ID
39876
Beskrivning
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.
Länk
https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201
Nyckelord
Versioner (1)
- 2020-02-26 2020-02-26 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
26 februari 2020
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 4.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201
Liver Imaging
- StudyEvent: ODM
Beskrivning
Liver imaging
Alias
- UMLS CUI-1
- C2711860
Beskrivning
Method of imaging test
Alias
- UMLS CUI-1
- C2711860
- UMLS CUI-2
- C0871511
Beskrivning
Method for imaging test
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2711860
- UMLS CUI [1,2]
- C0871511
Beskrivning
Other method
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0871511
- UMLS CUI [1,2]
- C0205394
Beskrivning
Image quality
Alias
- UMLS CUI-1
- C0806487
Beskrivning
Liver size
Alias
- UMLS CUI-1
- C0426688
Beskrivning
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-3
- C0015695
- UMLS CUI-4
- 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
No Gallstones or gallbladder lesions
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C3842395
- UMLS CUI [2,1]
- C1298908
- UMLS CUI [2,2]
- C0221198
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(s), 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(s)
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
C0011008 (UMLS CUI [1,2])
C0871511 (UMLS CUI-2)
C0871511 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0205219 (UMLS CUI-2)
C0015695 (UMLS CUI-3)
C1517526 (UMLS CUI-4)
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)
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])