Informações:
Falhas:
ID
38580
Descrição
Study ID: 108062 Clinical Study ID: 108062 Study Title: A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00908037 https://clinicaltrials.gov/ct2/show/NCT00908037 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: eltrombopag, Placebo Trade Name: N/A Study Indication: Purpura, Thrombocytopaenic, Idiopathic The study consists of a screening, Day 1 and three parts. All subjects were supposed to receive 24 weeks (6 months) of eltrombopag treatment during Part 2/3. Screening period: Up to 28 days prior to Day 1 of treatment. Day 1 Part 1 (Dose Finding Phase): A 24-week (6 months) open label treatment period for 5 subjects in each age cohort. (short: P1W1-P1W7, P1W8-23, P1W24/EW). A safety, PK and platelet count review took place after 12 weeks (3 months) of treatment. Subjects in the Dose Finding Phase did not participate in the Randomized Period. Part 2 (Randomized Period): A 7-week randomized, double-blind, placebo-controlled period involving 18 subjects per cohort (short: P2W1-P2W7). Part 3: An open-label treatment period where subjects randomized to eltrombopag in Part 2 received an additional 17 weeks of eltrombopag in Part 3 and subjects randomized to placebo in Part 2 received 24 weeks of eltrombopag in Part 3 (short: P3W8-P3W23, P3W24/EW, P3W8-30, P3W31/EW). Follow-up: 4 weeks following the last dose of eltrombopag (short: FUW1- FUW4). Additional ocular examinations were performed at 12 and 24 weeks (3 and 6 months) after the last dose of eltrombopag (short: FUM3, FUM6). The subjects were enrolled in 3 cohorts: Cohort 1: Subjects between 12 and 17 years old (<18 years of age at Day 1). Cohort 2: Subjects between 6 and 11 years old (<12 years of age at Day 1). Cohort 3: Subjects between 1 and 5 years old (<6 years of age at Day 1). The enrollment was started with the oldest cohort (Cohort 1). The younger cohorts were not enrolled until safety, PK and platelet counts had been reviewed in the older cohort(s). This document contains the liver biopsy form. It has to be filled in if a liver biopsy is taken during study.
Link
https://clinicaltrials.gov/ct2/show/NCT00908037
Palavras-chave
Versões (1)
- 24/10/2019 24/10/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
24 de outubro de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037
Similar models
Liver biopsy
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of liver biopsy
Item
Date of liver biopsy
date
C0193388 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Size of liver biopsy
Item
Approximate size of liver biopsy
integer
C1299482 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,2])
Item
Biopsy size unit
integer
C1299482 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C0193388 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
CL Item
MM (1)
Normal
Item
Normal
boolean
C0205307 (UMLS CUI [1])
Acute hepatitis
Item
Acute hepatitis
boolean
C0267797 (UMLS CUI [1])
Chronic hepatitis
Item
Chronic hepatitis
boolean
C0019189 (UMLS CUI [1])
Cholestatic hepatitis
Item
Cholestatic hepatitis
boolean
C0149904 (UMLS CUI [1])
Drug-induced cholestasis
Item
Drug-induced cholestasis
boolean
C2062350 (UMLS CUI [1])
Acute viral hepatitis
Item
Acute viral hepatitis
boolean
C0276622 (UMLS CUI [1])
Chronic viral hepatitis
Item
Chronic viral hepatitis
boolean
C0276623 (UMLS CUI [1])
Drug-induced hepatitis
Item
Drug-induced hepatitis
boolean
C1262760 (UMLS CUI [1])
Autoimmune hepatitis
Item
Autoimmune hepatitis
boolean
C0241910 (UMLS CUI [1])
Bridging necrosis
Item
Bridging necrosis
boolean
C0333511 (UMLS CUI [1])
Submassive hepatic necrosis
Item
Submassive hepatic necrosis
boolean
C0151798 (UMLS CUI [1])
Massive hepatic necrosis
Item
Massive hepatic necrosis
boolean
C0001364 (UMLS CUI [1])
Steatosis - microvesicular
Item
Steatosis - microvesicular
boolean
C1850415 (UMLS CUI [1])
Steatosis - macrovesicular
Item
Steatosis - macrovesicular
boolean
C1837256 (UMLS CUI [1])
Steatosis - mixed
Item
Steatosis - mixed
boolean
C0015695 (UMLS CUI [1,1])
C0205430 (UMLS CUI [1,2])
C0205430 (UMLS CUI [1,2])
Non-alcoholic steatohepatitis
Item
Non-alcoholic steatohepatitis
boolean
C3241937 (UMLS CUI [1])
Alcoholic hepatitis
Item
Alcoholic hepatitis
boolean
C0019187 (UMLS CUI [1])
Hepatic granulomas
Item
Hepatic granulomas
boolean
C0745754 (UMLS CUI [1])
Sarcoidosis
Item
Sarcoidosis
boolean
C0036202 (UMLS CUI [1])
Fibrosis
Item
Fibrosis
boolean
C0239946 (UMLS CUI [1])
Cirrhosis
Item
Cirrhosis
boolean
C0023890 (UMLS CUI [1])
Primary biliary cirrhosis
Item
Primary biliary cirrhosis
boolean
C0008312 (UMLS CUI [1])
Primary sclerosing cholangitis
Item
Primary sclerosing cholangitis
boolean
C0566602 (UMLS CUI [1])
Autoimmune overlap syndrome
Item
Autoimmune overlap syndrome
boolean
C2702837 (UMLS CUI [1])
Hemochromatosis
Item
Hemochromatosis
boolean
C0018995 (UMLS CUI [1])
Alpha-1-antitrypsin deficiency
Item
Alpha-1-antitrypsin deficiency
boolean
C0221757 (UMLS CUI [1])
Wilson's disease
Item
Wilson's disease
boolean
C0019202 (UMLS CUI [1])
Veno-occlusive disease
Item
Veno-occlusive disease
boolean
C0948441 (UMLS CUI [1])
Budd-Chiari syndrome
Item
Budd-Chiari syndrome
boolean
C0856761 (UMLS CUI [1])
Neoplasia
Item
Neoplasia
boolean
C1882062 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
Other final diagnosis
Item
Other final diagnosis
boolean
C0205394 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
Other final diagnosis specification
Item
If other final diagnosis, please specify
text
C0205394 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
Item Group
Liver Architecture
C0023884 (UMLS CUI-1)
C0935919 (UMLS CUI-2)
C0193388 (UMLS CUI-3)
C0935919 (UMLS CUI-2)
C0193388 (UMLS CUI-3)
Normal
Item
Normal
boolean
C0205307 (UMLS CUI [1])
Bridging fibrosis
Item
Bridging fibrosis
boolean
C0334160 (UMLS CUI [1])
Diffuse fibrosis
Item
Diffuse fibrosis
boolean
C0016059 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C0205219 (UMLS CUI [1,2])
Nodular regenerative hyperplasia
Item
Nodular regenerative hyperplasia
boolean
C0020510 (UMLS CUI [1])
Congenital hepatic fibrosis
Item
Congenital hepatic fibrosis
boolean
C0009714 (UMLS CUI [1])
Cirrhosis
Item
Cirrhosis
boolean
C0023890 (UMLS CUI [1])
Centrilobular congestion
Item
Centrilobular congestion
boolean
C0267821 (UMLS CUI [1,1])
C0442080 (UMLS CUI [1,2])
C0442080 (UMLS CUI [1,2])
Endophlebitis
Item
Endophlebitis
boolean
C0014234 (UMLS CUI [1])
Veno-occlusive disease
Item
Veno-occlusive disease
boolean
C0948441 (UMLS CUI [1])
Canalicular cholestasis
Item
Canalicular cholestasis
boolean
C3150342 (UMLS CUI [1])
Apoptosis
Item
Apoptosis
boolean
C0162638 (UMLS CUI [1])
Focal hepatocellular necrosis
Item
Focal (or spotty or mild ) hepatocellular necrosis
boolean
C0267800 (UMLS CUI [1])
lnterface hepatitis
Item
lnterface hepatitis (periportal hepatitis or piecemealnecrosis)
boolean
C0019158 (UMLS CUI [1,1])
C0333515 (UMLS CUI [1,2])
C0333515 (UMLS CUI [1,2])
lschaemic necrosis
Item
lschaemic necrosis
boolean
C3887513 (UMLS CUI [1])
Centrolobular (Zone 3) necrosis
Item
Centrolobular (Zone 3) necrosis
boolean
C3672032 (UMLS CUI [1])
Focal coagulative necrosis
Item
Focal coagulative necrosis
boolean
C0205234 (UMLS CUI [1,1])
C1522058 (UMLS CUI [1,2])
C1522058 (UMLS CUI [1,2])
Centrolobular (Zone 3) coagulative necrosis
Item
Centrolobular (Zone 3) coagulative necrosis
boolean
C0682619 (UMLS CUI [1,1])
C1522058 (UMLS CUI [1,2])
C1522058 (UMLS CUI [1,2])
Bridging hepatocellular necrosis
Item
Bridging hepatocellular necrosis
boolean
C1855038 (UMLS CUI [1,1])
C0333511 (UMLS CUI [1,2])
C0333511 (UMLS CUI [1,2])
Massive or panlobular hepatocellular necrosis
Item
Massive or panlobular hepatocellular necrosis
boolean
C0522501 (UMLS CUI [1,1])
C1855038 (UMLS CUI [1,2])
C0442131 (UMLS CUI [2,1])
C1855038 (UMLS CUI [2,2])
C1855038 (UMLS CUI [1,2])
C0442131 (UMLS CUI [2,1])
C1855038 (UMLS CUI [2,2])
Dysplasia liver
Item
Dysplasia liver
boolean
C0334044 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
Neoplasia liver
Item
Neoplasia liver
boolean
C1882062 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
Other liver architecture
Item
Other liver architecture
boolean
C0205394 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0935919 (UMLS CUI [1,3])
C0023884 (UMLS CUI [1,2])
C0935919 (UMLS CUI [1,3])
Other liver architecture specification
Item
If other liver architecture, please specify
text
C0205394 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0935919 (UMLS CUI [1,3])
C0023884 (UMLS CUI [1,2])
C0935919 (UMLS CUI [1,3])
Item Group
Description of Liver Cells or Hepatocytes
C0227525 (UMLS CUI-1)
C0678257 (UMLS CUI-2)
C0193388 (UMLS CUI-3)
C0678257 (UMLS CUI-2)
C0193388 (UMLS CUI-3)
Normal
Item
Normal
boolean
C0205307 (UMLS CUI [1])
Ballooning
Item
Ballooning
boolean
C0333445 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C0227525 (UMLS CUI [1,2])
Acidophilic
Item
Acidophilic
boolean
C0333931 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C0227525 (UMLS CUI [1,2])
Pseudoxanthomatous
Item
Pseudoxanthomatous
boolean
C0227525 (UMLS CUI [1,1])
C3277905 (UMLS CUI [1,2])
C3277905 (UMLS CUI [1,2])
Multinucleated giant hepatocytes
Item
Multinucleated giant hepatocytes
boolean
C3550474 (UMLS CUI [1,1])
C4054455 (UMLS CUI [1,2])
C4054455 (UMLS CUI [1,2])
Other Description of Liver Cells or Hepatocytes
Item
Other Description of Liver Cells or Hepatocytes
boolean
C0205394 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0227525 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Other Description of Liver Cells or Hepatocytes specification
Item
If other Description of Liver Cells or Hepatocytes, please specify
text
C0205394 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0227525 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Item Group
Liver Cell or Hepatocyte Inclusions or Vacuoles
C0227525 (UMLS CUI-1)
C0042219 (UMLS CUI-2)
C1512693 (UMLS CUI-3)
C0193388 (UMLS CUI-4)
C0042219 (UMLS CUI-2)
C1512693 (UMLS CUI-3)
C0193388 (UMLS CUI-4)
No inclusions
Item
No inclusions
boolean
C1512693 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,2])
Macrovesicular steatosis
Item
Macrovesicular steatosis
boolean
C1837256 (UMLS CUI [1])
Microvesicular steatosis
Item
Microvesicular steatosis
boolean
C1850415 (UMLS CUI [1])
Bile accumulation
Item
Bile accumulation
boolean
C3686784 (UMLS CUI [1])
Diastase-resistant, PAS-positive cytoplasmic inclusions
Item
Diastase-resistant, PAS-positive cytoplasmic inclusions
boolean
C1856311 (UMLS CUI [1,1])
C0205708 (UMLS CUI [1,2])
C0205708 (UMLS CUI [1,2])
Alpha-1-antitrypsin inclusions
Item
Alpha-1-antitrypsin inclusions
boolean
C0002191 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C0227525 (UMLS CUI [1,3])
C1512693 (UMLS CUI [1,2])
C0227525 (UMLS CUI [1,3])
Megamitochondria
Item
Megamitochondria
boolean
C0544931 (UMLS CUI [1])
Mallory bodies
Item
Mallory bodies
boolean
C0333744 (UMLS CUI [1])
Ground Glass inclusions
Item
Ground Glass inclusions
boolean
C0598786 (UMLS CUI [1])
Lipofuscin pigment
Item
Lipofuscin pigment
boolean
C0023789 (UMLS CUI [1])
Hemosiderin granules
Item
Hemosiderin granules
boolean
C0019113 (UMLS CUI [1])
Orcein positive cytoplasmin granules
Item
Orcein positive cytoplasmin granules
boolean
C0069596 (UMLS CUI [1])
Protoporphyrin crystals
Item
Protoporphyrin crystals (birefringent under polarised light)
boolean
C0033733 (UMLS CUI [1])
Uroporphyrin crystals
Item
Uroporphyrin crystals (red fluorescence under ultraviolet light)
boolean
C0042093 (UMLS CUI [1])
Other Liver Cell or Hepatocyte Inclusions or Vacuoles
Item
Other Liver Cell or Hepatocyte Inclusions or Vacuoles
boolean
C0205394 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C0042219 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C0227525 (UMLS CUI [1,2])
C0042219 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
Other Liver Cell or Hepatocyte Inclusions or Vacuoles specification
Item
If other Liver Cell or Hepatocyte Inclusions or Vacuoles, please specify
text
C0205394 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C0042219 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
C0227525 (UMLS CUI [1,2])
C0042219 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
Item Group
Hepatocyte or Liver Cell Nuclear Abnormalities
C0227525 (UMLS CUI-1)
C1849376 (UMLS CUI-2)
C0193388 (UMLS CUI-3)
C1849376 (UMLS CUI-2)
C0193388 (UMLS CUI-3)
None abnormality
Item
None abnormality
boolean
C0549184 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
Hepatocellular mitosis
Item
Hepatocellular mitosis
boolean
C0026255 (UMLS CUI [1,1])
C2697585 (UMLS CUI [1,2])
C2697585 (UMLS CUI [1,2])
Binucleated or multinucleated hepatocytes
Item
Binucleated or multinucleated hepatocytes
boolean
C0333909 (UMLS CUI [1])
C4054455 (UMLS CUI [2])
C4054455 (UMLS CUI [2])
CMV inclusion bodies
Item
CMV inclusion bodies
boolean
C0010825 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0227525 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
HSV inclusions
Item
HSV inclusions
boolean
C0319232 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0227525 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
Varicella inclusions
Item
Varicella inclusions
boolean
C0740380 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0227525 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
Other Hepatocyte or Liver Cell Nuclear Abnormalities
Item
Other Hepatocyte or Liver Cell Nuclear Abnormalities
boolean
C0205394 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,3])
C0227525 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,3])
Other Hepatocyte or Liver Cell Nuclear Abnormalities specification
Item
If other Hepatocyte or Liver Cell Nuclear Abnormalities, please sepcify
text
C0205394 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,3])
C0227525 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,3])
Item Group
Liver or Lobular Infiltrates
C1400896 (UMLS CUI-1)
C0193388 (UMLS CUI-2)
C0193388 (UMLS CUI-2)
None Liver or Lobular Infiltrates
Item
None Liver or Lobular Infiltrates
boolean
C0549184 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C1400896 (UMLS CUI [1,2])
Eosinophils
Item
Eosinophils
boolean
C0014467 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C1400896 (UMLS CUI [1,2])
Lymphocytes
Item
Lymphocytes
boolean
C0024264 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C1400896 (UMLS CUI [1,2])
Plasma cells
Item
Plasma cells
boolean
C0032112 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C1400896 (UMLS CUI [1,2])
Neutrophils
Item
Neutrophils
boolean
C0027950 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C1400896 (UMLS CUI [1,2])
Macrophages and proliferating Kupffer cells
Item
Macrophages and proliferating Kupffer cells
boolean
C0022801 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C1400896 (UMLS CUI [1,2])
Granulomas
Item
Granulomas
boolean
C0745754 (UMLS CUI [1])
Other Liver or Lobular Infiltrates
Item
Other Liver or Lobular Infiltrates
boolean
C0205394 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C1400896 (UMLS CUI [1,2])
Other Liver or Lobular Infiltrates specification
Item
If Other Liver or Lobular Infiltrates, please specify
text
C0205394 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C1400896 (UMLS CUI [1,2])
Item Group
Portal Tract Inflammation
C3854488 (UMLS CUI-1)
C0193388 (UMLS CUI-2)
C0193388 (UMLS CUI-2)
None Portal Tract Inflammation
Item
None Portal Tract Inflammation
boolean
C1298908 (UMLS CUI [1,1])
C3854488 (UMLS CUI [1,2])
C3854488 (UMLS CUI [1,2])
Eosinophils
Item
Eosinophils
boolean
C0014467 (UMLS CUI [1,1])
C3854488 (UMLS CUI [1,2])
C3854488 (UMLS CUI [1,2])
Lymphoid aggregates and/or follicles
Item
Lymphoid aggregates and/or follicles
boolean
C0229653 (UMLS CUI [1,1])
C3854488 (UMLS CUI [1,2])
C3854488 (UMLS CUI [1,2])
Plasma cells
Item
Plasma cells
boolean
C0032112 (UMLS CUI [1,1])
C3854488 (UMLS CUI [1,2])
C3854488 (UMLS CUI [1,2])
Neutrophils
Item
Neutrophils
boolean
C0027950 (UMLS CUI [1,1])
C3854488 (UMLS CUI [1,2])
C3854488 (UMLS CUI [1,2])
Histocytes and macrophages
Item
Histocytes and macrophages
boolean
C0019612 (UMLS CUI [1])
C0024432 (UMLS CUI [2])
C3854488 (UMLS CUI [3])
C0024432 (UMLS CUI [2])
C3854488 (UMLS CUI [3])
Other Portal Tract Inflammation
Item
Other Portal Tract Inflammation
boolean
C0205394 (UMLS CUI [1,1])
C3854488 (UMLS CUI [1,2])
C3854488 (UMLS CUI [1,2])
Other Portal Tract Inflammation specification
Item
If Other Portal Tract Inflammation, please specify
text
C0205394 (UMLS CUI [1,1])
C3854488 (UMLS CUI [1,2])
C3854488 (UMLS CUI [1,2])
Normal bile ducts
Item
Normal bile ducts
boolean
C0205307 (UMLS CUI [1,1])
C0005400 (UMLS CUI [1,2])
C0005400 (UMLS CUI [1,2])
Proliferation of bile ducts
Item
Proliferation of bile ducts (bile ductular reaction)
boolean
C0005400 (UMLS CUI [1,1])
C0334094 (UMLS CUI [1,2])
C0334094 (UMLS CUI [1,2])
Dilation, degeneration or disruption of portal bile ducts
Item
Dilation, degeneration or disruption of portal bile ducts
boolean
C0005400 (UMLS CUI [1])
C0011164 (UMLS CUI [2,1])
C0005400 (UMLS CUI [2,2])
C0700124 (UMLS CUI [3,1])
C0005400 (UMLS CUI [3,2])
C0332453 (UMLS CUI [4,1])
C0005400 (UMLS CUI [4,2])
C0011164 (UMLS CUI [2,1])
C0005400 (UMLS CUI [2,2])
C0700124 (UMLS CUI [3,1])
C0005400 (UMLS CUI [3,2])
C0332453 (UMLS CUI [4,1])
C0005400 (UMLS CUI [4,2])
Paucity of bile ducts
Item
Paucity of bile ducts
boolean
C4273160 (UMLS CUI [1])
Periductal fibrosis
Item
Periductal fibrosis
boolean
C0016059 (UMLS CUI [1,1])
C0005400 (UMLS CUI [1,2])
C0005400 (UMLS CUI [1,2])
Other Bile Ducts
Item
Other Bile Ducts
boolean
C0205394 (UMLS CUI [1,1])
C0005400 (UMLS CUI [1,2])
C0005400 (UMLS CUI [1,2])
Other Bile Ducts specification
Item
If other Bile Ducts, please specify
text
C0205394 (UMLS CUI [1,1])
C0005400 (UMLS CUI [1,2])
C0005400 (UMLS CUI [1,2])
Normal
Item
Normal
integer
C0205307 (UMLS CUI [1])
Pyelophlebitis
Item
Pyelophlebitis
boolean
C1405883 (UMLS CUI [1])
Thrombosis, sclerosis or occlusion of portal vein
Item
Thrombosis, sclerosis or occlusion of portal vein
boolean
C0155773 (UMLS CUI [1])
C0400960 (UMLS CUI [2])
C0028778 (UMLS CUI [3,1])
C0032718 (UMLS CUI [3,2])
C0400960 (UMLS CUI [2])
C0028778 (UMLS CUI [3,1])
C0032718 (UMLS CUI [3,2])
Neoplastic Invasion of portal vein
Item
Neoplastic Invasion of portal vein
boolean
C0585133 (UMLS CUI [1])
Granulomatous compression of portal vein
Item
Granulomatous compression of portal vein
boolean
C0032718 (UMLS CUI [1,1])
C0439667 (UMLS CUI [1,2])
C0728907 (UMLS CUI [1,3])
C0439667 (UMLS CUI [1,2])
C0728907 (UMLS CUI [1,3])
Other Portal Veins abnormality
Item
Other Portal Veins abnormality
boolean
C0205394 (UMLS CUI [1,1])
C0032718 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0032718 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Other Portal Veins abnormality specification
Item
If other Portal Veins abnormality, please specify
text
C0205394 (UMLS CUI [1,1])
C0032718 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0032718 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Normal
Item
Normal
boolean
C0205307 (UMLS CUI [1])
Leishmaniasis donovani
Item
Leishmaniasis donovani
boolean
C0023273 (UMLS CUI [1])
Plasmodium falciparum
Item
Plasmodium falciparum
boolean
C0032150 (UMLS CUI [1])
Toxoplasmosis
Item
Toxoplasmosis
boolean
C0040558 (UMLS CUI [1])
Cryptococcus neoformans
Item
Cryptococcus neoformans
boolean
C0010416 (UMLS CUI [1])
Histoplasma capsulatum
Item
Histoplasma capsulatum
boolean
C0319941 (UMLS CUI [1])
Mycobacterium tuberculois
Item
Mycobacterium tuberculois
boolean
C0026926 (UMLS CUI [1])
Other mycobacterial species
Item
Other mycobacterial species
boolean
C0205394 (UMLS CUI [1,1])
C0026912 (UMLS CUI [1,2])
C0026912 (UMLS CUI [1,2])
Other Liver Infections
Item
Other Liver Infections
boolean
C0205394 (UMLS CUI [1,1])
C1112211 (UMLS CUI [1,2])
C1112211 (UMLS CUI [1,2])
Other Liver Infections specification
Item
If Other Liver Infections, please specify
text
C0205394 (UMLS CUI [1,1])
C1112211 (UMLS CUI [1,2])
C1112211 (UMLS CUI [1,2])
Item Group
Parasites or Ova
C0030498 (UMLS CUI-1)
C1267673 (UMLS CUI-2)
C0023884 (UMLS CUI-3)
C0193388 (UMLS CUI-4)
C1267673 (UMLS CUI-2)
C0023884 (UMLS CUI-3)
C0193388 (UMLS CUI-4)
None Parasites or ova
Item
None Parasites or ova
boolean
C0549184 (UMLS CUI [1,1])
C0030498 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0549184 (UMLS CUI [2,1])
C1267673 (UMLS CUI [2,2])
C0030498 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0549184 (UMLS CUI [2,1])
C1267673 (UMLS CUI [2,2])
Schistosome and/or ova
Item
Schistosome and/or ova
boolean
C0036315 (UMLS CUI [1])
C1267673 (UMLS CUI [2,1])
C0036315 (UMLS CUI [2,2])
C1267673 (UMLS CUI [2,1])
C0036315 (UMLS CUI [2,2])
Ascaris and/or ova
Item
Ascaris and/or ova
boolean
C0003954 (UMLS CUI [1])
C3698183 (UMLS CUI [2])
C3698183 (UMLS CUI [2])
Toxocara and/or ova
Item
Toxocara and/or ova
boolean
C0040550 (UMLS CUI [1])
C1267673 (UMLS CUI [2,1])
C0040550 (UMLS CUI [2,2])
C1267673 (UMLS CUI [2,1])
C0040550 (UMLS CUI [2,2])
Echinococcus cysts
Item
Echinococcus cysts
boolean
C0013502 (UMLS CUI [1])
Hepatic capillariasis worms and/or ova
Item
Hepatic capillariasis worms and/or ova
boolean
C0277202 (UMLS CUI [1])
C1267673 (UMLS CUI [2,1])
C0277202 (UMLS CUI [2,2])
C1267673 (UMLS CUI [2,1])
C0277202 (UMLS CUI [2,2])
Other Parasites or ova
Item
Other Parasites or ova
boolean
C0205394 (UMLS CUI [1,1])
C0030498 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C1267673 (UMLS CUI [2,2])
C0030498 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C1267673 (UMLS CUI [2,2])
Other Parasites or ova specification
Item
If Other Parasites or ova, please specify
text
C0205394 (UMLS CUI [1,1])
C0030498 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C1267673 (UMLS CUI [2,2])
C0030498 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C1267673 (UMLS CUI [2,2])
Item Group
Histologic Staining or Additional Studies Obtained
C0487602 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
C0023884 (UMLS CUI-3)
C0193388 (UMLS CUI-4)
C0430022 (UMLS CUI-2)
C0023884 (UMLS CUI-3)
C0193388 (UMLS CUI-4)
Haematoxylin and eosin (or H&E)
Item
Haematoxylin and eosin (or H&E)
boolean
C0523207 (UMLS CUI [1])
Masson
Item
Masson
boolean
C1294297 (UMLS CUI [1])
Toluidine blue or Giemsa
Item
Toluidine blue or Giemsa
boolean
C0523203 (UMLS CUI [1])
C0017542 (UMLS CUI [2])
C0017542 (UMLS CUI [2])
Prussian blue
Item
Prussian blue
boolean
C1294004 (UMLS CUI [1])
Periodic Acidic Schiff (PAS) with or without diastase
Item
Periodic Acidic Schiff (PAS) with or without diastase
boolean
C0440048 (UMLS CUI [1])
C0002712 (UMLS CUI [2])
C0002712 (UMLS CUI [2])
Oil red O
Item
Oil red O
boolean
C1294000 (UMLS CUI [1])
Congo red
Item
Congo red
boolean
C0009742 (UMLS CUI [1])
Hall's stain
Item
Hall's stain
boolean
C1720394 (UMLS CUI [1])
Gridley's stain
Item
Gridley's stain
boolean
C1293978 (UMLS CUI [1])
Rhodanine (copper)
Item
Rhodanine (copper)
boolean
C0035486 (UMLS CUI [1,1])
C0487602 (UMLS CUI [1,2])
C0009968 (UMLS CUI [1,3])
C0487602 (UMLS CUI [1,2])
C0009968 (UMLS CUI [1,3])
Rubeanic acid (copper)
Item
Rubeanic acid (copper)
boolean
C0073680 (UMLS CUI [1,1])
C0487602 (UMLS CUI [1,2])
C0009968 (UMLS CUI [1,3])
C0487602 (UMLS CUI [1,2])
C0009968 (UMLS CUI [1,3])
Orcein, aldehyde fuchsin or Victoria blue
Item
Orcein, aldehyde fuchsin or Victoria blue
boolean
C1294001 (UMLS CUI [1])
C0491984 (UMLS CUI [2])
C0078232 (UMLS CUI [3,1])
C0487602 (UMLS CUI [3,2])
C0491984 (UMLS CUI [2])
C0078232 (UMLS CUI [3,1])
C0487602 (UMLS CUI [3,2])
Electron microscopy
Item
Electron microscopy
boolean
C0026019 (UMLS CUI [1])
Hepatitis A lmmunostains positive
Item
Hepatitis A lmmunostains positive
boolean
C0560226 (UMLS CUI [1,1])
C3687908 (UMLS CUI [1,2])
C3687908 (UMLS CUI [1,2])
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive
Item
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive
boolean
C0149709 (UMLS CUI [1,1])
C3687908 (UMLS CUI [1,2])
C3687908 (UMLS CUI [1,2])
Hepatitis D immunostains
Item
Hepatitis D immunostains
boolean
C0850990 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C3687908 (UMLS CUI [1,3])
C0021044 (UMLS CUI [1,2])
C3687908 (UMLS CUI [1,3])
Other immunostains
Item
Other immunostains
boolean
C0021044 (UMLS CUI [1,1])
C3687908 (UMLS CUI [1,2])
C3687908 (UMLS CUI [1,2])
Other Histologic Staining or Additional Studies Obtained
Item
Other Histologic Staining or Additional Studies Obtained
boolean
C0205394 (UMLS CUI [1,1])
C0487602 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0487602 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
Other Histologic Staining or Additional Studies Obtained specification
Item
If Other Histologic Staining or Additional Studies Obtained, please specify
text
C0205394 (UMLS CUI [1,1])
C0487602 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0487602 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])