ID
41957
Beschreibung
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
Stichworte
Versionen (1)
- 22.02.21 22.02.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
22. Februar 2021
DOI
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Lizenz
Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
CT Assessment
- StudyEvent: ODM
Beschreibung
CT Assessment Questions
Alias
- UMLS CUI-1
- C0040405
Beschreibung
CT Lymph Node Assesment required
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C0040405
- UMLS CUI [1,3]
- C1514873
Beschreibung
CT Organomegaly Assesment required
Datentyp
text
Alias
- UMLS CUI [1,1]
- C4054315
- UMLS CUI [1,2]
- C0040405
- UMLS CUI [1,3]
- C1514873
Beschreibung
Lymph Node CT Assessments
Alias
- UMLS CUI-1
- C0024204
- UMLS CUI-2
- C0040405
Beschreibung
Date of CT
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040405
Beschreibung
Lymph node number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C0237753
Beschreibung
[read only]
Datentyp
text
Alias
- UMLS CUI [1]
- C0024204
Beschreibung
[read only]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C0450429
Beschreibung
Lymph node, longest diameter
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C0552406
Beschreibung
Lymph node, shortest diameter
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C1301886
- UMLS CUI [1,3]
- C1806781
Ähnliche Modelle
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])