ID

42091

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 is for logging, if any concomitant medication, (non-)serious adverse events, blood (supportive care) products or additional scans occurred during the study.

Link

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

Keywords

  1. 3/30/21 3/30/21 -
  2. 4/7/21 4/7/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 7, 2021

DOI

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License

Creative Commons BY-NC 4.0

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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

Log Status

  1. StudyEvent: ODM
    1. Log Status
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
Log Status
Description

Log Status

Alias
UMLS CUI-1
C1708728
UMLS CUI-2
C0449438
Were any concomitant medications taken by the subject prior to screening and/or during the study?
Description

Concomitant medication taken prior to screening and/or during study

Data type

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0220908
UMLS CUI [2,1]
C2347852
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C2347804
Did the subject experience any non-serious adverse events during the study?
Description

Non-serious adverse events during study

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
Did the subject experience a serious adverse event during the study?
Description

Serious adverse event during study

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
Were any blood products / blood supportive care products taken by the subject during the study?
Description

Blood products / blood supportive care products taken during study

Data type

text

Alias
UMLS CUI [1,1]
C0456388
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
UMLS CUI [2,1]
C0018938
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C2347804
Were any other/additional scans performed
Description

Other/additional scans performed

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0011923
UMLS CUI [2,1]
C1524062
UMLS CUI [2,2]
C0011923

Similar models

Log Status

  1. StudyEvent: ODM
    1. Log Status
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
Log Status
C1708728 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Item
Were any concomitant medications taken by the subject prior to screening and/or during the study?
text
C2347852 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
C2347852 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
Code List
Were any concomitant medications taken by the subject prior to screening and/or during the study?
CL Item
yes (y)
CL Item
no (n)
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
yes (y)
CL Item
no (n)
Item
Did the subject experience a serious adverse event during the study?
text
C1519255 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Code List
Did the subject experience a serious adverse event during the study?
CL Item
yes (y)
CL Item
no (n)
Item
Were any blood products / blood supportive care products taken by the subject during the study?
text
C0456388 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0018938 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
Code List
Were any blood products / blood supportive care products taken by the subject during the study?
CL Item
yes (y)
CL Item
no (n)
Item
Were any other/additional scans performed
text
C0205394 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C1524062 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
Code List
Were any other/additional scans performed
CL Item
yes (y)
CL Item
no (n)

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