ID
44788
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. This form is for documentation of electronically transferred lab data and is used for screening, cycle 1 weeks 1-4 and observation, cycle 2 weeks 1-4 and observation and on a potential withdrawal visit, as well as any unscheduled lab data available.
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
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License
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
Electronically transferred lab data
- StudyEvent: ODM
Description
Electronically transferred lab data- blood sample
Alias
- UMLS CUI [1]
- C0005834
Description
Electronically transferred lab data - Neuro AB Panel
Alias
- UMLS CUI [1,1]
- C0027763
- UMLS CUI [1,2]
- C0003241
- UMLS CUI [1,3]
- C0370003
Description
Neuro Antibody panel sample taken
Data type
text
Alias
- UMLS CUI [1,1]
- C0027763
- UMLS CUI [1,2]
- C0003241
- UMLS CUI [1,3]
- C0370003
- UMLS CUI [1,4]
- C0884358
Description
Date neuro antibody panel sample taken
Data type
date
Alias
- UMLS CUI [1,1]
- C0027763
- UMLS CUI [1,2]
- C0003241
- UMLS CUI [1,3]
- C0370003
- UMLS CUI [1,4]
- C0011008
Description
Electronically transferred lab data - prognostic factors
Alias
- UMLS CUI [1,1]
- C1514474
- UMLS CUI [1,2]
- C0370003
Similar models
Electronically transferred lab data
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0011008 (UMLS CUI [1,2])
C0003241 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,3])
C0003241 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,3])
C0884358 (UMLS CUI [1,4])
C0003241 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0370003 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,3])
C0370003 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])