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31918

Beschreibung

Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

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Versionen (3)
  1. 30.09.18 30.09.18 -
  2. 08.10.18 08.10.18 -
  3. 08.10.18 08.10.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

8. Oktober 2018

DOI

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Creative Commons BY-NC 3.0
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    Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040

    Englisch

    Investigator Comment Log, Patient Discharge Notification Postcard, Last Dose of Study Drug Record, End of Study Record, Status of Randomization Code/ Investigator's Statement and Laboratory Comments

    1 Formulare  
    Administrative
    Beschreibung

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Site number
    Beschreibung

    Study Site; Numbers

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2825164
    UMLS CUI [1,2]
    C0237753
    Patient's initials
    Beschreibung

    Person Initials

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2986440
    Patient's trial number
    Beschreibung

    Clinical Trial Subject Unique Identifier

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Investigator Comment Log
    Beschreibung

    Investigator Comment Log

    Alias
    UMLS CUI-1
    C0008961
    UMLS CUI-2
    C0947611
    Comment Date
    Beschreibung

    Comment; Date in time

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0011008
    Page number
    Beschreibung

    Page (document); Numbers

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1704732
    UMLS CUI [1,2]
    C0237753
    Comments
    Beschreibung

    Comment

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    Patient Discharge Notification Postcard
    Beschreibung

    Patient Discharge Notification Postcard

    Alias
    UMLS CUI-1
    C0030685
    UMLS CUI-2
    C0422202
    Project number
    Beschreibung

    Project; Identification number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1709701
    UMLS CUI [1,2]
    C1300638
    Protocol number
    Beschreibung

    Study Protocol; Numbers

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C2348563
    UMLS CUI [1,2]
    C0237753
    Site number
    Beschreibung

    Study Site; Numbers

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2825164
    UMLS CUI [1,2]
    C0237753
    Date discharged
    Beschreibung

    Discharge date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2361123
    Patient's initials
    Beschreibung

    Person Initials

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2986440
    Patient's trial number
    Beschreibung

    Clinical Trial Subject Unique Identifier

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Last dose of study drug record
    Beschreibung

    Last dose of study drug record

    Alias
    UMLS CUI-1
    C3854006
    UMLS CUI-2
    C0178602
    UMLS CUI-3
    C0034869
    UMLS CUI-4
    C1517741
    Was study drug stopped permanently before completion of all 18 weeks of treatment and taper?
    Beschreibung

    Experimental drug; Discontinuation (procedure) | Completion Status; Therapeutic procedure

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0457454
    UMLS CUI [2,1]
    C0805732
    UMLS CUI [2,2]
    C0087111
    If study drug stopped, check the primary reason drug was stopped
    Beschreibung

    Experimental drug; Discontinuation (procedure); Indication of (contextual qualifier)

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0457454
    UMLS CUI [1,3]
    C0392360
    Date of last dose
    Beschreibung

    Date last dose

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1762893
    End of study record
    Beschreibung

    End of study record

    Alias
    UMLS CUI-1
    C0008976
    UMLS CUI-2
    C0444496
    Did the patient complete the Screen, Baseline, Treatment Phases and Taper?
    Beschreibung

    Baseline; Complete | Screening procedure; Complete | treatment phases; Complete | Tapering - action; Complete

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1442488
    UMLS CUI [1,2]
    C0205197
    UMLS CUI [2,1]
    C0220908
    UMLS CUI [2,2]
    C0205197
    UMLS CUI [3,1]
    C0815181
    UMLS CUI [3,2]
    C0205197
    UMLS CUI [4,1]
    C0441640
    UMLS CUI [4,2]
    C0205197
    If patient did not complete Screen, Baseline, Treatment Phases and Taper, check primary reason.
    Beschreibung

    Baseline; Screening procedure; treatment phases; Tapering - action; Complete; Reason and justification

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1442488
    UMLS CUI [1,2]
    C0205197
    UMLS CUI [1,3]
    C0566251
    UMLS CUI [2,1]
    C0220908
    UMLS CUI [2,2]
    C0205197
    UMLS CUI [2,3]
    C0566251
    UMLS CUI [3,1]
    C0815181
    UMLS CUI [3,2]
    C0205197
    UMLS CUI [3,3]
    C0566251
    UMLS CUI [4,1]
    C0441640
    UMLS CUI [4,2]
    C0205197
    UMLS CUI [4,3]
    C0566251
    Date patient discharged from the study
    Beschreibung

    No further protocol specified treatments or evaluations are planned

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C2361123
    UMLS CUI [1,2]
    C2603343
    Did the patient die anytime during the study (Baseline Day 1 through Taper and Folllow-Up Phases?)
    Beschreibung

    Cessation of life; Clinical Trials; During

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0011065
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0347984
    UMLS CUI [2]
    C1442488
    UMLS CUI [3]
    C0441640
    UMLS CUI [4]
    C1522577
    If patient died, onset date of the event wich led to death
    Beschreibung

    Death Related to Adverse Event; Date of onset

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1705232
    UMLS CUI [1,2]
    C0574845
    Date of death
    Beschreibung

    Date of death

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1148348
    Characterize the cause of death
    Beschreibung

    Cause of Death

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0007465
    If other cause of death, specify.
    Beschreibung

    Cause of Death; Other; Specification

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0007465
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Check attribution of death to study medication
    Beschreibung

    Cessation of life; Experimental drug; attribution

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0011065
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C0596130
    Was an autopsy performed?
    Beschreibung

    Autopsy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0004398
    Status of randomization code/ Investigator's statement
    Beschreibung

    Status of randomization code/ Investigator's statement

    Alias
    UMLS CUI-1
    C0034656
    UMLS CUI-2
    C0805701
    UMLS CUI-3
    C0449438
    UMLS CUI-4
    C0008961
    UMLS CUI-5
    C1710187
    Was the blind on the randomization code for this patient broken?
    Beschreibung

    Randomization; Code; Blinded Clinical Study Unit

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0805701
    UMLS CUI [1,3]
    C2347038
    UMLS CUI [1,4]
    C3846158
    Date of blind was broken
    Beschreibung

    Date in time; Blinded Clinical Study

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2347038
    UMLS CUI [1,3]
    C3846158
    Reason for breaking blind
    Beschreibung

    Date in time; Blinded Clinical Study

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2347038
    UMLS CUI [1,3]
    C3846158
    Investigator's statement
    Beschreibung

    Investigator's statement

    Alias
    UMLS CUI-1
    C0008961
    UMLS CUI-2
    C1710187
    Investigator's Signature
    Beschreibung

    Investigator Signature

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date of Signature
    Beschreibung

    Investigator Signature; Date in time

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Investigator's name
    Beschreibung

    Investigator Name

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2826892
    Laboratory Comments - Unscheduled Laboratory Assessment
    Beschreibung

    Laboratory Comments - Unscheduled Laboratory Assessment

    Alias
    UMLS CUI-1
    C0022877
    UMLS CUI-2
    C0947611
    UMLS CUI-3
    C0220825
    UMLS CUI-4
    C0022877
    UMLS CUI-5
    C3854240
    Do you consider any of the laboratory values at this clinic visit to be of potential OR actual clinical significance AND unexpected in this patient population?
    Beschreibung

    Laboratory Results; Clinical Significance; Unexpected

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C2826293
    UMLS CUI [1,3]
    C4055646
    Laboratory results that are of potential or actual clinical significance and unexpected
    Beschreibung

    Laboratory results that are of potential or actual clinical significance and unexpected

    Alias
    UMLS CUI-1
    C1254595
    UMLS CUI-2
    C2826293
    UMLS CUI-3
    C4055646
    Laboratory parameter
    Beschreibung

    Laboratory; Parameter Value

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0549193
    Comment (Laboratory parameter)
    Beschreibung

    Comment | Laboratory; Parameter Value

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    UMLS CUI [2,1]
    C0022877
    UMLS CUI [2,2]
    C0549193
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Investigator Comment Log, Patient Discharge Notification Postcard, Last Dose of Study Drug Record, End of Study Record, Status of Randomization Code/ Investigator's Statement and Laboratory Comments

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Study Site; Numbers
    Item
    Site number
    text
    C2825164 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Person Initials
    Item
    Patient's initials
    text
    C2986440 (UMLS CUI [1])
    Clinical Trial Subject Unique Identifier
    Item
    Patient's trial number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Investigator Comment Log
    C0008961 (UMLS CUI-1)
    C0947611 (UMLS CUI-2)
    Comment; Date in time
    Item
    Comment Date
    date
    C0947611 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Page (document); Numbers
    Item
    Page number
    integer
    C1704732 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Comment
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Patient Discharge Notification Postcard
    C0030685 (UMLS CUI-1)
    C0422202 (UMLS CUI-2)
    Project; Identification number
    Item
    Project number
    integer
    C1709701 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Study Protocol; Numbers
    Item
    Protocol number
    integer
    C2348563 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Study Site; Numbers
    Item
    Site number
    text
    C2825164 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Discharge date
    Item
    Date discharged
    date
    C2361123 (UMLS CUI [1])
    Person Initials
    Item
    Patient's initials
    text
    C2986440 (UMLS CUI [1])
    Clinical Trial Subject Unique Identifier
    Item
    Patient's trial number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Last dose of study drug record
    C3854006 (UMLS CUI-1)
    C0178602 (UMLS CUI-2)
    C0034869 (UMLS CUI-3)
    C1517741 (UMLS CUI-4)
    Experimental drug; Discontinuation (procedure) | Completion Status; Therapeutic procedure
    Item
    Was study drug stopped permanently before completion of all 18 weeks of treatment and taper?
    boolean
    C0304229 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    C0805732 (UMLS CUI [2,1])
    C0087111 (UMLS CUI [2,2])
    Item
    If study drug stopped, check the primary reason drug was stopped
    integer
    C0304229 (UMLS CUI [1,1])
    C0457454 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Experimental drug; Discontinuation (procedure); Indication of (contextual qualifier)
    Code List
    If study drug stopped, check the primary reason drug was stopped
    CL Item
    Adverse Experience (record details on ADVERSEnEXPERIENCES pages) (1)
    CL Item
    Death (Check only, if death is NOT an outcome of an adverse experience) (2)
    CL Item
    Inadequate response to study drug (including seizure exacerbation) (3)
    CL Item
    Consent withdrawn (4)
    CL Item
    Lost to follow-up (5)
    CL Item
    Protocol violation (non- compliance or pregnancy) (6)
    Date last dose
    Item
    Date of last dose
    date
    C1762893 (UMLS CUI [1])
    Item Group
    End of study record
    C0008976 (UMLS CUI-1)
    C0444496 (UMLS CUI-2)
    Baseline; Complete | Screening procedure; Complete | treatment phases; Complete | Tapering - action; Complete
    Item
    Did the patient complete the Screen, Baseline, Treatment Phases and Taper?
    boolean
    C1442488 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    C0220908 (UMLS CUI [2,1])
    C0205197 (UMLS CUI [2,2])
    C0815181 (UMLS CUI [3,1])
    C0205197 (UMLS CUI [3,2])
    C0441640 (UMLS CUI [4,1])
    C0205197 (UMLS CUI [4,2])
    Item
    If patient did not complete Screen, Baseline, Treatment Phases and Taper, check primary reason.
    integer
    C1442488 (UMLS CUI [1,1])
    C0205197 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    C0220908 (UMLS CUI [2,1])
    C0205197 (UMLS CUI [2,2])
    C0566251 (UMLS CUI [2,3])
    C0815181 (UMLS CUI [3,1])
    C0205197 (UMLS CUI [3,2])
    C0566251 (UMLS CUI [3,3])
    C0441640 (UMLS CUI [4,1])
    C0205197 (UMLS CUI [4,2])
    C0566251 (UMLS CUI [4,3])
    undefined item
    Code List
    If patient did not complete Screen, Baseline, Treatment Phases and Taper, check primary reason.
    CL Item
    Adverse Experience (record details on ADVERSEnEXPERIENCES pages) (1)
    CL Item
    Death (Check only, if death is NOT an outcome of an adverse experience) (2)
    CL Item
    Inadequate response to study drug (including seizure exacerbation) (3)
    CL Item
    Consent withdrawn (4)
    CL Item
    Lost to follow-up (5)
    CL Item
    Protocol violation (non- compliance or pregnancy) (6)
    Discharge date; Study
    Item
    Date patient discharged from the study
    date
    C2361123 (UMLS CUI [1,1])
    C2603343 (UMLS CUI [1,2])
    Cessation of life; Clinical Trials; During
    Item
    Did the patient die anytime during the study (Baseline Day 1 through Taper and Folllow-Up Phases?)
    boolean
    C0011065 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0347984 (UMLS CUI [1,3])
    C1442488 (UMLS CUI [2])
    C0441640 (UMLS CUI [3])
    C1522577 (UMLS CUI [4])
    Death Related to Adverse Event; Date of onset
    Item
    If patient died, onset date of the event wich led to death
    date
    C1705232 (UMLS CUI [1,1])
    C0574845 (UMLS CUI [1,2])
    Date of death
    Item
    Date of death
    date
    C1148348 (UMLS CUI [1])
    Item
    Characterize the cause of death
    integer
    C0007465 (UMLS CUI [1])
    Cause of Death
    Code List
    Characterize the cause of death
    CL Item
    Accidental (1)
    CL Item
    Seizure- related (If seizure- related, check one) (2)
    CL Item
    Aspiration (3)
    CL Item
    Status epilepticus (4)
    CL Item
    Drowning (5)
    CL Item
    Other (specify) (6)
    Cause of Death; Other; Specification
    Item
    If other cause of death, specify.
    text
    C0007465 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Check attribution of death to study medication
    integer
    C0011065 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C0596130 (UMLS CUI [1,3])
    undefined item
    Code List
    Check attribution of death to study medication
    CL Item
    Not a reasonable possibility (1)
    CL Item
    A resonable possibility (2)
    Autopsy
    Item
    Was an autopsy performed?
    boolean
    C0004398 (UMLS CUI [1])
    Item Group
    Status of randomization code/ Investigator's statement
    C0034656 (UMLS CUI-1)
    C0805701 (UMLS CUI-2)
    C0449438 (UMLS CUI-3)
    C0008961 (UMLS CUI-4)
    C1710187 (UMLS CUI-5)
    Randomization; Code; Blinded Clinical Study Unit
    Item
    Was the blind on the randomization code for this patient broken?
    boolean
    C0034656 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    C2347038 (UMLS CUI [1,3])
    C3846158 (UMLS CUI [1,4])
    Date in time; Blinded Clinical Study
    Item
    Date of blind was broken
    date
    C0011008 (UMLS CUI [1,1])
    C2347038 (UMLS CUI [1,2])
    C3846158 (UMLS CUI [1,3])
    Date in time; Blinded Clinical Study
    Item
    Reason for breaking blind
    text
    C0011008 (UMLS CUI [1,1])
    C2347038 (UMLS CUI [1,2])
    C3846158 (UMLS CUI [1,3])
    Item Group
    Investigator's statement
    C0008961 (UMLS CUI-1)
    C1710187 (UMLS CUI-2)
    Investigator Signature
    Item
    Investigator's Signature
    text
    C2346576 (UMLS CUI [1])
    Investigator Signature; Date in time
    Item
    Date of Signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Investigator Name
    Item
    Investigator's name
    text
    C2826892 (UMLS CUI [1])
    Item Group
    Laboratory Comments - Unscheduled Laboratory Assessment
    C0022877 (UMLS CUI-1)
    C0947611 (UMLS CUI-2)
    C0220825 (UMLS CUI-3)
    C0022877 (UMLS CUI-4)
    C3854240 (UMLS CUI-5)
    Laboratory Results; Clinical Significance; Unexpected
    Item
    Do you consider any of the laboratory values at this clinic visit to be of potential OR actual clinical significance AND unexpected in this patient population?
    boolean
    C1254595 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    C4055646 (UMLS CUI [1,3])
    Item Group
    Laboratory results that are of potential or actual clinical significance and unexpected
    C1254595 (UMLS CUI-1)
    C2826293 (UMLS CUI-2)
    C4055646 (UMLS CUI-3)
    Laboratory; Parameter Value
    Item
    Laboratory parameter
    text
    C0022877 (UMLS CUI [1,1])
    C0549193 (UMLS CUI [1,2])
    Comment | Laboratory; Parameter Value
    Item
    Comment (Laboratory parameter)
    text
    C0947611 (UMLS CUI [1])
    C0022877 (UMLS CUI [2,1])
    C0549193 (UMLS CUI [2,2])
    Zum Seitenanfang zurückkehren 

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