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ID

42091

Beschreibung

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

Stichworte

Versionen (2)
  1. 30.03.21 30.03.21 -
  2. 07.04.21 07.04.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

7. April 2021

DOI

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Lizenz

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

    Englisch

    Log Status

    1 Formulare  
    1. StudyEvent: ODM
      1. Log Status
    Administrative Data
    Beschreibung

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    date of visit/assessment
    Beschreibung

    date of visit/assessment

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    UMLS CUI [2]
    C2985720 (Assessment Date)
    subject number
    Beschreibung

    subject ID

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Log Status
    Beschreibung

    Log Status

    Alias
    UMLS CUI-1
    C1708728 (Event Log)
    UMLS CUI-2
    C0449438 (Status)
    SNOMED
    263490005
    LOINC
    LP73412-6
    Were any concomitant medications taken by the subject prior to screening and/or during the study?
    Beschreibung

    Concomitant medication taken prior to screening and/or during study

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [1,3]
    C0220908 (Screening procedure)
    SNOMED
    20135006
    LOINC
    LP34059-3
    UMLS CUI [2,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [2,2]
    C0347984 (During)
    SNOMED
    371881003
    UMLS CUI [2,3]
    C2347804 (Clinical Trial Period)
    Did the subject experience any non-serious adverse events during the study?
    Beschreibung

    Non-serious adverse events during study

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1518404 (Non-serious Adverse Event)
    UMLS CUI [1,2]
    C0347984 (During)
    SNOMED
    371881003
    UMLS CUI [1,3]
    C2347804 (Clinical Trial Period)
    Did the subject experience a serious adverse event during the study?
    Beschreibung

    Serious adverse event during study

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1519255 (Serious Adverse Event)
    UMLS CUI [1,2]
    C0347984 (During)
    SNOMED
    371881003
    UMLS CUI [1,3]
    C2347804 (Clinical Trial Period)
    Were any blood products / blood supportive care products taken by the subject during the study?
    Beschreibung

    Blood products / blood supportive care products taken during study

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0456388 (Blood product)
    SNOMED
    410652009
    LOINC
    LP32808-5
    UMLS CUI [1,2]
    C0347984 (During)
    SNOMED
    371881003
    UMLS CUI [1,3]
    C2347804 (Clinical Trial Period)
    UMLS CUI [2,1]
    C0018938 (Hematologic Agents)
    SNOMED
    373708006
    UMLS CUI [2,2]
    C0347984 (During)
    SNOMED
    371881003
    UMLS CUI [2,3]
    C2347804 (Clinical Trial Period)
    Were any other/additional scans performed
    Beschreibung

    Other/additional scans performed

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,2]
    C0011923 (Diagnostic Imaging)
    SNOMED
    363679005
    UMLS CUI [2,1]
    C1524062 (Additional)
    LOINC
    LP35025-3
    UMLS CUI [2,2]
    C0011923 (Diagnostic Imaging)
    SNOMED
    363679005
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Log Status

    1 Formulare
    1. StudyEvent: ODM
      1. Log Status
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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])
    Concomitant medication taken prior to screening and/or during study
    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])
    Concomitant medication taken prior to screening and/or during study
    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])
    Concomitant medication taken prior to screening and/or during study
    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])
    Concomitant medication taken prior to screening and/or during study
    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])
    Concomitant medication taken prior to screening and/or during study
    Code List
    Were any other/additional scans performed
    CL Item
    yes (y)
    CL Item
    no (n)
    Zum Seitenanfang zurückkehren 

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