0 Avaliações

ID

38652

Descrição

Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Palavras-chave

  1. 29/10/19 29/10/19 -
Titular dos direitos

GlaxoSmithKline

Transferido a

29 de octubre de 2019

DOI

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Licença

Creative Commons BY-NC 3.0

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    Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933

    Logs/ Repeats - 12-Lead ECG; ECG Abnormalities; Repeat- Pharmacokinetics Blood; Repeat Visual Analogue Scale; Repeat Nasal Endoscopy; Repeat Visual Nasal Examination

    12-Lead ECG
    Descrição

    12-Lead ECG

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

    Date and Time of ECG

    Tipo de dados

    datetime

    Alias
    UMLS CUI [1]
    C2826846
    Heart rate
    Descrição

    Heart rate

    Tipo de dados

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    PR Interval
    Descrição

    PR Interval

    Tipo de dados

    integer

    Unidades de medida
    • ms
    Alias
    UMLS CUI [1]
    C0429087
    ms
    QRS Duration
    Descrição

    QRS Duration

    Tipo de dados

    integer

    Unidades de medida
    • ms
    Alias
    UMLS CUI [1]
    C0429025
    ms
    Uncorrected QT Interval
    Descrição

    Uncorrected QT Interval

    Tipo de dados

    integer

    Unidades de medida
    • ms
    Alias
    UMLS CUI [1]
    C1287082
    ms
    QTc (b) Interval
    Descrição

    QTc (b) Interval

    Tipo de dados

    integer

    Unidades de medida
    • ms
    Alias
    UMLS CUI [1]
    C0489625
    ms
    Result of the ECG
    Descrição

    Result of the ECG

    Tipo de dados

    integer

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

    12-Lead ECG Abnormalities

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

    Date and Time of ECG

    Tipo de dados

    datetime

    Alias
    UMLS CUI [1]
    C2826846
    Record clinically significant abnormalities - A. Rhythm
    Descrição

    (check all that apply)

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C2826293
    UMLS CUI [2]
    C0199556
    If other abnormal rhythm, enter comment
    Descrição

    If other abnormal rhythm, enter comment

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0199556
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [2]
    C0947611
    Record clinically significant abnormalities - B. P-Wave Morphology
    Descrição

    (check all that apply)

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C2826293
    UMLS CUI [2]
    C2216025
    If other P-Wave Morphology, enter comment
    Descrição

    If other P-Wave Morphology, enter comment

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C2216025
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0947611
    Record clinically significant abnormalities - C. Conduction
    Descrição

    (check all that apply)

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C2826293
    UMLS CUI [2]
    C0232217
    If other conduction, enter comment
    Descrição

    If other conduction, enter comment

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0232217
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0947611
    Record clinically significant abnormalities - D. Myocardial infarction
    Descrição

    (check all that apply)

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C2826293
    UMLS CUI [2]
    C0027051
    If other myocardial infarction, enter comment.
    Descrição

    If other myocardial infarction, enter comment.

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0027051
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0947611
    Record clinically significant abnormalities - E. Depolarisation/Repolarisation (QRS-T) +
    Descrição

    (check all that apply)

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C2826293
    UMLS CUI [2,1]
    C1331539
    UMLS CUI [2,2]
    C0948857
    If other depololarisation/repolarisation, enter comment
    Descrição

    If other depololarisation/repolarisation, enter comment

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1331539
    UMLS CUI [1,2]
    C0948857
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C0947611
    If other abnormalities, enter comment
    Descrição

    If other abnormalities, enter comment

    Tipo de dados

    text

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

    Repeat Pharmacokinetics Blood

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    UMLS CUI-3
    C0205341
    Actual date/time
    Descrição

    Actual date/time

    Tipo de dados

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    Repeat Visual Analogue Scale
    Descrição

    Repeat Visual Analogue Scale

    Alias
    UMLS CUI-1
    C2959685
    UMLS CUI-2
    C0205341
    Date/ Time of assessment
    Descrição

    Date/ Time of assessment

    Tipo de dados

    datetime

    Alias
    UMLS CUI [1,1]
    C2985720
    UMLS CUI [1,2]
    C1264639
    Nose not runny/Nose extremely runny
    Descrição

    Nose not runny/Nose extremely runny

    Tipo de dados

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1]
    C1260880
    mm
    Nose clear/Nose completely blocked
    Descrição

    Nose clear/Nose completely blocked

    Tipo de dados

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1]
    C0027424
    mm
    Nose not itchy/Nose extremely itchy
    Descrição

    Nose not itchy/Nose extremely itchy

    Tipo de dados

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1]
    C0850060
    mm
    Nose not sore/Nose as sore as it has ever been
    Descrição

    Nose not sore/Nose as sore as it has ever been

    Tipo de dados

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1]
    C0857495
    mm
    Nose not dry/Nose as dry as it has ever been
    Descrição

    Nose not dry/Nose as dry as it has ever been

    Tipo de dados

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1]
    C0231919
    mm
    Throat not sore/Throat as sore as it has ever been
    Descrição

    Throat not sore/Throat as sore as it has ever been

    Tipo de dados

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1]
    C0242429
    mm
    Sense of taste normal/ Sense of taste completely abnormal
    Descrição

    Sense of taste normal/ Sense of taste completely abnormal

    Tipo de dados

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1]
    C0039336
    mm
    Taste nothing/Taste something very strongly
    Descrição

    Taste nothing/Taste something very strongly

    Tipo de dados

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1]
    C1301555
    mm
    Sense of smell normal/ Sense of smell completely abnormal
    Descrição

    Sense of smell normal/ Sense of smell completely abnormal

    Tipo de dados

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1]
    C0037361
    mm
    Smell nothing/Smell something very strongly
    Descrição

    Smell nothing/Smell something very strongly

    Tipo de dados

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1]
    C2712084
    mm
    Nasal symptom: (No symptoms/Worst symptoms I have ever had)
    Descrição

    Nasal symptom: (No symptoms/Worst symptoms I have ever had)

    Tipo de dados

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1]
    C0231918
    mm
    Repeat Visual Nasal Endoscopy
    Descrição

    Repeat Visual Nasal Endoscopy

    Alias
    UMLS CUI-1
    C0189024
    UMLS CUI-2
    C0205341
    Date/ Time of Assessment
    Descrição

    Date/ Time of Assessment

    Tipo de dados

    datetime

    Alias
    UMLS CUI [1,1]
    C2985720
    UMLS CUI [1,2]
    C1264639
    Left Nostril Colour
    Descrição

    Left Nostril Colour

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0475705
    UMLS CUI [1,2]
    C1720438
    Right Nostril Colour
    Descrição

    Right Nostril Colour

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0475705
    UMLS CUI [1,2]
    C1720679
    Left nostril concha media turbinate swelling
    Descrição

    Left nostril concha media turbinate swelling

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1266928
    UMLS CUI [1,2]
    C0205098
    UMLS CUI [1,3]
    C1720438
    Left nostril concha inferior turbinate swelling
    Descrição

    Left nostril concha inferior turbinate swelling

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1266928
    UMLS CUI [1,2]
    C0542339
    UMLS CUI [1,3]
    C1720438
    UMLS CUI [1,4]
    C0038999
    Right nostril concha media turbinate swelling
    Descrição

    Right nostril concha media turbinate swelling

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1266928
    UMLS CUI [1,2]
    C0205098
    UMLS CUI [1,3]
    C1720679
    UMLS CUI [1,4]
    C0038999
    Right nostril concha inferior turbinate swelling
    Descrição

    Right nostril concha inferior turbinate swelling

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1266928
    UMLS CUI [1,2]
    C0542339
    UMLS CUI [1,3]
    C1720679
    UMLS CUI [1,4]
    C0038999
    Alignment of the Septum
    Descrição

    Alignment of the Septum

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0027432
    Severity of right deviation
    Descrição

    Severity of right deviation

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0232296
    UMLS CUI [1,2]
    C0439793
    Severity of left deviation
    Descrição

    Severity of left deviation

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0232297
    UMLS CUI [1,2]
    C0439793
    Left nostril secretions
    Descrição

    Left nostril secretions

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1720438
    UMLS CUI [1,2]
    C0036537
    Right nostril secretions
    Descrição

    Right nostril secretions

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1720679
    UMLS CUI [1,2]
    C0036537
    Nasal infection
    Descrição

    Nasal infection

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0555970
    Post Nasal Drip
    Descrição

    Post Nasal Drip

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1739415
    Crusting
    Descrição

    Crusting

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0205204
    Signs of Bleeding
    Descrição

    Signs of Bleeding

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0019080
    If signs of bleeding, specify location
    Descrição

    If signs of bleeding, specify location

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0019080
    UMLS CUI [1,2]
    C0450429
    UMLS CUI [1,3]
    C2348235
    Presence of nasal polyps
    Descrição

    Presence of nasal polyps

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0027430
    If presece of nasal polyps, specify location
    Descrição

    If presece of nasal polyps, specify location

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0027430
    UMLS CUI [1,2]
    C0450429
    UMLS CUI [1,3]
    C2348235

    Similar models

    Logs/ Repeats - 12-Lead ECG; ECG Abnormalities; Repeat- Pharmacokinetics Blood; Repeat Visual Analogue Scale; Repeat Nasal Endoscopy; Repeat Visual Nasal Examination

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    12-Lead ECG
    C0430456 (UMLS CUI-1)
    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 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 (b) Interval
    Item
    QTc (b) Interval
    integer
    C0489625 (UMLS CUI [1])
    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 significant  (2)
    CL Item
    Abnormal - Clinically significant (complete the ECG abnormality form for all abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
    CL Item
    Abnormal - Clinically significant (complete the ECG abnormality form for all abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
    CL Item
    No result (not available) (4)
    Item Group
    12-Lead ECG Abnormalities
    C0522055 (UMLS CUI-1)
    Date and Time of ECG
    Item
    Date and Time of ECG
    datetime
    C2826846 (UMLS CUI [1])
    Item
    Record clinically significant abnormalities - A. Rhythm
    text
    C1704258 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    C0199556 (UMLS CUI [2])
    Code List
    Record clinically significant abnormalities - A. Rhythm
    CL Item
    Sinus bradycardia (A1)
    CL Item
    Sinus bradycardia (heart rate 40-50 beats/min) (A21)
    CL Item
    Sinus bradycardia (heart rate 30-39 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 atrial 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<=100 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
    Idiventricular rhythm (A19)
    CL Item
    Sustained ventricular tachycardia (A10)
    CL Item
    Non-sustained ventricular tachycardia (A11)
    CL Item
    Wide QRS tachycardia (diagnosis unknown) (A32)
    CL Item
    Ventricular tachycardia (A27)
    CL Item
    Monomorphic ventricular tachycardia (A30)
    CL Item
    Torsade 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 thythm, enter comment (A99)
    If other abnormal rhythm, enter comment
    Item
    If other abnormal rhythm, enter comment
    text
    C0199556 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C0947611 (UMLS CUI [2])
    Item
    Record clinically significant abnormalities - B. P-Wave Morphology
    text
    C1704258 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    C2216025 (UMLS CUI [2])
    Code List
    Record clinically significant abnormalities - 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)
    If other P-Wave Morphology, enter comment
    Item
    If other P-Wave Morphology, enter comment
    text
    C2216025 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item
    Record clinically significant abnormalities - C. Conduction
    text
    C1704258 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    C0232217 (UMLS CUI [2])
    Code List
    Record clinically significant abnormalities - C. Conduction
    CL Item
    First degree AV block (PR interval > 200msec) (C1)
    CL Item
    Short PR interval (C20)
    CL Item
    Second degree AV block (Mobitz type 1) (C2)
    CL Item
    Second degree AV block (Mobitz type 2) (C3)
    CL Item
    2:1 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
    Prolonged QT interval (C19)
    CL Item
    QT/QTc prolongation > 500 msec (C12)
    CL Item
    AV dissociation (C18)
    CL Item
    Other conduction, enter comment (C99)
    If other conduction, enter comment
    Item
    If other conduction, enter comment
    text
    C0232217 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item
    Record clinically significant abnormalities - D. Myocardial infarction
    text
    C1704258 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    C0027051 (UMLS CUI [2])
    Code List
    Record clinically significant abnormalities - 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)
    If other myocardial infarction, enter 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 - E. Depolarisation/Repolarisation (QRS-T) +
    text
    C1704258 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    C1331539 (UMLS CUI [2,1])
    C0948857 (UMLS CUI [2,2])
    Code List
    Record clinically significant abnormalities - 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 flattening/inversion (D17)
    CL Item
    Other depolarisation/repolarisation, enter comment (D99)
    If other depololarisation/repolarisation, enter comment
    Item
    If other depololarisation/repolarisation, enter comment
    text
    C1331539 (UMLS CUI [1,1])
    C0948857 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C0947611 (UMLS CUI [1,4])
    If other abnormalities, enter 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
    Repeat Pharmacokinetics Blood
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    C0205341 (UMLS CUI-3)
    Actual date/time
    Item
    Actual date/time
    datetime
    C1264639 (UMLS CUI [1])
    Item Group
    Repeat Visual Analogue Scale
    C2959685 (UMLS CUI-1)
    C0205341 (UMLS CUI-2)
    Date/ Time of assessment
    Item
    Date/ Time of assessment
    datetime
    C2985720 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    Nose not runny/Nose extremely runny
    Item
    Nose not runny/Nose extremely runny
    integer
    C1260880 (UMLS CUI [1])
    Nose clear/Nose completely blocked
    Item
    Nose clear/Nose completely blocked
    integer
    C0027424 (UMLS CUI [1])
    Nose not itchy/Nose extremely itchy
    Item
    Nose not itchy/Nose extremely itchy
    integer
    C0850060 (UMLS CUI [1])
    Nose not sore/Nose as sore as it has ever been
    Item
    Nose not sore/Nose as sore as it has ever been
    integer
    C0857495 (UMLS CUI [1])
    Nose not dry/Nose as dry as it has ever been
    Item
    Nose not dry/Nose as dry as it has ever been
    integer
    C0231919 (UMLS CUI [1])
    Throat not sore/Throat as sore as it has ever been
    Item
    Throat not sore/Throat as sore as it has ever been
    integer
    C0242429 (UMLS CUI [1])
    Sense of taste normal/ Sense of taste completely abnormal
    Item
    Sense of taste normal/ Sense of taste completely abnormal
    integer
    C0039336 (UMLS CUI [1])
    Taste nothing/Taste something very strongly
    Item
    Taste nothing/Taste something very strongly
    integer
    C1301555 (UMLS CUI [1])
    Sense of smell normal/ Sense of smell completely abnormal
    Item
    Sense of smell normal/ Sense of smell completely abnormal
    integer
    C0037361 (UMLS CUI [1])
    Smell nothing/Smell something very strongly
    Item
    Smell nothing/Smell something very strongly
    integer
    C2712084 (UMLS CUI [1])
    Nasal symptom: (No symptoms/Worst symptoms I have ever had)
    Item
    Nasal symptom: (No symptoms/Worst symptoms I have ever had)
    integer
    C0231918 (UMLS CUI [1])
    Item Group
    Repeat Visual Nasal Endoscopy
    C0189024 (UMLS CUI-1)
    C0205341 (UMLS CUI-2)
    Date/ Time of Assessment
    Item
    Date/ Time of Assessment
    datetime
    C2985720 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    Item
    Left Nostril Colour
    text
    C0475705 (UMLS CUI [1,1])
    C1720438 (UMLS CUI [1,2])
    Code List
    Left Nostril Colour
    CL Item
    Normal  (N)
    CL Item
    Abnormal, specify colour (A)
    CL Item
    Abnormal, red (R)
    CL Item
    Abnormal, blue (B)
    CL Item
    Abnormal, white (W)
    Item
    Right Nostril Colour
    text
    C0475705 (UMLS CUI [1,1])
    C1720679 (UMLS CUI [1,2])
    Code List
    Right Nostril Colour
    CL Item
    Normal (N)
    CL Item
    Abnormal (A)
    CL Item
    Abnormal, red (R)
    CL Item
    Abnormal, blue (B)
    CL Item
    Abnormal, white (W)
    Item
    Left nostril concha media turbinate swelling
    text
    C1266928 (UMLS CUI [1,1])
    C0205098 (UMLS CUI [1,2])
    C1720438 (UMLS CUI [1,3])
    Code List
    Left nostril concha media turbinate swelling
    CL Item
    Absent  (A)
    CL Item
    Mild  (M)
    CL Item
    Severe (S)
    Item
    Left nostril concha inferior turbinate swelling
    text
    C1266928 (UMLS CUI [1,1])
    C0542339 (UMLS CUI [1,2])
    C1720438 (UMLS CUI [1,3])
    C0038999 (UMLS CUI [1,4])
    Code List
    Left nostril concha inferior turbinate swelling
    CL Item
    Absent  (A)
    CL Item
    Mild  (M)
    CL Item
    Severe (S)
    Item
    Right nostril concha media turbinate swelling
    text
    C1266928 (UMLS CUI [1,1])
    C0205098 (UMLS CUI [1,2])
    C1720679 (UMLS CUI [1,3])
    C0038999 (UMLS CUI [1,4])
    Code List
    Right nostril concha media turbinate swelling
    CL Item
    Absent  (A)
    CL Item
    Mild  (M)
    CL Item
    Severe (S)
    Item
    Right nostril concha inferior turbinate swelling
    text
    C1266928 (UMLS CUI [1,1])
    C0542339 (UMLS CUI [1,2])
    C1720679 (UMLS CUI [1,3])
    C0038999 (UMLS CUI [1,4])
    Code List
    Right nostril concha inferior turbinate swelling
    CL Item
    Absent  (A)
    CL Item
    Mild  (M)
    CL Item
    Severe (S)
    Item
    Alignment of the Septum
    text
    C0027432 (UMLS CUI [1])
    Code List
    Alignment of the Septum
    CL Item
    Normal  (N)
    CL Item
    Right deviation  (RD)
    CL Item
    Left deviation (LD)
    CL Item
    Not Done (ND)
    Item
    Severity of right deviation
    text
    C0232296 (UMLS CUI [1,1])
    C0439793 (UMLS CUI [1,2])
    Code List
    Severity of right deviation
    CL Item
    Mild  (Mild)
    CL Item
    Moderate  (Moderate)
    CL Item
    Severe (Severe)
    Item
    Severity of left deviation
    text
    C0232297 (UMLS CUI [1,1])
    C0439793 (UMLS CUI [1,2])
    Code List
    Severity of left deviation
    CL Item
    Mild  (Mild)
    CL Item
    Moderate  (Moderate)
    CL Item
    Severe (Severe)
    Item
    Left nostril secretions
    text
    C1720438 (UMLS CUI [1,1])
    C0036537 (UMLS CUI [1,2])
    Code List
    Left nostril secretions
    CL Item
    Normal (N)
    CL Item
    Abnormal (A)
    CL Item
    Abnormal, Clear (CL)
    CL Item
    Abnormal, Opaque (OP)
    CL Item
    Abnormal, Purulent (PR)
    Item
    Right nostril secretions
    text
    C1720679 (UMLS CUI [1,1])
    C0036537 (UMLS CUI [1,2])
    Code List
    Right nostril secretions
    CL Item
    Normal  (N)
    CL Item
    Abnormal  (A)
    CL Item
    Abnormal, Clear  (CL)
    CL Item
    Abnormal, Opaque  (OP)
    CL Item
    Abnormal, Purulent (PR)
    Item
    Nasal infection
    text
    C0555970 (UMLS CUI [1])
    Code List
    Nasal infection
    CL Item
    No infection  (N)
    CL Item
    Viral infection  (V)
    CL Item
    Bacterial infection (B)
    Item
    Post Nasal Drip
    text
    C1739415 (UMLS CUI [1])
    Code List
    Post Nasal Drip
    CL Item
    Absent  (A)
    CL Item
    Present  (P)
    CL Item
    Present, Clear  (CL)
    CL Item
    Present, Opaque  (OP)
    CL Item
    Present, Purulent (PR)
    Item
    Crusting
    text
    C0205204 (UMLS CUI [1])
    Code List
    Crusting
    CL Item
    Absent  (A)
    CL Item
    Mild  (M)
    CL Item
    Severe (S)
    Item
    Signs of Bleeding
    text
    C0019080 (UMLS CUI [1])
    Code List
    Signs of Bleeding
    CL Item
    No  (N)
    CL Item
    Yes, specify location (Y)
    If signs of bleeding, specify location
    Item
    If signs of bleeding, specify location
    text
    C0019080 (UMLS CUI [1,1])
    C0450429 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Presence of nasal polyps
    text
    C0027430 (UMLS CUI [1])
    Code List
    Presence of nasal polyps
    CL Item
    Not Done (ND)
    CL Item
    Absent  (A)
    CL Item
    Yes, specify location (P)
    If presece of nasal polyps, specify location
    Item
    If presece of nasal polyps, specify location
    text
    C0027430 (UMLS CUI [1,1])
    C0450429 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])

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