ID
41056
Description
This form documents the liver imaging. To be assessed at liver event visit. Study ID: 103629 Clinical Study ID: TRX103629 Study Title: An open-label, randomized, 3-period crossover study to evaluate sumatriptan and naproxen pharmacokinetics for a combination tablet product containing sumatriptan/naproxen sodium followed by IMITREX™ (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System and a sumatriptan/naproxen sodium tablet followed by IMITREX (sumatriptan succinate) Injection 6mg administered using the STATdose system compared with an IMITREX tablet 100mg followed by an IMITREX tablet 100mg Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00875784 Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/show/NCT00875784 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders
Link
https://clinicaltrials.gov/ct2/show/NCT00875784
Keywords
Versions (2)
- 6/16/20 6/16/20 -
- 6/17/20 6/17/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
June 17, 2020
DOI
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License
Creative Commons BY-NC 4.0
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Sumatriptan pharmacokinetics for TREXIMA/IMITREX ID 103629
Liver Imaging
- StudyEvent: ODM
Description
Date of hepatic or liver imaging test
Alias
- UMLS CUI-1
- C2711860
- UMLS CUI-2
- C0011008
Description
What method was used for this imaging test?
Alias
- UMLS CUI-1
- C1275506
Description
method used for imaging test
Data type
text
Alias
- UMLS CUI [1]
- C1275506
Description
other method used for imaging test
Data type
text
Alias
- UMLS CUI [1,1]
- C1275506
- UMLS CUI [1,2]
- C3845569
Description
Are images technically adequate?
Alias
- UMLS CUI-1
- C0806487
- UMLS CUI-2
- C0205410
Description
Indicate the liver size
Alias
- UMLS CUI-1
- C0426688
Description
Indicate the 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
- C1517526
- UMLS CUI-4
- C0332448
Description
diffuse and/or geographic fatty infiltrate of the liver
Data type
text
Alias
- UMLS CUI [1,1]
- C0015695
- UMLS CUI [1,2]
- C0205219
- UMLS CUI [1,3]
- C0332448
- UMLS CUI [2,1]
- C0015695
- UMLS CUI [2,2]
- C1517526
- UMLS CUI [2,3]
- C0332448
Description
other grade of diffuse and/or geographic fatty infiltrate of the liver
Data type
text
Alias
- UMLS CUI [1,1]
- C0015695
- UMLS CUI [1,2]
- C0205219
- UMLS CUI [1,3]
- C3845569
- UMLS CUI [1,4]
- C0332448
- UMLS CUI [2,1]
- C0015695
- UMLS CUI [2,2]
- C1517526
- UMLS CUI [2,3]
- C3845569
- UMLS CUI [2,4]
- C0332448
Description
Ascites present
Alias
- UMLS CUI-1
- C0003962
Description
Are Focal Hepatic Lesions characterisable?
Alias
- UMLS CUI-1
- C0577053
- UMLS CUI-2
- C0205234
- UMLS CUI-3
- C1880022
Description
Focal Hepatic Lesions characterisable
Data type
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C1880022
Description
Solid Focal Hepatic Lesions
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205208
Description
Cystic Focal Hepatic Lesions
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205207
Description
Hemangioma Focal Hepatic Lesions
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0018916
Description
Focal Nodular Hyperplasia
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0020510
Description
Other Focal Hepatic Lesions
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
Description
Other Focal Hepatic Lesions specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C3845569
Description
Gallstones or gallbladder lesions?
Alias
- UMLS CUI-1
- C3842395
Description
Gallstones or gallbladder lesions
Data type
text
Alias
- UMLS CUI [1]
- C3842395
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]
- C0734014
- UMLS CUI [1,2]
- C0333139
Description
Cholecystitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0008325
Description
Gallbladder wall calcification
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0734014
- UMLS CUI [1,2]
- C1533591
Description
Gallbladder mass
Data type
boolean
Alias
- UMLS CUI [1]
- C3874422
Description
Other gallbladder lesions
Data type
boolean
Alias
- UMLS CUI [1]
- C0156213
Description
Other gallbladder lesions specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0156213
- UMLS CUI [1,2]
- C2348235
Description
Biliary ductal lesions?
Alias
- UMLS CUI-1
- C0005423
- UMLS CUI-2
- C0221198
Description
Biliary ductal lesions
Data type
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
Description
Intrahepatic ductal dilation, right hepatic lobe
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227481
Description
Intrahepatic ductal dilation, left hepatic lobe
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227486
Description
Extrahepatic ductal dilation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0206187
- UMLS CUI [1,2]
- C0012359
Description
Diffuse ductal dilation
Data type
boolean
Alias
- UMLS CUI [1]
- C0940779
Description
Acute Cholangitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0267917
Description
Primary sclerosing cholangitis
Data type
boolean
Alias
- UMLS CUI [1]
- C0566602
Description
Choledocholithiasis
Data type
boolean
Alias
- UMLS CUI [1]
- C0701818
Description
Ductal filling defect other than gallstone
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1512083
- UMLS CUI [1,2]
- C0332555
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0242216
Description
Ductal wall thickening or oedema
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1180044
- UMLS CUI [1,2]
- C0205400
- UMLS CUI [2,1]
- C1180044
- UMLS CUI [2,2]
- C0013604
Description
Choledochal cyst
Data type
boolean
Alias
- UMLS CUI [1]
- C0008340
Description
Ductal mass
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0577559
Description
Extrinsic mass compressing bile duct
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205101
- UMLS CUI [1,2]
- C0577559
- UMLS CUI [1,3]
- C0332260
- UMLS CUI [1,4]
- C0005400
Description
Other Biliary ductal lesions
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- 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]
- C3845569
Description
Portal/Hepatic vein abnormalities?
Alias
- UMLS CUI-1
- C0019155
- UMLS CUI-2
- C0032718
- UMLS CUI-3
- C1704258
Description
Portal/Hepatic vein abnormalities?
Data type
text
Alias
- UMLS CUI [1,1]
- C0019155
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2,1]
- C0032718
- UMLS CUI [2,2]
- 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]
- C0333203
- UMLS CUI [1,3]
- C1518371
Description
Hepatic vein thrombosis - bland
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019154
- UMLS CUI [1,2]
- C1518371
Description
Occlusive portal vein thrombosis - malignant
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0333203
- UMLS CUI [1,3]
- C0205282
Description
Hepatic vein thrombosis - malignant
Data type
text
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]
- C1183135
- UMLS CUI [1,2]
- C1314939
Description
Involvement of the right portal vein
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0226730
- UMLS CUI [1,2]
- C1314939
Description
Involvement of the left portal vein
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0933785
- UMLS CUI [1,2]
- C1314939
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]
- C3845569
- UMLS CUI [1,2]
- C0019155
- UMLS CUI [1,3]
- C1704258
- UMLS CUI [2,1]
- C3845569
- UMLS CUI [2,2]
- C0032718
- UMLS CUI [2,3]
- C1704258
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Liver Imaging
- StudyEvent: ODM
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C0023884 (UMLS CUI [1,2])
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C1517526 (UMLS CUI-3)
C0332448 (UMLS CUI-4)
C0205219 (UMLS CUI [1,2])
C0332448 (UMLS CUI [1,3])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
C0332448 (UMLS CUI [2,3])
C0205219 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C0332448 (UMLS CUI [1,4])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
C3845569 (UMLS CUI [2,3])
C0332448 (UMLS CUI [2,4])
C3845569 (UMLS CUI [1,2])
C0205234 (UMLS CUI-2)
C1880022 (UMLS CUI-3)
C0205234 (UMLS CUI [1,2])
C1880022 (UMLS CUI [1,3])
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])
C3845569 (UMLS CUI [1,3])
C0734014 (UMLS CUI [2,1])
C0013604 (UMLS CUI [2,2])
C0333139 (UMLS CUI [1,2])
C1533591 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0221198 (UMLS CUI-2)
C0221198 (UMLS CUI [1,2])
C0012359 (UMLS CUI [1,2])
C0227481 (UMLS CUI [1,3])
C0012359 (UMLS CUI [1,2])
C0227486 (UMLS CUI [1,3])
C0012359 (UMLS CUI [1,2])
C0332555 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0242216 (UMLS CUI [1,4])
C0205400 (UMLS CUI [1,2])
C1180044 (UMLS CUI [2,1])
C0013604 (UMLS CUI [2,2])
C0577559 (UMLS CUI [1,2])
C0577559 (UMLS CUI [1,2])
C0332260 (UMLS CUI [1,3])
C0005400 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0221198 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C0032718 (UMLS CUI-2)
C1704258 (UMLS CUI-3)
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0700124 (UMLS CUI [1,2])
C0700124 (UMLS CUI [1,2])
C0333204 (UMLS CUI [1,2])
C0333203 (UMLS CUI [1,2])
C1518371 (UMLS CUI [1,3])
C1518371 (UMLS CUI [1,2])
C0333203 (UMLS CUI [1,2])
C0205282 (UMLS CUI [1,3])
C0205282 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,2])
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])
C3845569 (UMLS CUI [2,1])
C0032718 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])