ID

42514

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. The different parts of this form have to be filled out at the Screening Visit and/or at unscheduled visits.

Link

https://clinicaltrials.gov/ct2/show/NCT00811733

Keywords

Versions (1)
  1. 8/11/21 8/11/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 11, 2021

DOI

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License

Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

English

Histology

1 forms  
  1. StudyEvent: ODM
    1. Histology
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
date of visit/assessment
Description

date of visit/assessment

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
subject number
Description

subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
visit type
Description

visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Waldenstrom's Histology
Description

Waldenstrom's Histology

Alias
UMLS CUI-1
C0024419
UMLS CUI-2
C0019638
Date sample taken
Description

Waldenstrom Histology, Date sample taken

Data type

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0024419
UMLS CUI [1,3]
C0019638
Waldenstrom histology confirmation
Description

Positive - Unequivocal histologic evidence of WM Negative - No Histologic evidence of WM Indeterminate - Bone marrow demonstrates lymphoplastic cells whose identity cannot be determined

Data type

text

Alias
UMLS CUI [1,1]
C0024419
UMLS CUI [1,2]
C0019638
Diagnosis of WM confirmed
Description

[hidden]

Data type

boolean

Alias
UMLS CUI [1,1]
C0024419
UMLS CUI [1,2]
C0750484
Any evidence of lymphoplasmacytic lymphoma?
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0334633
UMLS CUI [1,2]
C3887511
Morphologic description
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0332437
UMLS CUI [1,2]
C0678257
Lymphoplasmacytic lymphoma histology
Description

Lymphoplasmacytic lymphoma histology

Alias
UMLS CUI-1
C0334633
UMLS CUI-2
C0019638
Laboratory ID
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C2986056
Laboratories
Description

[read-only]

Data type

text

Alias
UMLS CUI [1]
C0022877
Laboratory used for this sample
Description

Select the correct laboratory number, based on the laboratories entered in the LABS form.

Data type

integer

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C1524063
Lymphocytes upper value
Description

Please enter % of overall cellularity (estimated range to 10%)

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0024264
UMLS CUI [1,3]
C1282910
UMLS CUI [1,4]
C0439165
%
Lymphocytes, lower value
Description

Please enter % of overall cellularity (estimated range to 10%)

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0024264
UMLS CUI [1,3]
C0205251
UMLS CUI [1,4]
C0439165
%
Plasma Cells, upper value
Description

Please enter % of overall cellularity (estimated range to 10%)

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0032112
UMLS CUI [1,3]
C1282910
UMLS CUI [1,4]
C0439165
%
Plasma Cells, lower value
Description

Please enter % of overall cellularity (estimated range to 10%)

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0032112
UMLS CUI [1,3]
C0205251
UMLS CUI [1,4]
C0439165
%
CD138+ staining, upper value
Description

Please enter % of overall cellularity (estimated range to 10%)

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0021044
UMLS CUI [1,2]
C0753253
UMLS CUI [1,3]
C0487602
UMLS CUI [1,4]
C1282910
UMLS CUI [1,5]
C0439165
%
CD138+ staining, lower value
Description

Please enter % of overall cellularity (estimated range to 10%)

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0021044
UMLS CUI [1,2]
C0753253
UMLS CUI [1,3]
C0487602
UMLS CUI [1,4]
C0205251
UMLS CUI [1,5]
C0439165
%
CD46+ staining, upper value
Description

Please enter % of overall cellularity (estimated range to 10%)

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0021044
UMLS CUI [1,2]
C0285488
UMLS CUI [1,3]
C0487602
UMLS CUI [1,4]
C1282910
UMLS CUI [1,5]
C0439165
%
CD46+ staining, lower value
Description

Please enter % of overall cellularity (estimated range to 10%)

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0021044
UMLS CUI [1,2]
C0285488
UMLS CUI [1,3]
C0487602
UMLS CUI [1,4]
C0205251
UMLS CUI [1,5]
C0439165
%
CD55+ staining, upper value
Description

Please enter % of overall cellularity (estimated range to 10%)

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0021044
UMLS CUI [1,2]
C0108793
UMLS CUI [1,3]
C0487602
UMLS CUI [1,4]
C1282910
UMLS CUI [1,5]
C0439165
%
CD55+ staining, lower value
Description

Please enter % of overall cellularity (estimated range to 10%)

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0021044
UMLS CUI [1,2]
C0108793
UMLS CUI [1,3]
C0487602
UMLS CUI [1,4]
C0205251
UMLS CUI [1,5]
C0439165
%
CD59+ staining, upper value
Description

Please enter % of overall cellularity (estimated range to 10%)

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0021044
UMLS CUI [1,2]
C0054966
UMLS CUI [1,3]
C0487602
UMLS CUI [1,4]
C1282910
UMLS CUI [1,5]
C0439165
%
CD59+ staining, lower value
Description

Please enter % of overall cellularity (estimated range to 10%)

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0021044
UMLS CUI [1,2]
C0054966
UMLS CUI [1,3]
C0487602
UMLS CUI [1,4]
C0205251
UMLS CUI [1,5]
C0439165
%
Lymphoid aggregates present
Description

Lymphoid aggregates present

Data type

boolean

Alias
UMLS CUI [1,1]
C0229653
UMLS CUI [1,2]
C0150312
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Similar models

Histology

1 forms
  1. StudyEvent: ODM
    1. Histology
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
date of visit/assessment
Item
date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
subject ID
Item
subject number
text
C2348585 (UMLS CUI [1])
Item
visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
visit type
Code List
visit type
CL Item
screening (1)
CL Item
unscheduled visit (2)
Item Group
Waldenstrom's Histology
C0024419 (UMLS CUI-1)
C0019638 (UMLS CUI-2)
Waldenstrom Histology, Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1,1])
C0024419 (UMLS CUI [1,2])
C0019638 (UMLS CUI [1,3])
Item
Waldenstrom histology confirmation
text
C0024419 (UMLS CUI [1,1])
C0019638 (UMLS CUI [1,2])
Waldenstrom histology confirmation
Code List
Waldenstrom histology confirmation
CL Item
positive (pos)
CL Item
negative (neg)
CL Item
indeterminate (ind)
Diagnosis of WM confirmed
Item
Diagnosis of WM confirmed
boolean
C0024419 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
Item
Any evidence of lymphoplasmacytic lymphoma?
text
C0334633 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
Evidence of lymphoplasmacytic lymphoma
Code List
Any evidence of lymphoplasmacytic lymphoma?
CL Item
Yes (Y)
CL Item
Negative (Neg)
CL Item
Indeterminate (Ind)
Morphologic description
Item
Morphologic description
text
C0332437 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item Group
Lymphoplasmacytic lymphoma histology
C0334633 (UMLS CUI-1)
C0019638 (UMLS CUI-2)
Laboratory ID
Item
Laboratory ID
text
C2986056 (UMLS CUI [1])
Laboratories
Item
Laboratories
text
C0022877 (UMLS CUI [1])
Item
Laboratory used for this sample
integer
C0022877 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Laboratory used
Code List
Laboratory used for this sample
CL Item
Laboratory 1  (1)
CL Item
Laboratory 2 (2)
CL Item
Laboratory 3 (3)
CL Item
Laboratory 4 (4)
CL Item
Laboratory 5 (5)
CL Item
Laboratory 6 (6)
Histologic Review, Lymphocytes, upper value
Item
Lymphocytes upper value
integer
C0019638 (UMLS CUI [1,1])
C0024264 (UMLS CUI [1,2])
C1282910 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
Histologic Review, Lymphocytes, lower value
Item
Lymphocytes, lower value
integer
C0019638 (UMLS CUI [1,1])
C0024264 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
Histologic Review, Plasma Cells, upper value
Item
Plasma Cells, upper value
integer
C0019638 (UMLS CUI [1,1])
C0032112 (UMLS CUI [1,2])
C1282910 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
Histologic Review, Plasma Cells, lower value
Item
Plasma Cells, lower value
integer
C0019638 (UMLS CUI [1,1])
C0032112 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
Immunohistochemistry, CD138+ staining, upper value
Item
CD138+ staining, upper value
integer
C0021044 (UMLS CUI [1,1])
C0753253 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])
C1282910 (UMLS CUI [1,4])
C0439165 (UMLS CUI [1,5])
Immunohistochemistry, CD138+ staining, lower value
Item
CD138+ staining, lower value
integer
C0021044 (UMLS CUI [1,1])
C0753253 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,4])
C0439165 (UMLS CUI [1,5])
Immunohistochemistry, CD46+ staining, upper value
Item
CD46+ staining, upper value
integer
C0021044 (UMLS CUI [1,1])
C0285488 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])
C1282910 (UMLS CUI [1,4])
C0439165 (UMLS CUI [1,5])
Immunohistochemistry, CD46+ staining, lower value
Item
CD46+ staining, lower value
integer
C0021044 (UMLS CUI [1,1])
C0285488 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,4])
C0439165 (UMLS CUI [1,5])
Immunohistochemistry, CD55+ staining, upper value
Item
CD55+ staining, upper value
integer
C0021044 (UMLS CUI [1,1])
C0108793 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])
C1282910 (UMLS CUI [1,4])
C0439165 (UMLS CUI [1,5])
Immunohistochemistry, CD55+ staining, lower value
Item
CD55+ staining, lower value
integer
C0021044 (UMLS CUI [1,1])
C0108793 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,4])
C0439165 (UMLS CUI [1,5])
Immunohistochemistry, CD59+ staining, upper value
Item
CD59+ staining, upper value
integer
C0021044 (UMLS CUI [1,1])
C0054966 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])
C1282910 (UMLS CUI [1,4])
C0439165 (UMLS CUI [1,5])
Immunohistochemistry, CD59+ staining, lower value
Item
CD59+ staining, lower value
integer
C0021044 (UMLS CUI [1,1])
C0054966 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])
C0205251 (UMLS CUI [1,4])
C0439165 (UMLS CUI [1,5])
Lymphoid aggregates present
Item
Lymphoid aggregates present
boolean
C0229653 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
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