ID
44785
Descripción
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
Palabras clave
Versiones (1)
- 26/11/21 26/11/21 - Sarah Riepenhausen
Titular de derechos de autor
GlaxoSmithKline
Subido en
26 de noviembre de 2021
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
Liver imaging
- StudyEvent: ODM
Descripción
What method was used for this imaging test?
Alias
- UMLS CUI-1
- C1275506
Descripción
method used for imaging test
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1275506
Descripción
other method used for imaging test
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1275506
- UMLS CUI [1,2]
- C3845569
Descripción
Are images technically adequate?
Alias
- UMLS CUI-1
- C0806487
- UMLS CUI-2
- C0205410
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
- C1517526
- UMLS CUI-4
- C0332448
Descripción
diffuse and/or geographic fatty infiltrate of the liver
Tipo de datos
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
Descripción
other grade of diffuse and/or geographic fatty infiltrate of the liver
Tipo de datos
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
Descripción
Ascites present
Alias
- UMLS CUI-1
- C0003962
Descripción
Are Focal Hepatic Lesions characterisable?
Alias
- UMLS CUI-1
- C0577053
- UMLS CUI-2
- C0205234
- UMLS CUI-3
- C1880022
Descripción
Focal Hepatic Lesions characterisable
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C1880022
Descripción
Solid Focal Hepatic Lesions
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205208
Descripción
Cystic Focal Hepatic Lesions
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205207
Descripción
Hemangioma Focal Hepatic Lesions
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0018916
Descripción
Focal Nodular Hyperplasia
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0020510
Descripción
Other Focal Hepatic Lesions
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C0205394
Descripción
Other Focal Hepatic Lesions specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0577053
- UMLS CUI [1,2]
- C0205234
- UMLS CUI [1,3]
- C3845569
Descripción
Gallstones or gallbladder lesions?
Alias
- UMLS CUI-1
- C3842395
Descripción
Gallstones or gallbladder lesions
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3842395
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]
- C0734014
- UMLS CUI [1,2]
- C0333139
Descripción
Cholecystitis
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0008325
Descripción
Gallbladder wall calcification
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0734014
- UMLS CUI [1,2]
- C1533591
Descripción
Gallbladder mass
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3874422
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 [1,1]
- C0156213
- UMLS CUI [1,2]
- C2348235
Descripción
Biliary ductal lesions?
Alias
- UMLS CUI-1
- C0005423
- UMLS CUI-2
- C0221198
Descripción
Biliary ductal lesions
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
Descripción
Intrahepatic ductal dilation
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227481
Descripción
Intrahepatic ductal dilation
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227486
Descripción
Intrahepatic ductal dilation
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0005401
- UMLS CUI [1,2]
- C0012359
- UMLS CUI [1,3]
- C0227486
- UMLS CUI [1,4]
- C0227481
Descripción
Extrahepatic ductal dilation
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0206187
- UMLS CUI [1,2]
- C0012359
Descripción
Diffuse ductal dilation
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0940779
Descripción
Acute Cholangitis
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0267917
Descripción
Primary sclerosing cholangitis
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0566602
Descripción
Choledocholithiasis
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0701818
Descripción
Ductal filling defect other than gallstone
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1512083
- UMLS CUI [1,2]
- C0332555
- UMLS CUI [1,3]
- C1705847
- UMLS CUI [1,4]
- C0242216
Descripción
Ductal wall thickening or oedema
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1180044
- UMLS CUI [1,2]
- C0205400
- UMLS CUI [2,1]
- C1180044
- UMLS CUI [2,2]
- C0013604
Descripción
Choledochal cyst
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0008340
Descripción
Ductal mass
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0577559
Descripción
Extrinsic mass compressing bile duct
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0205101
- UMLS CUI [1,2]
- C0577559
- UMLS CUI [1,3]
- C0332260
- UMLS CUI [1,4]
- C0005400
Descripción
Other Biliary ductal lesions
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0005423
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- 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]
- C3845569
Descripción
Portal/Hepatic vein abnormalities?
Alias
- UMLS CUI-1
- C0019155
- UMLS CUI-2
- C0032718
- UMLS CUI-3
- C1704258
Descripción
Portal/Hepatic vein abnormalities?
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0019155
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2,1]
- C0032718
- UMLS CUI [2,2]
- 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]
- C0333203
- UMLS CUI [1,3]
- C1518371
Descripción
Hepatic vein thrombosis - bland
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0019154
- UMLS CUI [1,2]
- C1518371
Descripción
Occlusive portal vein thrombosis - malignant
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0155773
- UMLS CUI [1,2]
- C0333203
- UMLS CUI [1,3]
- C0205282
Descripción
Hepatic vein thrombosis - malignant
Tipo de datos
text
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]
- C1183135
- UMLS CUI [1,2]
- C1314939
Descripción
Involvement of the right portal vein
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0226730
- UMLS CUI [1,2]
- C1314939
Descripción
Involvement of the left portal vein
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0933785
- UMLS CUI [1,2]
- C1314939
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]
- 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])
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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])