ID

30435

Beschreibung

https://www.gsk-clinicalstudyregister.com/study/102886/003?search=study&study_ids=102886#csr Study ID : 102886/003 Clinical Study ID : 102886/003 Study Title :Safety, tolerance and preliminary pharmacokinetics of single ascending intravenous doses of halofantrine [SK&F 102886] in healthy male volunteers. Clinicaltrials.gov Identifier : Sponsor : GlaxoSmithKline Collaborators :N/A Phase :N/A Study Recruitment Status :Completed Generic Name :halofantrine Trade Name :Halfan Study Indication Malaria

Link

https://www.gsk-clinicalstudyregister.com/study/102886/003?search=study&study_ids=102886#csr

Stichworte

Versionen (2)
  1. 05.06.18 05.06.18 - Halim Ugurlu
  2. 20.09.21 20.09.21 -
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

5. Juni 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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    Safety, tolerance and preliminary pharmacokinetics of single ascending intravenous doses of halofantrine [SK&F 102886] in healthy male volunteers.

    Englisch

    Glucose assay, plasma drug assay, volunteer completion/withdrawal, investigator's statement, concominant medication, missing data form

    1 Formulare  
    Administration
    Beschreibung

    Administration

    Alias
    UMLS CUI-1
    C1320722
    Vol. No.
    Beschreibung

    Vol. No.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID.
    Beschreibung

    Panel ID.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3846158
    Study Period
    Beschreibung

    Study Period

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2347804
    Glucose Assay
    Beschreibung

    Glucose Assay

    Alias
    UMLS CUI-1
    C0202042
    Actual time of start of infusion
    Beschreibung

    start time infusion

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0574032
    UMLS CUI [1,2]
    C0439659
    UMLS CUI [1,3]
    C0040223
    Glucose Assay
    Beschreibung

    Glucose Assay

    Alias
    UMLS CUI-1
    C0202042
    Time Relative to start of infusion
    Beschreibung

    Time Relative to start of infusion

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0574032
    UMLS CUI [1,2]
    C0439659
    UMLS CUI [1,3]
    C0040223
    Date
    Beschreibung

    Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Actual time
    Beschreibung

    Actual time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Sample Taken
    Beschreibung

    Sample Taken

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0200345
    Initials
    Beschreibung

    Initials

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2986440
    Plasma Drug Assay
    Beschreibung

    Plasma Drug Assay

    Alias
    UMLS CUI-1
    C1609077
    UMLS CUI-2
    C1261153
    Actual time of start of infusion
    Beschreibung

    start of infusion

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0574032
    UMLS CUI [1,3]
    C0439659
    Plasma Drug Assay
    Beschreibung

    Plasma Drug Assay

    Alias
    UMLS CUI-1
    C1609077
    UMLS CUI-2
    C1261153
    Time relative to start of infusion
    Beschreibung

    Time relative to start of infusion

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C3469597
    UMLS CUI [1,3]
    C0304229
    Date
    Beschreibung

    Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Actual time
    Beschreibung

    Actual time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Sample Taken
    Beschreibung

    Sample Taken

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0200345
    Initials
    Beschreibung

    Initials

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2986440
    Volunteer Completion/Withdrawal
    Beschreibung

    Volunteer Completion/Withdrawal

    Alias
    UMLS CUI-1
    C0805732
    UMLS CUI-2
    C2349954
    Date/time
    Beschreibung

    Date/time

    Datentyp

    datetime

    Alias
    UMLS CUI [1]
    C1717740
    Did the volunteer complete the study?
    Beschreibung

    Did the volunteer complete the study?

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2348577
    If no, please complete the following
    Beschreibung

    Reason for withdrawal. Please tick the SINGLE most appropriate reason only

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0008976
    Reason for withdrawal-Details
    Beschreibung

    Details

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2349954
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0008976
    When did the volunteer last take any study medication?
    Beschreibung

    Please record to appropriate precision

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0946444
    Investigator's checklist
    Beschreibung

    Investigator's checklist

    Alias
    UMLS CUI-1
    C1707357
    UMLS CUI-2
    C0008961
    Check all Adverse Event forms are up to date and complete
    Beschreibung

    all Adverse Event forms are up to date and complete

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0920316
    UMLS CUI [1,3]
    C0205197
    Check that the Concominant Medication form is up to date
    Beschreibung

    Concominant Medication form is up to date

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0920316
    UMLS CUI [1,3]
    C0237400
    Check that all pages are signed (thus indicating completion) and dated
    Beschreibung

    all pages are signed (thus indicating completion) and dated

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1283174
    UMLS CUI [1,2]
    C1519316
    Check that laboratory results are included
    Beschreibung

    laboratory results are included

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C0920316
    Recorder's initials
    Beschreibung

    Recorder's initials

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2986440
    date
    Beschreibung

    date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Study director
    Beschreibung

    Study director

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0025081
    date
    Beschreibung

    date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Investigator's Statement
    Beschreibung

    Investigator's Statement

    Alias
    UMLS CUI-1
    C0008961
    UMLS CUI-2
    C1710187
    I.........(the investigator) take full responsibility for the pages completed in this book.
    Beschreibung

    Investigator-take full responsibility

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0678341
    UMLS CUI [1,2]
    C2826892
    Study Director
    Beschreibung

    Study Director

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0025081
    date
    Beschreibung

    date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Concominant Medication
    Beschreibung

    Concominant Medication

    Alias
    UMLS CUI-1
    C2347852
    Drug name
    Beschreibung

    Drug name

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2360065
    Dose
    Beschreibung

    units

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3174092
    Freq/day
    Beschreibung

    Freq/day

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3476109
    Route
    Beschreibung

    Route

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0013153
    Indication
    Beschreibung

    Fill in an Adverse Event form if necessary

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3146298
    Start Date and Time
    Beschreibung

    Start Date and Time

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C1301880
    End Date and Time
    Beschreibung

    End Date and Time

    Datentyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C1301880
    Continuing at the end of the study
    Beschreibung

    Continuing at the end of the study

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1553904
    If no concominant medication is taken during the study, please select
    Beschreibung

    To be completed at the end of the study

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1298908
    Missing Data-Human
    Beschreibung

    Missing Data-Human

    Alias
    UMLS CUI-1
    C1705492
    UMLS CUI-2
    C1511726
    Study Day
    Beschreibung

    Study Day

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2826182
    Missing Data Point
    Beschreibung

    Missing Data Point

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0814891
    Reason
    Beschreibung

    Reason

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0392360
    Initials
    Beschreibung

    Initials

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3166278
    Missing Data-Haem
    Beschreibung

    Missing Data-Haem

    Alias
    UMLS CUI-1
    C1705492
    UMLS CUI-2
    C1511726
    Study Day
    Beschreibung

    Study Day

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2826182
    Missing Data Point
    Beschreibung

    Missing Data Point

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0814891
    Reason
    Beschreibung

    Reason

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0392360
    Initials
    Beschreibung

    Initials

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3166278
    Missing Data-Clin
    Beschreibung

    Missing Data-Clin

    Alias
    UMLS CUI-1
    C1705492
    UMLS CUI-2
    C1511726
    Study Day
    Beschreibung

    Study Day

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2826182
    Missing Data Point
    Beschreibung

    Missing Data Point

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0814891
    Reason
    Beschreibung

    Reason

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0392360
    Initials
    Beschreibung

    Initials

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3166278
    Missing Data-Urine
    Beschreibung

    Missing Data-Urine

    Alias
    UMLS CUI-1
    C1705492
    UMLS CUI-2
    C1511726
    Study Day
    Beschreibung

    Study Day

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2826182
    Missing Data Point
    Beschreibung

    Missing Data Point

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0814891
    Reason
    Beschreibung

    Reason

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0392360
    Initials
    Beschreibung

    Initials

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3166278
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Glucose assay, plasma drug assay, volunteer completion/withdrawal, investigator's statement, concominant medication, missing data form

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administration
    C1320722 (UMLS CUI-1)
    Vol. No.
    Item
    Vol. No.
    text
    C2348585 (UMLS CUI [1])
    Panel ID.
    Item
    Panel ID.
    text
    C3846158 (UMLS CUI [1])
    Study Period
    Item
    Study Period
    text
    C2347804 (UMLS CUI [1])
    Item Group
    Glucose Assay
    C0202042 (UMLS CUI-1)
    start time infusion
    Item
    Actual time of start of infusion
    datetime
    C0574032 (UMLS CUI [1,1])
    C0439659 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item Group
    Glucose Assay
    C0202042 (UMLS CUI-1)
    Item
    Time Relative to start of infusion
    integer
    C0574032 (UMLS CUI [1,1])
    C0439659 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Time Relative to start of infusion
    Code List
    Time Relative to start of infusion
    CL Item
    -5 mins (1)
    CL Item
    +15 mins (2)
    CL Item
    +30 mins (3)
    CL Item
    +50 mins (4)
    CL Item
    +75 mins (5)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Actual time
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    Sample Taken
    Item
    Sample Taken
    boolean
    C0200345 (UMLS CUI [1])
    Initials
    Item
    Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Plasma Drug Assay
    C1609077 (UMLS CUI-1)
    C1261153 (UMLS CUI-2)
    start of infusion
    Item
    Actual time of start of infusion
    datetime
    C0011008 (UMLS CUI [1,1])
    C0574032 (UMLS CUI [1,2])
    C0439659 (UMLS CUI [1,3])
    Item Group
    Plasma Drug Assay
    C1609077 (UMLS CUI-1)
    C1261153 (UMLS CUI-2)
    Item
    Time relative to start of infusion
    integer
    C0439564 (UMLS CUI [1,1])
    C3469597 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    Time relative to start of infusion
    Code List
    Time relative to start of infusion
    CL Item
    -0.5 hours (1)
    CL Item
    +0.25 hours (2)
    CL Item
    +0.5 hours (3)
    CL Item
    +0.83 hours (4)
    CL Item
    +2 hours (5)
    CL Item
    +3 hours (6)
    CL Item
    +5 hours (7)
    CL Item
    +7 hours (8)
    CL Item
    +10 hours (9)
    CL Item
    +12 hours (10)
    CL Item
    +24 hours (11)
    CL Item
    +48 hours (12)
    CL Item
    +72 hours (13)
    CL Item
    +144 hours (14)
    CL Item
    +216 hours (15)
    CL Item
    +336 hours (16)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Actual time
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    Sample Taken
    Item
    Sample Taken
    boolean
    C0200345 (UMLS CUI [1])
    Initials
    Item
    Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Volunteer Completion/Withdrawal
    C0805732 (UMLS CUI-1)
    C2349954 (UMLS CUI-2)
    Date/time
    Item
    Date/time
    datetime
    C1717740 (UMLS CUI [1])
    Did the volunteer complete the study?
    Item
    Did the volunteer complete the study?
    boolean
    C2348577 (UMLS CUI [1])
    Item
    If no, please complete the following
    integer
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Reason for withdrawal
    Code List
    If no, please complete the following
    CL Item
    Significant adverse events (adverse events form must be completed) (3)
    CL Item
    Lack of subject compliance (4)
    CL Item
    Subject lost to follow-up (5)
    CL Item
    Protocol violation (specify below) (6)
    CL Item
    Concurrent disease (specify below) (7)
    CL Item
    Other reason (specify below) (8)
    Reason for withdrawal
    Item
    Reason for withdrawal-Details
    text
    C2349954 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    When did the volunteer last take any study medication
    Item
    When did the volunteer last take any study medication?
    datetime
    C0304229 (UMLS CUI [1,1])
    C0946444 (UMLS CUI [1,2])
    Item Group
    Investigator's checklist
    C1707357 (UMLS CUI-1)
    C0008961 (UMLS CUI-2)
    all Adverse Event forms are up to date and complete
    Item
    Check all Adverse Event forms are up to date and complete
    boolean
    C0877248 (UMLS CUI [1,1])
    C0920316 (UMLS CUI [1,2])
    C0205197 (UMLS CUI [1,3])
    Concominant Medication form is up to date
    Item
    Check that the Concominant Medication form is up to date
    boolean
    C2347852 (UMLS CUI [1,1])
    C0920316 (UMLS CUI [1,2])
    C0237400 (UMLS CUI [1,3])
    all pages are signed (thus indicating completion) and dated
    Item
    Check that all pages are signed (thus indicating completion) and dated
    boolean
    C1283174 (UMLS CUI [1,1])
    C1519316 (UMLS CUI [1,2])
    laboratory results are included
    Item
    Check that laboratory results are included
    boolean
    C1254595 (UMLS CUI [1,1])
    C0920316 (UMLS CUI [1,2])
    Recorder's initials
    Item
    Recorder's initials
    text
    C2986440 (UMLS CUI [1])
    date
    Item
    date
    date
    C0011008 (UMLS CUI [1])
    Study director
    Item
    Study director
    text
    C0025081 (UMLS CUI [1])
    date
    Item
    date
    date
    C0011008 (UMLS CUI [1])
    Item Group
    Investigator's Statement
    C0008961 (UMLS CUI-1)
    C1710187 (UMLS CUI-2)
    Investigator-take full responsibility
    Item
    I.........(the investigator) take full responsibility for the pages completed in this book.
    text
    C0678341 (UMLS CUI [1,1])
    C2826892 (UMLS CUI [1,2])
    Study Director
    Item
    Study Director
    text
    C0025081 (UMLS CUI [1])
    date
    Item
    date
    date
    C0011008 (UMLS CUI [1])
    Item Group
    Concominant Medication
    C2347852 (UMLS CUI-1)
    Drug name
    Item
    Drug name
    text
    C2360065 (UMLS CUI [1])
    Dose
    Item
    Dose
    text
    C3174092 (UMLS CUI [1])
    Freq/day
    Item
    Freq/day
    text
    C3476109 (UMLS CUI [1])
    Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Indication
    Item
    Indication
    text
    C3146298 (UMLS CUI [1])
    Start Date and Time
    Item
    Start Date and Time
    datetime
    C0808070 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    End Date and Time
    Item
    End Date and Time
    datetime
    C0806020 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Continuing at the end of the study
    Item
    Continuing at the end of the study
    boolean
    C1553904 (UMLS CUI [1])
    undefined item
    Item
    If no concominant medication is taken during the study, please select
    boolean
    C2347852 (UMLS CUI [1,1])
    C1298908 (UMLS CUI [1,2])
    Item Group
    Missing Data-Human
    C1705492 (UMLS CUI-1)
    C1511726 (UMLS CUI-2)
    Study Day
    Item
    Study Day
    date
    C2826182 (UMLS CUI [1])
    Missing Data Point
    Item
    Missing Data Point
    text
    C0814891 (UMLS CUI [1])
    Reason
    Item
    Reason
    text
    C0392360 (UMLS CUI [1])
    Initials
    Item
    Initials
    text
    C3166278 (UMLS CUI [1])
    Item Group
    Missing Data-Haem
    C1705492 (UMLS CUI-1)
    C1511726 (UMLS CUI-2)
    Study Day
    Item
    Study Day
    date
    C2826182 (UMLS CUI [1])
    Missing Data Point
    Item
    Missing Data Point
    text
    C0814891 (UMLS CUI [1])
    Reason
    Item
    Reason
    text
    C0392360 (UMLS CUI [1])
    Initials
    Item
    Initials
    text
    C3166278 (UMLS CUI [1])
    Item Group
    Missing Data-Clin
    C1705492 (UMLS CUI-1)
    C1511726 (UMLS CUI-2)
    Study Day
    Item
    Study Day
    date
    C2826182 (UMLS CUI [1])
    Missing Data Point
    Item
    Missing Data Point
    text
    C0814891 (UMLS CUI [1])
    Reason
    Item
    Reason
    text
    C0392360 (UMLS CUI [1])
    Initials
    Item
    Initials
    text
    C3166278 (UMLS CUI [1])
    Item Group
    Missing Data-Urine
    C1705492 (UMLS CUI-1)
    C1511726 (UMLS CUI-2)
    Study Day
    Item
    Study Day
    date
    C2826182 (UMLS CUI [1])
    Missing Data Point
    Item
    Missing Data Point
    text
    C0814891 (UMLS CUI [1])
    Reason
    Item
    Reason
    text
    C0392360 (UMLS CUI [1])
    Initials
    Item
    Initials
    text
    C3166278 (UMLS CUI [1])
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