ID

38652

Description

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

Keywords

  1. 10/29/19 10/29/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 29, 2019

DOI

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License

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
Description

12-Lead ECG

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

Date and Time of ECG

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

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 (b) Interval
Description

QTc (b) Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
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

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

Date and Time of ECG

Data type

datetime

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

(check all that apply)

Data type

text

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

If other abnormal rhythm, enter comment

Data type

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
Description

(check all that apply)

Data type

text

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

If other P-Wave Morphology, enter comment

Data type

text

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

(check all that apply)

Data type

text

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

If other conduction, enter comment

Data type

text

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

(check all that apply)

Data type

text

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

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
Record clinically significant abnormalities - E. Depolarisation/Repolarisation (QRS-T) +
Description

(check all that apply)

Data type

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
Description

If other depololarisation/repolarisation, enter comment

Data type

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
Description

If other abnormalities, enter comment

Data type

text

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

Repeat Pharmacokinetics Blood

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

Actual date/time

Data type

datetime

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

Repeat Visual Analogue Scale

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

Date/ Time of assessment

Data type

datetime

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

Nose not runny/Nose extremely runny

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1]
C1260880
mm
Nose clear/Nose completely blocked
Description

Nose clear/Nose completely blocked

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1]
C0027424
mm
Nose not itchy/Nose extremely itchy
Description

Nose not itchy/Nose extremely itchy

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1]
C0850060
mm
Nose not sore/Nose as sore as it has ever been
Description

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

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1]
C0857495
mm
Nose not dry/Nose as dry as it has ever been
Description

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

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1]
C0231919
mm
Throat not sore/Throat as sore as it has ever been
Description

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

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1]
C0242429
mm
Sense of taste normal/ Sense of taste completely abnormal
Description

Sense of taste normal/ Sense of taste completely abnormal

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1]
C0039336
mm
Taste nothing/Taste something very strongly
Description

Taste nothing/Taste something very strongly

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1]
C1301555
mm
Sense of smell normal/ Sense of smell completely abnormal
Description

Sense of smell normal/ Sense of smell completely abnormal

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1]
C0037361
mm
Smell nothing/Smell something very strongly
Description

Smell nothing/Smell something very strongly

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1]
C2712084
mm
Nasal symptom: (No symptoms/Worst symptoms I have ever had)
Description

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

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1]
C0231918
mm
Repeat Visual Nasal Endoscopy
Description

Repeat Visual Nasal Endoscopy

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

Date/ Time of Assessment

Data type

datetime

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

Left Nostril Colour

Data type

text

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

Right Nostril Colour

Data type

text

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

Left nostril concha media turbinate swelling

Data type

text

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

Left nostril concha inferior turbinate swelling

Data type

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
Description

Right nostril concha media turbinate swelling

Data type

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
Description

Right nostril concha inferior turbinate swelling

Data type

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
Description

Alignment of the Septum

Data type

text

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

Severity of right deviation

Data type

text

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

Severity of left deviation

Data type

text

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

Left nostril secretions

Data type

text

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

Right nostril secretions

Data type

text

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

Nasal infection

Data type

text

Alias
UMLS CUI [1]
C0555970
Post Nasal Drip
Description

Post Nasal Drip

Data type

text

Alias
UMLS CUI [1]
C1739415
Crusting
Description

Crusting

Data type

text

Alias
UMLS CUI [1]
C0205204
Signs of Bleeding
Description

Signs of Bleeding

Data type

text

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

If signs of bleeding, specify location

Data type

text

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

Presence of nasal polyps

Data type

text

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

If presece of nasal polyps, specify location

Data type

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
Type
Description | Question | Decode (Coded Value)
Data type
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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