ID
39876
Description
Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the liver imaging form. It has to be filled in if a liver imaging was taken during study.
Link
https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201
Keywords
Versions (1)
- 2/26/20 2/26/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 26, 2020
DOI
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License
Creative Commons BY-NC 4.0
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Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201
Liver Imaging
- StudyEvent: ODM
Description
Liver imaging
Alias
- UMLS CUI-1
- C2711860
Description
Method of imaging test
Alias
- UMLS CUI-1
- C2711860
- UMLS CUI-2
- C0871511
Description
Method for imaging test
Data type
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C0871511
Description
Other method
Data type
text
Alias
- UMLS CUI [1,1]
- C0871511
- UMLS CUI [1,2]
- C0205394
Description
Image quality
Alias
- UMLS CUI-1
- C0806487
Description
Liver size
Alias
- UMLS CUI-1
- C0426688
Description
Liver texture
Alias
- UMLS CUI-1
- C0679033
- UMLS CUI-2
- C0023884
Description
Grade the diffuse and/or geographic fatty infiltrate of the liver
Alias
- UMLS CUI-1
- C0015695
- UMLS CUI-2
- C0205219
- UMLS CUI-3
- C0015695
- UMLS CUI-4
- C1517526
Description
Diffuse and/or geographic fatty infiltrate of liver
Data type
text
Alias
- UMLS CUI [1,1]
- C0015695
- UMLS CUI [1,2]
- C0205219
- UMLS CUI [2,1]
- C0015695
- UMLS CUI [2,2]
- C1517526
Description
Other diffuse and/or geographic fatty infiltrate of liver
Data type
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
Description
Ascites present
Alias
- UMLS CUI-1
- C0003962
Description
Are Focal Hepatic Lesions characterisable?
Alias
- UMLS CUI-1
- C0577053
- UMLS CUI-2
- C0205234
Description
Focal hepatic lesions: Not applicable - no hepatic lesions
Data type
boolean
Alias
- UMLS CUI [1]
- C1272460
- UMLS CUI [2,1]
- C0577053
- UMLS CUI [2,2]
- C0205234
- UMLS CUI [2,3]
- C1298908
Description
Focal hepatic lesions: Solid
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205208
Description
Focal hepatic lesions: Cystic
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205207
Description
Focal hepatic lesions: Hemangioma
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0018916
Description
Focal hepatic lesions: Focal Nodular Hyperplasia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0020510
Description
Focal hepatic lesions: Other
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
Description
Focal hepatic lesions: Other, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
Description
Gallstones or gallbladder lesions
Alias
- UMLS CUI-1
- C3842395
- UMLS CUI-2
- C0221198
Description
No Gallstones or gallbladder lesions
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C3842395
- UMLS CUI [2,1]
- C1298908
- UMLS CUI [2,2]
- C0221198
Description
Gallstones
Data type
boolean
Alias
- UMLS CUI [1]
- C0008350
Description
Gallbladder polyps
Data type
boolean
Alias
- UMLS CUI [1]
- C0262493
Description
Sludge
Data type
boolean
Alias
- UMLS CUI [1]
- C0860209
Description
Gallbladder wall thickening/oedema
Data type
boolean
Alias
- UMLS CUI [1]
- C0744257
- UMLS CUI [2,1]
- C0734014
- UMLS CUI [2,2]
- C0013604
Description
Gallbladder wall gas
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2246573
- UMLS CUI [1,2]
- C0016976
Description
Cholecystitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0008325
Description
Gallbladder wall calcification
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0016976
- UMLS CUI [1,2]
- C1533591
Description
Gallbladder mass
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0016976
- UMLS CUI [1,2]
- C0577559
Description
Other gallbladder lesions
Data type
boolean
Alias
- UMLS CUI [1]
- C0156213
Description
Other gallbladder lesions specification
Data type
text
Alias
- UMLS CUI [1]
- C0156213
Description
Biliary ductal lesions
Alias
- UMLS CUI-1
- C0005423
- UMLS CUI-2
- C0221198
- UMLS CUI-3
- C2711860
Description
No Biliary ductal lesions
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C2711860
- UMLS CUI [1,4]
- C1298908
Description
Intrahepatic ductal dilation, right lobe
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545796
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227481
- UMLS CUI [1,4]
- C2711860
Description
Intrahepatic ductal dilation, left lobe
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0545796
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227486
- UMLS CUI [1,4]
- C2711860
Description
lntrahepatic ductal dilation, both lobes
Data type
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
Description
Extrahepatic ductal dilation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012359
- UMLS CUI [1,2]
- C2711860
- UMLS CUI [1,3]
- C0206187
Description
Diffuse ductal dilation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0940779
- UMLS CUI [1,2]
- C2711860
Description
Acute Cholangitis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0267917
- UMLS CUI [1,2]
- C2711860
Description
Primary sclerosing cholangitis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0566602
- UMLS CUI [1,2]
- C2711860
Description
Choledocholithiasis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0701818
- UMLS CUI [1,2]
- C2711860
Description
Ductal filling defect(s), other than gallstone
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0940806
- UMLS CUI [1,2]
- C2711860
Description
Ductal wall thickening or oedema
Data type
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
Description
Choledochal cyst
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0008340
- UMLS CUI [1,2]
- C2711860
Description
Ductal mass
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005400
- UMLS CUI [1,2]
- C0577559
- UMLS CUI [1,3]
- C2711860
Description
Extrinsic mass compressing bile duct(s)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005400
- UMLS CUI [1,2]
- C0332459
- UMLS CUI [1,3]
- C2711860
Description
Other Biliary ductal lesions
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C2711860
- UMLS CUI [1,4]
- C0205394
Description
Other Biliary ductal lesions specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C2711860
- UMLS CUI [1,4]
- C0205394
Description
Portal/Hepatic vein abnormalities?
Alias
- UMLS CUI-1
- C0019155
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0032718
- UMLS CUI-4
- C1704258
Description
None Portal/Hepatic vein abnormalities
Data type
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
Description
Portal vein enlargement
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C0700124
Description
Hepatic vein enlargement
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019155
- UMLS CUI [1,2]
- C0700124
Description
Nonocclusive portal vein thrombosis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0333204
Description
Occlusive portal vein thrombosis - bland
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C1947917
Description
Hepatic vein thrombosis - bland
Data type
boolean
Alias
- UMLS CUI [1]
- C0019154
Description
Occlusive portal vein thrombosis - malignant
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0205282
Description
Hepatic vein thrombosis - malignant
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019154
- UMLS CUI [1,2]
- C0205282
Description
Involvement of the main portal vein
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0392760
- UMLS CUI [1,2]
- C1183135
Description
Involvement of the right portal vein
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0392760
- UMLS CUI [1,2]
- C0205090
- UMLS CUI [1,3]
- C0032718
Description
Involvement of the left portal vein
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0392760
- UMLS CUI [1,2]
- C0205091
- UMLS CUI [1,3]
- C0032718
Description
Budd-Chiari syndrome
Data type
boolean
Alias
- UMLS CUI [1]
- C0856761
Description
Other Portal/Hepatic vein abnormalities
Data type
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
Description
Other Portal/Hepatic vein abnormalities specification
Data type
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
C0011008 (UMLS CUI [1,2])
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C0871511 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
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C0205219 (UMLS CUI [1,3])
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C0205394 (UMLS CUI [1,2])
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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)
C3842395 (UMLS CUI [1,2])
C1298908 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
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])