ID

37680

Beskrivning

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

Nyckelord

  1. 2019-08-16 2019-08-16 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

16 augusti 2019

DOI

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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)

    Logs/ Repeats - Concomitant Medication; 12-Lead/ Holter/ Telemetry ECG; 12-Lead ECG Abnormalities

    Concomitant Medication
    Beskrivning

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852
    Concomitant Medication - Sequence number
    Beskrivning

    Concomitant Medication - Sequence number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2348184
    Concomitant Medication - Drug Name
    Beskrivning

    (Trade Name preferred)

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2360065
    Concomitant Medication - Modified reported term
    Beskrivning

    Concomitant Medicatin - Modified reported term

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2826819
    GSK Drug synonym
    Beskrivning

    GSK Drug synonym

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0871468
    GSK Drug Collection code
    Beskrivning

    GSK Drug Collection code

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C1516698
    UMLS CUI [1,3]
    C0805701
    Concomitant Medication - Failed coding
    Beskrivning

    Concomitant Medication - Failed coding

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0805701
    UMLS CUI [1,3]
    C0231175
    Concomitant Medication Unit Dose
    Beskrivning

    Concomitant Medication Unit Dose

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826646
    Concomitant Medication Units
    Beskrivning

    Concomitant Medication Units

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0439148
    Concomitant Medication Frequency
    Beskrivning

    Concomitant Medication Frequency

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2826654
    Concomitant Medication Route
    Beskrivning

    Concomitant Medication Route

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2826730
    Reason for Medication
    Beskrivning

    Reason for Medication

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0013227
    Medication Start Date and Time
    Beskrivning

    Medication Start Date and Time

    Datatyp

    datetime

    Alias
    UMLS CUI [1]
    C2826734
    UMLS CUI [2,1]
    C2347852
    UMLS CUI [2,2]
    C1301880
    Medication taken Prior to Study?
    Beskrivning

    Medication taken Prior to Study?

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2826667
    Concomitant medication ongoing?
    Beskrivning

    Concomitant medication ongoing?

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    End date and time of concomitant medication
    Beskrivning

    End date and time of concomitant medication

    Datatyp

    datetime

    Alias
    UMLS CUI [1]
    C2826744
    UMLS CUI [2]
    C1522314
    12-Lead/ Holter/ Telemetry ECG
    Beskrivning

    12-Lead/ Holter/ Telemetry ECG

    Alias
    UMLS CUI-1
    C0430456
    UMLS CUI-2
    C0013801
    UMLS CUI-3
    C1623258
    UMLS CUI-4
    C0039451
    Date and Time of ECG
    Beskrivning

    Date and Time of ECG

    Datatyp

    datetime

    Alias
    UMLS CUI [1]
    C2826846
    Heart rate
    Beskrivning

    Heart rate

    Datatyp

    integer

    Måttenheter
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    PR lnterval
    Beskrivning

    PR lnterval

    Datatyp

    integer

    Måttenheter
    • ms
    Alias
    UMLS CUI [1]
    C0429087
    ms
    QRS Duration
    Beskrivning

    QRS Duration

    Datatyp

    integer

    Måttenheter
    • ms
    Alias
    UMLS CUI [1]
    C0429025
    ms
    Uncorrected QT lnterval
    Beskrivning

    Uncorrected QT lnterval

    Datatyp

    integer

    Måttenheter
    • ms
    Alias
    UMLS CUI [1]
    C1287082
    ms
    QTc Interval
    Beskrivning

    QTc Interval

    Datatyp

    integer

    Måttenheter
    • ms
    Alias
    UMLS CUI [1]
    C0489625
    ms
    Method of QTc Calculation
    Beskrivning

    Method of QTc Calculation

    Datatyp

    integer

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

    Result of the ECG

    Datatyp

    integer

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

    12-Lead ECG Abnormalities

    Alias
    UMLS CUI-1
    C0430456
    UMLS CUI-2
    C1704258
    Date and Time of ECG
    Beskrivning

    Date and Time of ECG

    Datatyp

    datetime

    Alias
    UMLS CUI [1]
    C2826846
    A. Rhythm
    Beskrivning

    Record clinically significant abnormalities

    Datatyp

    text

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

    A. If other abnormal rhythm, enter comment

    Datatyp

    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
    Beskrivning

    Record clinically significant abnormalities

    Datatyp

    text

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

    B. If other morphology, enter comment

    Datatyp

    text

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

    C. Conduction

    Datatyp

    text

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

    C. If other conduction, enter comment

    Datatyp

    text

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

    D. Myocardial Infarction

    Datatyp

    text

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

    D. If other myocardial infarction, enter comment

    Datatyp

    text

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

    E. Depolarisation/Repolarisation (QRS-T)

    Datatyp

    text

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

    E. If other depolarisation/ repolarisation, enter comment

    Datatyp

    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
    Beskrivning

    If other abnormalities, enter comment

    Datatyp

    text

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

    Similar models

    Logs/ Repeats - Concomitant Medication; 12-Lead/ Holter/ Telemetry ECG; 12-Lead ECG Abnormalities

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Concomitant Medication - Sequence number
    Item
    Concomitant Medication - Sequence number
    integer
    C2347852 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Concomitant Medication - Drug Name
    Item
    Concomitant Medication - Drug Name
    text
    C2347852 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    Concomitant Medicatin - Modified reported term
    Item
    Concomitant Medication - Modified reported term
    text
    C2347852 (UMLS CUI [1,1])
    C2826819 (UMLS CUI [1,2])
    GSK Drug synonym
    Item
    GSK Drug synonym
    text
    C0013227 (UMLS CUI [1,1])
    C0871468 (UMLS CUI [1,2])
    GSK Drug Collection code
    Item
    GSK Drug Collection code
    text
    C0013227 (UMLS CUI [1,1])
    C1516698 (UMLS CUI [1,2])
    C0805701 (UMLS CUI [1,3])
    Concomitant Medication - Failed coding
    Item
    Concomitant Medication - Failed coding
    text
    C2347852 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    C0231175 (UMLS CUI [1,3])
    Concomitant Medication Unit Dose
    Item
    Concomitant Medication Unit Dose
    text
    C2826646 (UMLS CUI [1])
    Item
    Concomitant Medication Units
    integer
    C2347852 (UMLS CUI [1,1])
    C0439148 (UMLS CUI [1,2])
    Code List
    Concomitant Medication Units
    CL Item
    Actuation  (1)
    CL Item
    Ampoule  (2)
    CL Item
    Application  (3)
    CL Item
    Area under curve  (4)
    CL Item
    Bottle  (5)
    CL Item
    Capsule  (6)
    CL Item
    Cubic centimeter  (7)
    CL Item
    Cup  (8)
    CL Item
    Gamma per kilogram per minute (9)
    CL Item
    Gram  (10)
    CL Item
    Drops  (11)
    CL Item
    100 International units/ml (12)
    CL Item
    Inhalation  (13)
    CL Item
    International units (14)
    CL Item
    International units per kilogram (15)
    CL Item
    International units per kilogram per hour  (16)
    CL Item
    International units per millilitre  (17)
    CL Item
    Litre (18)
    CL Item
    Lozenge  (19)
    CL Item
    Litre per minute  (20)
    CL Item
    Minimum alveolar concentration  (21)
    CL Item
    Mega becquerels (MBq) MBQ  (22)
    CL Item
    Microgram (MCG) (23)
    CL Item
    Micrograms per hour  (24)
    CL Item
    Microgram/kilogram  (25)
    CL Item
    Microgram/kilogram per minute  (26)
    CL Item
    Micrograms per minute  (27)
    CL Item
    Micrograms per millitre  (28)
    CL Item
    Microlitre  (29)
    CL Item
    Milliequivalent  (30)
    CL Item
    Milliequivalent per 24  (31)
    CL Item
    Milligram  (32)
    CL Item
    Milligram per day  (33)
    CL Item
    Milligram per hour  (34)
    CL Item
    Milligram/kilogram  (35)
    CL Item
    Milligram/kilogram per hour  (36)
    CL Item
    Milligram/kilogram per minute  (37)
    CL Item
    Milligram/metre squared  (38)
    CL Item
    Milligram/millilitre  (39)
    CL Item
    Milligrams percent  (40)
    CL Item
    Million international units  (41)
    CL Item
    Millilitre  (42)
    CL Item
    Millilitre per hour  (43)
    CL Item
    Millilitre per minute  (44)
    CL Item
    Millimole  (45)
    CL Item
    Megaunits (million units)  (46)
    CL Item
    Nebule  (47)
    CL Item
    Ounce  (48)
    CL Item
    Patch  (49)
    CL Item
    Percent  (50)
    CL Item
    Puff  (51)
    CL Item
    Sachet  (52)
    CL Item
    Spray  (53)
    CL Item
    Suppository  (54)
    CL Item
    Tablet (55)
    CL Item
    Tablespoon  (56)
    CL Item
    Teaspoon  (57)
    CL Item
    Microgram (UG)  (58)
    CL Item
    Units per hour  (59)
    CL Item
    Units per kilogram per minute  (60)
    CL Item
    Units per minute  (61)
    CL Item
    Units  (62)
    CL Item
    Unknown  (63)
    CL Item
    Vial  (64)
    Item
    Concomitant Medication Frequency
    integer
    C2826654 (UMLS CUI [1])
    Code List
    Concomitant Medication Frequency
    CL Item
    2 times per week  (1)
    CL Item
    3 times per week  (2)
    CL Item
    4 times per week  (3)
    CL Item
    5 times per day  (4)
    CL Item
    5 times per week  (5)
    CL Item
    AC  (6)
    CL Item
    BID  (7)
    CL Item
    Continuous infusion  (8)
    CL Item
    HS  (9)
    CL Item
    Once daily  (10)
    CL Item
    Once only (11)
    CL Item
    PC  (12)
    CL Item
    PRN  (13)
    CL Item
    Q12H  (14)
    CL Item
    Q2H  (15)
    CL Item
    Every 2 weeks  (16)
    CL Item
    Q3D  (17)
    CL Item
    Every 3 months  (18)
    CL Item
    Every 3 weeks  (19)
    CL Item
    Q4D  (20)
    CL Item
    Q4H  (21)
    CL Item
    Q6H  (22)
    CL Item
    Q8H  (23)
    CL Item
    QAM  (24)
    CL Item
    QH  (25)
    CL Item
    QID  (26)
    CL Item
    Once a month  (27)
    CL Item
    Every other day  (28)
    CL Item
    QPM  (29)
    CL Item
    Once a week  (30)
    CL Item
    TID  (31)
    CL Item
    Unknown (32)
    Item
    Concomitant Medication Route
    integer
    C2826730 (UMLS CUI [1])
    Code List
    Concomitant Medication Route
    CL Item
    Epidural (1)
    CL Item
    Gastrostomy tube (2)
    CL Item
    Intra-arterial  (3)
    CL Item
    Intra-articular  (4)
    CL Item
    Intra-bursa (5)
    CL Item
    Intradermal  (6)
    CL Item
    Inhalation  (7)
    CL Item
    Intralesional (8)
    CL Item
    Intramuscular (9)
    CL Item
    Intranasal (10)
    CL Item
    Injection (11)
    CL Item
    Intraocular (12)
    CL Item
    Intraosteal (13)
    CL Item
    Intraperitoneal (14)
    CL Item
    Intrathecal (15)
    CL Item
    Intrauterine (16)
    CL Item
    Intravenous (17)
    CL Item
    Nasogastric (18)
    CL Item
    Nasal (19)
    CL Item
    Right eye (20)
    CL Item
    Ophthalmic  (21)
    CL Item
    Left eye (22)
    CL Item
    Otic (23)
    CL Item
    Other (24)
    CL Item
    Both eyes (25)
    CL Item
    Oral (26)
    CL Item
    Rectal (27)
    CL Item
    Subcutaneous (28)
    CL Item
    Sublingual (29)
    CL Item
    Transdermal (30)
    CL Item
    Topical (31)
    CL Item
    Unknown (32)
    CL Item
    Vaginal (33)
    Reason for Medication
    Item
    Reason for Medication
    text
    C0392360 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Medication Start Date and Time
    Item
    Medication Start Date and Time
    datetime
    C2826734 (UMLS CUI [1])
    C2347852 (UMLS CUI [2,1])
    C1301880 (UMLS CUI [2,2])
    Medication taken Prior to Study?
    Item
    Medication taken Prior to Study?
    boolean
    C2826667 (UMLS CUI [1])
    Concomitant medication ongoing?
    Item
    Concomitant medication ongoing?
    boolean
    C2826666 (UMLS CUI [1])
    End date and time of concomitant medication
    Item
    End date and time of concomitant medication
    datetime
    C2826744 (UMLS CUI [1])
    C1522314 (UMLS CUI [2])
    Item Group
    12-Lead/ Holter/ Telemetry ECG
    C0430456 (UMLS CUI-1)
    C0013801 (UMLS CUI-2)
    C1623258 (UMLS CUI-3)
    C0039451 (UMLS CUI-4)
    Date and Time of ECG
    Item
    Date and Time of ECG
    datetime
    C2826846 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    PR lnterval
    Item
    PR lnterval
    integer
    C0429087 (UMLS CUI [1])
    QRS Duration
    Item
    QRS Duration
    integer
    C0429025 (UMLS CUI [1])
    Uncorrected QT lnterval
    Item
    Uncorrected QT lnterval
    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])
    Code List
    Method of QTc Calculation
    CL Item
    Machine  (1)
    CL Item
    Manual (2)
    Item
    Result of the ECG
    integer
    C0438154 (UMLS CUI [1])
    Code List
    Result of the ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significan  (2)
    CL Item
    Abnormal, clinically significant (complete the AE form if clinically rignificant abnormalities meet the protocol definition for an AE) (3)
    CL Item
    No result (not available) (4)
    Item Group
    12-Lead ECG Abnormalities
    C0430456 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    Date and Time of ECG
    Item
    Date and Time of ECG
    datetime
    C2826846 (UMLS CUI [1])
    Item
    A. Rhythm
    text
    C0232187 (UMLS CUI [1])
    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])
    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])
    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])
    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])
    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])

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