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ID

44420

Description

Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram

Keywords

  1. 8/28/18 8/28/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0

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    Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384

    Repeat Local laboratory, urinalysis, vital signs, ECG and Pharmacokinetics

    Local Laboratory
    Description

    Local Laboratory

    Alias
    UMLS CUI-1
    C0022877
    UMLS CUI-2
    C0205276
    Date and time sample taken
    Description

    Specimen Collection; Date in time; Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0200345
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Has the subject fasted?
    Description

    Fasting

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0015663
    Laboratory Test
    Description

    Laboratory Procedures

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0022885
    If Laboratory Test was Clinical Chemistry, please specify.
    Description

    Chemistry, Clinical; Specification

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C2348235
    If Laboratory Test was Hematology, please specify.
    Description

    Hematology (discipline); Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0018943
    UMLS CUI [1,2]
    C2348235
    Laboratory Test Result
    Description

    Laboratory test finding

    Data type

    text

    Alias
    UMLS CUI [1]
    C0587081
    Numeric Test result
    Description

    Numeric Test Result

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347373
    Character Test result
    Description

    Laboratory test finding; Data Type -Character

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0587081
    UMLS CUI [1,2]
    C2350015
    Local Urinalysis
    Description

    Local Urinalysis

    Alias
    UMLS CUI-1
    C0042014
    UMLS CUI-2
    C0205276
    Date and time sample taken
    Description

    Date in time; Time; Specimen Collection

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0200345
    Result of dipstick
    Description

    Urine dipstick test; Laboratory test finding

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0430370
    UMLS CUI [1,2]
    C0587081
    If result of dipstick was positive, was sedimentary microscopy performed?
    Description

    If yes, provide details of repeated tests in the add entry section below.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0430370
    UMLS CUI [1,2]
    C1446409
    UMLS CUI [2,1]
    C0430397
    UMLS CUI [2,2]
    C2700128
    Laboratory Test
    Description

    Laboratory Procedures

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0022885
    If Laboratory Test was Urine dipstick, please specify.
    Description

    Urine dipstick test; Specification

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0430370
    UMLS CUI [1,2]
    C2348235
    If Laboratory Test was microscopy, please specify.
    Description

    Microscopic urinalysis; Specification

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0430397
    UMLS CUI [1,2]
    C2348235
    Laboratory Test Result
    Description

    Laboratory test finding

    Data type

    text

    Alias
    UMLS CUI [1]
    C0587081
    Numeric Test result
    Description

    Numeric Test Result

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347373
    Character Test result
    Description

    Laboratory test finding; Data Type -Character

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0587081
    UMLS CUI [1,2]
    C2350015
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Actual date/ time
    Description

    Date in time; Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    Blood pressure
    Description

    Blood Pressure

    Data type

    text

    Alias
    UMLS CUI [1]
    C0005823
    Blood pressure finding (systolic/ diastolic)
    Description

    Blood pressure finding

    Data type

    text

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C1271104
    mmHg
    Heart rate
    Description

    heart rate

    Data type

    text

    Alias
    UMLS CUI [1]
    C0018810
    Heart rate finding
    Description

    Finding of heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0577802
    beats/min
    Respiration rate
    Description

    Respiratory rate

    Data type

    text

    Alias
    UMLS CUI [1]
    C0231832
    Respiration rate finding
    Description

    Finding of rate of respiration

    Data type

    integer

    Measurement units
    • breaths/min
    Alias
    UMLS CUI [1]
    C0577970
    breaths/min
    12- Lead ECG
    Description

    12- Lead ECG

    Alias
    UMLS CUI-1
    C0430456
    Date and Time of ECG
    Description

    Electrocardiogram Collection Date Time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C2826846
    Heart rate
    Description

    heart rate

    Data type

    integer

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

    Electrocardiogram: P-R interval

    Data type

    float

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

    QRS complex duration (observable entity)

    Data type

    float

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

    QT interval - finding

    Data type

    float

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

    qtc interval

    Data type

    float

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

    qtc interval; Measurement method

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0489625
    UMLS CUI [1,2]
    C1299991
    Result of ECG
    Description

    EKG finding

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0438154
    ECG Abnormalities
    Description

    ECG Abnormalities

    Alias
    UMLS CUI-1
    C0522055
    Date and Time of ECG
    Description

    Electrocardiogram Collection Date Time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C2826846
    Record clinically significant abnormalities (check all that apply) Rhythm
    Description

    ECG abnormality; Clinically Significant Indicator | Cardiac rhythm type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C2985739
    UMLS CUI [2]
    C0232187
    If other abnormal rhythm, enter comment
    Description

    heart; rhythm abnormal (symptom); Other; Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1533266
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0947611
    Record clinically significant abnormalities (check all that apply) Morphology
    Description

    ECG abnormality; Clinically Significant Indicator | Morphology

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C2985739
    UMLS CUI [2]
    C0332437
    If other morphology, enter comment.
    Description

    Morphology; Other; Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0332437
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0947611
    Record clinically significant abnormalities (check all that apply) Conduction
    Description

    Abnormal cardiac conduction; Clinically Significant Indicator

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0232219
    UMLS CUI [1,2]
    C2985739
    If other conduction, enter comment.
    Description

    Abnormal cardiac conduction; Other; Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0232219
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0947611
    Record clinically significant abnormalities (check all that apply) Myocardial infarction
    Description

    ECG abnormality; Clinically Significant Indicator | Myocardial Infarction

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C2985739
    UMLS CUI [2]
    C0027051
    If other myocardial infarction, enter comment.
    Description

    Myocardial Infarction; Other; Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0027051
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0947611
    Record clinically significant abnormalities (check all that apply) Depolarisation/ Repolarisation
    Description

    Electrocardiogram repolarisation abnormality; Clinically Significant Indicator

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0948857
    UMLS CUI [1,2]
    C2985739
    If other depolarisation/ repolarisation, enter comment.
    Description

    Electrocardiogram repolarisation abnormality; Other; Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0948857
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0947611
    Other abnormalities
    Description

    Electrocardiogram abnormal; C0205394 Other

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C0205394
    If other abnormalities, enter comment
    Description

    Electrocardiogram abnormal; Other; Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0947611
    Pharmacokinetics Blood
    Description

    Pharmacokinetics Blood

    Alias
    UMLS CUI-1
    C0031327
    UMLS CUI-2
    C0005767
    Actual date/ time
    Description

    Date in time; Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    Summary Holter- 12- Lead
    Description

    Summary Holter- 12- Lead

    Alias
    UMLS CUI-1
    C0430456
    UMLS CUI-2
    C0013801
    UMLS CUI-3
    C0242482
    Start Date and Time of Holter
    Description

    Holter Electrocardiography; Start Date and Time of Procedure

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C3897500
    Stop Date and Time of Holter
    Description

    Holter Electrocardiography; End Date and Time of Procedure

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C3899266
    Interpretation of Holter
    Description

    Holter Electrocardiography; EKG finding

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C0438154
    Summary Holter Abnormalities
    Description

    Summary Holter Abnormalities

    Alias
    UMLS CUI-1
    C0013801
    UMLS CUI-2
    C0522055
    UMLS CUI-3
    C0242482
    Start Date and Time of Holter
    Description

    Holter Electrocardiography; Start Date and Time of Procedure

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C3897500
    Stop Date and Time of Holter
    Description

    Holter Electrocardiography; End Date and Time of Procedure

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C3899266
    Record clinically significant abnormalities below. Check all that apply.
    Description

    Holter Electrocardiography; Electrocardiogram abnormal; Clinically Significant Indicator

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C0522055
    UMLS CUI [1,3]
    C2985739
    If other abnormal heart rhythm, please specify.
    Description

    heart; rhythm abnormal (symptom); Other; Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1533266
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    If other ECG morphology, please specify.
    Description

    Electrocardiography; Morphology; Other; Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0332437
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    If other cardiac conduction, please specify.
    Description

    Abnormal cardiac conduction; Other; Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0232219
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    If other myocardial infarction, please specify.
    Description

    Myocardial Infarction; Other; Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0027051
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    If other cardiac depolarisation/ repolarisation, please specify.
    Description

    Electrocardiogram repolarisation abnormality; Other; Specification

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0948857
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    If other ECG abnormality, please specify / Cardiologist comments
    Description

    ECG abnormality; Other; Specification | Cardiologists; Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    UMLS CUI [2,1]
    C0175906
    UMLS CUI [2,2]
    C0947611

    Similar models

    Repeat Local laboratory, urinalysis, vital signs, ECG and Pharmacokinetics

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Local Laboratory
    C0022877 (UMLS CUI-1)
    C0205276 (UMLS CUI-2)
    Specimen Collection; Date in time; Time
    Item
    Date and time sample taken
    datetime
    C0200345 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Fasting
    Item
    Has the subject fasted?
    boolean
    C0015663 (UMLS CUI [1])
    Item
    Laboratory Test
    integer
    C0022885 (UMLS CUI [1])
    Code List
    Laboratory Test
    CL Item
    Clinical Chemistry (98)
    CL Item
    Haematology (99)
    Item
    If Laboratory Test was Clinical Chemistry, please specify.
    integer
    C0008000 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Code List
    If Laboratory Test was Clinical Chemistry, please specify.
    CL Item
    Albumin (1)
    CL Item
    Alkaline Phosphatase (2)
    CL Item
    ALT (3)
    CL Item
    AST (4)
    CL Item
    Chloride (5)
    CL Item
    Creatinine (6)
    CL Item
    GGT (7)
    CL Item
    Glucose, fasting (8)
    CL Item
    Potassium (9)
    CL Item
    Sodium (10)
    CL Item
    Total Bilirubin (11)
    CL Item
    Direct Bilirubin (12)
    CL Item
    Total Protein (13)
    CL Item
    Uric Acid (14)
    CL Item
    BUN (15)
    CL Item
    Calcium (16)
    CL Item
    Total CO2 (17)
    CL Item
    Creatine Phosphokinase (18)
    Item
    If Laboratory Test was Hematology, please specify.
    text
    C0018943 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Code List
    If Laboratory Test was Hematology, please specify.
    CL Item
    Basophils (1)
    CL Item
    Eosinophils (2)
    CL Item
    Haemoglobin (3)
    CL Item
    Lymphocytes (4)
    CL Item
    Monocytes (5)
    CL Item
    Neutrophils (6)
    CL Item
    Platelets (7)
    CL Item
    RBC (8)
    CL Item
    WBC (9)
    CL Item
    MCH (10)
    CL Item
    MCHC (11)
    CL Item
    MCV (12)
    CL Item
    Reticulocyte (13)
    Item
    Laboratory Test Result
    text
    C0587081 (UMLS CUI [1])
    Code List
    Laboratory Test Result
    CL Item
    Numeric result (97)
    CL Item
    Character result (98)
    CL Item
    No result (99)
    Numeric Test Result
    Item
    Numeric Test result
    text
    C2347373 (UMLS CUI [1])
    Laboratory test finding; Data Type -Character
    Item
    Character Test result
    text
    C0587081 (UMLS CUI [1,1])
    C2350015 (UMLS CUI [1,2])
    Item Group
    Local Urinalysis
    C0042014 (UMLS CUI-1)
    C0205276 (UMLS CUI-2)
    Date in time; Time; Specimen Collection
    Item
    Date and time sample taken
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0200345 (UMLS CUI [1,3])
    Item
    Result of dipstick
    text
    C0430370 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    CL Item
    No result (NR)
    CL Item
    Negative (NEG)
    CL Item
    Positive (POS)
    Urine dipstick test; Positive | Microscopic urinalysis; Urine Sediment Analysis Measurement
    Item
    If result of dipstick was positive, was sedimentary microscopy performed?
    boolean
    C0430370 (UMLS CUI [1,1])
    C1446409 (UMLS CUI [1,2])
    C0430397 (UMLS CUI [2,1])
    C2700128 (UMLS CUI [2,2])
    Item
    Laboratory Test
    integer
    C0022885 (UMLS CUI [1])
    Code List
    Laboratory Test
    CL Item
    Urine dipstick (98)
    CL Item
    Urine microscopy (99)
    Item
    If Laboratory Test was Urine dipstick, please specify.
    integer
    C0430370 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Code List
    If Laboratory Test was Urine dipstick, please specify.
    CL Item
    Protein (1)
    CL Item
    Glucose (2)
    CL Item
    Ketones (3)
    CL Item
    Blood (4)
    CL Item
    pH (5)
    CL Item
    Specific Gravity (6)
    Item
    If Laboratory Test was microscopy, please specify.
    integer
    C0430397 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Code List
    If Laboratory Test was microscopy, please specify.
    CL Item
    White blood cells (1)
    CL Item
    Red blood cells (2)
    CL Item
    Hyaline casts (3)
    CL Item
    Granular casts (4)
    CL Item
    Cellular casts (5)
    Item
    Laboratory Test Result
    text
    C0587081 (UMLS CUI [1])
    Code List
    Laboratory Test Result
    CL Item
    Numeric result (97)
    CL Item
    Character result  (98)
    CL Item
    No result (99)
    Numeric Test Result
    Item
    Numeric Test result
    text
    C2347373 (UMLS CUI [1])
    Laboratory test finding; Data Type -Character
    Item
    Character Test result
    text
    C0587081 (UMLS CUI [1,1])
    C2350015 (UMLS CUI [1,2])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Date in time; Time
    Item
    Actual date/ time
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Blood pressure
    text
    C0005823 (UMLS CUI [1])
    Code List
    Blood pressure
    CL Item
    Not done (ND)
    CL Item
    Done (Y)
    Blood pressure finding
    Item
    Blood pressure finding (systolic/ diastolic)
    text
    C1271104 (UMLS CUI [1])
    Item
    Heart rate
    text
    C0018810 (UMLS CUI [1])
    Code List
    Heart rate
    CL Item
    Not done (ND)
    CL Item
    Done (Y)
    Finding of heart rate
    Item
    Heart rate finding
    integer
    C0577802 (UMLS CUI [1])
    Item
    Respiration rate
    text
    C0231832 (UMLS CUI [1])
    Code List
    Respiration rate
    CL Item
    Not done (ND)
    CL Item
    Done (Y)
    Finding of rate of respiration
    Item
    Respiration rate finding
    integer
    C0577970 (UMLS CUI [1])
    Item Group
    12- Lead ECG
    C0430456 (UMLS CUI-1)
    Electrocardiogram Collection Date Time
    Item
    Date and Time of ECG
    datetime
    C2826846 (UMLS CUI [1])
    heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Electrocardiogram: P-R interval
    Item
    PR Interval
    float
    C0429087 (UMLS CUI [1])
    QRS complex duration (observable entity)
    Item
    QRS Duration
    float
    C0429025 (UMLS CUI [1])
    QT interval - finding
    Item
    Uncorrected QT Interval
    float
    C1287082 (UMLS CUI [1])
    qtc interval
    Item
    QTc Interval
    float
    C0489625 (UMLS CUI [1])
    Item
    Method of QTc Calculation
    integer
    C0489625 (UMLS CUI [1,1])
    C1299991 (UMLS CUI [1,2])
    Code List
    Method of QTc Calculation
    CL Item
    Machine (1)
    CL Item
    Manual (2)
    Item
    Result of ECG
    integer
    C0438154 (UMLS CUI [1])
    Code List
    Result of ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - Clinically significant (complete the ECG abnormality form for all clinically significant abnormalities, and additionaly complete the AE form if the abnormality meets the protocol definition for an AE) (3)
    CL Item
    No result (not available) (4)
    Item Group
    ECG Abnormalities
    C0522055 (UMLS CUI-1)
    Electrocardiogram Collection Date Time
    Item
    Date and Time of ECG
    datetime
    C2826846 (UMLS CUI [1])
    Item
    Record clinically significant abnormalities (check all that apply) Rhythm
    integer
    C0522055 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    C0232187 (UMLS CUI [2])
    Code List
    Record clinically significant abnormalities (check all that apply) Rhythm
    CL Item
    Sinus bradyycardia (1)
    CL Item
    Sinus bradycadia (heart rate 40- 50 beats/min) (21)
    CL Item
    Sinus bradycadia (heart rate 30- 39 beats/min) (22)
    CL Item
    Sinus bradycadia (heart rate <30 beats/min) (23)
    CL Item
    Sinus pause (3)
    CL Item
    Sinus tachycardia (heart rate >100 beats/min) (2)
    CL Item
    Ectopic supraventricular beats (4)
    CL Item
    Ectopic supraventricular rhythm (20)
    CL Item
    Wandering atrial pacemaker (17)
    CL Item
    Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (26)
    CL Item
    Supraventricular tachycardia (heart rate >100 beats/min) (6)
    CL Item
    Atrial flutter (7)
    CL Item
    Atrial fibrillation (8)
    CL Item
    Junctional rhythm (heart rate <= 100 beats/min) (9)
    CL Item
    Junctional rhythm (25)
    CL Item
    Junctional tachycardia (heart rate >100 beats/min) (24)
    CL Item
    Ectopic ventricular beats (9)
    CL Item
    Ventricular cpouplets (12)
    CL Item
    Bigeminy (13)
    CL Item
    Tigeminy (28)
    CL Item
    Electral alterans (14)
    CL Item
    R on T phenomenon (29)
    CL Item
    Ventricular fibrillation (18)
    CL Item
    Idioventricular rhythm (19)
    CL Item
    Sustained ventricular tachycardia (10)
    CL Item
    Non- sustained ventricular tachycardia (11)
    CL Item
    Wide QRS tachycardia (diagnosis unknown) (32)
    CL Item
    Ventricular tachycardia (27)
    CL Item
    Monomorphic ventricular tachycardia (30)
    CL Item
    Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (15)
    CL Item
    Polymorphic (sustained and non- sustained) ventricular tachycardia (31)
    CL Item
    Artificial Pacemaker (16)
    CL Item
    Other abnormal rhythm, enter comment (99)
    heart; rhythm abnormal (symptom); Other; Comment
    Item
    If other abnormal rhythm, enter comment
    text
    C1533266 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item
    Record clinically significant abnormalities (check all that apply) Morphology
    integer
    C0522055 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    C0332437 (UMLS CUI [2])
    Code List
    Record clinically significant abnormalities (check all that apply) Morphology
    CL Item
    Left atrial abnormality (P mitrale) (1)
    CL Item
    Right atrial abnormality (P pulmonale) (2)
    CL Item
    Right ventricular hypertrophy (3)
    CL Item
    Intraatrial conduction delay (5)
    CL Item
    Increased voltage consistent with left ventricular hypertrophy (14)
    CL Item
    Other morphology, enter comment (99)
    Morphology; Other; Comment
    Item
    If other morphology, enter comment.
    text
    C0332437 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item
    Record clinically significant abnormalities (check all that apply) Conduction
    integer
    C0232219 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    Code List
    Record clinically significant abnormalities (check all that apply) Conduction
    CL Item
    First degree AV block (PR interval >200msec) (1)
    CL Item
    Short PR interval (20)
    CL Item
    Second degree AV block (Mobitz type 1) (2)
    CL Item
    Second degree AV block (Mobitz type 2) (3)
    CL Item
    2:1 AV block (16)
    CL Item
    Thrid degree AV block (4)
    CL Item
    Left axis deviation (QRS axis more negative than -30 degrees) (5)
    CL Item
    Right axis deviation (QRS axis more positive than +110 degrees) (6)
    CL Item
    Incomplete right bundle branch block (7)
    CL Item
    Incomplete left bundle branch block (13)
    CL Item
    Right bundle branch block (8)
    CL Item
    Left anterior hemiblock (synonymous to left anterior fascicular block) (14)
    CL Item
    Left posterior hemiblock (synonymous to left posterior fascicular block) (15)
    CL Item
    Left bundle branch block (9)
    CL Item
    Bifascicular block (17)
    CL Item
    Non- specific intraventricular conduction delay (QRS>= 120msec) (10)
    CL Item
    Accessory pathway (Wollf- Parkinson Wite, Lown- Ganong- Levine) (11)
    CL Item
    Prolonged QT interval (19)
    CL Item
    QT/ QTc prolongation >= 500msec (12)
    CL Item
    AV dissociation (18)
    CL Item
    Other conduction, enter comment (99)
    Abnormal cardiac conduction; Other; Comment
    Item
    If other conduction, enter comment.
    text
    C0232219 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item
    Record clinically significant abnormalities (check all that apply) Myocardial infarction
    integer
    C0522055 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    C0027051 (UMLS CUI [2])
    Code List
    Record clinically significant abnormalities (check all that apply) Myocardial infarction
    CL Item
    Myocardial infarction, old (1)
    CL Item
    Myocardial infarction, anterior (2)
    CL Item
    Myocardial infarction, lateral (3)
    CL Item
    Myocardial infarction, posterior (4)
    CL Item
    Myocardial infarction, inferior (5)
    CL Item
    Myocardial infarction, septal (6)
    CL Item
    Myocardial infarction, Non Q-wave (20)
    CL Item
    Other myocardial infarction, enter comment (99)
    Myocardial Infarction; Other; Comment
    Item
    If other myocardial infarction, enter comment.
    text
    C0027051 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item
    Record clinically significant abnormalities (check all that apply) Depolarisation/ Repolarisation
    integer
    C0948857 (UMLS CUI [1,1])
    C2985739 (UMLS CUI [1,2])
    Code List
    Record clinically significant abnormalities (check all that apply) Depolarisation/ Repolarisation
    CL Item
    Non-specific ST-T changes (7)
    CL Item
    J point elevation (19)
    CL Item
    ST elevation (8)
    CL Item
    ST- elevation- pericarditis (21)
    CL Item
    ST depression (9)
    CL Item
    U waves abnormal (10)
    CL Item
    T wave inversion (11)
    CL Item
    T wave peaked (12)
    CL Item
    T waves flat (15)
    CL Item
    T waves biphasic (16)
    CL Item
    Notched T- waves (18)
    CL Item
    Low QRS voltage (13)
    CL Item
    T- wave flattering/ inversion (17)
    CL Item
    Other depolarisation/ repolarisation, enter comment (99)
    Electrocardiogram repolarisation abnormality; Other; Comment
    Item
    If other depolarisation/ repolarisation, enter comment.
    text
    C0948857 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item
    Other abnormalities
    integer
    C0522055 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Code List
    Other abnormalities
    CL Item
    Yes (99)
    Electrocardiogram abnormal; Other; Comment
    Item
    If other abnormalities, enter comment
    text
    C0522055 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item Group
    Pharmacokinetics Blood
    C0031327 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Date in time; Time
    Item
    Actual date/ time
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item Group
    Summary Holter- 12- Lead
    C0430456 (UMLS CUI-1)
    C0013801 (UMLS CUI-2)
    C0242482 (UMLS CUI-3)
    Holter Electrocardiography; Start Date and Time of Procedure
    Item
    Start Date and Time of Holter
    datetime
    C0013801 (UMLS CUI [1,1])
    C3897500 (UMLS CUI [1,2])
    Holter Electrocardiography; End Date and Time of Procedure
    Item
    Stop Date and Time of Holter
    datetime
    C0013801 (UMLS CUI [1,1])
    C3899266 (UMLS CUI [1,2])
    Item
    Interpretation of Holter
    integer
    C0013801 (UMLS CUI [1,1])
    C0438154 (UMLS CUI [1,2])
    Code List
    Interpretation of Holter
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - Clinically significant (3)
    CL Item
    No result (4)
    CL Item
    Unable to evaluate (5)
    Item Group
    Summary Holter Abnormalities
    C0013801 (UMLS CUI-1)
    C0522055 (UMLS CUI-2)
    C0242482 (UMLS CUI-3)
    Holter Electrocardiography; Start Date and Time of Procedure
    Item
    Start Date and Time of Holter
    datetime
    C0013801 (UMLS CUI [1,1])
    C3897500 (UMLS CUI [1,2])
    Holter Electrocardiography; End Date and Time of Procedure
    Item
    Stop Date and Time of Holter
    datetime
    C0013801 (UMLS CUI [1,1])
    C3899266 (UMLS CUI [1,2])
    Item
    Record clinically significant abnormalities below. Check all that apply.
    integer
    C0013801 (UMLS CUI [1,1])
    C0522055 (UMLS CUI [1,2])
    C2985739 (UMLS CUI [1,3])
    Code List
    Record clinically significant abnormalities below. Check all that apply.
    CL Item
    No abnormalities (0)
    CL Item
    Sinus bradycardia (50- 59 beats/min) (1)
    CL Item
    Sinus bradycardia (40- 49 beats/min) (2)
    CL Item
    Sinus bradycardia (30- 39 beats/min) (3)
    CL Item
    Sinus bradycardia (<30 beats/min) (4)
    CL Item
    Sinus pause (5)
    CL Item
    Sinus tachycardia (>100 beats/min) (6)
    CL Item
    Ectopic supraventricular beats (7)
    CL Item
    Ectopic supraventricular rhythm (8)
    CL Item
    Wandering atrial pacemaker (9)
    CL Item
    Multifocal atrial tachycaria (wandering atrial pacemaker w/rate >100 beats/min) (10)
    CL Item
    Non- sustained supraventricular tachycardia (>100beats/min, >30 beats) (11)
    CL Item
    Sustained supraventricular tachycardia (>100beats/min, >30 beats) (12)
    CL Item
    Atrial flutter (13)
    CL Item
    Atrial fibrillation (14)
    CL Item
    Junctional rhythm (<=100 beats/min, defined by narrow QRS complex) (15)
    CL Item
    Junctional tachycardia (>100 beats/min) (16)
    CL Item
    Ventricular premature depolarisation (17)
    CL Item
    Ventricular couplets (18)
    CL Item
    Bigeminy (19)
    CL Item
    Trigeminy (20)
    CL Item
    Electrical alterrans (21)
    CL Item
    R on T phenomenon (22)
    CL Item
    Ventricular fibrillation (23)
    CL Item
    Idioventricular rhythm (<=100 beats/min, defined by wide QRS complex) (24)
    CL Item
    Non- sustained ventricular tachycardia (>100 beats/min, 3- 30 beats) (25)
    CL Item
    Sustained ventricular tachycardia (>100 beats/min, >30 beats) (26)
    CL Item
    Wide QRS tachycardia (diagnosis unknown) (27)
    CL Item
    Monomorphic non- sustained ventricular tachycardia (>100 beats/min, 3- 30 beats) (28)
    CL Item
    Monomorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (29)
    CL Item
    Polymorphic non- sustained ventricular tachycardia (>100 beats/min, 3- 30 beats) (30)
    CL Item
    Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (31)
    CL Item
    Torsade de Pointes (TdP) (32)
    CL Item
    Pacemaker (33)
    CL Item
    First degree AV block (PR Interval >200msec) (34)
    CL Item
    Short PR Interval (35)
    CL Item
    Second degree AV block (Mobitz type 1) (36)
    CL Item
    Second degree AV block (Mobitz type 2) (37)
    CL Item
    2:1 AV blovk (38)
    CL Item
    Third degree AV block (39)
    CL Item
    Left axis deviation (QRS axis more negative than -30 degrees) (40)
    CL Item
    Right axis deviation (QRS axis mor positive than +110 degreees) (41)
    CL Item
    Incomplete right bundle branch block (42)
    CL Item
    Incomplete left bundle branch block (43)
    CL Item
    Right bundle branc block (44)
    CL Item
    Left anterior hemiblock (45)
    CL Item
    Left posterior hemiblock (46)
    CL Item
    Left bundle branch block (47)
    CL Item
    Bifascicular block (48)
    CL Item
    Non- specific intraventircular conduction delay (QRS >= 120msec) (49)
    CL Item
    Accessory pahway (Wollf- Parkinson- White, Lown- Ganong- Levine) (50)
    CL Item
    QTc prolongation >= 500 msec (51)
    CL Item
    AV dissociation (52)
    CL Item
    Myocardial infarction, old (53)
    CL Item
    Myocardial infarction, non- Q- wave (54)
    CL Item
    Non- specific ST-T changes (55)
    CL Item
    J point elevation (56)
    CL Item
    ST elevation (57)
    CL Item
    ST depression (58)
    CL Item
    ST segment abnormality (59)
    CL Item
    U waves (60)
    CL Item
    T wave inversion (61)
    CL Item
    T wave peaked (62)
    CL Item
    T waves biphasic (63)
    CL Item
    T waves flat (64)
    CL Item
    Notched T- waves (65)
    CL Item
    Low QRS voltage (66)
    CL Item
    T wave abnormality (67)
    CL Item
    Other abnormal rhythm (94)
    CL Item
    Other morphology (95)
    CL Item
    Other conduction (96)
    CL Item
    Other myocardial infarction (97)
    CL Item
    Other depolarisation/ repolarisation (98)
    CL Item
    Other abnormality/ Cardiologist comments (99)
    heart; rhythm abnormal (symptom); Other; Specification
    Item
    If other abnormal heart rhythm, please specify.
    text
    C1533266 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Electrocardiography; Morphology; Other; Specification
    Item
    If other ECG morphology, please specify.
    text
    C1623258 (UMLS CUI [1,1])
    C0332437 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Abnormal cardiac conduction; Other; Specification
    Item
    If other cardiac conduction, please specify.
    text
    C0232219 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Myocardial Infarction; Other; Specification
    Item
    If other myocardial infarction, please specify.
    text
    C0027051 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Electrocardiogram repolarisation abnormality; Other; Specification
    Item
    If other cardiac depolarisation/ repolarisation, please specify.
    text
    C0948857 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    ECG abnormality; Other; Specification | Cardiologists; Comment
    Item
    If other ECG abnormality, please specify / Cardiologist comments
    text
    C0522055 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    C0175906 (UMLS CUI [2,1])
    C0947611 (UMLS CUI [2,2])

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