ID
41889
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 has to be filled out at the screening visit, the weekly visits during the cycles of treatment, the cycle observation visits, unscheduled visits, withdrawal visits and visits at the end of study/ treatment.
Link
https://clinicaltrials.gov/ct2/show/NCT00811733
Keywords
Versions (1)
- 2/9/21 2/9/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 9, 2021
DOI
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License
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
Constitutional Symptoms and ECOG
- StudyEvent: ODM
Description
Constitutional Symptoms
Alias
- UMLS CUI-1
- C0009812
Description
Night sweats without signs of infection
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0028081
- UMLS CUI [1,2]
- C0009450
- UMLS CUI [1,3]
- C0332197
Description
Recent unintentional weight loss
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C2363736
Description
Recurrent, unexplained fever
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2945760
- UMLS CUI [1,2]
- C1844662
Description
Extreme fatigue
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205403
- UMLS CUI [1,2]
- C0015672
Description
ECOG Performance Status Scale
Alias
- UMLS CUI-1
- C1520224
Similar models
Constitutional Symptoms and ECOG
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0009450 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C2363736 (UMLS CUI [1,2])
C1844662 (UMLS CUI [1,2])
C0015672 (UMLS CUI [1,2])
C2964552 (UMLS CUI [1,2])
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