ID

41965

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 any unscheduled visits.

Link

https://clinicaltrials.gov/ct2/show/NCT00811733

Keywords

Versions (2)
  1. 2/22/21 2/22/21 -
  2. 2/24/21 2/24/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 24, 2021

DOI

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License

Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

English

Unscheduled Assessments

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
date of visit/assessment
Description

date of visit/assessment

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
subject number
Description

subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Unscheduled Assessments
Description

Unscheduled Assessments

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C3854240
Lab
Description

Select any unscheduled assessments that were performed at this visit.

Data type

boolean

Alias
UMLS CUI [1]
C0022885
Lab - Local
Description

Select any unscheduled assessments that were performed at this visit.

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0205276
Lab - Bone Marrow
Description

Select any unscheduled assessments that were performed at this visit.

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0022885
Constitutional symptoms
Description

Select any unscheduled assessments that were performed at this visit.

Data type

boolean

Alias
UMLS CUI [1]
C0009812
ECOG Performance status scale
Description

Select any unscheduled assessments that were performed at this visit.

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Vital signs
Description

Select any unscheduled assessments that were performed at this visit.

Data type

boolean

Alias
UMLS CUI [1]
C0518766
Physical exam organ
Description

Select any unscheduled assessments that were performed at this visit.

Data type

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0178784
Physical exam lymph node
Description

Select any unscheduled assessments that were performed at this visit.

Data type

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024204
Response evaluation
Description

Select any unscheduled assessments that were performed at this visit.

Data type

boolean

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0220825
CT Organ/Lymph node Assessment
Description

Select any unscheduled assessments that were performed at this visit.

Data type

boolean

Alias
UMLS CUI [1,1]
C0040405
UMLS CUI [1,2]
C0178784
UMLS CUI [2,1]
C0040405
UMLS CUI [2,2]
C0024204
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Similar models

Unscheduled Assessments

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
date of visit/assessment
Item
date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
subject ID
Item
subject number
text
C2348585 (UMLS CUI [1])
Item Group
Unscheduled Assessments
C0220825 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Lab Assessment
Item
Lab
boolean
C0022885 (UMLS CUI [1])
Lab - Local Assessment
Item
Lab - Local
boolean
C0022885 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Lab - Bone Marrow Assessment
Item
Lab - Bone Marrow
boolean
C0005953 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Constitutional symptoms
Item
Constitutional symptoms
boolean
C0009812 (UMLS CUI [1])
ECOG Performance status scale
Item
ECOG Performance status scale
boolean
C1520224 (UMLS CUI [1])
Vital signs
Item
Vital signs
boolean
C0518766 (UMLS CUI [1])
Physical exam organ
Item
Physical exam organ
boolean
C0031809 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
Physical exam lymph node
Item
Physical exam lymph node
boolean
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
Response evaluation
Item
Response evaluation
boolean
C0521982 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
CT Organ/Lymph node Assessment
Item
CT Organ/Lymph node Assessment
boolean
C0040405 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0040405 (UMLS CUI [2,1])
C0024204 (UMLS CUI [2,2])
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