0 Valutazioni
ID

38682

Descrizione

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

Keywords

versioni (2)
  1. 04/03/19 04/03/19 -
  2. 30/10/19 30/10/19 - Sarah Riepenhausen
Titolare del copyright

GlaxoSmithKline

Caricato su

30 ottobre 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

  • i più nuovi
  • i più vecchi
  • Popolare
  • i più nuovi
    • i più nuovi
    • i più vecchi
    • Popolare

    Non ci sono commenti

    Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

    Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556

    Inglese

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

    1 moduli  
    Administrative
    Descrizione

    Administrative

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Number
    Descrizione

    Subject Number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Visit Date
    Descrizione

    Visit Date

    Alias
    UMLS CUI-1
    C1320303 (Date of visit)
    SNOMED
    406543005
    Check if Not Applicable
    Descrizione

    Check if Not Applicable

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C1272460 (Not Applicable)
    SNOMED
    385432009
    LOINC
    LA4543-0
    Date of Visit
    Descrizione

    Date of Visit

    Tipo di dati

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    PK Sampling - Plasma Samples
    Descrizione

    PK Sampling - Plasma Samples

    Alias
    UMLS CUI-1
    C0031327 (Drug Kinetics)
    UMLS CUI-2
    C1277698 (Blood sample taken)
    SNOMED
    313334002
    UMLS CUI-3
    C1609077 (Plasma - SpecimenType)
    LOINC
    LA17760-2
    Check if Not Applicable
    Descrizione

    Check if Not Applicable

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C1272460 (Not Applicable)
    SNOMED
    385432009
    LOINC
    LA4543-0
    Time Point
    Descrizione

    Time Point

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C2348792 (Timepoint)
    Date of Sampling
    Descrizione

    Date of Sampling

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0870078 (Sampling)
    Time of Sampling
    Descrizione

    Time of Sampling

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0870078 (Sampling)
    Check if Not Done
    Descrizione

    Check if Not Done

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C1272696 (Not Done)
    SNOMED
    385660001
    SRT501 Administration
    Descrizione

    SRT501 Administration

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    UMLS CUI-2
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Was SRT501 administered at this visit?
    Descrizione

    Was SRT501 administered at this visit?

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Date administered
    Descrizione

    Date administered

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C1521801 (Having administered)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Kit #
    Descrizione

    Kit #

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C2981406 (Kit Number)
    Time Administered
    Descrizione

    Time Administered

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C1521801 (Having administered)
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Study Treatment Compliance (Return)
    Descrizione

    Study Treatment Compliance (Return)

    Alias
    UMLS CUI-1
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    Check if Not Applicable
    Descrizione

    Check if Not Applicable

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C1272460 (Not Applicable)
    SNOMED
    385432009
    LOINC
    LA4543-0
    Has the subject returned their diary card?
    Descrizione

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

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C3890583 (Subject Diary)
    UMLS CUI [1,2]
    C0332156 (Return to (contextual qualifier) (qualifier value))
    SNOMED
    7528007
    Has the subject been compliant with dosing of study drug?
    Descrizione

    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 di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C0304229 (Experimental drug)
    UMLS CUI [1,3]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    No. of missed dates:
    Descrizione

    No. of missed dates:

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C1705492 (Missing)
    LOINC
    LA14698-7
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,3]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Dates dose missed:
    Descrizione

    Dates dose missed:

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C1705492 (Missing)
    LOINC
    LA14698-7
    UMLS CUI [1,3]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    New Adverse Events and Concomitant Treatment
    Descrizione

    New Adverse Events and Concomitant Treatment

    Alias
    UMLS CUI-1
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI-2
    C2347852 (Concomitant Agent)
    Check if Not Applicable
    Descrizione

    Check if Not Applicable

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C1272460 (Not Applicable)
    SNOMED
    385432009
    LOINC
    LA4543-0
    Has the subject experienced any new adverse events or worsening of an existing adverse event or condition prior to this visit?
    Descrizione

    If Yes, please record details on Adverse Events page.

    Tipo di dati

    boolean

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

    If Yes, please record details on Concomitant Treatment page.

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    UMLS CUI [2,1]
    C0678766 (Drug dose)
    SNOMED
    398232005
    UMLS CUI [2,2]
    C0205217 (Increased)
    SNOMED
    35105006
    LOINC
    LA24377-6
    UMLS CUI [3,1]
    C0678766 (Drug dose)
    SNOMED
    398232005
    UMLS CUI [3,2]
    C0205216 (Decreased)
    SNOMED
    1250004
    UMLS CUI [4,1]
    C0439603 (Frequencies (time pattern))
    SNOMED
    272123002
    LOINC
    LP130485-8
    UMLS CUI [4,2]
    C0205217 (Increased)
    SNOMED
    35105006
    LOINC
    LA24377-6
    UMLS CUI [5,1]
    C0439603 (Frequencies (time pattern))
    SNOMED
    272123002
    LOINC
    LP130485-8
    UMLS CUI [5,2]
    C0205216 (Decreased)
    SNOMED
    1250004
    Ritorna all'inizio della pagina

    Similar models

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

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    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])
    Ritorna all'inizio della pagina 

    Aiuto

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial