ID
44785
Description
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
Keywords
Versions (1)
- 11/26/21 11/26/21 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
November 26, 2021
DOI
To request one please log in.
License
Creative Commons BY-NC 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
Liver imaging
- StudyEvent: ODM
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
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227481
Description
Intrahepatic ductal dilation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227486
Description
Intrahepatic ductal dilation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227486
- UMLS CUI [1,4]
- C0227481
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
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])