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ID

41067

Beschreibung

Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

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Versionen (1)
  1. 18/6/20 18/6/20 -
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GlaxoSmithKline

Hochgeladen am

18 de junio de 2020

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    Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447

    Englisch

    Pharmacokinetics - Blood

    1 Formulare  
    Administrative
    Beschreibung

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beschreibung

    Subject Identifier

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Pharmacokinetics - Blood (Session 1)
    Beschreibung

    Pharmacokinetics - Blood (Session 1)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    Planned Relative Time
    Beschreibung

    Time Relative to Dosing

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0439564
    Date Sample Taken
    Beschreibung

    Date Sample Taken

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Actual Time
    Beschreibung

    Actual Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Sample Number
    Beschreibung

    Sample Number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1299222
    Pharmacokinetics - Blood (Session 1)
    Beschreibung

    Pharmacokinetics - Blood (Session 1)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    Planned Relative Time
    Beschreibung

    Time Relative to Dosing

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0439564
    Date Sample Taken
    Beschreibung

    Date Sample Taken

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Actual Time
    Beschreibung

    Actual Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Sample Number
    Beschreibung

    Sample Number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1299222
    Pharmacokinetics - Blood (Session 2)
    Beschreibung

    Pharmacokinetics - Blood (Session 2)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    Planned Relative Time
    Beschreibung

    Time Relative to Dosing

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0439564
    Date Sample Taken
    Beschreibung

    Date Sample Taken

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Actual Time
    Beschreibung

    Actual Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Sample Number
    Beschreibung

    Sample Number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1299222
    Pharmacokinetics - Blood (Session 2)
    Beschreibung

    Pharmacokinetics - Blood (Session 2)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    Planned Relative Time
    Beschreibung

    Time Relative to Dosing

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0439564
    Date Sample Taken
    Beschreibung

    Date Sample Taken

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Actual Time
    Beschreibung

    Actual Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Sample Number
    Beschreibung

    Sample Number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1299222
    Pharmacokinetics - Blood (Session 3)
    Beschreibung

    Pharmacokinetics - Blood (Session 3)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    Planned Relative Time
    Beschreibung

    Time Relative to Dosing

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0439564
    Date Sample Taken
    Beschreibung

    Date Sample Taken

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Actual Time
    Beschreibung

    Actual Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Sample Number
    Beschreibung

    Sample Number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1299222
    Pharmacokinetics - Blood (Session 3)
    Beschreibung

    Pharmacokinetics - Blood (Session 3)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    Planned Relative Time
    Beschreibung

    Time Relative to Dosing

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0439564
    Date Sample Taken
    Beschreibung

    Date Sample Taken

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Actual Time
    Beschreibung

    Actual Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Sample Number
    Beschreibung

    Sample Number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1299222
    Pharmacokinetics - Blood (Session 4)
    Beschreibung

    Pharmacokinetics - Blood (Session 4)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    Planned Relative Time
    Beschreibung

    Time Relative to Dosing

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0439564
    Date Sample Taken
    Beschreibung

    Date Sample Taken

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Actual Time
    Beschreibung

    Actual Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Sample Number
    Beschreibung

    Sample Number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1299222
    Pharmacokinetics - Blood (Session 4)
    Beschreibung

    Pharmacokinetics - Blood (Session 4)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    Planned Relative Time
    Beschreibung

    Time Relative to Dosing

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0439564
    Date Sample Taken
    Beschreibung

    Date Sample Taken

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Actual Time
    Beschreibung

    Actual Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Sample Number
    Beschreibung

    Sample Number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1299222
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    Ähnliche Modelle

    Pharmacokinetics - Blood

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Pharmacokinetics - Blood (Session 1)
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Item
    Planned Relative Time
    integer
    C0439564 (UMLS CUI [1])
    Planned Relative Time
    Code List
    Planned Relative Time
    CL Item
    Predose (1)
    CL Item
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    CL Item
    1 hr (3)
    CL Item
    1.5 hr (4)
    CL Item
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    CL Item
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    CL Item
    12 hr (10)
    CL Item
    24 hr (11)
    Date Sample Taken
    Item
    Date Sample Taken
    date
    C1302413 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Item
    Sample Number
    integer
    C1299222 (UMLS CUI [1])
    Sample Number
    Code List
    Sample Number
    CL Item
    101 (1)
    CL Item
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    103 (3)
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    104 (4)
    CL Item
    105 (5)
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    106 (6)
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    107 (7)
    CL Item
    108 (8)
    CL Item
    109 (9)
    CL Item
    110 (10)
    CL Item
    111 (11)
    Item Group
    Pharmacokinetics - Blood (Session 1)
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Item
    Planned Relative Time
    integer
    C0439564 (UMLS CUI [1])
    Planned Relative Time
    Code List
    Planned Relative Time
    CL Item
    Predose  (1)
    CL Item
    0.5 hr  (2)
    CL Item
    1 hr  (3)
    CL Item
    1.5 hr  (4)
    CL Item
    2 hr  (5)
    CL Item
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    12 hr  (10)
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    24 hr (11)
    CL Item
    36h (12)
    CL Item
    48hr (13)
    Date Sample Taken
    Item
    Date Sample Taken
    date
    C1302413 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Item
    Sample Number
    integer
    C1299222 (UMLS CUI [1])
    Sample Number
    Code List
    Sample Number
    CL Item
    112 (1)
    CL Item
    113 (2)
    CL Item
    114 (3)
    CL Item
    115 (4)
    CL Item
    116 (5)
    CL Item
    117 (6)
    CL Item
    118 (7)
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    120 (9)
    CL Item
    121 (10)
    CL Item
    122 (11)
    CL Item
    123 (12)
    CL Item
    124 (13)
    Item Group
    Pharmacokinetics - Blood (Session 2)
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
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    Planned Relative Time
    integer
    C0439564 (UMLS CUI [1])
    Planned Relative Time
    Code List
    Planned Relative Time
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    CL Item
    0.5 hr  (2)
    CL Item
    1 hr  (3)
    CL Item
    1.5 hr  (4)
    CL Item
    2 hr  (5)
    CL Item
    3 hr  (6)
    CL Item
    4 hr  (7)
    CL Item
    6 hr  (8)
    CL Item
    8 hr  (9)
    CL Item
    12 hr (10)
    CL Item
    24 hr (11)
    Date Sample Taken
    Item
    Date Sample Taken
    date
    C1302413 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Item
    Sample Number
    integer
    C1299222 (UMLS CUI [1])
    Sample Number
    Code List
    Sample Number
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    CL Item
    211 (11)
    Item Group
    Pharmacokinetics - Blood (Session 2)
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Item
    Planned Relative Time
    integer
    C0439564 (UMLS CUI [1])
    Planned Relative Time
    Code List
    Planned Relative Time
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    CL Item
    0.5 hr  (2)
    CL Item
    1 hr  (3)
    CL Item
    1.5 hr  (4)
    CL Item
    2 hr  (5)
    CL Item
    3 hr  (6)
    CL Item
    4 hr  (7)
    CL Item
    6 hr  (8)
    CL Item
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    12 hr (10)
    CL Item
    24 hr (11)
    CL Item
    36 hr (12)
    CL Item
    48 hr (13)
    Date Sample Taken
    Item
    Date Sample Taken
    date
    C1302413 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Item
    Sample Number
    integer
    C1299222 (UMLS CUI [1])
    Sample Number
    Code List
    Sample Number
    CL Item
    212 (1)
    CL Item
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    CL Item
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    CL Item
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    CL Item
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    CL Item
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    222 (11)
    CL Item
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    CL Item
    224 (13)
    Item Group
    Pharmacokinetics - Blood (Session 3)
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    C0005767 (UMLS CUI-2)
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    Planned Relative Time
    integer
    C0439564 (UMLS CUI [1])
    Planned Relative Time
    Code List
    Planned Relative Time
    CL Item
    Predose  (1)
    CL Item
    0.5 hr  (2)
    CL Item
    1 hr  (3)
    CL Item
    1.5 hr  (4)
    CL Item
    2 hr  (5)
    CL Item
    3 hr  (6)
    CL Item
    4 hr  (7)
    CL Item
    6 hr  (8)
    CL Item
    8 hr  (9)
    CL Item
    12 hr (10)
    CL Item
    24 hr (11)
    Date Sample Taken
    Item
    Date Sample Taken
    date
    C1302413 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Item
    Sample Number
    integer
    C1299222 (UMLS CUI [1])
    Sample Number
    Code List
    Sample Number
    CL Item
    301 (1)
    CL Item
    302 (2)
    CL Item
    303 (3)
    CL Item
    304 (4)
    CL Item
    305 (5)
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    306 (6)
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    CL Item
    308 (8)
    CL Item
    309 (9)
    CL Item
    310 (10)
    CL Item
    311 (11)
    Item Group
    Pharmacokinetics - Blood (Session 3)
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Item
    Planned Relative Time
    integer
    C0439564 (UMLS CUI [1])
    Planned Relative Time
    Code List
    Planned Relative Time
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    Predose  (1)
    CL Item
    0.5 hr  (2)
    CL Item
    1 hr  (3)
    CL Item
    1.5 hr  (4)
    CL Item
    2 hr  (5)
    CL Item
    3 hr  (6)
    CL Item
    4 hr  (7)
    CL Item
    6 hr  (8)
    CL Item
    8 hr  (9)
    CL Item
    12 hr (10)
    CL Item
    24 hr (11)
    CL Item
    36 hr (12)
    CL Item
    48 hr (13)
    Date Sample Taken
    Item
    Date Sample Taken
    date
    C1302413 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Item
    Sample Number
    integer
    C1299222 (UMLS CUI [1])
    Sample Number
    Code List
    Sample Number
    CL Item
    312 (1)
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    CL Item
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    CL Item
    324 (13)
    Item Group
    Pharmacokinetics - Blood (Session 4)
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    C0005767 (UMLS CUI-2)
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    Planned Relative Time
    integer
    C0439564 (UMLS CUI [1])
    Planned Relative Time
    Code List
    Planned Relative Time
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    Predose  (1)
    CL Item
    0.5 hr  (2)
    CL Item
    1 hr  (3)
    CL Item
    1.5 hr  (4)
    CL Item
    2 hr  (5)
    CL Item
    3 hr  (6)
    CL Item
    4 hr  (7)
    CL Item
    6 hr  (8)
    CL Item
    8 hr  (9)
    CL Item
    12 hr (10)
    CL Item
    24 hr (11)
    Date Sample Taken
    Item
    Date Sample Taken
    date
    C1302413 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Item
    Sample Number
    integer
    C1299222 (UMLS CUI [1])
    Sample Number
    Code List
    Sample Number
    CL Item
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    CL Item
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    CL Item
    405 (5)
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    CL Item
    408 (8)
    CL Item
    409 (9)
    CL Item
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    CL Item
    411 (11)
    Item Group
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    C0005767 (UMLS CUI-2)
    Item
    Planned Relative Time
    integer
    C0439564 (UMLS CUI [1])
    Planned Relative Time
    Code List
    Planned Relative Time
    CL Item
    Predose  (1)
    CL Item
    0.5 hr  (2)
    CL Item
    1 hr  (3)
    CL Item
    1.5 hr  (4)
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    2 hr  (5)
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    3 hr  (6)
    CL Item
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    CL Item
    6 hr  (8)
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    CL Item
    12 hr (10)
    CL Item
    24 hr (11)
    CL Item
    36 hr (12)
    CL Item
    48 hr (13)
    Date Sample Taken
    Item
    Date Sample Taken
    date
    C1302413 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Item
    Sample Number
    integer
    C1299222 (UMLS CUI [1])
    Sample Number
    Code List
    Sample Number
    CL Item
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    CL Item
    423 (12)
    CL Item
    424 (13)
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