0 Evaluaciones
ID

42287

Descripción

Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer

Palabras clave

Versiones (2)
  1. 2021-05-04 2021-05-04 -
  2. 2021-05-04 2021-05-04 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

4 maj 2021

DOI

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Licencia

Creative Commons BY 4.0
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    Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410)

    Inglés

    Laboratory Reference Ranges; Concomitant Medication; Adverse Experiences (Non-serious)

    1 formularios  
    Administrative
    Descripción

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Centre Number
    Descripción

    Centre Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Course Number
    Descripción

    Course Number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C0750729
    Patient Number
    Descripción

    Patient Number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Patient Initials
    Descripción

    Patient Initials

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2986440
    Laboratory Reference Ranges
    Descripción

    Laboratory Reference Ranges

    Alias
    UMLS CUI-1
    C0883335
    Investigator
    Descripción

    Investigator

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826892
    Date for which these reference ranges became effective
    Descripción

    Date for which these reference ranges became effective

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0883335
    UMLS CUI [1,2]
    C0011008
    Laboratory Name
    Descripción

    Laboratory Name

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3258037
    Laboratory Address
    Descripción

    Laboratory Address

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1442065
    UMLS CUI [1,2]
    C0022877
    Reference range gender
    Descripción

    Reference range gender

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0883335
    UMLS CUI [1,2]
    C0079399
    Age range
    Descripción

    Age range

    Tipo de datos

    text

    Unidades de medida
    • Years
    Alias
    UMLS CUI [1,1]
    C0001779
    UMLS CUI [1,2]
    C1514721
    Years
    Laboratory Reference Ranges
    Descripción

    Laboratory Reference Ranges

    Alias
    UMLS CUI-1
    C0883335
    Test - Haematology
    Descripción

    Test - Haematology

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0018941
    Test - Blood Chemistry
    Descripción

    Test - Blood Chemistry

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0525044
    Unit
    Descripción

    Unit

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1519795
    Low Reference Value
    Descripción

    Low Reference Value

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C1272773
    High Reference Value
    Descripción

    High Reference Value

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C1299400
    Concomitant Medication - Continued
    Descripción

    Concomitant Medication - Continued

    Alias
    UMLS CUI-1
    C2347852
    Drug Name
    Descripción

    Trade Name Preferred

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2360065
    Total Daily Dose
    Descripción

    (e.g. 500mg)

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348070
    Route
    Descripción

    Route

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0013153
    Medical Condition
    Descripción

    Medical Condition

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0012634
    Medication Start Date
    Descripción

    Medication Start Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826734
    Medication End Date
    Descripción

    Medication End Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826744
    Medication Continuing
    Descripción

    Medication Continuing

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0549178
    Adverse Experiences (Non-serious)
    Descripción

    Adverse Experiences (Non-serious)

    Alias
    UMLS CUI-1
    C1518404
    If no adverse experiences occured during the study, please sign form below and mark this box
    Descripción

    If no adverse experiences occured during the study, please sign form below and mark this box

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1298908
    Adverse Experiences (Non-serious)
    Descripción

    Adverse Experiences (Non-serious)

    Alias
    UMLS CUI-1
    C1518404
    Adverse Experience
    Descripción

    Adverse Experience

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0877248
    Adverse Experience Onset Date and Time
    Descripción

    Adverse Experience Onset Date and Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1]
    C2985916
    UMLS CUI [2]
    C2697889
    Adverse Experience End Date and Time
    Descripción

    If ongoing please leave blank

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1]
    C2826793
    Adverse Experience Outcome
    Descripción

    If patient died, STOP: go to SAE section and follow instructions given there

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1705586
    Experience Course
    Descripción

    Experience Course

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0750729
    If Intermittent Course, record number of episodes
    Descripción

    If Intermittent Course, record number of episodes

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0750729
    UMLS CUI [1,2]
    C0205267
    UMLS CUI [1,3]
    C4086638
    Common Toxicity Grade
    Descripción

    Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2826262
    Action Taken with Respect to Investigational Drug
    Descripción

    Action Taken with Respect to Investigational Drug

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2826626
    Relationship to Investigational Drug
    Descripción

    Relationship to Investigational Drug

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0013230
    UMLS CUI [1,3]
    C0439849
    Corrective Therapy
    Descripción

    If 'Yes' record details in the Concomitant Medication section

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0087111
    Was patient withdrawn due to this specific AE?
    Descripción

    Was patient withdrawn due to this specific AE?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C1518404
    Investigator's Signature (Adverse Experience)
    Descripción

    Investigator's Signature (Adverse Experience)

    Alias
    UMLS CUI-1
    C2346576
    UMLS CUI-2
    C0877248
    Investigator's Signature
    Descripción

    Investigator's Signature

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator's Signature Date
    Descripción

    Investigator's Signature Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
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    Similar models

    Laboratory Reference Ranges; Concomitant Medication; Adverse Experiences (Non-serious)

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Centre Number
    Item
    Centre Number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Course Number
    Item
    Course Number
    integer
    C0237753 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    Patient Number
    Item
    Patient Number
    text
    C2348585 (UMLS CUI [1])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Laboratory Reference Ranges
    C0883335 (UMLS CUI-1)
    Investigator
    Item
    Investigator
    text
    C2826892 (UMLS CUI [1])
    Date for which these reference ranges became effective
    Item
    Date for which these reference ranges became effective
    date
    C0883335 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Laboratory Name
    Item
    Laboratory Name
    text
    C3258037 (UMLS CUI [1])
    Laboratory Address
    Item
    Laboratory Address
    text
    C1442065 (UMLS CUI [1,1])
    C0022877 (UMLS CUI [1,2])
    Item
    Reference range gender
    text
    C0883335 (UMLS CUI [1,1])
    C0079399 (UMLS CUI [1,2])
    Reference range male or female
    Code List
    Reference range gender
    CL Item
    Male (M)
    CL Item
    Female (F)
    Age range
    Item
    Age range
    text
    C0001779 (UMLS CUI [1,1])
    C1514721 (UMLS CUI [1,2])
    Item Group
    Laboratory Reference Ranges
    C0883335 (UMLS CUI-1)
    Item
    Test - Haematology
    integer
    C0018941 (UMLS CUI [1])
    Test - Haematology
    Code List
    Test - Haematology
    CL Item
    Haemoglobin (1)
    CL Item
    Haematokrit (2)
    CL Item
    RBC (3)
    CL Item
    WBC (4)
    CL Item
    Neutrophils - segmented (5)
    CL Item
    Bands (6)
    CL Item
    Lymphocytes (7)
    CL Item
    Monocytes (8)
    CL Item
    Eosinophils (9)
    CL Item
    Basophils (10)
    CL Item
    Platelets (11)
    Item
    Test - Blood Chemistry
    integer
    C0525044 (UMLS CUI [1])
    Test - Blood Chemistry
    Code List
    Test - Blood Chemistry
    CL Item
    Sodium (1)
    CL Item
    Potassium (2)
    CL Item
    Chloride (3)
    CL Item
    Biocarbonate (4)
    CL Item
    Magnesium (5)
    CL Item
    Calcium (6)
    CL Item
    Phosphorus (7)
    CL Item
    Uric acid (8)
    CL Item
    BUN (9)
    CL Item
    Urea (10)
    CL Item
    Creatinine (11)
    CL Item
    Creatinine Clearance (12)
    CL Item
    Alkaline Phosphatase (13)
    CL Item
    SGOT/AST (14)
    CL Item
    SGPT/ALT (15)
    CL Item
    Total Bilirubin (16)
    CL Item
    Total Protein (17)
    CL Item
    Albumin (18)
    CL Item
    LDH (19)
    CL Item
    Serum Beta HCG (20)
    Unit
    Item
    Unit
    text
    C1519795 (UMLS CUI [1])
    Low Reference Value
    Item
    Low Reference Value
    float
    C1272773 (UMLS CUI [1])
    High Reference Value
    Item
    High Reference Value
    float
    C1299400 (UMLS CUI [1])
    Item Group
    Concomitant Medication - Continued
    C2347852 (UMLS CUI-1)
    Drug Name
    Item
    Drug Name
    text
    C2360065 (UMLS CUI [1])
    Total Daily Dose
    Item
    Total Daily Dose
    text
    C2348070 (UMLS CUI [1])
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Route
    Code List
    Route
    CL Item
    by mouth (PO)
    CL Item
    intravenous (IV)
    CL Item
    intramuscular (IM)
    CL Item
    intra-arterial (IAR)
    CL Item
    topical (TO)
    CL Item
    sublingual (SL)
    CL Item
    intrathecal (IT)
    CL Item
    vaginal (VA)
    CL Item
    nasal (NA)
    CL Item
    intra-articular injection (IA)
    CL Item
    transdermal (TD)
    CL Item
    inhaled (IH)
    CL Item
    subcutaneous (SC)
    CL Item
    rectal (PR)
    CL Item
    intradermal (ID)
    Medical Condition
    Item
    Medical Condition
    text
    C0012634 (UMLS CUI [1])
    Medication Start Date
    Item
    Medication Start Date
    date
    C2826734 (UMLS CUI [1])
    Medication End Date
    Item
    Medication End Date
    date
    C2826744 (UMLS CUI [1])
    Item
    Medication Continuing
    integer
    C0013227 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Medication Continuing
    Code List
    Medication Continuing
    CL Item
    Medication Continuing (1)
    Item Group
    Adverse Experiences (Non-serious)
    C1518404 (UMLS CUI-1)
    Item
    If no adverse experiences occured during the study, please sign form below and mark this box
    integer
    C0877248 (UMLS CUI [1,1])
    C1298908 (UMLS CUI [1,2])
    If no adverse experiences occured during the study, please sign form below and mark this box
    Code List
    If no adverse experiences occured during the study, please sign form below and mark this box
    CL Item
    No Adverse Experience (1)
    Item Group
    Adverse Experiences (Non-serious)
    C1518404 (UMLS CUI-1)
    Adverse Experience
    Item
    Adverse Experience
    text
    C0877248 (UMLS CUI [1])
    Adverse Experience Onset Date and Time
    Item
    Adverse Experience Onset Date and Time
    datetime
    C2985916 (UMLS CUI [1])
    C2697889 (UMLS CUI [2])
    Adverse Experience End Date and Time
    Item
    Adverse Experience End Date and Time
    datetime
    C2826793 (UMLS CUI [1])
    Item
    Adverse Experience Outcome
    integer
    C1705586 (UMLS CUI [1])
    Adverse Experience Outcome
    Code List
    Adverse Experience Outcome
    CL Item
    Resolved  (1)
    CL Item
    Ongoing  (2)
    CL Item
    Died (3)
    Item
    Experience Course
    integer
    C0877248 (UMLS CUI [1,1])
    C0750729 (UMLS CUI [1,2])
    Experience Course
    Code List
    Experience Course
    CL Item
    Intermittent  (1)
    CL Item
    Constant (2)
    If Intermittent Course, record number of episodes
    Item
    If Intermittent Course, record number of episodes
    integer
    C0750729 (UMLS CUI [1,1])
    C0205267 (UMLS CUI [1,2])
    C4086638 (UMLS CUI [1,3])
    Common Toxicity Grade
    Item
    Common Toxicity Grade
    integer
    C2826262 (UMLS CUI [1])
    Item
    Action Taken with Respect to Investigational Drug
    integer
    C2826626 (UMLS CUI [1])
    Action Taken with Respect to Investigational Drug
    Code List
    Action Taken with Respect to Investigational Drug
    CL Item
    None  (1)
    CL Item
    Dose reduced  (2)
    CL Item
    Dose increased  (3)
    CL Item
    Drug stopped  (4)
    CL Item
    Drug interrupted/ restarted  (5)
    CL Item
    Dose dealyed  (6)
    CL Item
    Dose delayed and decreased (7)
    Item
    Relationship to Investigational Drug
    integer
    C1518404 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [1,3])
    Relationship to Investigational Drug
    Code List
    Relationship to Investigational Drug
    CL Item
    Not related  (4)
    CL Item
    Unlikely  (3)
    CL Item
    Suspected (reasonable possibility)  (2)
    CL Item
    Probable (1)
    Corrective Therapy
    Item
    Corrective Therapy
    boolean
    C0877248 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    Was patient withdrawn due to this specific AE?
    Item
    Was patient withdrawn due to this specific AE?
    boolean
    C0422727 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Item Group
    Investigator's Signature (Adverse Experience)
    C2346576 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    Investigator's Signature
    Item
    Investigator's Signature
    text
    C2346576 (UMLS CUI [1])
    Investigator's Signature Date
    Item
    Investigator's Signature Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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