ID

37668

Description

Study ID: 105377 Clinical Study ID: 105377 Study Title: A randomised, open-label, parallel-group design study to evaluate the pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lamotrigine Study Indication: Epilepsy

Keywords

Versions (2)
  1. 8/14/19 8/14/19 -
  2. 8/14/19 8/14/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 14, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    Pharmacokinetic characteristics, safety and tolerability of single oral doses of three prototype 300mg enteric coated - modified release formulations of Lamotrigine (Study ID: 105377)

    English

    Visit 1 - Randomisation Number; 12-Lead ECG; 12-Lead ECG Abnormalities; Vital Signs; Investigational Product; Treatment Confirmation; Electronically Transferred Lab Data; Pharmacokinetics Blood

    1 forms  
    Date of Visit/ Assessment
    Description

    Date of Visit/ Assessment

    Alias
    UMLS CUI-1
    C1320303
    UMLS CUI-2
    C2985720
    Date of Visit/ Assessment
    Description

    Date of Visit/ Assessment

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C2985720
    Randomisation
    Description

    Randomisation

    Alias
    UMLS CUI-1
    C0034656
    Was the subject able to be randomised?
    Description

    Was the subject able to be randomised?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0034656
    Randomisation Number
    Description

    Randomisation Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0237753
    Date of randomisation
    Description

    Date of randomisation

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C0011008
    12-Lead ECG
    Description

    12-Lead ECG

    Alias
    UMLS CUI-1
    C0430456
    12-Lead ECG - Dosing Date and Time
    Description

    12-Lead ECG - Dosing Date and Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [2,1]
    C0430456
    UMLS CUI [2,2]
    C0178602
    UMLS CUI [2,3]
    C0040223
    Date and Time of ECG (Pre-dose)
    Description

    Date and Time of ECG (Pre-dose)

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C2826846
    UMLS CUI [2]
    C0439565
    Heart Rate
    Description

    Heart Rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    PR Interval
    Description

    PR Interval

    Data type

    integer

    Measurement units
    • ms
    Alias
    UMLS CUI [1]
    C0429087
    ms
    QRS Duration
    Description

    QRS Duration

    Data type

    integer

    Measurement units
    • ms
    Alias
    UMLS CUI [1]
    C0429025
    ms
    Uncorrected QT Interval
    Description

    Uncorrected QT Interval

    Data type

    integer

    Measurement units
    • ms
    Alias
    UMLS CUI [1]
    C1287082
    ms
    QTc Interval
    Description

    QTc Interval

    Data type

    integer

    Measurement units
    • ms
    Alias
    UMLS CUI [1]
    C0489625
    ms
    Method of QTc Calculation
    Description

    Method of QTc Calculation

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0855331
    UMLS CUI [1,2]
    C2911685
    Result of the ECG
    Description

    Result of the ECG

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0438154
    12-Lead ECG Abnormalities
    Description

    12-Lead ECG Abnormalities

    Date and Time of ECG
    Description

    Date and Time of ECG

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C2826846
    A. Rhythm
    Description

    Record clinically significant abnormalities

    Data type

    text

    Alias
    UMLS CUI [1]
    C0232187
    A. If other abnormal rhythm, enter comment
    Description

    A. If other abnormal rhythm, enter comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0232187
    UMLS CUI [1,2]
    C0205161
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C0947611
    B. P-Wave Morphology
    Description

    Record clinically significant abnormalities

    Data type

    text

    Alias
    UMLS CUI [1]
    C2216025
    B. If other morphology, enter comment
    Description

    B. If other morphology, enter comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0332437
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0947611
    C. Conduction
    Description

    C. Conduction

    Data type

    text

    Alias
    UMLS CUI [1]
    C0232217
    C. If other conduction, enter comment
    Description

    C. If other conduction, enter comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0232217
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0947611
    D. Myocardial Infarction
    Description

    D. Myocardial Infarction

    Data type

    text

    Alias
    UMLS CUI [1]
    C0027051
    D. If other myocardial infarction, enter comment
    Description

    D. If other myocardial infarction, enter comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0027051
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0947611
    E. Depolarisation/Repolarisation (QRS-T)
    Description

    E. Depolarisation/Repolarisation (QRS-T)

    Data type

    text

    Alias
    UMLS CUI [1]
    C1395184
    UMLS CUI [2]
    C0948857
    E. If other depolarisation/ repolarisation, enter comment
    Description

    E. If other depolarisation/ repolarisation, enter comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1395184
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0947611
    UMLS CUI [2,1]
    C0948857
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [2,3]
    C0947611
    If other abnormalities, enter comment
    Description

    If other abnormalities, enter comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C0947611
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Vital Signs - Dosing date/time
    Description

    Vital Signs - Dosing date/time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [2,1]
    C0518766
    UMLS CUI [2,2]
    C0178602
    UMLS CUI [2,3]
    C0040223
    Vital Signs - Actual date/time (Pre-dose)
    Description

    Vital Signs - Actual date/time (Pre-dose)

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C1264639
    UMLS CUI [2]
    C0439565
    Systolic Blood pressure
    Description

    Systolic Blood pressure

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0871470
    mm[Hg]
    Diastolic Blood pressure
    Description

    Diastolic Blood pressure

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0428883
    mm[Hg]
    Vital Signs - Heart rate
    Description

    Vital Signs - Heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0018810
    beats/min
    Investigational Product
    Description

    Investigational Product

    Alias
    UMLS CUI-1
    C0304229
    Investigational product - Date/time of dose
    Description

    Investigational product - Date/time of dose

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [2,1]
    C0304229
    UMLS CUI [2,2]
    C0178602
    UMLS CUI [2,3]
    C0040223
    Treatment Confirmation
    Description

    Treatment Confirmation

    Alias
    UMLS CUI-1
    C0750484
    UMLS CUI-2
    C0087111
    Did the subject receive the correct treatment ( e.g., treatment which the subject was assigned to) during this dosing interval?
    Description

    Did the subject receive the correct treatment

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0750484
    UMLS CUI [1,2]
    C0087111
    If subject did not receive the correct treatment, record reason
    Description

    If subject did not receive the correct treatment, record reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C2349182
    UMLS CUI [1,3]
    C0392360
    Electronically Transferred Lab Data
    Description

    Electronically Transferred Lab Data

    Alias
    UMLS CUI-1
    C0745590
    UMLS CUI-2
    C1705822
    Haematology Date and time sample taken
    Description

    Haematology Date and time sample taken

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Haematology sample not taken
    Description

    Haematology sample not taken

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0018941
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C1272696
    Clinical Chemistry Date and time sample taken
    Description

    Clinical Chemistry Date and time sample taken

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C1264639
    Clinical Chemistry sample not taken
    Description

    Clinical Chemistry sample not taken

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C1272696
    Clinical Chemistry same as the Haematology sample
    Description

    Clinical Chemistry same as the Haematology sample

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0200345
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [2]
    C0018941
    Urinalysis Date and time sample taken
    Description

    Urinalysis Date and time sample taken

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C1264639
    Urinalysis sample not taken.
    Description

    Urinalysis sample not taken.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C1272696
    Pharmacokinetics Blood Pre-36h (Lamotrigine) - Dosing Date and Time
    Description

    Pharmacokinetics Blood Pre-36h (Lamotrigine) - Dosing Date and Time

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    UMLS CUI-3
    C0064636
    UMLS CUI-4
    C0178602
    UMLS CUI-5
    C0011008
    UMLS CUI-6
    C0040223
    Pharmacokinetics Blood Pre-36h (Lamotrigine) - Dosing Date and Time
    Description

    Pharmacokinetics Blood Pre-36h (Lamotrigine) - Dosing Date and Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0064636
    UMLS CUI [2,1]
    C0178602
    UMLS CUI [2,2]
    C0011008
    UMLS CUI [2,3]
    C0040223
    Pharmacokinetics Blood Pre-36h (Lamotrigine)
    Description

    Pharmacokinetics Blood Pre-36h (Lamotrigine)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    UMLS CUI-3
    C0064636
    UMLS CUI-4
    C0178602
    UMLS CUI-5
    C0011008
    UMLS CUI-6
    C0040223
    Pharmacokinetics Blood Pre-36h (Lamotrigine) - Timepoint
    Description

    Pharmacokinetics Blood Pre-36h (Lamotrigine) - Timepoint

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0064636
    UMLS CUI [2]
    C2348792
    Pharmacokinetics Blood Pre-36h (Lamotrigine) - Actual date/time
    Description

    Pharmacokinetics Blood Pre-36h (Lamotrigine) - Actual date/time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0064636
    UMLS CUI [2]
    C1264639
    Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Dosing Date and Time
    Description

    Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Dosing Date and Time

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    UMLS CUI-3
    C0064636
    UMLS CUI-4
    C0178602
    UMLS CUI-5
    C0011008
    UMLS CUI-6
    C0040223
    Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Dosing Date and Time
    Description

    Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Dosing Date and Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0064636
    UMLS CUI [2,1]
    C0178602
    UMLS CUI [2,2]
    C0011008
    UMLS CUI [2,3]
    C0040223
    Pharmacokinetics Blood 48h - 144h (Lamotrigine)
    Description

    Pharmacokinetics Blood 48h - 144h (Lamotrigine)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    UMLS CUI-3
    C0064636
    UMLS CUI-4
    C0178602
    UMLS CUI-5
    C0011008
    UMLS CUI-6
    C0040223
    Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Timepoint
    Description

    Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Timepoint

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0064636
    UMLS CUI [2]
    C2348792
    Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Actual date/time
    Description

    Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Actual date/time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0005767
    UMLS CUI [1,3]
    C0064636
    UMLS CUI [2]
    C1264639
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    Similar models

    Visit 1 - Randomisation Number; 12-Lead ECG; 12-Lead ECG Abnormalities; Vital Signs; Investigational Product; Treatment Confirmation; Electronically Transferred Lab Data; Pharmacokinetics Blood

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Date of Visit/ Assessment
    C1320303 (UMLS CUI-1)
    C2985720 (UMLS CUI-2)
    Date of Visit/ Assessment
    Item
    Date of Visit/ Assessment
    date
    C1320303 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Item Group
    Randomisation
    C0034656 (UMLS CUI-1)
    Was the subject able to be randomised?
    Item
    Was the subject able to be randomised?
    boolean
    C0034656 (UMLS CUI [1])
    Randomisation Number
    Item
    Randomisation Number
    text
    C0034656 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Date of randomisation
    Item
    Date of randomisation
    date
    C0034656 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    12-Lead ECG
    C0430456 (UMLS CUI-1)
    12-Lead ECG - Dosing Date and Time
    Item
    12-Lead ECG - Dosing Date and Time
    datetime
    C0430456 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0430456 (UMLS CUI [2,1])
    C0178602 (UMLS CUI [2,2])
    C0040223 (UMLS CUI [2,3])
    Date and Time of ECG (Pre-dose)
    Item
    Date and Time of ECG (Pre-dose)
    datetime
    C2826846 (UMLS CUI [1])
    C0439565 (UMLS CUI [2])
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    PR Interval
    Item
    PR Interval
    integer
    C0429087 (UMLS CUI [1])
    QRS Duration
    Item
    QRS Duration
    integer
    C0429025 (UMLS CUI [1])
    Uncorrected QT Interval
    Item
    Uncorrected QT Interval
    integer
    C1287082 (UMLS CUI [1])
    QTc Interval
    Item
    QTc Interval
    integer
    C0489625 (UMLS CUI [1])
    Item
    Method of QTc Calculation
    integer
    C0855331 (UMLS CUI [1,1])
    C2911685 (UMLS CUI [1,2])
    Method of QTc Calculation
    Code List
    Method of QTc Calculation
    CL Item
    Machine (1)
    CL Item
    Manual (2)
    Item
    Result of the ECG
    integer
    C0438154 (UMLS CUI [1])
    Result of the ECG
    Code List
    Result of the ECG
    CL Item
    Normal  (1)
    CL Item
    Abnormal - Not clinically significant  (2)
    CL Item
    Abnormal, clinically significant (complete the AE form if clinically significant abnormalities meet the protocol definition for an AE)  (3)
    CL Item
    No result (not available) (4)
    Item Group
    12-Lead ECG Abnormalities
    Date and Time of ECG
    Item
    Date and Time of ECG
    datetime
    C2826846 (UMLS CUI [1])
    Item
    A. Rhythm
    text
    C0232187 (UMLS CUI [1])
    A. Rhythm
    Code List
    A. Rhythm
    CL Item
    Sinus bradycardia (A1)
    CL Item
    Sinus bradycardia (heart rate 40-50 beats/min) (A21)
    CL Item
    Sinus bradycardia (heart rate 3(}-39 beats/min) (A22)
    CL Item
    Sinus bradycardia (heart rate <30 beats/min) (A23)
    CL Item
    Sinus pause (A3)
    CL Item
    Sinus tachycardia (heart rate> 100 beats/min) (A2)
    CL Item
    Ectopic supraventricular beats (A4)
    CL Item
    Ectopic supraventricular rhythm (A20)
    CL Item
    Wandering atrial pacemaker (A17)
    CL Item
    Multifocal atrial tachycardia (wandering attial pacemaker w/rate > 100 beats/min) (A26)
    CL Item
    Supraventricular tachycardia (heart rate> 100 beats/min) (A6)
    CL Item
    Atrial flutter (A7)
    CL Item
    Atrial fibrillation (A8)
    CL Item
    Junctional rhythm (heart rate <=I00 beats/min) (A5)
    CL Item
    Junctional rhythm (A25)
    CL Item
    Junctional tachycardia (heart rate >100 beats/min) (A24)
    CL Item
    Ectopic ventricular beats (A9)
    CL Item
    Ventricular couplets (A12)
    CL Item
    Bigeminy (A13)
    CL Item
    Trigeminy (A28)
    CL Item
    Electrical alternans (A14)
    CL Item
    R on T phenomenon (A29)
    CL Item
    Ventricular fibrillation (A18)
    CL Item
    ldioventricular rhythm (A19)
    CL Item
    Sustained ventricular tachycardia (A10)
    CL Item
    Non-sustained ventricular tachycardia (A11)
    CL Item
    Ventricular tachycardia (A27)
    CL Item
    Monomorphic venlricular tachycardia (A30)
    CL Item
    Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (A15)
    CL Item
    Polymorphic (sustained and non-sustained) ventricular tachycardia (A31)
    CL Item
    Artificial Pacemaker (A16)
    CL Item
    Other abnormal rhythm, enter comment (A99)
    A. If other abnormal rhythm, enter comment
    Item
    A. If other abnormal rhythm, enter comment
    text
    C0232187 (UMLS CUI [1,1])
    C0205161 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C0947611 (UMLS CUI [1,4])
    Item
    B. P-Wave Morphology
    text
    C2216025 (UMLS CUI [1])
    B. P-Wave Morphology
    Code List
    B. P-Wave Morphology
    CL Item
    Left atrial abnormality (P mitrale) (B1)
    CL Item
    Right atrial abnormality (P pulmonale) (B2)
    CL Item
    Right ventricular hypertrophy (B3)
    CL Item
    Intraatrial conduction delay (B5)
    CL Item
    Increased voltage consistent with left ventricular hypertrophy (D14)
    CL Item
    Other morphology, enter comment (B99)
    B. If other morphology, enter comment
    Item
    B. If other morphology, enter comment
    text
    C0332437 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item
    C. Conduction
    text
    C0232217 (UMLS CUI [1])
    C. Conduction
    Code List
    C. Conduction
    CL Item
    First degree AV block (PR interval > 200msec) (C1)
    CL Item
    Second degree AV block (Mobitz type 1) (C2)
    CL Item
    Second degree AV block (Mobitz type 2) (C3)
    CL Item
    AV block (C16)
    CL Item
    Third degree AV block (C4)
    CL Item
    Left axis deviation (QRS axis more negative than -30 degrees) (C5)
    CL Item
    Right axis deviation (QRS axis more positive than + 110 degrees) (C6)
    CL Item
    Incomplete right bundle branch block (C7)
    CL Item
    Incomplete left bundle branch block (C13)
    CL Item
    Right bundle branch block (C8)
    CL Item
    Left anterior hemiblock (synonymous to left anterior fascicular block) (C14)
    CL Item
    Left posterior hemiblock (synonymous to left posterior fascicular block) (C15)
    CL Item
    Left bundle branch block (C9)
    CL Item
    Bifascicular block (C17)
    CL Item
    Non-specific intraventricular conduction delay (QRS >= 120 msec) (C10)
    CL Item
    Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (C11)
    CL Item
    QT/QTc prolongation >= 500 msec (C12)
    CL Item
    AV dissociation (C18)
    CL Item
    Other conduction, enter comment (C99)
    C. If other conduction, enter comment
    Item
    C. If other conduction, enter comment
    text
    C0232217 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item
    D. Myocardial Infarction
    text
    C0027051 (UMLS CUI [1])
    D. Myocardial Infarction
    Code List
    D. Myocardial Infarction
    CL Item
    Myocardial infarction, old (D1)
    CL Item
    Myocardial infarction, anterior (D2)
    CL Item
    Myocardial infarction, lateral (D3)
    CL Item
    Myocardial infarction, posterior (D4)
    CL Item
    Myocardial infarction, inferior (D5)
    CL Item
    Myocardial infarction, septal (D6)
    CL Item
    Myocardial infarction, Non Q-wave (D20)
    CL Item
    Other myocardial infarction, enter comment (D98)
    D. If other myocardial infarction, enter comment
    Item
    D. If other myocardial infarction, enter comment
    text
    C0027051 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item
    E. Depolarisation/Repolarisation (QRS-T)
    text
    C1395184 (UMLS CUI [1])
    C0948857 (UMLS CUI [2])
    E. Depolarisation/Repolarisation (QRS-T)
    Code List
    E. Depolarisation/Repolarisation (QRS-T)
    CL Item
    Non-specific ST-T changes (D7)
    CL Item
    J point elevation (D19)
    CL Item
    ST elevation (D8)
    CL Item
    ST-elevation - pericarditis (D21)
    CL Item
    ST depression (D9)
    CL Item
    U waves abnormal (D10)
    CL Item
    T wave inversion (D11)
    CL Item
    T wave peaked (D12)
    CL Item
    T waves flat (D15)
    CL Item
    T waves biphasic (D16)
    CL Item
    Notched T-waves (D18)
    CL Item
    Low QRS voltage (D13)
    CL Item
    T-wave flattering/ inversion (D17)
    CL Item
    Other depolarisation/ repolarisation, enter comment (D99)
    E. If other depolarisation/ repolarisation, enter comment
    Item
    E. If other depolarisation/ repolarisation, enter comment
    text
    C1395184 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    C0948857 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0947611 (UMLS CUI [2,3])
    If other abnormalities, enter comment
    Item
    If other abnormalities, enter comment
    text
    C0430456 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C0947611 (UMLS CUI [1,4])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Vital Signs - Dosing date/time
    Item
    Vital Signs - Dosing date/time
    datetime
    C0518766 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0518766 (UMLS CUI [2,1])
    C0178602 (UMLS CUI [2,2])
    C0040223 (UMLS CUI [2,3])
    Vital Signs - Actual date/time (Pre-dose)
    Item
    Vital Signs - Actual date/time (Pre-dose)
    datetime
    C0518766 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    C0439565 (UMLS CUI [2])
    Systolic Blood pressure
    Item
    Systolic Blood pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic Blood pressure
    Item
    Diastolic Blood pressure
    integer
    C0428883 (UMLS CUI [1])
    Vital Signs - Heart rate
    Item
    Vital Signs - Heart rate
    integer
    C0518766 (UMLS CUI [1,1])
    C0018810 (UMLS CUI [1,2])
    Item Group
    Investigational Product
    C0304229 (UMLS CUI-1)
    Investigational product - Date/time of dose
    Item
    Investigational product - Date/time of dose
    datetime
    C0304229 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0304229 (UMLS CUI [2,1])
    C0178602 (UMLS CUI [2,2])
    C0040223 (UMLS CUI [2,3])
    Item Group
    Treatment Confirmation
    C0750484 (UMLS CUI-1)
    C0087111 (UMLS CUI-2)
    Did the subject receive the correct treatment
    Item
    Did the subject receive the correct treatment ( e.g., treatment which the subject was assigned to) during this dosing interval?
    boolean
    C0750484 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    If subject did not receive the correct treatment, record reason
    Item
    If subject did not receive the correct treatment, record reason
    text
    C0087111 (UMLS CUI [1,1])
    C2349182 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Item Group
    Electronically Transferred Lab Data
    C0745590 (UMLS CUI-1)
    C1705822 (UMLS CUI-2)
    Haematology Date and time sample taken
    Item
    Haematology Date and time sample taken
    datetime
    C0018941 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Item
    Haematology sample not taken
    integer
    C0018941 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Haematology sample not taken
    Code List
    Haematology sample not taken
    CL Item
    Not done (1)
    Clinical Chemistry Date and time sample taken
    Item
    Clinical Chemistry Date and time sample taken
    datetime
    C0008000 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C1264639 (UMLS CUI [1,3])
    Item
    Clinical Chemistry sample not taken
    integer
    C0008000 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Clinical Chemistry sample not taken
    Code List
    Clinical Chemistry sample not taken
    CL Item
    Not done (1)
    Item
    Clinical Chemistry same as the Haematology sample
    integer
    C0200345 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0018941 (UMLS CUI [2])
    Clinical Chemistry same as the Haematology sample
    Code List
    Clinical Chemistry same as the Haematology sample
    CL Item
    Same as the Haematology sample (1)
    Urinalysis Date and time sample taken
    Item
    Urinalysis Date and time sample taken
    datetime
    C0042014 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C1264639 (UMLS CUI [1,3])
    Item
    Urinalysis sample not taken.
    integer
    C0042014 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Urinalysis sample not taken.
    Code List
    Urinalysis sample not taken.
    CL Item
    Not done (1)
    Item Group
    Pharmacokinetics Blood Pre-36h (Lamotrigine) - Dosing Date and Time
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    C0064636 (UMLS CUI-3)
    C0178602 (UMLS CUI-4)
    C0011008 (UMLS CUI-5)
    C0040223 (UMLS CUI-6)
    Pharmacokinetics Blood Pre-36h (Lamotrigine) - Dosing Date and Time
    Item
    Pharmacokinetics Blood Pre-36h (Lamotrigine) - Dosing Date and Time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0064636 (UMLS CUI [1,3])
    C0178602 (UMLS CUI [2,1])
    C0011008 (UMLS CUI [2,2])
    C0040223 (UMLS CUI [2,3])
    Item Group
    Pharmacokinetics Blood Pre-36h (Lamotrigine)
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    C0064636 (UMLS CUI-3)
    C0178602 (UMLS CUI-4)
    C0011008 (UMLS CUI-5)
    C0040223 (UMLS CUI-6)
    Item
    Pharmacokinetics Blood Pre-36h (Lamotrigine) - Timepoint
    integer
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0064636 (UMLS CUI [1,3])
    C2348792 (UMLS CUI [2])
    Pharmacokinetics Blood Pre-36h (Lamotrigine) - Timepoint
    Code List
    Pharmacokinetics Blood Pre-36h (Lamotrigine) - Timepoint
    CL Item
    Pre-Dose (1)
    CL Item
    0.5h (2)
    CL Item
    1h (3)
    CL Item
    2h (4)
    CL Item
    3h (5)
    CL Item
    4h (6)
    CL Item
    6h (7)
    CL Item
    8h (8)
    CL Item
    10h (9)
    CL Item
    12h (10)
    CL Item
    13h (11)
    CL Item
    14h (12)
    CL Item
    15h (13)
    CL Item
    16h (14)
    CL Item
    18h (15)
    CL Item
    20h (16)
    CL Item
    22h (17)
    CL Item
    24h (18)
    CL Item
    26h (19)
    CL Item
    36h (20)
    Pharmacokinetics Blood Pre-36h (Lamotrigine) - Actual date/time
    Item
    Pharmacokinetics Blood Pre-36h (Lamotrigine) - Actual date/time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0064636 (UMLS CUI [1,3])
    C1264639 (UMLS CUI [2])
    Item Group
    Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Dosing Date and Time
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    C0064636 (UMLS CUI-3)
    C0178602 (UMLS CUI-4)
    C0011008 (UMLS CUI-5)
    C0040223 (UMLS CUI-6)
    Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Dosing Date and Time
    Item
    Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Dosing Date and Time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0064636 (UMLS CUI [1,3])
    C0178602 (UMLS CUI [2,1])
    C0011008 (UMLS CUI [2,2])
    C0040223 (UMLS CUI [2,3])
    Item Group
    Pharmacokinetics Blood 48h - 144h (Lamotrigine)
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    C0064636 (UMLS CUI-3)
    C0178602 (UMLS CUI-4)
    C0011008 (UMLS CUI-5)
    C0040223 (UMLS CUI-6)
    Item
    Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Timepoint
    integer
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0064636 (UMLS CUI [1,3])
    C2348792 (UMLS CUI [2])
    Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Timepoint
    Code List
    Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Timepoint
    CL Item
    48h (1)
    CL Item
    72h (2)
    CL Item
    96h (3)
    CL Item
    120h (4)
    CL Item
    144h (5)
    Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Actual date/time
    Item
    Pharmacokinetics Blood 48h - 144h (Lamotrigine) - Actual date/time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0005767 (UMLS CUI [1,2])
    C0064636 (UMLS CUI [1,3])
    C1264639 (UMLS CUI [2])
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