0 Ratings
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])
    Back to the top of the page 

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