Informações: Esta não é a versão mais recente do modelo de dados. Uma visão geral da versão pode ser encontrada à esquerda em Versões. Para a versão mais recente, clique aqui.
Informações:
Falhas:
ID
41602
Descrição
Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2
Palavras-chave
Versões (3)
- 21/11/2020 21/11/2020 -
- 21/11/2020 21/11/2020 -
- 29/11/2020 29/11/2020 -
Titular dos direitos
GlaxoSmithKline
Transferido a
21 de novembro de 2020
DOI
Para um pedido faça login.
Licença
Creative Commons BY 4.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692
Liver Biopsy; Liver Events Assessment; Liver Imaging; Liver Event Follow-Up Chemistries
Similar models
Liver Biopsy; Liver Events Assessment; Liver Imaging; Liver Event Follow-Up Chemistries
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Subject
Item
Subject
text
C2348585 (UMLS CUI [1])
Status
Item
Status
text
C0449438 (UMLS CUI [1])
Doc#
Item
Doc#
integer
C1301746 (UMLS CUI [1])
Is Page Blank?
Item
Is Page Blank?
boolean
C1704732 (UMLS CUI [1,1])
C0750479 (UMLS CUI [1,2])
C0750479 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (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])
Approximate 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
Liver Biopsy - Final Diagnosis
integer
C1546485 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Acute Hepatitis (2)
CL Item
Chronic Hepatitis (3)
CL Item
Cholestatic Hepatitis (4)
CL Item
Drug-Induced Cholestasis (5)
CL Item
Acute Viral Hepatitis (6)
CL Item
Chronic Viral Hepatitis (7)
CL Item
Drug-Induced Hepatitis (8)
CL Item
Autoimmune Hepatitis (9)
CL Item
Briding Necrosis (10)
CL Item
Submassive Hepatic Necrosis (11)
CL Item
Massive Hepatic Necrosis (12)
CL Item
Steatosis - Microvesicular (13)
CL Item
Steatosis - Macrovesicular (14)
CL Item
Steatosis - Mixed (15)
CL Item
Non-Alcoholic Steatohepatitis (16)
CL Item
Alcoholic Hepatitis (17)
CL Item
Hepatic Granulomas (18)
CL Item
Sarcoidosis (19)
CL Item
Fibrosis (20)
CL Item
Cirrhosis (21)
CL Item
Primary Biliary Cirrhosis (22)
CL Item
Primary Sclerosing Cholangitis (23)
CL Item
Autoimmune Overlap Syndrome (24)
CL Item
Hemochromatosis (25)
CL Item
Alpha-1-Antitrypsin Deficiency (26)
CL Item
Wilson's Disease (27)
CL Item
Veno-Occlusive Disease (28)
CL Item
Budd-Chiary Syndrome (29)
CL Item
Neoplasia (30)
CL Item
Other (31)
Spcify other final diagnosis
Item
Spcify other final diagnosis
text
C1546485 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
Liver Architecture
integer
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0935919 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Bridging Fibrosis (2)
CL Item
Diffuse Fibrosis (3)
CL Item
Nodular Regenerative Hyperplasia (4)
CL Item
Congenital Hepatic Fibrosis (5)
CL Item
Cirrhosis (6)
CL Item
Centrilobular Congestion (7)
CL Item
Endophlebitis (8)
CL Item
Veno-Occlusive Disease (9)
CL Item
Canalicular Cholestatis (10)
CL Item
Apoptosis (11)
CL Item
Focal (or spotty or mild) Hepatocellular Necrosis (12)
CL Item
Interface Hepatitis (Periportal Hepatitis or Piecemeal Necrosis) (13)
CL Item
Ischaemic Necrosis (14)
CL Item
Centrolobular (Zone 3) Necrosis (15)
CL Item
Focal Coagulative Necrosis (16)
CL Item
Centrolobular (Zone 3) Coagulative Necrosis (17)
CL Item
Bridging Hepatocellular Necrosis (18)
CL Item
Massive Or Panlobular Hepatocellular Necrosis (19)
CL Item
Dysplasia (20)
CL Item
Neoplasia (21)
CL Item
Other (22)
Specify other liver architecture
Item
Specify other liver architecture
text
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0935919 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
Description of Liver Cells or Hepatocytes
integer
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Ballooning (2)
CL Item
Acidophilic (3)
CL Item
Pseudoxanthomatous (4)
CL Item
Multinucleated Giant Hepatocytes (5)
CL Item
Other (6)
Specify other Description of Liver Cells or Hepatocytes
Item
Specify other Description of Liver Cells or Hepatocytes
text
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0678257 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
Liver Cells or Hepatocyte Inclusions or Vacuoles
integer
C0227525 (UMLS CUI [1])
C0042219 (UMLS CUI [2])
C1512693 (UMLS CUI [3])
C0042219 (UMLS CUI [2])
C1512693 (UMLS CUI [3])
Code List
Liver Cells or Hepatocyte Inclusions or Vacuoles
CL Item
No Inclusions (1)
CL Item
Macrovesicular Steatosis (2)
CL Item
Microvesicular Steatosis (3)
CL Item
Bile Accumulation (4)
CL Item
Diastase-Resistant, PAS-Positive Cytoplasmic Inclusions (5)
CL Item
Alpha-1-Antitrypsin-Inclusions (6)
CL Item
Megamitochondria (7)
CL Item
Mallory Bodies (8)
CL Item
"Ground Glass" Inclusions (9)
CL Item
Lipofuscin Pigment (10)
CL Item
Hemosiderin Granules (11)
CL Item
Orcein-Positive Cytoplasmin Granules (12)
CL Item
Protoporphyrin Crystals (Birefringent Under Polarised Light) (13)
CL Item
Uroporphyrin Crystals (Red Fluorescence Under Ultraviolet Light) (14)
CL Item
Other (15)
Secify other liver cells or hepatocyte inclusions or vaculoles
Item
Secify other liver cells or hepatocyte inclusions or vaculoles
text
C0227525 (UMLS CUI [1])
C0042219 (UMLS CUI [2])
C1512693 (UMLS CUI [3])
C0205394 (UMLS CUI [4])
C2348235 (UMLS CUI [5])
C0042219 (UMLS CUI [2])
C1512693 (UMLS CUI [3])
C0205394 (UMLS CUI [4])
C2348235 (UMLS CUI [5])
Item
Hepatocyte or Liver Cell Nuclear Abnormalities
integer
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,2])
Code List
Hepatocyte or Liver Cell Nuclear Abnormalities
CL Item
None (1)
CL Item
Hepatocellular Mitoses (2)
CL Item
Binucleated or Multinucleated Hepatocytes (3)
CL Item
CMV Inclusion Bodies (4)
CL Item
HSV Inclusions (5)
CL Item
Varicella Inclusions (6)
CL Item
Other (7)
Specify other hepatocyte or liver cell nuclear abnormalites
Item
Specify other hepatocyte or liver cell nuclear abnormalites
text
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C1849376 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
Liver or Lobular Infiltrates
integer
C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C1400896 (UMLS CUI [1,2])
CL Item
None (1)
CL Item
Eosinophils (2)
CL Item
Lymphocytes (3)
CL Item
Plasma Cells (4)
CL Item
Neutrophils (5)
CL Item
Macrophages and Proliferating Kupfer Cells (6)
CL Item
Granulomas (7)
CL Item
Other (8)
Specify other liver or lobular infiltrates
Item
Specify other liver or lobular infiltrates
text
C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C1400896 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
CL Item
None (1)
CL Item
Eosinophils (2)
CL Item
Lymphoid Aggregates and/or Follicles (3)
CL Item
Plasma Cells (4)
CL Item
Neutrophils (5)
CL Item
Histocytes and Macrophages (6)
CL Item
Other (7)
Specify other portal tract inflammation
Item
Specify other portal tract inflammation
text
C3854488 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
CL Item
Normal (1)
CL Item
Proliferation of Bile Ducts (Bile Ductular Reaction) (2)
CL Item
Dilation, Degeneration or Disruption of Portal Bile Ducts (3)
CL Item
Paucity of Bile Ducts (4)
CL Item
Periductal Fibrosis (5)
CL Item
Other (6)
Specify other bile ducts
Item
Specify other bile ducts
text
C0005400 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
CL Item
Normal (1)
CL Item
Pyelophlebitis (2)
CL Item
Thrombosis, Sclerosis or Occlusion of Portal Vein (3)
CL Item
Neoplastic Invasion of Portal Vein (4)
CL Item
Granulomatous Compression of Portal Vein (5)
CL Item
Other (6)
Specify other portal veins
Item
Specify other portal veins
text
C0032718 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
CL Item
Normal (1)
CL Item
Leishmaniasis Donovani (2)
CL Item
Plasmodium Falciparum (3)
CL Item
Toxoplasmosis (4)
CL Item
Cryptococcus Neoformans (5)
CL Item
Histoplasma Capsulatum (6)
CL Item
Mycobacterium Tuberculosis (7)
CL Item
Other Mycobacterial Species (8)
CL Item
Other (9)
Specify other liver infections
Item
Specify other liver infections
text
C1112211 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
CL Item
None (1)
CL Item
Schistosome and/or Ova (2)
CL Item
Ascaris and/or Ova (3)
CL Item
Toxocara and/or Ova (4)
CL Item
Echinococcus Cysts (5)
CL Item
Hepatic Capillariasis Worm and/or Ova (6)
CL Item
Other (7)
Specify other parasites or Ova
Item
Specify other parasites or Ova
text
C0030498 (UMLS CUI [1])
C0555117 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
C0555117 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
Item
Histologic Staining or Additional Studies Obtained
integer
C0487602 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
C0008972 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0205462 (UMLS CUI [1,2])
C0008972 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
Code List
Histologic Staining or Additional Studies Obtained
CL Item
Haematoxylin and Eosin (1)
CL Item
Masson (2)
CL Item
Toluidine Blue or Giemsa (3)
CL Item
Prussian Blue (4)
CL Item
Periodic Acidic Schiff (PAS), wih or without Diastase (5)
CL Item
Oil Red O (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
Orcein, Aldehyde Fuchsin or Victoria Blue (12)
CL Item
Electron Microscopy (13)
CL Item
Hepatitis A Immunostains 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 (18)
Specify other Histologic Staining or Additional Studies Obtained
Item
Specify other Histologic Staining or Additional Studies Obtained
text
C0487602 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
C0008972 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
C0205462 (UMLS CUI [1,2])
C0008972 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
Item Group
Liver Events Assessment
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-3)
C0220825 (UMLS CUI-5)
C0877248 (UMLS CUI-3)
C0220825 (UMLS CUI-5)
Have liver chemistry results reached or exceeded protocol-defined stopping criteria?
Item
Have liver chemistry results reached or exceeded protocol-defined stopping criteria?
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C2746065 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C2746065 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
AE/SAE Reference Number
Item
AE/SAE Reference Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
integer
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2])
C2746065 (UMLS CUI [3,1])
C0243161 (UMLS CUI [3,2])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2])
C2746065 (UMLS CUI [3,1])
C0243161 (UMLS CUI [3,2])
Code List
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
CL Item
ALT (alanine aminotransferase) (1)
CL Item
AST (aspartate aminotransferase) (2)
CL Item
Total bilirubin (3)
CL Item
Other, specify (4)
Specify other liver chemistry result
Item
Specify other liver chemistry result
text
C0008000 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C0587081 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
Is the subject age 55 or older?
Item
Is the subject age 55 or older?
boolean
C0001779 (UMLS CUI [1])
Item
If female, is the subject pregnant?
integer
C0032961 (UMLS CUI [1])
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (3)
Were any diagnostic imaging tests of the liver or hepatobiliary system performed?
Item
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
C0011923 (UMLS CUI [1])
C1711359 (UMLS CUI [2])
C0023884 (UMLS CUI [3])
C1456803 (UMLS CUI [4,1])
C0023884 (UMLS CUI [4,2])
C0040405 (UMLS CUI [5])
C0024485 (UMLS CUI [6])
C0008310 (UMLS CUI [7])
C0205394 (UMLS CUI [8])
C1711359 (UMLS CUI [2])
C0023884 (UMLS CUI [3])
C1456803 (UMLS CUI [4,1])
C0023884 (UMLS CUI [4,2])
C0040405 (UMLS CUI [5])
C0024485 (UMLS CUI [6])
C0008310 (UMLS CUI [7])
C0205394 (UMLS CUI [8])
Were diagnostic imaging test results normal?
Item
Were diagnostic imaging test results normal?
boolean
C1274040 (UMLS CUI [1])
C0011923 (UMLS CUI [2])
C0205307 (UMLS CUI [3])
C0011923 (UMLS CUI [2])
C0205307 (UMLS CUI [3])
Were any liver biopsies performed?
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C2240391 (UMLS CUI [1])
C1148474 (UMLS CUI [2])
C0002346 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0281875 (UMLS CUI [5])
C1148474 (UMLS CUI [2])
C0002346 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0281875 (UMLS CUI [5])
Did the subject fast or undergo significant dietary change in the past week?
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C0015663 (UMLS CUI [1])
C3671772 (UMLS CUI [2])
C3671772 (UMLS CUI [2])
Was a pharmacokinetic blood sample obtained?
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
If Yes, date and time sample taken:
Item
If Yes, date and time sample taken:
datetime
C0200345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0011008 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
If Yes, date and time of last investigational product dose prior to PK sample
Item
If Yes, date and time of last investigational product dose prior to PK sample
datetime
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0946444 (UMLS CUI [2,2])
C0201734 (UMLS CUI [3,1])
C0178913 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
C1762893 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0946444 (UMLS CUI [2,2])
C0201734 (UMLS CUI [3,1])
C0178913 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
Record the average number of units of alcohol consumed per week
Item
Record the average number of units of alcohol consumed per week
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
C0560579 (UMLS CUI [1,2])
Item Group
Liver Disease Medical Conditions
C0023895 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0262926 (UMLS CUI-2)
Item
Specific Condition
integer
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
CL Item
Acute Viral Hepatitis A (1)
CL Item
Chronic Hepatitis B (2)
CL Item
Chronic Hepatitis C (3)
CL Item
Cytomegalovirus Hepatitis (4)
CL Item
Epsein Barr Virus Infectious Mononucleosis (5)
CL Item
Herpes Simplex Hepatitis (6)
CL Item
Alcoholic Liver Disease (7)
CL Item
Non-Alcoholic Steatohepatitis (8)
CL Item
Fatty Liver (9)
CL Item
Hepatic Cirrhosis (10)
CL Item
Hemochromatosis (11)
CL Item
Autoimmune Hepatitis (12)
CL Item
Gallbladder Disease or Biliary Disease (13)
Item
Check only one response for each condition
integer
C1704632 (UMLS CUI [1])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical condition (3)
Item Group
Drug related Liver Disease Conditions
C0023895 (UMLS CUI-1)
C0277579 (UMLS CUI-2)
C0277579 (UMLS CUI-2)
Item
Specific Condition
integer
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
CL Item
Drug related Liver Disease (1)
Item
Check only one response for each condition
integer
C1704632 (UMLS CUI [1])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical condition (3)
Item Group
Other Liver Disease Conditions
C0023895 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI-2)
Specific Condition
Item
Specific Condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Item
Check only one response for each condition
integer
C1704632 (UMLS CUI [1])
CL Item
Current (1)
CL Item
Past (2)
Item Group
Other Medical Conditions
C0012634 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI-2)
Item
Specific Condition
integer
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
CL Item
Drug Allergies (1)
CL Item
Rheumatoid Artheritis (2)
CL Item
Psoriasis (3)
CL Item
Thyroid Disease (4)
CL Item
Iflammatory Bowel Disease (5)
CL Item
Lupus (6)
CL Item
Sjogren's Syndrome (7)
CL Item
Vitiligo (8)
Item
Check only one response for each condition
integer
C1704632 (UMLS CUI [1])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical condition (3)
Date of hepatic or liver imaging test:
Item
Date of hepatic or liver imaging test:
date
C2711860 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
What method was used for this imaging test?
integer
C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
C1275506 (UMLS CUI [1,2])
CL Item
Ultrasound - transabdominal (1)
CL Item
Ultrasound - endoscopic (2)
CL Item
Magnetic Resonance Imaging (MRI) (3)
CL Item
Computerised Tomography (CT) (4)
CL Item
Endoscopic Retrograde Cholangiopancreatography (ERCP) (5)
CL Item
Positron Emission Tomography (PET) (6)
CL Item
Positron Emission Tomography/Computed Tomography (PET/CT) (7)
CL Item
Other, specify (8)
Specify other method
Item
Specify other method
text
C0871511 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Are images technically adequate?
Item
Are images technically adequate?
float
C0806487 (UMLS CUI [1])
Specify other image quality
Item
Specify other image quality
text
C0806487 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
CL Item
Normal size (1)
CL Item
Hypertrophy (or enlarged) (2)
CL Item
Atrophy (or smaller than normal) (3)
CL Item
Segmental hypertrophy (4)
CL Item
Other specify (5)
Specify other liver size
Item
Specify other liver size
text
C0426688 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Item
Indicate the liver texture
integer
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Heterogeneous (2)
CL Item
Suggestive of fibrosis (3)
CL Item
Nodular or suggestive of cirrhosis (4)
CL Item
Other, specify (5)
Specify other liver texture
Item
Specify other liver texture
text
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
C0023884 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
Item
Grade the diffuse and/or geographic fatty infiltrate of the liver
text
C0015695 (UMLS CUI [1])
C0205219 (UMLS CUI [2])
C1517526 (UMLS CUI [3])
C0205219 (UMLS CUI [2])
C1517526 (UMLS CUI [3])
Code List
Grade the diffuse and/or geographic fatty infiltrate of the liver
CL Item
Not applicable - no fatty infiltration (1)
CL Item
25%) (Mild (<)
CL Item
Moderate (>25% to <75%) (3)
CL Item
75%) (Severe (>)
CL Item
Other, specify (5)
Specify other fatty infiltrate of the liver
Item
Specify other fatty infiltrate of the liver
text
C0015695 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
CL Item
Non present (1)
CL Item
Yes - small amount (2)
CL Item
Yes - moderate or severe amount (3)
CL Item
Other, specify (4)
Specify other ascites
Item
Specify other ascites
text
C0003962 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Item
Are focal hepatic lesions characterisable?
integer
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205234 (UMLS CUI [1,2])
CL Item
Not applicable - no hepatic lesions (1)
CL Item
Solid (2)
CL Item
Cystic (3)
CL Item
Haemangioma (4)
CL Item
Focal nodular hyperplasia (5)
CL Item
Other (6)
Specify other hepatic lesions
Item
Specify other hepatic lesions
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
Item
Gallstones or gallbladder lesions?
integer
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
CL Item
None (1)
CL Item
Gallstones (2)
CL Item
Gallbladder Polyps (S) (3)
CL Item
Sludge (4)
CL Item
Gallbladder Wall Thickening/Oedema (5)
CL Item
Gallbladder Wall Gas (6)
CL Item
Cholecystitis (7)
CL Item
Gallbladder Wall Calcification (8)
CL Item
Gallbladder Mass (9)
CL Item
Other (10)
Specify other gallstone or gallbladder lesions
Item
Specify other gallstone or gallbladder lesions
text
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
Item
Biliary ductal lesions
integer
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
CL Item
None (1)
CL Item
Intrahepatic ductal dilation (focal involving the right hepatic lobe) (2)
CL Item
Intrahepatic ductal dilation (focal involving the left hepatic lobe) (3)
CL Item
Intrahepatic ductal dilation (involving both right and left hepatic lobes) (4)
CL Item
Extrahepatic ductal dilation (5)
CL Item
Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts) (6)
CL Item
Acute Cholangitis (7)
CL Item
Primary sclerosing cholangitis (8)
CL Item
Choledocholithiasis (gallstone in duct) (9)
CL Item
Ductal filling defect (s), other than gallstone (10)
CL Item
Ductal wall thickening or oedema (11)
CL Item
Choledochal cyst (12)
CL Item
Ductal mass (13)
CL Item
Extrinsic mass compressing bile duct (s) (14)
CL Item
Other (15)
Specify other biliary ductal lesions
Item
Specify other biliary ductal lesions
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
Item
Portal/Hepatic vein abnormalities
integer
C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
CL Item
None (1)
CL Item
Portal vein enlargement (2)
CL Item
Hepatic vein enlargement (3)
CL Item
Nonocclusive portal vein thrombosis (4)
CL Item
Occlusive portal vein thrombosis - bland (5)
CL Item
Hepatic vein thrombosis - bland (6)
CL Item
Oclcusive portal vein thrombosis - malignant (7)
CL Item
Hepatic vein thrombosis - malignant (8)
CL Item
Involvement of the main portal vein (9)
CL Item
Involvement of the right portal vein (10)
CL Item
Involvement of the left portal vein (11)
CL Item
Budd-Chiari Syndrome (12)
CL Item
Other (13)
Specify other portal/hepatic vein abnormalities
Item
Specify other portal/hepatic vein abnormalities
text
C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [3])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [3])
Item Group
Liver event follow-up chemistries
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1522577 (UMLS CUI-4)
C0008000 (UMLS CUI-6)
C0877248 (UMLS CUI-2)
C1522577 (UMLS CUI-4)
C0008000 (UMLS CUI-6)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Were liver chemistries (ALT, AST, ALP, bilirubin) performed?
Item
Were liver chemistries (ALT, AST, ALP, bilirubin) performed?
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0008000 (UMLS CUI [1,2])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
Did liver chemistries (AST, ALT, ALP, bilirubin) resolve, stabilize, or return to within Baseline values?
Item
Did liver chemistries (AST, ALT, ALP, bilirubin) resolve, stabilize, or return to within Baseline values?
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C3714811 (UMLS CUI [6])
C1293130 (UMLS CUI [7])
C0332156 (UMLS CUI [8,1])
C1442488 (UMLS CUI [8,2])
C0008000 (UMLS CUI [1,2])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C3714811 (UMLS CUI [6])
C1293130 (UMLS CUI [7])
C0332156 (UMLS CUI [8,1])
C1442488 (UMLS CUI [8,2])