ID
33280
Beskrivning
Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the liver imaging form. It has to be filled in during study, if a liver imaging was taken from subject.
Länk
https://clinicaltrials.gov/ct2/show/NCT00599612
Nyckelord
Versioner (1)
- 2018-12-04 2018-12-04 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
4 december 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612
Liver Imaging
- StudyEvent: ODM
Beskrivning
Liver imaging
Alias
- UMLS CUI-1
- C2711860
Beskrivning
What method was used for this imaging test?
Alias
- UMLS CUI-1
- C2711860
- UMLS CUI-2
- C0871511
Beskrivning
Method
Datatyp
text
Alias
- UMLS CUI [1]
- C0871511
Beskrivning
Other method
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0871511
- UMLS CUI [1,2]
- C0205394
Beskrivning
Are images technically adequate?
Alias
- UMLS CUI-1
- C0806487
Beskrivning
Indicate the liver size
Alias
- UMLS CUI-1
- C0426688
Beskrivning
Indicate the liver texture
Alias
- UMLS CUI-1
- C0679033
- UMLS CUI-2
- C0023884
Beskrivning
Grade the diffuse and/or geographic fatty infiltrate of the liver
Alias
- UMLS CUI-1
- C0015695
- UMLS CUI-2
- C0205219
- UMLS CUI-4
- C0015695
- UMLS CUI-5
- C1517526
Beskrivning
Diffuse and/or geographic fatty infiltrate of liver
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0015695
- UMLS CUI [1,2]
- C0205219
- UMLS CUI [2,1]
- C0015695
- UMLS CUI [2,2]
- C1517526
Beskrivning
Other diffuse and/or geographic fatty infiltrate of liver
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0015695
- UMLS CUI [1,3]
- C0205219
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C0015695
- UMLS CUI [2,3]
- C1517526
Beskrivning
Ascites present
Alias
- UMLS CUI-1
- C0003962
Beskrivning
Are Focal Hepatic Lesions characterisable?
Alias
- UMLS CUI-1
- C0577053
- UMLS CUI-2
- C0205234
Beskrivning
Focal hepatic lesions: Not applicable - no hepatic lesions
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1272460
- UMLS CUI [2,1]
- C0577053
- UMLS CUI [2,2]
- C0205234
- UMLS CUI [2,3]
- C1298908
Beskrivning
Focal hepatic lesions: Solid
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205208
Beskrivning
Focal hepatic lesions: Cystic
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205207
Beskrivning
Focal hepatic lesions: Hemangioma
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0018916
Beskrivning
Focal hepatic lesions: Focal Nodular Hyperplasia
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0020510
Beskrivning
Focal hepatic lesions: Other
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
Beskrivning
Focal hepatic lesions: Other, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
Beskrivning
Gallstones or gallbladder lesions?
Alias
- UMLS CUI-1
- C3842395
- UMLS CUI-2
- C0221198
Beskrivning
None
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0549184
Beskrivning
Gallstones
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0008350
Beskrivning
Gallbladder polyps
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0262493
Beskrivning
Sludge
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0860209
Beskrivning
Gallbladder wall thickening/oedema
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0744257
- UMLS CUI [2,1]
- C0734014
- UMLS CUI [2,2]
- C0013604
Beskrivning
Gallbladder wall gas
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2246573
- UMLS CUI [1,2]
- C0016976
Beskrivning
Cholecystitis
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0008325
Beskrivning
Gallbladder wall calcification
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0016976
- UMLS CUI [1,2]
- C1533591
Beskrivning
Gallbladder mass
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0016976
- UMLS CUI [1,2]
- C0577559
Beskrivning
Other gallbladder lesions
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0156213
Beskrivning
Other gallbladder lesions specification
Datatyp
text
Alias
- UMLS CUI [1]
- C0156213
Beskrivning
Biliary ductal lesions?
Alias
- UMLS CUI-1
- C0005423
- UMLS CUI-2
- C0221198
- UMLS CUI-3
- C2711860
Beskrivning
No Biliary ductal lesions
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C2711860
- UMLS CUI [1,4]
- C1298908
Beskrivning
Intrahepatic ductal dilation, right lobe
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0545796
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227481
- UMLS CUI [1,4]
- C2711860
Beskrivning
Intrahepatic ductal dilation, left lobe
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0545796
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227486
- UMLS CUI [1,4]
- C2711860
Beskrivning
lntrahepatic ductal dilation, both lobes
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0545796
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227486
- UMLS CUI [2,1]
- C0545796
- UMLS CUI [2,2]
- C0012359
- UMLS CUI [2,3]
- C0227481
Beskrivning
Extrahepatic ductal dilation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0012359
- UMLS CUI [1,2]
- C2711860
- UMLS CUI [1,3]
- C0206187
Beskrivning
Diffuse ductal dilation
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0940779
- UMLS CUI [1,2]
- C2711860
Beskrivning
Acute Cholangitis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0267917
- UMLS CUI [1,2]
- C2711860
Beskrivning
Primary sclerosing cholangitis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0566602
- UMLS CUI [1,2]
- C2711860
Beskrivning
Choledocholithiasis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0701818
- UMLS CUI [1,2]
- C2711860
Beskrivning
Ductal filling defect other than gallstone
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0940806
- UMLS CUI [1,2]
- C2711860
Beskrivning
Ductal wall thickening or oedema
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1180044
- UMLS CUI [1,2]
- C0205400
- UMLS CUI [1,3]
- C2711860
- UMLS CUI [2,1]
- C0013604
- UMLS CUI [2,2]
- C1180044
- UMLS CUI [2,3]
- C2711860
Beskrivning
Choledochal cyst
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0008340
- UMLS CUI [1,2]
- C2711860
Beskrivning
Ductal mass
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005400
- UMLS CUI [1,2]
- C0577559
- UMLS CUI [1,3]
- C2711860
Beskrivning
Extrinsic mass compressing bile duct
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005400
- UMLS CUI [1,2]
- C0332459
- UMLS CUI [1,3]
- C2711860
Beskrivning
Other Biliary ductal lesions
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C2711860
- UMLS CUI [1,4]
- C0205394
Beskrivning
Other Biliary ductal lesions specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C2711860
- UMLS CUI [1,4]
- C0205394
Beskrivning
Portal/Hepatic vein abnormalities?
Alias
- UMLS CUI-1
- C0019155
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0032718
- UMLS CUI-4
- C1704258
Beskrivning
None Portal/Hepatic vein abnormalities
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0549184
- UMLS CUI [1,2]
- C0019155
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [2,1]
- C0549184
- UMLS CUI [2,2]
- C0032718
- UMLS CUI [2,3]
- C1704258
Beskrivning
Portal vein enlargement
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C0700124
Beskrivning
Hepatic vein enlargement
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0019155
- UMLS CUI [1,2]
- C0700124
Beskrivning
Nonocclusive portal vein thrombosis
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0333204
Beskrivning
Occlusive portal vein thrombosis - bland
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C1947917
Beskrivning
Hepatic vein thrombosis - bland
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0019154
Beskrivning
Occlusive portal vein thrombosis - malignant
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0205282
Beskrivning
Hepatic vein thrombosis - malignant
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0019154
- UMLS CUI [1,2]
- C0205282
Beskrivning
Involvement of the main portal vein
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0392760
- UMLS CUI [1,2]
- C1183135
Beskrivning
Involvement of the right portal vein
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0392760
- UMLS CUI [1,2]
- C0205090
- UMLS CUI [1,3]
- C0032718
Beskrivning
Involvement of the left portal vein
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0392760
- UMLS CUI [1,2]
- C0205091
- UMLS CUI [1,3]
- C0032718
Beskrivning
Budd-Chiari syndrome
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0856761
Beskrivning
Other Portal/Hepatic vein abnormalities
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0019155
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C0032718
- UMLS CUI [2,3]
- C1704258
Beskrivning
Other Portal/Hepatic vein abnormalities specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0019155
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [2,1]
- C0205394
- UMLS CUI [2,2]
- C0032718
- UMLS CUI [2,3]
- C1704258
Similar models
Liver Imaging
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0871511 (UMLS CUI-2)
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0205219 (UMLS CUI-2)
C0015695 (UMLS CUI-4)
C1517526 (UMLS CUI-5)
C0205219 (UMLS CUI [1,2])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
C0015695 (UMLS CUI [1,2])
C0205219 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C0015695 (UMLS CUI [2,2])
C1517526 (UMLS CUI [2,3])
C0205394 (UMLS CUI [1,2])
C0205234 (UMLS CUI-2)
C0577053 (UMLS CUI [2,1])
C0205234 (UMLS CUI [2,2])
C1298908 (UMLS CUI [2,3])
C0205234 (UMLS CUI [1,2])
C0205208 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C0205207 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C0018916 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C0020510 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0221198 (UMLS CUI-2)
C0734014 (UMLS CUI [2,1])
C0013604 (UMLS CUI [2,2])
C0016976 (UMLS CUI [1,2])
C1533591 (UMLS CUI [1,2])
C0577559 (UMLS CUI [1,2])
C0221198 (UMLS CUI-2)
C2711860 (UMLS CUI-3)
C0221198 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C1298908 (UMLS CUI [1,4])
C0012359 (UMLS CUI [1,2])
C0227481 (UMLS CUI [1,3])
C2711860 (UMLS CUI [1,4])
C0012359 (UMLS CUI [1,2])
C0227486 (UMLS CUI [1,3])
C2711860 (UMLS CUI [1,4])
C0012359 (UMLS CUI [1,2])
C0227486 (UMLS CUI [1,3])
C0545796 (UMLS CUI [2,1])
C0012359 (UMLS CUI [2,2])
C0227481 (UMLS CUI [2,3])
C2711860 (UMLS CUI [1,2])
C0206187 (UMLS CUI [1,3])
C2711860 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,2])
C0205400 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0013604 (UMLS CUI [2,1])
C1180044 (UMLS CUI [2,2])
C2711860 (UMLS CUI [2,3])
C2711860 (UMLS CUI [1,2])
C0577559 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0332459 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0221198 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C1704258 (UMLS CUI-2)
C0032718 (UMLS CUI-3)
C1704258 (UMLS CUI-4)
C0019155 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0549184 (UMLS CUI [2,1])
C0032718 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])
C0700124 (UMLS CUI [1,2])
C0700124 (UMLS CUI [1,2])
C0333204 (UMLS CUI [1,2])
C1947917 (UMLS CUI [1,2])
C0205282 (UMLS CUI [1,2])
C0205282 (UMLS CUI [1,2])
C1183135 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,2])
C0032718 (UMLS CUI [1,3])
C0205091 (UMLS CUI [1,2])
C0032718 (UMLS CUI [1,3])
C0019155 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C0032718 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])
C0019155 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C0032718 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])