ID
41957
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. Both of these forms have to be filled out at the observation visits for the cycles of treatment and possible unscheduled visits. The Lymph Node CT Assessments form also has to be filled out at a possible withdrawal visit.
Link
https://clinicaltrials.gov/ct2/show/NCT00811733
Keywords
Versions (1)
- 2/22/21 2/22/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 22, 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
CT Assessment
- StudyEvent: ODM
Description
CT Assessment Questions
Alias
- UMLS CUI-1
- C0040405
Description
CT Lymph Node Assesment required
Data type
text
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C0040405
- UMLS CUI [1,3]
- C1514873
Description
CT Organomegaly Assesment required
Data type
text
Alias
- UMLS CUI [1,1]
- C4054315
- UMLS CUI [1,2]
- C0040405
- UMLS CUI [1,3]
- C1514873
Description
Lymph Node CT Assessments
Alias
- UMLS CUI-1
- C0024204
- UMLS CUI-2
- C0040405
Description
Date of CT
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040405
Description
Lymph node number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C0237753
Description
[read only]
Data type
text
Alias
- UMLS CUI [1]
- C0024204
Description
[read only]
Data type
text
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C0450429
Description
Lymph node, longest diameter
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C0552406
Description
Lymph node, shortest diameter
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C1301886
- UMLS CUI [1,3]
- C1806781
Similar models
CT Assessment
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0040405 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0040405 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0040405 (UMLS CUI-2)
C0040405 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0450429 (UMLS CUI [1,2])
C0552406 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,2])
C1806781 (UMLS CUI [1,3])