ID
33900
Descripción
Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 4 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) 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/NCT01209026?term=NCT01209026
Palabras clave
Versiones (1)
- 6/1/19 6/1/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
6 de enero de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026
Liver Imaging
- StudyEvent: ODM
Descripción
Liver imaging
Alias
- UMLS CUI-1
- C2711860
Descripción
What method was used for this imaging test?
Alias
- UMLS CUI-1
- C2711860
- UMLS CUI-2
- C0871511
Descripción
Method
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0871511
Descripción
Other method
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0871511
- UMLS CUI [1,2]
- C0205394
Descripción
Are images technically adequate?
Alias
- UMLS CUI-1
- C0806487
Descripción
Indicate the liver size
Alias
- UMLS CUI-1
- C0426688
Descripción
Indicate the liver texture
Alias
- UMLS CUI-1
- C0679033
- UMLS CUI-2
- C0023884
Descripción
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
Descripción
Diffuse and/or geographic fatty infiltrate of liver
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0015695
- UMLS CUI [1,2]
- C0205219
- UMLS CUI [2,1]
- C0015695
- UMLS CUI [2,2]
- C1517526
Descripción
Other diffuse and/or geographic fatty infiltrate of liver
Tipo de datos
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
Descripción
Ascites present
Alias
- UMLS CUI-1
- C0003962
Descripción
Are Focal Hepatic Lesions characterisable?
Alias
- UMLS CUI-1
- C0577053
- UMLS CUI-2
- C0205234
Descripción
Focal hepatic lesions: Not applicable - no hepatic lesions
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1272460
- UMLS CUI [2,1]
- C0577053
- UMLS CUI [2,2]
- C0205234
- UMLS CUI [2,3]
- C1298908
Descripción
Focal hepatic lesions: Solid
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205208
Descripción
Focal hepatic lesions: Cystic
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205207
Descripción
Focal hepatic lesions: Hemangioma
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0018916
Descripción
Focal hepatic lesions: Focal Nodular Hyperplasia
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0020510
Descripción
Focal hepatic lesions: Other
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
Descripción
Focal hepatic lesions: Other, specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
Descripción
Gallstones or gallbladder lesions
Alias
- UMLS CUI-1
- C3842395
- UMLS CUI-2
- C0221198
Descripción
No Gallstones or gallbladder lesions
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1298908
- UMLS CUI [1,2]
- C3842395
- UMLS CUI [2,1]
- C1298908
- UMLS CUI [2,2]
- C0221198
Descripción
Gallstones
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0008350
Descripción
Gallbladder polyps
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0262493
Descripción
Sludge
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0860209
Descripción
Gallbladder wall thickening/oedema
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0744257
- UMLS CUI [2,1]
- C0734014
- UMLS CUI [2,2]
- C0013604
Descripción
Gallbladder wall gas
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2246573
- UMLS CUI [1,2]
- C0016976
Descripción
Cholecystitis
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0008325
Descripción
Gallbladder wall calcification
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0016976
- UMLS CUI [1,2]
- C1533591
Descripción
Gallbladder mass
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0016976
- UMLS CUI [1,2]
- C0577559
Descripción
Other gallbladder lesions
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0156213
Descripción
Other gallbladder lesions specification
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0156213
Descripción
Biliary ductal lesions
Alias
- UMLS CUI-1
- C0005423
- UMLS CUI-2
- C0221198
- UMLS CUI-3
- C2711860
Descripción
No Biliary ductal lesions
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C2711860
- UMLS CUI [1,4]
- C1298908
Descripción
Intrahepatic ductal dilation, right lobe
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0545796
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227481
- UMLS CUI [1,4]
- C2711860
Descripción
Intrahepatic ductal dilation, left lobe
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0545796
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227486
- UMLS CUI [1,4]
- C2711860
Descripción
lntrahepatic ductal dilation, both lobes
Tipo de datos
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
Descripción
Extrahepatic ductal dilation
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0012359
- UMLS CUI [1,2]
- C2711860
- UMLS CUI [1,3]
- C0206187
Descripción
Diffuse ductal dilation
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0940779
- UMLS CUI [1,2]
- C2711860
Descripción
Acute Cholangitis
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0267917
- UMLS CUI [1,2]
- C2711860
Descripción
Primary sclerosing cholangitis
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0566602
- UMLS CUI [1,2]
- C2711860
Descripción
Choledocholithiasis
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0701818
- UMLS CUI [1,2]
- C2711860
Descripción
Ductal filling defect(s), other than gallstone
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0940806
- UMLS CUI [1,2]
- C2711860
Descripción
Ductal wall thickening or oedema
Tipo de datos
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
Descripción
Choledochal cyst
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0008340
- UMLS CUI [1,2]
- C2711860
Descripción
Ductal mass
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0005400
- UMLS CUI [1,2]
- C0577559
- UMLS CUI [1,3]
- C2711860
Descripción
Extrinsic mass compressing bile duct(s)
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0005400
- UMLS CUI [1,2]
- C0332459
- UMLS CUI [1,3]
- C2711860
Descripción
Other Biliary ductal lesions
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C2711860
- UMLS CUI [1,4]
- C0205394
Descripción
Other Biliary ductal lesions specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C2711860
- UMLS CUI [1,4]
- C0205394
Descripción
Portal/Hepatic vein abnormalities?
Alias
- UMLS CUI-1
- C0019155
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0032718
- UMLS CUI-4
- C1704258
Descripción
None Portal/Hepatic vein abnormalities
Tipo de datos
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
Descripción
Portal vein enlargement
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C0700124
Descripción
Hepatic vein enlargement
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0019155
- UMLS CUI [1,2]
- C0700124
Descripción
Nonocclusive portal vein thrombosis
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0333204
Descripción
Occlusive portal vein thrombosis - bland
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C1947917
Descripción
Hepatic vein thrombosis - bland
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0019154
Descripción
Occlusive portal vein thrombosis - malignant
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0205282
Descripción
Hepatic vein thrombosis - malignant
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0019154
- UMLS CUI [1,2]
- C0205282
Descripción
Involvement of the main portal vein
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0392760
- UMLS CUI [1,2]
- C1183135
Descripción
Involvement of the right portal vein
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0392760
- UMLS CUI [1,2]
- C0205090
- UMLS CUI [1,3]
- C0032718
Descripción
Involvement of the left portal vein
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0392760
- UMLS CUI [1,2]
- C0205091
- UMLS CUI [1,3]
- C0032718
Descripción
Budd-Chiari syndrome
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0856761
Descripción
Other Portal/Hepatic vein abnormalities
Tipo de datos
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
Descripción
Other Portal/Hepatic vein abnormalities specification
Tipo de datos
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])