ID
41857
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00811733
Keywords
Versions (2)
- 2/1/21 2/1/21 -
- 2/5/21 2/5/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 5, 2021
DOI
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License
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
Inform Screening
- StudyEvent: ODM
Description
Inform Screening
Alias
- UMLS CUI-1
- C1552002
- UMLS CUI-2
- C1710032
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C2986440
Description
Date of Birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
how did you learn about this study?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0683836
- UMLS CUI [1,2]
- C0012625
- UMLS CUI [1,3]
- C0008976
Description
primary cause for interest in study
Data type
text
Alias
- UMLS CUI [1,1]
- C0205225
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0008976
- UMLS CUI [1,4]
- C0543488
Description
source of information, other interned provider
Data type
text
Alias
- UMLS CUI [1,1]
- C0683836
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1138603
Description
source of information, other
Data type
text
Alias
- UMLS CUI [1,1]
- C0683836
- UMLS CUI [1,2]
- C0205394
Description
Trial screen failure
Data type
boolean
Alias
- UMLS CUI [1]
- C1710476
Description
check all that apply
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C1512693
- UMLS CUI [2,1]
- C1710476
- UMLS CUI [2,2]
- C0680251
Description
Check all that apply
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0877248
Description
Check all that apply
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0235828
Description
Check all that apply
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C1705236
Description
Check all that apply
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C2348563
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Description
Check all that apply
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C2348570
Description
Check all that apply
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C1302313
Description
Check all that apply
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [1,3]
- C0022423
Description
investigator discretion specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0022423
- UMLS CUI [1,3]
- C2348235
Description
Check all that apply
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C1707492
Description
Consent withdrawn, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C1707492
- UMLS CUI [1,2]
- C2348235
Similar models
Inform Screening
- StudyEvent: ODM
C2985720 (UMLS CUI [2])
C0012625 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0543488 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C1138603 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,2])
C1710476 (UMLS CUI [2,1])
C0680251 (UMLS CUI [2,2])
C0877248 (UMLS CUI [1,2])
C0235828 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C2348570 (UMLS CUI [1,2])
C1302313 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1707492 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])