ID
41836
Beschreibung
Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document documents any liver imaging, if taken during the study.
Link
https://clinicaltrials.gov/ct2/show/NCT00821054
Stichworte
Versionen (1)
- 26.01.21 26.01.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
26. Januar 2021
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 4.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054
Liver imaging
- StudyEvent: ODM
Beschreibung
What method was used for this imaging test?
Alias
- UMLS CUI-1
- C1275506
Beschreibung
method used for imaging test
Datentyp
text
Alias
- UMLS CUI [1]
- C1275506
Beschreibung
other method used for imaging test
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1275506
- UMLS CUI [1,2]
- C3845569
Beschreibung
Are images technically adequate?
Alias
- UMLS CUI-1
- C0806487
- UMLS CUI-2
- C0205410
Beschreibung
Indicate the liver size
Alias
- UMLS CUI-1
- C0426688
Beschreibung
Indicate the liver texture
Alias
- UMLS CUI-1
- C0679033
- UMLS CUI-2
- C0023884
Beschreibung
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
Beschreibung
diffuse and/or geographic fatty infiltrate of the liver
Datentyp
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
Beschreibung
other grade of diffuse and/or geographic fatty infiltrate of the liver
Datentyp
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
Beschreibung
Ascites present
Alias
- UMLS CUI-1
- C0003962
Beschreibung
Are Focal Hepatic Lesions characterisable?
Alias
- UMLS CUI-1
- C0577053
- UMLS CUI-2
- C0205234
- UMLS CUI-3
- C1880022
Beschreibung
Focal Hepatic Lesions characterisable
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C1880022
Beschreibung
Solid Focal Hepatic Lesions
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205208
Beschreibung
Cystic Focal Hepatic Lesions
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205207
Beschreibung
Hemangioma Focal Hepatic Lesions
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0018916
Beschreibung
Focal Nodular Hyperplasia
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0020510
Beschreibung
Other Focal Hepatic Lesions
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
Beschreibung
Other Focal Hepatic Lesions specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C3845569
Beschreibung
Gallstones or gallbladder lesions?
Alias
- UMLS CUI-1
- C3842395
Beschreibung
Gallstones or gallbladder lesions
Datentyp
text
Alias
- UMLS CUI [1]
- C3842395
Beschreibung
Gallstones
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0008350
Beschreibung
Gallbladder polyps
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0262493
Beschreibung
Sludge
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0860209
Beschreibung
Gallbladder wall thickening/oedema
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0744257
- UMLS CUI [2,1]
- C0734014
- UMLS CUI [2,2]
- C0013604
Beschreibung
Gallbladder wall gas
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0734014
- UMLS CUI [1,2]
- C0333139
Beschreibung
Cholecystitis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0008325
Beschreibung
Gallbladder wall calcification
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0734014
- UMLS CUI [1,2]
- C1533591
Beschreibung
Gallbladder mass
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3874422
Beschreibung
Other gallbladder lesions
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0156213
Beschreibung
Other gallbladder lesions specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0156213
- UMLS CUI [1,2]
- C2348235
Beschreibung
Biliary ductal lesions?
Alias
- UMLS CUI-1
- C0005423
- UMLS CUI-2
- C0221198
Beschreibung
Biliary ductal lesions
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
Beschreibung
Intrahepatic ductal dilation
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227481
Beschreibung
Intrahepatic ductal dilation
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227486
Beschreibung
Extrahepatic ductal dilation
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0206187
- UMLS CUI [1,2]
- C0012359
Beschreibung
Diffuse ductal dilation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0940779
Beschreibung
Acute Cholangitis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0267917
Beschreibung
Primary sclerosing cholangitis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0566602
Beschreibung
Choledocholithiasis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0701818
Beschreibung
Ductal filling defect other than gallstone
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1512083
- UMLS CUI [1,2]
- C0332555
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0242216
Beschreibung
Ductal wall thickening or oedema
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1180044
- UMLS CUI [1,2]
- C0205400
- UMLS CUI [2,1]
- C1180044
- UMLS CUI [2,2]
- C0013604
Beschreibung
Choledochal cyst
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0008340
Beschreibung
Ductal mass
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0577559
Beschreibung
Extrinsic mass compressing bile duct
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205101
- UMLS CUI [1,2]
- C0577559
- UMLS CUI [1,3]
- C0332260
- UMLS CUI [1,4]
- C0005400
Beschreibung
Other Biliary ductal lesions
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0205394
Beschreibung
Other Biliary ductal lesions specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C3845569
Beschreibung
Portal/Hepatic vein abnormalities?
Alias
- UMLS CUI-1
- C0019155
- UMLS CUI-2
- C0032718
- UMLS CUI-3
- C1704258
Beschreibung
Portal/Hepatic vein abnormalities?
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0019155
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2,1]
- C0032718
- UMLS CUI [2,2]
- C1704258
Beschreibung
Portal vein enlargement
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0032718
- UMLS CUI [1,2]
- C0700124
Beschreibung
Hepatic vein enlargement
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0019155
- UMLS CUI [1,2]
- C0700124
Beschreibung
Nonocclusive portal vein thrombosis
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0333204
Beschreibung
Occlusive portal vein thrombosis - bland
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0333203
- UMLS CUI [1,3]
- C1518371
Beschreibung
Hepatic vein thrombosis - bland
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0019154
- UMLS CUI [1,2]
- C1518371
Beschreibung
Occlusive portal vein thrombosis - malignant
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0333203
- UMLS CUI [1,3]
- C0205282
Beschreibung
Hepatic vein thrombosis - malignant
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0019154
- UMLS CUI [1,2]
- C0205282
Beschreibung
Involvement of the main portal vein
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1183135
- UMLS CUI [1,2]
- C1314939
Beschreibung
Involvement of the right portal vein
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0226730
- UMLS CUI [1,2]
- C1314939
Beschreibung
Involvement of the left portal vein
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0933785
- UMLS CUI [1,2]
- C1314939
Beschreibung
Budd-Chiari syndrome
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0856761
Beschreibung
Other Portal/Hepatic vein abnormalities
Datentyp
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
Beschreibung
Other Portal/Hepatic vein abnormalities specification
Datentyp
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
Ähnliche Modelle
Liver imaging
- StudyEvent: ODM
C0011008 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
(Comment:en)
C0860888 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C3845569 (UMLS CUI [1,2])
C0205410 (UMLS CUI-2)
C0205410 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C0205219 (UMLS CUI-2)
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])