0 Ratings
ID

42549

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 whenever/if additional scans have to be done during study.

Link

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

Keywords

Versions (1)
  1. 8/25/21 8/25/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 25, 2021

DOI

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License

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

    English

    Additional Scan

    1 forms  
    1. StudyEvent: ODM
      1. Additional Scan
    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
    Other protocol specified and/or additional scan
    Description

    Other protocol specified and/or additional scan

    Alias
    UMLS CUI-1
    C2348563
    UMLS CUI-2
    C0011923
    UMLS CUI-3
    C0205394
    UMLS CUI-4
    C1524062
    Method
    Description

    Scan Method

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0871511
    Date of Scan
    Description

    Date of Scan

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C0011008
    Anatomic location of image coverage
    Description

    Anatomic location of image coverage

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C1515974
    If other, specify
    Description

    Other anatomic location of image coverage

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C1515974
    UMLS CUI [1,3]
    C0205394
    Reason for scan
    Description

    Reminder: Any new lesions identified need to be indicated on the Response form and the details of the new lesions need to be entered onto the New Lesion form.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C3146298
    If other, specify
    Description

    Reminder: Any new lesions identified need to be indicated on the Response form and the details of the new lesions need to be entered onto the New Lesion form.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C3146298
    UMLS CUI [1,3]
    C0205394
    Results
    Description

    If the result of the scan is unequivocal progression, ensure the Response Assessment form is completed.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C1274040
    If inconclusive, specify
    Description

    If the result of the scan is unequivocal progression, ensure the Response Assessment form is completed.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C1274040
    UMLS CUI [1,3]
    C1629507
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    Similar models

    Additional Scan

    1 forms
    1. StudyEvent: ODM
      1. Additional Scan
    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
    Other protocol specified and/or additional scan
    C2348563 (UMLS CUI-1)
    C0011923 (UMLS CUI-2)
    C0205394 (UMLS CUI-3)
    C1524062 (UMLS CUI-4)
    Item
    Method
    text
    C0011923 (UMLS CUI [1,1])
    C0871511 (UMLS CUI [1,2])
    Scan Method
    Code List
    Method
    CL Item
    Bone Scan (BS)
    CL Item
    Conventional CT scan (C)
    CL Item
    Direct measure by physical exam  (D)
    CL Item
    DCE or MRI  (DM)
    CL Item
    Endoscopy  (E)
    CL Item
    High-resolution CT scan  (HC)
    CL Item
    Lymphangiogram  (L)
    CL Item
    MRI  (M)
    CL Item
    Mammography  (MA)
    CL Item
    Not Done  (ND)
    CL Item
    Nuclear Scan  (NS)
    CL Item
    Medical photography  (P)
    CL Item
    PET/CT scan (PC)
    CL Item
    Panendoscopy  (PE)
    CL Item
    PET scan  (PT)
    CL Item
    Spiral CT scan  (SC)
    CL Item
    Transvaginal ultrasound  (TU)
    CL Item
    Ultrasound  (UL)
    CL Item
    X-ray  (XR)
    Date of Scan
    Item
    Date of Scan
    date
    C0011923 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Anatomic location of image coverage
    text
    C0011923 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    Anatomic location of image coverage
    Code List
    Anatomic location of image coverage
    CL Item
    Abdomen (AB)
    CL Item
    Bone (BE)
    CL Item
    Chest (CH)
    CL Item
    Head (HD)
    CL Item
    Head and neck (includes brain) (HN)
    CL Item
    Neck (NK)
    CL Item
    Pelvis (PV)
    CL Item
    Other (OT)
    Other anatomic location of image coverage
    Item
    If other, specify
    text
    C0011923 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Item
    Reason for scan
    text
    C0011923 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Reason for scan
    Code List
    Reason for scan
    CL Item
    New symptoms warranting a scan (2)
    CL Item
    Used to confirm the results of the scan being used to follow a Target/NonTarget lesion (3)
    CL Item
    Previous scan was inconclusive (4)
    CL Item
    Other (OT)
    Other reason for scan
    Item
    If other, specify
    text
    C0011923 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Item
    Results
    text
    C0011923 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Results of scan
    Code List
    Results
    CL Item
    Absent (negative scan) (ABS)
    CL Item
    Present (P)
    CL Item
    Unequivocal progression (UPD)
    CL Item
    Inconclusive (e.g. image quality, necrosis, fibrosis, cavitation) (I)
    Results of scan inconclusive
    Item
    If inconclusive, specify
    text
    C0011923 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    C1629507 (UMLS CUI [1,3])
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