ID

24862

Description

Study ID: 100571 (M138) Clinical Study ID: 100571 Study Title: Double-blind randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 12 month schedule in healthy adult volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A Vaccine, Inactivated Trade Name: Havrix Study Indication: Hepatitis A https://clinicaltrials.gov/ct2/show/NCT00291876

Link

https://clinicaltrials.gov/ct2/show/NCT00291876

Keywords

Versions (1)
  1. 8/20/17 8/20/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 20, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK Hepatitis A Vaccine VISIT 23 ADDITIONAL VACCINATION SOLICITED ADVERSE EVENTS NCT00291876

English

GSK Hepatitis A Vaccine VISIT 23 ADDITIONAL VACCINATION SOLICITED ADVERSE EVENTS NCT00291876

1 forms  
Study administration
Description

Study administration

Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Description

Subject Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS
Description

SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS

Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Description

If Yes is ticked, please complete all following items.

Data type

text

Alias
UMLS CUI [1,1]
C0851536
UMLS CUI [1,2]
C0037088
Redness
Description

Administration site erythema

Data type

boolean

Alias
UMLS CUI [1]
C3805283
Size (of redness at administration site) Day 0
Description

Size of erythema at administration site Day 0

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C3805283
UMLS CUI [1,2]
C0456389
mm
Size (of redness at administration site) Day 1
Description

Size of erythema at administration site Day 1

Data type

integer

Measurement units
  • C
Alias
UMLS CUI [1,1]
C3805283
UMLS CUI [1,2]
C0456389
C
Size (of redness at administration site) Day 2
Description

Size of erythema at administration site Day 2

Data type

integer

Measurement units
  • C
Alias
UMLS CUI [1,1]
C3805283
UMLS CUI [1,2]
C0456389
C
Size (of redness at administration site) Day 3
Description

Size of erythema at administration site Day 3

Data type

integer

Measurement units
  • C
Alias
UMLS CUI [1,1]
C3805283
UMLS CUI [1,2]
C0456389
C
Ongoing after Day 3?
Description

Erythema ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C3805283
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
Swelling
Description

Administration site swelling

Data type

boolean

Alias
UMLS CUI [1]
C3854415
Size (of swelling at administration site) Day 0
Description

Size of swelling at administration site Day 0

Data type

integer

Measurement units
  • C
Alias
UMLS CUI [1,1]
C3854415
UMLS CUI [1,2]
C0456389
C
Size (of swelling at administration site) Day 1
Description

Size of swelling at administration site Day 1

Data type

integer

Measurement units
  • C
Alias
UMLS CUI [1,1]
C3854415
UMLS CUI [1,2]
C0456389
C
Size (of swelling at administration site) Day 2
Description

Size of swelling at administration site Day 2

Data type

integer

Measurement units
  • C
Alias
UMLS CUI [1,1]
C3854415
UMLS CUI [1,2]
C0456389
C
Size (of swelling at administration site) Day 3
Description

Size of swelling at administration site Day 3

Data type

integer

Measurement units
  • C
Alias
UMLS CUI [1,1]
C3854415
UMLS CUI [1,2]
C0456389
C
Ongoing after day 3?
Description

Swelling ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C3854415
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
Pain
Description

Administration site pain

Data type

boolean

Alias
UMLS CUI [1]
C0521491
Intensity (of pain at administration site) Day 0
Description

Intensity: 0: None 1: Mild 2: Moderate 3: Severe

Data type

integer

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C1320357
Intensity (of pain at administration site) Day 1
Description

Intensity: 0: None 1: Mild 2: Moderate 3: Severe

Data type

integer

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C1320357
Intensity (of pain at administration site) Day 2
Description

Intensity: 0: None 1: Mild 2: Moderate 3: Severe

Data type

integer

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C1320357
Intensity (of pain at administration site) Day 3
Description

Intensity: 0: None 1: Mild 2: Moderate 3: Severe

Data type

integer

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C1320357
Ongoing after day 3?
Description

Pain ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C2700396
SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS
Description

SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS

Has the subject experienced any of the following signs/symptoms during the solicited period?
Description

Adverse Events General Symptoms

Data type

text

Alias
UMLS CUI [1]
C1556354
Fever
Description

Fever

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Fever measurement site
Description

body temperature site

Data type

integer

Alias
UMLS CUI [1]
C0489453
Fever Day 0
Description

Fever Day 0

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Not taken
Description

Temperature Day 0 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C2826301
UMLS CUI [1,2]
C0437722
Fever Day 1
Description

Fever Day 1

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Not taken
Description

Temperature Day 1 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C1442449
UMLS CUI [1,2]
C0437722
Fever Day 2
Description

Fever Day 2

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Not taken
Description

Temperature Day 2 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C3842676
UMLS CUI [1,2]
C0437722
Fever Day 3
Description

Fever Day 3

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0015967
°C
Not taken
Description

Temperature Day 3 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C3842675
UMLS CUI [1,2]
C0437722
Ongoing after day 3?
Description

symptom ongoing

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C3174772
Date of last day of symptoms
Description

date last symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Causality?
Description

Causality

Data type

boolean

Alias
UMLS CUI [1,1]
C1314792
UMLS CUI [1,2]
C0015967
Fatigue
Description

Fatigue

Data type

boolean

Alias
UMLS CUI [1]
C0015672
Fatigue Day 0
Description

Fatigue Day 0

Data type

integer

Alias
UMLS CUI [1]
C0015672
Fatigue Day 1
Description

Fatigue Day 1

Data type

integer

Alias
UMLS CUI [1]
C0015672
Fatigue Day 2
Description

Fatigue Day 2

Data type

integer

Alias
UMLS CUI [1]
C0015672
Fatigue Day 3
Description

Fatigue Day 3

Data type

integer

Alias
UMLS CUI [1]
C0015672
Ongoing after day 3?
Description

Fatigue ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C3174772
Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0015672
UMLS CUI [1,3]
C2700396
Causality
Description

Causality

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0015672
Headache
Description

Headache

Data type

boolean

Alias
UMLS CUI [1]
C0018681
Headache, Intensity
Description

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0522510
Headache on Day 0
Description

Headache on Day 0

Data type

integer

Alias
UMLS CUI [1]
C0018681
Headache on Day 1
Description

Headache on Day 1

Data type

integer

Alias
UMLS CUI [1]
C0018681
Headache on Day 2
Description

Headache on Day 2

Data type

integer

Alias
UMLS CUI [1]
C0018681
Headache on Day 3
Description

Headache on Day 3

Data type

integer

Alias
UMLS CUI [1]
C0018681
Headache ongoing after day 3?
Description

Headache ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1]
C0018681
Date of last day of symptoms
Description

Headache ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0011008
Causality
Description

Causality

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0018681
Gastrointestinal symptoms
Description

Gastrointestinal symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms, Intensity
Description

If Yes, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0522510
Gastrointestinal symptoms on Day 0
Description

Gastrointestinal symptoms on Day 0

Data type

integer

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms on Day 1
Description

Gastrointestinal symptoms on Day 1

Data type

integer

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms on Day 2
Description

Gastrointestinal symptoms on Day 2

Data type

integer

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms on Day 3
Description

Gastrointestinal symptoms on Day 3

Data type

integer

Alias
UMLS CUI [1]
C0426576
Gastrointestinal symptoms ongoing after day 3?
Description

Gastrointestinal symptoms ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1]
C0426576
Date of last day of symptoms
Description

Gastrointestinal symptoms ongoing after day 3? If Yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0011008
Causality?
Description

Causality

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0426576
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Similar models

GSK Hepatitis A Vaccine VISIT 23 ADDITIONAL VACCINATION SOLICITED ADVERSE EVENTS NCT00291876

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study administration
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Subject Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C0851536 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
signs or symptoms at administration site
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (U)
CL Item
No vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
Administration site erythema
Item
Redness
boolean
C3805283 (UMLS CUI [1])
Size of erythema at administration site Day 0
Item
Size (of redness at administration site) Day 0
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of erythema at administration site Day 1
Item
Size (of redness at administration site) Day 1
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of erythema at administration site Day 2
Item
Size (of redness at administration site) Day 2
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of erythema at administration site Day 3
Item
Size (of redness at administration site) Day 3
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Erythema ongoing after day 3
Item
Ongoing after Day 3?
boolean
C3805283 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Administration site swelling
Item
Swelling
boolean
C3854415 (UMLS CUI [1])
Size of swelling at administration site Day 0
Item
Size (of swelling at administration site) Day 0
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of swelling at administration site Day 1
Item
Size (of swelling at administration site) Day 1
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of swelling at administration site Day 2
Item
Size (of swelling at administration site) Day 2
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of swelling at administration site Day 3
Item
Size (of swelling at administration site) Day 3
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling ongoing after day 3
Item
Ongoing after day 3?
boolean
C3854415 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Administration site pain
Item
Pain
boolean
C0521491 (UMLS CUI [1])
Intensity of pain at administration site Day 0
Item
Intensity (of pain at administration site) Day 0
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Intensity of pain at administration site Day 1
Item
Intensity (of pain at administration site) Day 1
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Intensity of pain at administration site Day 2
Item
Intensity (of pain at administration site) Day 2
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Intensity of pain at administration site Day 3
Item
Intensity (of pain at administration site) Day 3
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Pain ongoing after day 3
Item
Ongoing after day 3?
boolean
C0521491 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item Group
SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C1556354 (UMLS CUI [1])
Hib-MenCY vaccine
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
No [N] (1)
CL Item
Information not retrievable [U] (2)
CL Item
No vaccine administered [NA] (3)
CL Item
Yes [Y] (4)
Fever
Item
Fever
boolean
C0015967 (UMLS CUI [1])
Item
Fever measurement site
integer
C0489453 (UMLS CUI [1])
body temperature site
Code List
Fever measurement site
CL Item
Oral (recommended) (1)
CL Item
Axillary(recommended) (2)
CL Item
Rectal (3)
Fever Day 0
Item
Fever Day 0
float
C0015967 (UMLS CUI [1])
Temperature Day 0 not taken
Item
Not taken
boolean
C2826301 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Fever Day 1
Item
Fever Day 1
float
C0015967 (UMLS CUI [1])
Temperature Day 1 not taken
Item
Not taken
boolean
C1442449 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Fever Day 2
Item
Fever Day 2
float
C0015967 (UMLS CUI [1])
Temperature Day 2 not taken
Item
Not taken
boolean
C3842676 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Fever Day 3
Item
Fever Day 3
float
C0015967 (UMLS CUI [1])
Temperature Day 3 not taken
Item
Not taken
boolean
C3842675 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
symptom ongoing
Item
Ongoing after day 3?
boolean
C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
date last symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Causality
Item
Causality?
boolean
C1314792 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Fatigue
Item
Fatigue
boolean
C0015672 (UMLS CUI [1])
Item
Fatigue Day 0
integer
C0015672 (UMLS CUI [1])
Fatigue Day 0
Code List
Fatigue Day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Fatigue Day 1
integer
C0015672 (UMLS CUI [1])
Fatigue Day 0
Code List
Fatigue Day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Fatigue Day 2
integer
C0015672 (UMLS CUI [1])
Fatigue Day 0
Code List
Fatigue Day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Fatigue Day 3
integer
C0015672 (UMLS CUI [1])
Fatigue Day 0
Code List
Fatigue Day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Fatigue ongoing after day 3
Item
Ongoing after day 3?
boolean
C0015672 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Causality
Item
Causality
boolean
C0015127 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
Headache
Item
Headache
boolean
C0018681 (UMLS CUI [1])
Item
Headache, Intensity
integer
C0018681 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Fatigue Day 0
Code List
Headache, Intensity
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Headache on Day 0
integer
C0018681 (UMLS CUI [1])
Fatigue Day 0
Code List
Headache on Day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Headache on Day 1
integer
C0018681 (UMLS CUI [1])
Fatigue Day 0
Code List
Headache on Day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Headache on Day 2
integer
C0018681 (UMLS CUI [1])
Fatigue Day 0
Code List
Headache on Day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Headache on Day 3
integer
C0018681 (UMLS CUI [1])
Fatigue Day 0
Code List
Headache on Day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Headache ongoing after day 3
Item
Headache ongoing after day 3?
boolean
C0018681 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0018681 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality
Item
Causality
boolean
C0015127 (UMLS CUI [1,1])
C0018681 (UMLS CUI [1,2])
Gastrointestinal symptoms
Item
Gastrointestinal symptoms
boolean
C0426576 (UMLS CUI [1])
Item
Gastrointestinal symptoms, Intensity
integer
C0426576 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Fatigue Day 0
Code List
Gastrointestinal symptoms, Intensity
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Gastrointestinal symptoms on Day 0
integer
C0426576 (UMLS CUI [1])
Fatigue Day 0
Code List
Gastrointestinal symptoms on Day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Gastrointestinal symptoms on Day 1
integer
C0426576 (UMLS CUI [1])
Fatigue Day 0
Code List
Gastrointestinal symptoms on Day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Gastrointestinal symptoms on Day 2
integer
C0426576 (UMLS CUI [1])
Fatigue Day 0
Code List
Gastrointestinal symptoms on Day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Gastrointestinal symptoms on Day 3
integer
C0426576 (UMLS CUI [1])
Fatigue Day 0
Code List
Gastrointestinal symptoms on Day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Gastrointestinal symptoms ongoing after day 3
Item
Gastrointestinal symptoms ongoing after day 3?
boolean
C0426576 (UMLS CUI [1])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0426576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0426576 (UMLS CUI [1,2])
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