0 Bedömningar
ID

42548

Beskrivning

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 This form has to be filled out whenever/if Pharmacogenetic Research consent has to be given/withdrawn or blood samples have to be collected during study.

Länk

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

Nyckelord

Versioner (1)
  1. 2021-08-25 2021-08-25 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

25 augusti 2021

DOI

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Licens

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

    Engelsk

    Pharmacogenetic Research

    1 Formulär  
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    date of visit/assessment
    Beskrivning

    date of visit/assessment

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    UMLS CUI [2]
    C2985720
    subject number
    Beskrivning

    subject ID

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Pharmacogenetic (PGx) Research Consent/Blood Sample Collection
    Beskrivning

    Pharmacogenetic (PGx) Research Consent/Blood Sample Collection

    Alias
    UMLS CUI-1
    C2347500
    UMLS CUI-2
    C0021430
    UMLS CUI-3
    C0005834
    Has informed consent been obtained for PGx research?
    Beskrivning

    Informed consent for PGx research

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    If yes, record Date informed consent obtained for PGx research
    Beskrivning

    Informed consent for PGx research, Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0011008
    Has blood sample been collected for PGx research?
    Beskrivning

    Blood sample for PGx research

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C2347500
    If yes, record Date sample taken
    Beskrivning

    Blood sample for PGx research, Date sample taken

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C1302413
    If no, check reason
    Beskrivning

    No informed consent for PGx research, reason

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1298908
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C2347500
    UMLS CUI [1,4]
    C0566251
    If other, specify
    Beskrivning

    No informed consent for PGx research, other reason

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1298908
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C2347500
    UMLS CUI [1,4]
    C0566251
    UMLS CUI [1,5]
    C0205394
    Sample Type
    Beskrivning

    [hidden]

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2347029
    Withdrawal of Consent for PGx (DNA) / Blood Sample Destruction
    Beskrivning

    Withdrawal of Consent for PGx (DNA) / Blood Sample Destruction

    Alias
    UMLS CUI-1
    C1707492
    UMLS CUI-2
    C2347500
    UMLS CUI-3
    C1948029
    UMLS CUI-4
    C0178913
    Has subject withdrawn consent for PGx research?
    Beskrivning

    Consent withdrawn for PGx research

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1707492
    UMLS CUI [1,2]
    C2347500
    If yes, date informed consent withdrawn
    Beskrivning

    Consent withdrawn for PGx research, Date

    Datatyp

    partialDate

    Alias
    UMLS CUI [1,1]
    C1707492
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0011008
    Has a request been made for (insert sample type) sample destruction?
    Beskrivning

    Please replace 'blood' with the appropriate sample type as specified in the protocol.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1272683
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C0178913
    UMLS CUI [1,4]
    C2347500
    If yes, check reason
    Beskrivning

    Please replace 'blood' with the appropriate sample type as specified in the protocol. Screen failure is an optional choice.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1272683
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C0178913
    UMLS CUI [1,4]
    C0566251
    UMLS CUI [1,5]
    C2347500
    If other, specify
    Beskrivning

    Please replace 'blood' with the appropriate sample type as specified in the protocol.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1272683
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C0178913
    UMLS CUI [1,4]
    C0566251
    UMLS CUI [1,5]
    C0205394
    UMLS CUI [1,6]
    C2347500
    Sample type
    Beskrivning

    [hidden]

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2347029
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    Similar models

    Pharmacogenetic Research

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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
    Pharmacogenetic (PGx) Research Consent/Blood Sample Collection
    C2347500 (UMLS CUI-1)
    C0021430 (UMLS CUI-2)
    C0005834 (UMLS CUI-3)
    Informed consent for PGx research
    Item
    Has informed consent been obtained for PGx research?
    boolean
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Informed consent for PGx research, Date
    Item
    If yes, record Date informed consent obtained for PGx research
    date
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Blood sample for PGx research
    Item
    Has blood sample been collected for PGx research?
    boolean
    C0005834 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Blood sample for PGx research, Date sample taken
    Item
    If yes, record Date sample taken
    date
    C0005834 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C1302413 (UMLS CUI [1,3])
    Item
    If no, check reason
    text
    C1298908 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C2347500 (UMLS CUI [1,3])
    C0566251 (UMLS CUI [1,4])
    No informed consent for PGx research, reason
    Code List
    If no, check reason
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by Investigator (2)
    CL Item
    Other, specify (Z)
    No informed consent for PGx research, other reason
    Item
    If other, specify
    text
    C1298908 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C2347500 (UMLS CUI [1,3])
    C0566251 (UMLS CUI [1,4])
    C0205394 (UMLS CUI [1,5])
    Sample Type
    Item
    Sample Type
    text
    C2347029 (UMLS CUI [1])
    Item Group
    Withdrawal of Consent for PGx (DNA) / Blood Sample Destruction
    C1707492 (UMLS CUI-1)
    C2347500 (UMLS CUI-2)
    C1948029 (UMLS CUI-3)
    C0178913 (UMLS CUI-4)
    Consent withdrawn for PGx research
    Item
    Has subject withdrawn consent for PGx research?
    boolean
    C1707492 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Consent withdrawn for PGx research, Date
    Item
    If yes, date informed consent withdrawn
    partialDate
    C1707492 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Request for sample destruction
    Item
    Has a request been made for (insert sample type) sample destruction?
    boolean
    C1272683 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C0178913 (UMLS CUI [1,3])
    C2347500 (UMLS CUI [1,4])
    Item
    If yes, check reason
    text
    C1272683 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C0178913 (UMLS CUI [1,3])
    C0566251 (UMLS CUI [1,4])
    C2347500 (UMLS CUI [1,5])
    Request for sample destruction, reason
    Code List
    If yes, check reason
    CL Item
    Subject withdrew consent for PGx (3)
    CL Item
    Other (Z)
    CL Item
    Screen failure (1)
    Request for sample destruction, other reason
    Item
    If other, specify
    text
    C1272683 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C0178913 (UMLS CUI [1,3])
    C0566251 (UMLS CUI [1,4])
    C0205394 (UMLS CUI [1,5])
    C2347500 (UMLS CUI [1,6])
    Sample type
    Item
    Sample type
    text
    C2347029 (UMLS CUI [1])
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