0 Evaluaciones
ID

38682

Descripción

Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

Palabras clave

Versiones (2)
  1. 4/3/19 4/3/19 -
  2. 30/10/19 30/10/19 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

30 de octubre de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556

    Inglés

    Cycle 1 Day 20 - PK Sampling - Plasma Samples; SRT501 Administration; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

    1 formularios  
    Administrative
    Descripción

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Descripción

    Subject Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Descripción

    Visit Date

    Alias
    UMLS CUI-1
    C1320303
    Check if Not Applicable
    Descripción

    Check if Not Applicable

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1272460
    Date of Visit
    Descripción

    Date of Visit

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    PK Sampling - Plasma Samples
    Descripción

    PK Sampling - Plasma Samples

    Alias
    UMLS CUI-1
    C0031327
    UMLS CUI-2
    C1277698
    UMLS CUI-3
    C1609077
    Check if Not Applicable
    Descripción

    Check if Not Applicable

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1272460
    Time Point
    Descripción

    Time Point

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348792
    Date of Sampling
    Descripción

    Date of Sampling

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0870078
    Time of Sampling
    Descripción

    Time of Sampling

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0870078
    Check if Not Done
    Descripción

    Check if Not Done

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1272696
    SRT501 Administration
    Descripción

    SRT501 Administration

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C1320722
    Was SRT501 administered at this visit?
    Descripción

    Was SRT501 administered at this visit?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1320722
    Date administered
    Descripción

    Date administered

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1521801
    UMLS CUI [1,2]
    C0011008
    Kit #
    Descripción

    Kit #

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2981406
    Time Administered
    Descripción

    Time Administered

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C1521801
    UMLS CUI [1,2]
    C0040223
    Study Treatment Compliance (Return)
    Descripción

    Study Treatment Compliance (Return)

    Alias
    UMLS CUI-1
    C1321605
    Check if Not Applicable
    Descripción

    Check if Not Applicable

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1272460
    Has the subject returned their diary card?
    Descripción

    If No, please complete the comments page or the protocol deviations page.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C3890583
    UMLS CUI [1,2]
    C0332156
    Has the subject been compliant with dosing of study drug?
    Descripción

    If No, please complete the comments page or the protocol deviations page. If No, please provide the number of missed doses and the dates that the doses were missed

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C0178602
    No. of missed dates:
    Descripción

    No. of missed dates:

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1705492
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0237753
    Dates dose missed:
    Descripción

    Dates dose missed:

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1705492
    UMLS CUI [1,3]
    C0178602
    New Adverse Events and Concomitant Treatment
    Descripción

    New Adverse Events and Concomitant Treatment

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C2347852
    Check if Not Applicable
    Descripción

    Check if Not Applicable

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1272460
    Has the subject experienced any new adverse events or worsening of an existing adverse event or condition prior to this visit?
    Descripción

    If Yes, please record details on Adverse Events page.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Has the subject started any new concomitant treatment or increased/decreased dosing/frequency of any existing concomitant medications prior to this visit?
    Descripción

    If Yes, please record details on Concomitant Treatment page.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    UMLS CUI [2,1]
    C0678766
    UMLS CUI [2,2]
    C0205217
    UMLS CUI [3,1]
    C0678766
    UMLS CUI [3,2]
    C0205216
    UMLS CUI [4,1]
    C0439603
    UMLS CUI [4,2]
    C0205217
    UMLS CUI [5,1]
    C0439603
    UMLS CUI [5,2]
    C0205216
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    Similar models

    Cycle 1 Day 20 - PK Sampling - Plasma Samples; SRT501 Administration; Study Treatment Compliance (Return); New Adverse Events and Concomitant Treatment

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Visit Date
    C1320303 (UMLS CUI-1)
    Item
    Check if Not Applicable
    integer
    C1272460 (UMLS CUI [1])
    Check if Not Applicable
    Code List
    Check if Not Applicable
    CL Item
    Not Applicable (1)
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    PK Sampling - Plasma Samples
    C0031327 (UMLS CUI-1)
    C1277698 (UMLS CUI-2)
    C1609077 (UMLS CUI-3)
    Item
    Check if Not Applicable
    integer
    C1272460 (UMLS CUI [1])
    Check if Not Applicable
    Code List
    Check if Not Applicable
    CL Item
    Not Applicable (1)
    Item
    Time Point
    integer
    C2348792 (UMLS CUI [1])
    Time Point
    Code List
    Time Point
    CL Item
    Pre-dose  (1)
    CL Item
    30mins  (2)
    CL Item
    1hr  (3)
    CL Item
    2hr  (4)
    CL Item
    4hr  (5)
    CL Item
    6hr (6)
    Date of Sampling
    Item
    Date of Sampling
    date
    C0011008 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    Time of Sampling
    Item
    Time of Sampling
    time
    C0040223 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    Item
    Check if Not Done
    integer
    C1272696 (UMLS CUI [1])
    Position
    Code List
    Check if Not Done
    CL Item
    Not Done (1)
    Item Group
    SRT501 Administration
    C0304229 (UMLS CUI-1)
    C1320722 (UMLS CUI-2)
    Was SRT501 administered at this visit?
    Item
    Was SRT501 administered at this visit?
    boolean
    C0304229 (UMLS CUI [1,1])
    C1320722 (UMLS CUI [1,2])
    Date administered
    Item
    Date administered
    date
    C1521801 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Kit #
    Item
    Kit #
    integer
    C2981406 (UMLS CUI [1])
    Time Administered
    Item
    Time Administered
    time
    C1521801 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item Group
    Study Treatment Compliance (Return)
    C1321605 (UMLS CUI-1)
    Item
    Check if Not Applicable
    integer
    C1272460 (UMLS CUI [1])
    Check if Not Applicable
    Code List
    Check if Not Applicable
    CL Item
    Not Applicable (1)
    Has the subject been issued with a diary card?
    Item
    Has the subject returned their diary card?
    boolean
    C3890583 (UMLS CUI [1,1])
    C0332156 (UMLS CUI [1,2])
    Has the subject received SRT501 approximately 15-30 minutes following breakfast consumption?
    Item
    Has the subject been compliant with dosing of study drug?
    boolean
    C1321605 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    No. of missed dates:
    Item
    No. of missed dates:
    integer
    C1705492 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    Dates dose missed:
    Item
    Dates dose missed:
    text
    C0011008 (UMLS CUI [1,1])
    C1705492 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    Item Group
    New Adverse Events and Concomitant Treatment
    C0877248 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Item
    Check if Not Applicable
    integer
    C1272460 (UMLS CUI [1])
    Check if Not Applicable
    Code List
    Check if Not Applicable
    CL Item
    Not Applicable (1)
    Has the subject experienced any new adverse events or worsening of an existing adverse event or condition prior to this visit?
    Item
    Has the subject experienced any new adverse events or worsening of an existing adverse event or condition prior to this visit?
    boolean
    C2347852 (UMLS CUI [1])
    Has the subject started any new concomitant treatment or increased/decreased dosing/frequency of any existing concomitant medications prior to this visit?
    Item
    Has the subject started any new concomitant treatment or increased/decreased dosing/frequency of any existing concomitant medications prior to this visit?
    boolean
    C2347852 (UMLS CUI [1])
    C0678766 (UMLS CUI [2,1])
    C0205217 (UMLS CUI [2,2])
    C0678766 (UMLS CUI [3,1])
    C0205216 (UMLS CUI [3,2])
    C0439603 (UMLS CUI [4,1])
    C0205217 (UMLS CUI [4,2])
    C0439603 (UMLS CUI [5,1])
    C0205216 (UMLS CUI [5,2])
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