ID
38261
Beschrijving
Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. 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/NCT00833989
Trefwoorden
Versies (1)
- 05-10-19 05-10-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
5 oktober 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989
Liver Imaging
- StudyEvent: ODM
Beschrijving
Liver imaging
Alias
- UMLS CUI-1
- C2711860
Beschrijving
What method was used for this imaging test?
Alias
- UMLS CUI-1
- C2711860
- UMLS CUI-2
- C0871511
Beschrijving
Method
Datatype
text
Alias
- UMLS CUI [1]
- C0871511
Beschrijving
Other method
Datatype
text
Alias
- UMLS CUI [1,1]
- C0871511
- UMLS CUI [1,2]
- C0205394
Beschrijving
Are images technically adequate?
Alias
- UMLS CUI-1
- C0806487
Beschrijving
Indicate the liver size
Alias
- UMLS CUI-1
- C0426688
Beschrijving
Indicate the liver texture
Alias
- UMLS CUI-1
- C0679033
- UMLS CUI-2
- C0023884
Beschrijving
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
Beschrijving
Diffuse and/or geographic fatty infiltrate of liver
Datatype
text
Alias
- UMLS CUI [1,1]
- C0015695
- UMLS CUI [1,2]
- C0205219
- UMLS CUI [2,1]
- C0015695
- UMLS CUI [2,2]
- C1517526
Beschrijving
Other diffuse and/or geographic fatty infiltrate of liver
Datatype
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
Beschrijving
Ascites present
Alias
- UMLS CUI-1
- C0003962
Beschrijving
Are Focal Hepatic Lesions characterisable?
Alias
- UMLS CUI-1
- C0577053
- UMLS CUI-2
- C0205234
Beschrijving
Focal hepatic lesions: Not applicable - no hepatic lesions
Datatype
boolean
Alias
- UMLS CUI [1]
- C1272460
- UMLS CUI [2,1]
- C0577053
- UMLS CUI [2,2]
- C0205234
- UMLS CUI [2,3]
- C1298908
Beschrijving
Focal hepatic lesions: Solid
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205208
Beschrijving
Focal hepatic lesions: Cystic
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205207
Beschrijving
Focal hepatic lesions: Hemangioma
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0018916
Beschrijving
Focal hepatic lesions: Focal Nodular Hyperplasia
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0020510
Beschrijving
Focal hepatic lesions: Other
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
Beschrijving
Focal hepatic lesions: Other, specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
Beschrijving
Gallstones or gallbladder lesions
Alias
- UMLS CUI-1
- C3842395
- UMLS CUI-2
- C0221198
Beschrijving
No Gallstones or gallbladder lesions
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C3842395
- UMLS CUI [2,1]
- C1298908
- UMLS CUI [2,2]
- C0221198
Beschrijving
Gallstones
Datatype
boolean
Alias
- UMLS CUI [1]
- C0008350
Beschrijving
Gallbladder polyps
Datatype
boolean
Alias
- UMLS CUI [1]
- C0262493
Beschrijving
Sludge
Datatype
boolean
Alias
- UMLS CUI [1]
- C0860209
Beschrijving
Gallbladder wall thickening/oedema
Datatype
boolean
Alias
- UMLS CUI [1]
- C0744257
- UMLS CUI [2,1]
- C0734014
- UMLS CUI [2,2]
- C0013604
Beschrijving
Gallbladder wall gas
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2246573
- UMLS CUI [1,2]
- C0016976
Beschrijving
Cholecystitis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0008325
Beschrijving
Gallbladder wall calcification
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0016976
- UMLS CUI [1,2]
- C1533591
Beschrijving
Gallbladder mass
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0016976
- UMLS CUI [1,2]
- C0577559
Beschrijving
Other gallbladder lesions
Datatype
boolean
Alias
- UMLS CUI [1]
- C0156213
Beschrijving
Other gallbladder lesions specification
Datatype
text
Alias
- UMLS CUI [1]
- C0156213
Beschrijving
Biliary ductal lesions
Alias
- UMLS CUI-1
- C0005423
- UMLS CUI-2
- C0221198
- UMLS CUI-3
- C2711860
Beschrijving
No Biliary ductal lesions
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C2711860
- UMLS CUI [1,4]
- C1298908
Beschrijving
Intrahepatic ductal dilation, right lobe
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545796
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227481
- UMLS CUI [1,4]
- C2711860
Beschrijving
Intrahepatic ductal dilation, left lobe
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0545796
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227486
- UMLS CUI [1,4]
- C2711860
Beschrijving
lntrahepatic ductal dilation, both lobes
Datatype
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
Beschrijving
Extrahepatic ductal dilation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0012359
- UMLS CUI [1,2]
- C2711860
- UMLS CUI [1,3]
- C0206187
Beschrijving
Diffuse ductal dilation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0940779
- UMLS CUI [1,2]
- C2711860
Beschrijving
Acute Cholangitis
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0267917
- UMLS CUI [1,2]
- C2711860
Beschrijving
Primary sclerosing cholangitis
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0566602
- UMLS CUI [1,2]
- C2711860
Beschrijving
Choledocholithiasis
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0701818
- UMLS CUI [1,2]
- C2711860
Beschrijving
Ductal filling defect(s), other than gallstone
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0940806
- UMLS CUI [1,2]
- C2711860
Beschrijving
Ductal wall thickening or oedema
Datatype
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
Beschrijving
Choledochal cyst
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0008340
- UMLS CUI [1,2]
- C2711860
Beschrijving
Ductal mass
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005400
- UMLS CUI [1,2]
- C0577559
- UMLS CUI [1,3]
- C2711860
Beschrijving
Extrinsic mass compressing bile duct(s)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005400
- UMLS CUI [1,2]
- C0332459
- UMLS CUI [1,3]
- C2711860
Beschrijving
Other Biliary ductal lesions
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C2711860
- UMLS CUI [1,4]
- C0205394
Beschrijving
Other Biliary ductal lesions specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C2711860
- UMLS CUI [1,4]
- C0205394
Beschrijving
Portal/Hepatic vein abnormalities?
Alias
- UMLS CUI-1
- C0019155
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0032718
- UMLS CUI-4
- C1704258
Beschrijving
None Portal/Hepatic vein abnormalities
Datatype
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
Beschrijving
Portal vein enlargement
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C0700124
Beschrijving
Hepatic vein enlargement
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0019155
- UMLS CUI [1,2]
- C0700124
Beschrijving
Nonocclusive portal vein thrombosis
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0333204
Beschrijving
Occlusive portal vein thrombosis - bland
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C1947917
Beschrijving
Hepatic vein thrombosis - bland
Datatype
boolean
Alias
- UMLS CUI [1]
- C0019154
Beschrijving
Occlusive portal vein thrombosis - malignant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0205282
Beschrijving
Hepatic vein thrombosis - malignant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0019154
- UMLS CUI [1,2]
- C0205282
Beschrijving
Involvement of the main portal vein
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0392760
- UMLS CUI [1,2]
- C1183135
Beschrijving
Involvement of the right portal vein
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0392760
- UMLS CUI [1,2]
- C0205090
- UMLS CUI [1,3]
- C0032718
Beschrijving
Involvement of the left portal vein
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0392760
- UMLS CUI [1,2]
- C0205091
- UMLS CUI [1,3]
- C0032718
Beschrijving
Budd-Chiari syndrome
Datatype
boolean
Alias
- UMLS CUI [1]
- C0856761
Beschrijving
Other Portal/Hepatic vein abnormalities
Datatype
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
Beschrijving
Other Portal/Hepatic vein abnormalities specification
Datatype
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)
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-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])