0 Ratings
ID

41942

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 the Screening Visit, the first and last weekly visits during the cycles of therapy, the cycle observation visits, unscheduled visits, withdrawal visits and the visits at the end of study/treatment.

Link

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

Keywords

Versions (1)
  1. 2/19/21 2/19/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 19, 2021

DOI

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License

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

    English

    Physical Examination

    1 forms  
    1. StudyEvent: ODM
      1. Physical Examination
    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
    visit type
    Description

    visit type

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Physical Lymph Node Examination
    Description

    Physical Lymph Node Examination

    Alias
    UMLS CUI-1
    C0031809
    UMLS CUI-2
    C0024204
    Palpation Location
    Description

    Please choose the location of the palpation, then answer the following questions

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0030247
    UMLS CUI [1,2]
    C0450429
    Are there palpable lymph nodes in location?
    Description

    Please record palpable lymph nodes (> = 1.5cm)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024204
    UMLS CUI [1,2]
    C0522499
    Lymph node width
    Description

    Please specify the size of the largest palpable lymph node

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1,1]
    C0024204
    UMLS CUI [1,2]
    C0487742
    cm
    Lymph node length
    Description

    Please specify the size of the largest palpable lymph node

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1,1]
    C0024204
    UMLS CUI [1,2]
    C1444754
    cm
    Lymph node product
    Description

    If yes, please specify the size of the largest palpable lymph node

    Data type

    integer

    Measurement units
    • cm2
    Alias
    UMLS CUI [1,1]
    C0024204
    UMLS CUI [1,2]
    C0456389
    cm2
    Physical Organ Exam
    Description

    Physical Organ Exam

    Alias
    UMLS CUI-1
    C0031809
    UMLS CUI-2
    C0178784
    Liver Enlargement
    Description

    Hepatomegaly

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019209
    If yes, please record cm below costal margin
    Description

    Liver size below costal margin

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1,1]
    C0456389
    UMLS CUI [1,2]
    C0023884
    UMLS CUI [1,3]
    C0542339
    UMLS CUI [1,4]
    C1288448
    cm
    Spleen Enlargement
    Description

    Splenomegaly

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038002
    If yes, please record cm below costal margin
    Description

    Spleen size below costal margin

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1,1]
    C0037993
    UMLS CUI [1,2]
    C0456389
    UMLS CUI [1,3]
    C0542339
    UMLS CUI [1,4]
    C1288448
    cm
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    Similar models

    Physical Examination

    1 forms
    1. StudyEvent: ODM
      1. Physical Examination
    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
    visit type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    visit type
    Code List
    visit type
    CL Item
    screening  (A)
    CL Item
    Cycle 1 Week 1 (B)
    CL Item
    Cycle 1 Week 4 (C)
    CL Item
    Cycle 1 Observation  (D)
    CL Item
    Unscheduled Visit (E)
    CL Item
    Withdrawal visit (F)
    CL Item
    End of Study (G)
    CL Item
    Cycle 2 Week 1 (H)
    CL Item
    Cycle 2 Week 4  (I)
    CL Item
    Cycle 2 Observation (J)
    Item Group
    Physical Lymph Node Examination
    C0031809 (UMLS CUI-1)
    C0024204 (UMLS CUI-2)
    Item
    Palpation Location
    integer
    C0030247 (UMLS CUI [1,1])
    C0450429 (UMLS CUI [1,2])
    Palpation Location
    Code List
    Palpation Location
    CL Item
    cervical right  (1)
    CL Item
    cervical left (2)
    CL Item
    supraclavicular right (3)
    CL Item
    supraclavicular left (4)
    CL Item
    axillary right (5)
    CL Item
    axillary left (6)
    CL Item
    inguinal right (7)
    CL Item
    inguinal left  (8)
    CL Item
    femoral right (9)
    CL Item
    femoral left (10)
    Palpable lymph nodes
    Item
    Are there palpable lymph nodes in location?
    boolean
    C0024204 (UMLS CUI [1,1])
    C0522499 (UMLS CUI [1,2])
    Lymph node width
    Item
    Lymph node width
    integer
    C0024204 (UMLS CUI [1,1])
    C0487742 (UMLS CUI [1,2])
    Lymph node length
    Item
    Lymph node length
    integer
    C0024204 (UMLS CUI [1,1])
    C1444754 (UMLS CUI [1,2])
    Lymph node size
    Item
    Lymph node product
    integer
    C0024204 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    Item Group
    Physical Organ Exam
    C0031809 (UMLS CUI-1)
    C0178784 (UMLS CUI-2)
    Hepatomegaly
    Item
    Liver Enlargement
    boolean
    C0019209 (UMLS CUI [1])
    Liver size below costal margin
    Item
    If yes, please record cm below costal margin
    integer
    C0456389 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    C0542339 (UMLS CUI [1,3])
    C1288448 (UMLS CUI [1,4])
    Splenomegaly
    Item
    Spleen Enlargement
    boolean
    C0038002 (UMLS CUI [1])
    Spleen size below costal margin
    Item
    If yes, please record cm below costal margin
    integer
    C0037993 (UMLS CUI [1,1])
    C0456389 (UMLS CUI [1,2])
    C0542339 (UMLS CUI [1,3])
    C1288448 (UMLS CUI [1,4])
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