C0032718 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Item
Liver Infections
integer
C1112211 (UMLS CUI [1])
Final Diagnosis Liver Biopsy
Code List
Liver Infections
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
If Liver Infections, specify
integer
C1112211 (UMLS CUI [1])
Liver Infections
Code List
If Liver Infections, specify
CL Item
Leishmaniasis donovani (1)
CL Item
Plasmodium falciparum (2)
CL Item
Toxoplasmosis (3)
CL Item
Cryptococcus neoformans (4)
CL Item
Histoplasma capsulatum (5)
CL Item
Mycobacterium tuberculois (6)
CL Item
Other mycobacterial species (7)
CL Item
Other, specify (8)
Liver Infections
Item
If Other Liver Infections, specify
text
C1112211 (UMLS CUI [1])
Parasites or ova
Item
Parasites or ova
boolean
C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [2])
Item
If Parasites or ova, specify
integer
C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [2])
Parasites or ova
Code List
If Parasites or ova, specify
CL Item
Schistosome and/or ova (1)
CL Item
Ascaris and/or ova (2)
CL Item
Toxocara and/or ova (3)
CL Item
Echinococcus cysts (4)
CL Item
Hepatic capillariasis worms and/or ova (5)
CL Item
Other, specify (6)
Parasites or ova
Item
If Other Parasites or ova, specify
text
C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [2])
Item
Histologic Staining or Additional Studies Obtained
integer
C0487602 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
Histologic Staining or Additional Studies Obtained
Code List
Histologic Staining or Additional Studies Obtained
CL Item
Haematoxylin and eosin ( or H&E) (1)
CL Item
Masson (2)
CL Item
Toluidine blue or Giemsa (3)
CL Item
Prussian blue (4)
CL Item
Periodic Acidic Schiff (PAS), with or without diastase (5)
CL Item
Oil red  (6)
CL Item
Congo red (7)
CL Item
Hall's stain (8)
CL Item
Gridley's stain (9)
CL Item
Rhodanine (copper) (10)
CL Item
Rubeanic acid (copper) (11)
CL Item
Orce in, aldehyde fuchsin or Victoria blue (12)
CL Item
Electronmicroscopy (13)
CL Item
Hepatitls A lmmunostains positive (14)
CL Item
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive (15)
CL Item
Hepatitis D immunostains (16)
CL Item
Other immunostains (17)
CL Item
Other, specify (18)
Histologic Staining or Additional Studies Obtained
Item
If Other Histologic Staining or Additional Studies Obtained, specify
text
C0487602 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
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