ID

38818

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. 11/6/19 11/6/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 6, 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

Visual Nasal Examination (Period 1 - 5; Day 1 - Day 16)

Repeat Visual Nasal Endoscopy (Period 1 - 5)
Description

Repeat Visual Nasal Endoscopy (Period 1 - 5)

Alias
UMLS CUI-1
C0189024
UMLS CUI-2
C0205341
Time point of assessment
Description

Time point of assessment

Data type

integer

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C0220825
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
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
Repeat Visual Nasal Endoscopy (Day 1 - 13)
Description

Repeat Visual Nasal Endoscopy (Day 1 - 13)

Alias
UMLS CUI-1
C0189024
UMLS CUI-2
C0205341
Time point of assessment
Description

Time point of assessment

Data type

integer

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C0220825
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
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
Repeat Visual Nasal Endoscopy (Day 14 - 16)
Description

Repeat Visual Nasal Endoscopy (Day 14 - 16)

Alias
UMLS CUI-1
C0189024
UMLS CUI-2
C0205341
Time point of assessment
Description

Time point of assessment

Data type

integer

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C0220825
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
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

Similar models

Visual Nasal Examination (Period 1 - 5; Day 1 - Day 16)

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Repeat Visual Nasal Endoscopy (Period 1 - 5)
C0189024 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Item
Time point of assessment
integer
C2348792 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Code List
Time point of assessment
CL Item
Pre dose (1)
CL Item
30 m (2)
CL Item
1 hr (3)
CL Item
4 hr (4)
CL Item
8 hr (5)
CL Item
24 hr (6)
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
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 Group
Repeat Visual Nasal Endoscopy (Day 1 - 13)
C0189024 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Item
Time point of assessment
integer
C2348792 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Code List
Time point of assessment
CL Item
Pre dose  (1)
CL Item
30 m  (2)
CL Item
1 hr (3)
CL Item
2 hr (4)
CL Item
4 hr  (5)
CL Item
8 hr  (6)
CL Item
12 hr (7)
CL Item
12 hr:30 M (8)
CL Item
12 hr (9)
CL Item
14 hr (10)
CL Item
16 hr (11)
CL Item
20 hr (12)
CL Item
24 hr (13)
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
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 Group
Repeat Visual Nasal Endoscopy (Day 14 - 16)
C0189024 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Item
Time point of assessment
integer
C2348792 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Code List
Time point of assessment
CL Item
Pre dose  (1)
CL Item
30 m  (2)
CL Item
1 hr  (3)
CL Item
4 hr  (4)
CL Item
8 hr  (5)
CL Item
12 hr  (6)
CL Item
12 hr:30 M  (7)
CL Item
13 hr (8)
CL Item
16 hr (9)
CL Item
20 hr (10)
CL Item
24 hr (11)
CL Item
36 hr (12)
CL Item
48 hr (13)
CL Item
60 hr (14)
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
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])

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