0 Evaluaciones

ID

41889

Descripción

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 weekly visits during the cycles of treatment, the cycle observation visits, unscheduled visits, withdrawal visits and visits at the end of study/ treatment.

Link

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

Palabras clave

  1. 9/2/21 9/2/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

9 de febrero de 2021

DOI

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Licencia

Creative Commons BY-NC 4.0

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    GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

    Constitutional Symptoms and ECOG

    Administrative Data
    Descripción

    Administrative Data

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

    date of visit/assessment

    Tipo de datos

    date

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

    subject ID

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    visit type
    Descripción

    visit type

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Constitutional Symptoms
    Descripción

    Constitutional Symptoms

    Alias
    UMLS CUI-1
    C0009812
    Night sweats without signs of infection
    Descripción

    Night sweats without signs of infection

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0028081
    UMLS CUI [1,2]
    C0009450
    UMLS CUI [1,3]
    C0332197
    Unintentional weight loss >= 10% within the previous 6 months
    Descripción

    Recent unintentional weight loss

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0332185
    UMLS CUI [1,2]
    C2363736
    Recurrent, unexplained fever of greater than 100°F for 2 weeks without signs of infection
    Descripción

    Recurrent, unexplained fever

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2945760
    UMLS CUI [1,2]
    C1844662
    Extreme fatigue
    Descripción

    Extreme fatigue

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0205403
    UMLS CUI [1,2]
    C0015672
    ECOG Performance Status Scale
    Descripción

    ECOG Performance Status Scale

    Alias
    UMLS CUI-1
    C1520224
    Total Score
    Descripción

    ECOG Performance status, total score

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1520224
    UMLS CUI [1,2]
    C2964552

    Similar models

    Constitutional Symptoms and ECOG

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
    Code List
    visit type
    CL Item
    Screening visit (A)
    CL Item
    Cycle 1 week 1 (B)
    CL Item
    Cycle 1 week 2 (C)
    CL Item
    Cycle 1 week 3  (D)
    CL Item
    Cycle 1 week 4 (E)
    CL Item
    Cycle 1 Observation  (F)
    CL Item
    unscheduled visit (G)
    CL Item
    Withdrawal visit (H)
    CL Item
    End of Study / Treatment (I)
    CL Item
    Cycle 2 Week 1 (J)
    CL Item
    Cycle 2 Week 2 (K)
    CL Item
    Cycle 2 Week 3 (L)
    CL Item
    Cycle 2 Week 4 (M)
    CL Item
    Cycle 2 Observation (N)
    Item Group
    Constitutional Symptoms
    C0009812 (UMLS CUI-1)
    Night sweats without signs of infection
    Item
    Night sweats without signs of infection
    boolean
    C0028081 (UMLS CUI [1,1])
    C0009450 (UMLS CUI [1,2])
    C0332197 (UMLS CUI [1,3])
    Recent unintentional weight loss
    Item
    Unintentional weight loss >= 10% within the previous 6 months
    boolean
    C0332185 (UMLS CUI [1,1])
    C2363736 (UMLS CUI [1,2])
    Recurrent, unexplained fever
    Item
    Recurrent, unexplained fever of greater than 100°F for 2 weeks without signs of infection
    boolean
    C2945760 (UMLS CUI [1,1])
    C1844662 (UMLS CUI [1,2])
    Extreme fatigue
    Item
    Extreme fatigue
    boolean
    C0205403 (UMLS CUI [1,1])
    C0015672 (UMLS CUI [1,2])
    Item Group
    ECOG Performance Status Scale
    C1520224 (UMLS CUI-1)
    ECOG Performance status, total score
    Item
    Total Score
    text
    C1520224 (UMLS CUI [1,1])
    C2964552 (UMLS CUI [1,2])

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