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.
Lien
https://clinicaltrials.gov/ct2/show/NCT00811733
Mots-clés
Versions (1)
- 22/02/2021 22/02/2021 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
22 février 2021
DOI
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Licence
Creative Commons BY-NC 4.0
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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
Type de données
text
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C0040405
- UMLS CUI [1,3]
- C1514873
Description
CT Organomegaly Assesment required
Type de données
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
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040405
Description
Lymph node number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C0237753
Description
[read only]
Type de données
text
Alias
- UMLS CUI [1]
- C0024204
Description
[read only]
Type de données
text
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C0450429
Description
Lymph node, longest diameter
Type de données
integer
Unités de mesure
- cm
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C0552406
Description
Lymph node, shortest diameter
Type de données
integer
Unités de mesure
- 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])