ID
44785
Beschrijving
Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. Record the details of any Adverse Events or exacerbations of Adverse Events on the Non-Serious Adverse Event Form or the Serious Adverse Event form. Exacerbations of Adverse Events include increases in frequency and severity. It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study. This form has to be filled out whenever / if liver imaging is performed (in case of a liver event).
Link
https://clinicaltrials.gov/ct2/show/NCT00811733
Trefwoorden
Versies (1)
- 26-11-21 26-11-21 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
26 november 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
Liver imaging
- StudyEvent: ODM
Beschrijving
What method was used for this imaging test?
Alias
- UMLS CUI-1
- C1275506
Beschrijving
method used for imaging test
Datatype
text
Alias
- UMLS CUI [1]
- C1275506
Beschrijving
other method used for imaging test
Datatype
text
Alias
- UMLS CUI [1,1]
- C1275506
- UMLS CUI [1,2]
- C3845569
Beschrijving
Are images technically adequate?
Alias
- UMLS CUI-1
- C0806487
- UMLS CUI-2
- C0205410
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
- C1517526
- UMLS CUI-4
- C0332448
Beschrijving
diffuse and/or geographic fatty infiltrate of the liver
Datatype
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
Beschrijving
other grade of diffuse and/or geographic fatty infiltrate of the liver
Datatype
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
Beschrijving
Ascites present
Alias
- UMLS CUI-1
- C0003962
Beschrijving
Are Focal Hepatic Lesions characterisable?
Alias
- UMLS CUI-1
- C0577053
- UMLS CUI-2
- C0205234
- UMLS CUI-3
- C1880022
Beschrijving
Focal Hepatic Lesions characterisable
Datatype
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C1880022
Beschrijving
Solid Focal Hepatic Lesions
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205208
Beschrijving
Cystic Focal Hepatic Lesions
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205207
Beschrijving
Hemangioma Focal Hepatic Lesions
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0018916
Beschrijving
Focal Nodular Hyperplasia
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0020510
Beschrijving
Other Focal Hepatic Lesions
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
Beschrijving
Other Focal Hepatic Lesions specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C3845569
Beschrijving
Gallstones or gallbladder lesions?
Alias
- UMLS CUI-1
- C3842395
Beschrijving
Gallstones or gallbladder lesions
Datatype
text
Alias
- UMLS CUI [1]
- C3842395
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]
- C0734014
- UMLS CUI [1,2]
- C0333139
Beschrijving
Cholecystitis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0008325
Beschrijving
Gallbladder wall calcification
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0734014
- UMLS CUI [1,2]
- C1533591
Beschrijving
Gallbladder mass
Datatype
boolean
Alias
- UMLS CUI [1]
- C3874422
Beschrijving
Other gallbladder lesions
Datatype
boolean
Alias
- UMLS CUI [1]
- C0156213
Beschrijving
Other gallbladder lesions specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0156213
- UMLS CUI [1,2]
- C2348235
Beschrijving
Biliary ductal lesions?
Alias
- UMLS CUI-1
- C0005423
- UMLS CUI-2
- C0221198
Beschrijving
Biliary ductal lesions
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
Beschrijving
Intrahepatic ductal dilation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227481
Beschrijving
Intrahepatic ductal dilation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227486
Beschrijving
Intrahepatic ductal dilation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227486
- UMLS CUI [1,4]
- C0227481
Beschrijving
Extrahepatic ductal dilation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0206187
- UMLS CUI [1,2]
- C0012359
Beschrijving
Diffuse ductal dilation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0940779
Beschrijving
Acute Cholangitis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0267917
Beschrijving
Primary sclerosing cholangitis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0566602
Beschrijving
Choledocholithiasis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0701818
Beschrijving
Ductal filling defect other than gallstone
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1512083
- UMLS CUI [1,2]
- C0332555
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0242216
Beschrijving
Ductal wall thickening or oedema
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1180044
- UMLS CUI [1,2]
- C0205400
- UMLS CUI [2,1]
- C1180044
- UMLS CUI [2,2]
- C0013604
Beschrijving
Choledochal cyst
Datatype
boolean
Alias
- UMLS CUI [1]
- C0008340
Beschrijving
Ductal mass
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0577559
Beschrijving
Extrinsic mass compressing bile duct
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205101
- UMLS CUI [1,2]
- C0577559
- UMLS CUI [1,3]
- C0332260
- UMLS CUI [1,4]
- C0005400
Beschrijving
Other Biliary ductal lesions
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0205394
Beschrijving
Other Biliary ductal lesions specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C3845569
Beschrijving
Portal/Hepatic vein abnormalities?
Alias
- UMLS CUI-1
- C0019155
- UMLS CUI-2
- C0032718
- UMLS CUI-3
- C1704258
Beschrijving
Portal/Hepatic vein abnormalities?
Datatype
text
Alias
- UMLS CUI [1,1]
- C0019155
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2,1]
- C0032718
- UMLS CUI [2,2]
- 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]
- C0333203
- UMLS CUI [1,3]
- C1518371
Beschrijving
Hepatic vein thrombosis - bland
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0019154
- UMLS CUI [1,2]
- C1518371
Beschrijving
Occlusive portal vein thrombosis - malignant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0333203
- UMLS CUI [1,3]
- C0205282
Beschrijving
Hepatic vein thrombosis - malignant
Datatype
text
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]
- C1183135
- UMLS CUI [1,2]
- C1314939
Beschrijving
Involvement of the right portal vein
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0226730
- UMLS CUI [1,2]
- C1314939
Beschrijving
Involvement of the left portal vein
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0933785
- UMLS CUI [1,2]
- C1314939
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]
- 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
Similar models
Liver imaging
- StudyEvent: ODM
C0011008 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
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])
C0227486 (UMLS CUI [1,3])
C0227481 (UMLS CUI [1,4])
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])