ID
41957
Descripción
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
Palabras clave
Versiones (1)
- 22/2/21 22/2/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
22 de febrero de 2021
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 4.0
Comentarios del modelo :
Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.
Comentarios de grupo de elementos para :
Comentarios del elemento para :
Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.
GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733
CT Assessment
- StudyEvent: ODM
Descripción
CT Assessment Questions
Alias
- UMLS CUI-1
- C0040405
Descripción
CT Lymph Node Assesment required
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C0040405
- UMLS CUI [1,3]
- C1514873
Descripción
CT Organomegaly Assesment required
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C4054315
- UMLS CUI [1,2]
- C0040405
- UMLS CUI [1,3]
- C1514873
Descripción
Lymph Node CT Assessments
Alias
- UMLS CUI-1
- C0024204
- UMLS CUI-2
- C0040405
Descripción
Date of CT
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040405
Descripción
Lymph node number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C0237753
Descripción
[read only]
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0024204
Descripción
[read only]
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C0450429
Descripción
Lymph node, longest diameter
Tipo de datos
integer
Unidades de medida
- cm
Alias
- UMLS CUI [1,1]
- C0024204
- UMLS CUI [1,2]
- C0552406
Descripción
Lymph node, shortest diameter
Tipo de datos
integer
Unidades de medida
- 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])