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ID

40155

Description

Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

Keywords

Versions (1)
  1. 3/18/20 3/18/20 -
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GlaxoSmithKline

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March 18, 2020

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Creative Commons BY-NC 4.0
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    Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455

    English

    Visit 2 - Tender Joint Count; Swollen Joint Count; Swollen/Tender Joint Count; ESR

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Date of Visit/ Assessment
    Description

    Date of Visit/ Assessment

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C2985720
    Tender Joint Count Page 1
    Description

    Tender Joint Count Page 1

    Alias
    UMLS CUI-1
    C0451530
    Joint Pain/ Tenderness
    Description

    Joint Pain/ Tenderness

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0240094
    UMLS CUI [1,2]
    C0003862
    Joint Pain/Tenderness Finding
    Description

    Joint Pain/Tenderness Finding

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0240094
    UMLS CUI [1,2]
    C0003862
    UMLS CUI [1,3]
    C0243095
    Tender Joint Count Page 2
    Description

    Tender Joint Count Page 2

    Alias
    UMLS CUI-1
    C0451530
    Joint Pain/ Tenderness
    Description

    Joint Pain/ Tenderness

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0240094
    UMLS CUI [1,2]
    C0003862
    Joint Pain/Tenderness Finding
    Description

    Joint Pain/Tenderness Finding

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0240094
    UMLS CUI [1,2]
    C0003862
    UMLS CUI [1,3]
    C0243095
    Joint Assessor Initials - Joint Pain/Tenderness
    Description

    Joint Assessor Initials - Joint Pain/Tenderness

    Alias
    UMLS CUI-1
    C2986440
    UMLS CUI-2
    C0240094
    UMLS CUI-3
    C0220825
    UMLS CUI-4
    C0240094
    UMLS CUI-5
    C0003862
    Initials of Independent joint assessor who performed evaluation - Joint Pain/Tenderness
    Description

    Initials of Independent joint assessor who performed evaluation - Joint Pain/Tenderness

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2986440
    UMLS CUI [1,2]
    C0220825
    UMLS CUI [2,1]
    C0240094
    UMLS CUI [2,2]
    C0003862
    Calculations - Joint Pain/Tenderness
    Description

    Calculations - Joint Pain/Tenderness

    Alias
    UMLS CUI-1
    C1441506
    UMLS CUI-2
    C0240094
    UMLS CUI-3
    C0003862
    Tender/Painful joint count (based on 68 joint count)
    Description

    Tender/Painful joint count (based on 68 joint count)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0451530
    UMLS CUI [2,1]
    C0003862
    UMLS CUI [2,2]
    C0750480
    Total number of tender/painful joints assessed (based on 68 joint count)
    Description

    Total number of tender/painful joints assessed (based on 68 joint count)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0451530
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [1,3]
    C0220825
    UMLS CUI [2,1]
    C0003862
    UMLS CUI [2,2]
    C0750480
    UMLS CUI [2,3]
    C0237753
    UMLS CUI [2,4]
    C0220825
    Tender/Painful joint count subset (based on 28 joint count)
    Description

    Tender/Painful joint count subset (based on 28 joint count)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0451530
    UMLS CUI [1,2]
    C1515021
    UMLS CUI [2,1]
    C0003862
    UMLS CUI [2,2]
    C0750480
    UMLS CUI [2,3]
    C1515021
    Total number of tender/painful joints assessed subset (based on 28 joint count)
    Description

    Total number of tender/painful joints assessed subset (based on 28 joint count)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0451530
    UMLS CUI [1,2]
    C1515021
    UMLS CUI [1,3]
    C0237753
    UMLS CUI [1,4]
    C0220825
    UMLS CUI [2,1]
    C0003862
    UMLS CUI [2,2]
    C0750480
    UMLS CUI [2,3]
    C1515021
    UMLS CUI [2,4]
    C0237753
    UMLS CUI [2,5]
    C0220825
    Swollen Joint Count Page 1
    Description

    Swollen Joint Count Page 1

    Alias
    UMLS CUI-1
    C0451521
    Joint Swelling
    Description

    Joint Swelling

    Data type

    text

    Alias
    UMLS CUI [1]
    C0152031
    Joint Swelling Finding
    Description

    Joint Swelling Finding

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0152031
    UMLS CUI [1,2]
    C0243095
    Swollen Joint Count Page 2
    Description

    Swollen Joint Count Page 2

    Alias
    UMLS CUI-1
    C0451521
    Joint Swelling
    Description

    Joint Swelling

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0152031
    Joint Swelling Finding
    Description

    Joint Swelling Finding

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0152031
    UMLS CUI [1,2]
    C0243095
    Joint Assessor Initials - Joint Swelling
    Description

    Joint Assessor Initials - Joint Swelling

    Alias
    UMLS CUI-1
    C2986440
    UMLS CUI-2
    C0220825
    UMLS CUI-3
    C0152031
    Initials of Independent joint assessor who performed evaluation - Joint Swelling
    Description

    Initials of Independent joint assessor who performed evaluation - Joint Swelling

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2986440
    UMLS CUI [1,2]
    C0220825
    UMLS CUI [2]
    C0152031
    Calculations - Joint Swelling
    Description

    Calculations - Joint Swelling

    Alias
    UMLS CUI-1
    C1441506
    UMLS CUI-2
    C0152031
    Swollen joint count (based on 66 joint count)
    Description

    Swollen joint count (based on 66 joint count)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0451521
    Total number of swollen joints assessed (based on 66 joint count)
    Description

    Total number of swollen joints assessed (based on 66 joint count)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0451521
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [1,3]
    C0220825
    Swollen joint count subset (based on 28 joint count)
    Description

    Swollen joint count subset (based on 28 joint count)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0451521
    UMLS CUI [1,2]
    C1515021
    Total number of swollen joints assessed subset (based on 28 joint count)
    Description

    Total number of swollen joints assessed subset (based on 28 joint count)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0451521
    UMLS CUI [1,2]
    C1515021
    UMLS CUI [1,3]
    C0237753
    UMLS CUI [1,4]
    C0220825
    Swollen/ Tender Joint Count
    Description

    Swollen/ Tender Joint Count

    Alias
    UMLS CUI-1
    C0451521
    UMLS CUI-2
    C0451530
    Does the patient have > 8 swollen joints and > 8 tender joints?'
    Description

    If the response is NO, patient is not eligible to continue in the study. Complete the Run-In Failure form.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0451521
    UMLS CUI [1,2]
    C0451530
    ESR - Local Laboratory
    Description

    ESR - Local Laboratory

    Alias
    UMLS CUI-1
    C1176468
    UMLS CUI-2
    C0022885
    ESR Date
    Description

    ESR Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1176468
    UMLS CUI [1,2]
    C0011008
    ESR
    Description

    ESR

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1176468
    ESR numeric result
    Description

    ESR numeric result

    Data type

    integer

    Measurement units
    • mm/h
    Alias
    UMLS CUI [1,1]
    C1176468
    UMLS CUI [1,2]
    C2347373
    mm/h
    Back to the top of the page

    Similar models

    Visit 2 - Tender Joint Count; Swollen Joint Count; Swollen/Tender Joint Count; ESR

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Date of Visit/ Assessment
    Item
    Date of Visit/ Assessment
    date
    C1320303 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Item Group
    Tender Joint Count Page 1
    C0451530 (UMLS CUI-1)
    Item
    Joint Pain/ Tenderness
    integer
    C0240094 (UMLS CUI [1,1])
    C0003862 (UMLS CUI [1,2])
    Joint Pain/ Tenderness
    Code List
    Joint Pain/ Tenderness
    CL Item
    Temporomandibular left (1)
    CL Item
    Temporomandibular right (2)
    CL Item
    Sternoclavicular left (3)
    CL Item
    Sternoclavicular right (4)
    CL Item
    Acromioclavicular left (5)
    CL Item
    Acromioclaicular right (6)
    CL Item
    Shoulder left (7)
    CL Item
    Shoulder right (8)
    CL Item
    Elbow left (9)
    CL Item
    Elbow right (10)
    CL Item
    Wrist left (11)
    CL Item
    Wrist right (12)
    CL Item
    MCP 1 left (13)
    CL Item
    MCP 1 right (14)
    CL Item
    MCP 2 left (15)
    CL Item
    MCP 2 right (16)
    CL Item
    MCP 3 left (17)
    CL Item
    MCP 3 right (18)
    CL Item
    MCP 4 left (19)
    CL Item
    MCP 4 right (20)
    CL Item
    MCP 5 left (21)
    CL Item
    MCP 5 right (22)
    CL Item
    IP (thumb) left (23)
    CL Item
    IP (thumb) right (24)
    CL Item
    PIP 2 (finger) left (25)
    CL Item
    PIP 2 (finger) right (26)
    CL Item
    PIP 3 (finger) left (27)
    CL Item
    PIP 3 (finger) right (28)
    CL Item
    PIP 4 (finger) left (29)
    CL Item
    PIP 4 (finger) right (30)
    CL Item
    PIP 5 (finger) left (31)
    CL Item
    PIP 5 (finger) right (32)
    Item
    Joint Pain/Tenderness Finding
    integer
    C0240094 (UMLS CUI [1,1])
    C0003862 (UMLS CUI [1,2])
    C0243095 (UMLS CUI [1,3])
    Joint Pain/Tenderness Finding
    Code List
    Joint Pain/Tenderness Finding
    CL Item
    Absent (0)
    CL Item
    Present (1)
    CL Item
    Non-Evaluable injection (3)
    CL Item
    Non-Evaluable Other (e.g replacement arthroplasty, small joint synovectomy or has fused) (4)
    Item Group
    Tender Joint Count Page 2
    C0451530 (UMLS CUI-1)
    Item
    Joint Pain/ Tenderness
    integer
    C0240094 (UMLS CUI [1,1])
    C0003862 (UMLS CUI [1,2])
    Joint Pain/ Tenderness
    Code List
    Joint Pain/ Tenderness
    CL Item
    DIP 1 left (33)
    CL Item
    DIP 1 right (34)
    CL Item
    DIP 2 left (35)
    CL Item
    DIP 2 right (36)
    CL Item
    DIP 3 left (37)
    CL Item
    DIP 3 right (38)
    CL Item
    DIP 4 left (39)
    CL Item
    DIP 4 right (40)
    CL Item
    HIP left (41)
    CL Item
    HIP right (42)
    CL Item
    Knee left (43)
    CL Item
    Knee right (44)
    CL Item
    Ankle Mortise left (45)
    CL Item
    Ankle Mortise right (46)
    CL Item
    Tarsi (midfoot) left (47)
    CL Item
    Tarsi (midfoot) right (48)
    CL Item
    MTP 1 left (49)
    CL Item
    MTP 1 right (50)
    CL Item
    MTP 2 left (51)
    CL Item
    MTP 2 right (52)
    CL Item
    MTP 3 left (53)
    CL Item
    MTP 3 right (54)
    CL Item
    MTP 4 left (55)
    CL Item
    MTP 4 right (56)
    CL Item
    MTP 5 left (57)
    CL Item
    MTP 5 right (58)
    CL Item
    IP (toe) left (59)
    CL Item
    IP (toe) right (60)
    CL Item
    PIP 2 (toe) left (61)
    CL Item
    PIP 2 (toe) right (62)
    CL Item
    PIP 3 (toe) left (63)
    CL Item
    PIP 3 (toe) right (64)
    CL Item
    PIP 4 (toe) left (65)
    CL Item
    PIP 4 (toe) right (66)
    CL Item
    PIP 5 (toe) left (67)
    CL Item
    PIP 5 (toe) right (68)
    Item
    Joint Pain/Tenderness Finding
    integer
    C0240094 (UMLS CUI [1,1])
    C0003862 (UMLS CUI [1,2])
    C0243095 (UMLS CUI [1,3])
    Joint Pain/Tenderness Finding
    Code List
    Joint Pain/Tenderness Finding
    CL Item
    Absent  (0)
    CL Item
    Present  (1)
    CL Item
    Non-Evaluable injection  (3)
    CL Item
    Non-Evaluable Other (e.g replacement arthroplasty, small joint synovectomy or has fused) (4)
    Item Group
    Joint Assessor Initials - Joint Pain/Tenderness
    C2986440 (UMLS CUI-1)
    C0240094 (UMLS CUI-2)
    C0220825 (UMLS CUI-3)
    C0240094 (UMLS CUI-4)
    C0003862 (UMLS CUI-5)
    Initials of Independent joint assessor who performed evaluation - Joint Pain/Tenderness
    Item
    Initials of Independent joint assessor who performed evaluation - Joint Pain/Tenderness
    text
    C2986440 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    C0240094 (UMLS CUI [2,1])
    C0003862 (UMLS CUI [2,2])
    Item Group
    Calculations - Joint Pain/Tenderness
    C1441506 (UMLS CUI-1)
    C0240094 (UMLS CUI-2)
    C0003862 (UMLS CUI-3)
    Tender/Painful joint count (based on 68 joint count)
    Item
    Tender/Painful joint count (based on 68 joint count)
    integer
    C0451530 (UMLS CUI [1])
    C0003862 (UMLS CUI [2,1])
    C0750480 (UMLS CUI [2,2])
    Total number of tender/painful joints assessed (based on 68 joint count)
    Item
    Total number of tender/painful joints assessed (based on 68 joint count)
    integer
    C0451530 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C0220825 (UMLS CUI [1,3])
    C0003862 (UMLS CUI [2,1])
    C0750480 (UMLS CUI [2,2])
    C0237753 (UMLS CUI [2,3])
    C0220825 (UMLS CUI [2,4])
    Tender/Painful joint count subset (based on 28 joint count)
    Item
    Tender/Painful joint count subset (based on 28 joint count)
    integer
    C0451530 (UMLS CUI [1,1])
    C1515021 (UMLS CUI [1,2])
    C0003862 (UMLS CUI [2,1])
    C0750480 (UMLS CUI [2,2])
    C1515021 (UMLS CUI [2,3])
    Total number of tender/painful joints assessed subset (based on 28 joint count)
    Item
    Total number of tender/painful joints assessed subset (based on 28 joint count)
    integer
    C0451530 (UMLS CUI [1,1])
    C1515021 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    C0220825 (UMLS CUI [1,4])
    C0003862 (UMLS CUI [2,1])
    C0750480 (UMLS CUI [2,2])
    C1515021 (UMLS CUI [2,3])
    C0237753 (UMLS CUI [2,4])
    C0220825 (UMLS CUI [2,5])
    Item Group
    Swollen Joint Count Page 1
    C0451521 (UMLS CUI-1)
    Item
    Joint Swelling
    text
    C0152031 (UMLS CUI [1])
    Joint Swelling
    Code List
    Joint Swelling
    CL Item
    Temporomandibular left (1)
    CL Item
    Temporomandibular right (2)
    CL Item
    Sternoclavicular left (3)
    CL Item
    Sternoclavicular right (4)
    CL Item
    Acromioclavicular left (5)
    CL Item
    Acromioclaicular right (6)
    CL Item
    Shoulder left (7)
    CL Item
    Shoulder right (8)
    CL Item
    Elbow left (9)
    CL Item
    Elbow right (10)
    CL Item
    Wrist left (11)
    CL Item
    Wrist right (12)
    CL Item
    MCP 1 left (13)
    CL Item
    MCP 1 right (14)
    CL Item
    MCP 2 left (15)
    CL Item
    MCP 2 right (16)
    CL Item
    MCP 3 left (17)
    CL Item
    MCP 3 right (18)
    CL Item
    MCP 4 left (19)
    CL Item
    MCP 4 right (20)
    CL Item
    MCP 5 left (21)
    CL Item
    MCP 5 right (22)
    CL Item
    IP (thumb) left (23)
    CL Item
    IP (thumb) right (24)
    CL Item
    PIP 2 (finger) left (25)
    CL Item
    PIP 2 (finger) right (26)
    CL Item
    PIP 3 (finger) left (27)
    CL Item
    PIP 3 (finger) right (28)
    CL Item
    PIP 4 (finger) left (29)
    CL Item
    PIP 4 (finger) right (30)
    CL Item
    PIP 5 (finger) left (31)
    CL Item
    PIP 5 (finger) right (32)
    Item
    Joint Swelling Finding
    integer
    C0152031 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    Joint Swelling Finding
    Code List
    Joint Swelling Finding
    CL Item
    Absent  (0)
    CL Item
    Present  (1)
    CL Item
    Non-Evaluable injection (3)
    CL Item
    Non-Evaluable Other (e.g replacement arthroplasty, small joint synovectomy or has fused) (4)
    Item Group
    Swollen Joint Count Page 2
    C0451521 (UMLS CUI-1)
    Item
    Joint Swelling
    integer
    C0152031 (UMLS CUI [1])
    undefined item
    Code List
    Joint Swelling
    CL Item
    DIP 1 left (33)
    CL Item
    DIP 1 right (34)
    CL Item
    DIP 2 left (35)
    CL Item
    DIP 2 right (36)
    CL Item
    DIP 3 left (37)
    CL Item
    DIP 3 right (38)
    CL Item
    DIP 4 left (39)
    CL Item
    DIP 4 right (40)
    CL Item
    HIP left (41)
    CL Item
    HIP right (42)
    CL Item
    Knee left (43)
    CL Item
    Knee right (44)
    CL Item
    Ankle Mortise left (45)
    CL Item
    Ankle Mortise right (46)
    CL Item
    Tarsi (midfoot) left (47)
    CL Item
    Tarsi (midfoot) right (48)
    CL Item
    MTP 1 left (49)
    CL Item
    MTP 1 right (50)
    CL Item
    MTP 2 left (51)
    CL Item
    MTP 2 right (52)
    CL Item
    MTP 3 left (53)
    CL Item
    MTP 3 right (54)
    CL Item
    MTP 4 left (55)
    CL Item
    MTP 4 right (56)
    CL Item
    MTP 5 left (57)
    CL Item
    MTP 5 right (58)
    CL Item
    IP (toe) left (59)
    CL Item
    IP (toe) right (60)
    CL Item
    PIP 2 (toe) left (61)
    CL Item
    PIP 2 (toe) right (62)
    CL Item
    PIP 3 (toe) left (63)
    CL Item
    PIP 3 (toe) right (64)
    CL Item
    PIP 4 (toe) left (65)
    CL Item
    PIP 4 (toe) right (66)
    CL Item
    PIP 5 (toe) left (67)
    CL Item
    PIP 5 (toe) right (68)
    Item
    Joint Swelling Finding
    integer
    C0152031 (UMLS CUI [1,1])
    C0243095 (UMLS CUI [1,2])
    Joint Swelling Finding
    Code List
    Joint Swelling Finding
    CL Item
    Absent  (0)
    CL Item
    Present  (1)
    CL Item
    Non-Evaluable injection  (3)
    CL Item
    Non-Evaluable Other (e.g replacement arthroplasty, small joint synovectomy or has fused) (4)
    Item Group
    Joint Assessor Initials - Joint Swelling
    C2986440 (UMLS CUI-1)
    C0220825 (UMLS CUI-2)
    C0152031 (UMLS CUI-3)
    Initials of Independent joint assessor who performed evaluation - Joint Swelling
    Item
    Initials of Independent joint assessor who performed evaluation - Joint Swelling
    text
    C2986440 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    C0152031 (UMLS CUI [2])
    Item Group
    Calculations - Joint Swelling
    C1441506 (UMLS CUI-1)
    C0152031 (UMLS CUI-2)
    Swollen joint count (based on 66 joint count)
    Item
    Swollen joint count (based on 66 joint count)
    integer
    C0451521 (UMLS CUI [1])
    Total number of swollen joints assessed (based on 66 joint count)
    Item
    Total number of swollen joints assessed (based on 66 joint count)
    integer
    C0451521 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C0220825 (UMLS CUI [1,3])
    Swollen joint count subset (based on 28 joint count)
    Item
    Swollen joint count subset (based on 28 joint count)
    integer
    C0451521 (UMLS CUI [1,1])
    C1515021 (UMLS CUI [1,2])
    Total number of swollen joints assessed subset (based on 28 joint count)
    Item
    Total number of swollen joints assessed subset (based on 28 joint count)
    integer
    C0451521 (UMLS CUI [1,1])
    C1515021 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    C0220825 (UMLS CUI [1,4])
    Item Group
    Swollen/ Tender Joint Count
    C0451521 (UMLS CUI-1)
    C0451530 (UMLS CUI-2)
    Does the patient have > 8 swollen joints and > 8 tender joints?'
    Item
    Does the patient have > 8 swollen joints and > 8 tender joints?'
    boolean
    C0451521 (UMLS CUI [1,1])
    C0451530 (UMLS CUI [1,2])
    Item Group
    ESR - Local Laboratory
    C1176468 (UMLS CUI-1)
    C0022885 (UMLS CUI-2)
    ESR Date
    Item
    ESR Date
    date
    C1176468 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    ESR
    integer
    C1176468 (UMLS CUI [1])
    ESR
    Code List
    ESR
    CL Item
    Numeric result (97)
    CL Item
    No result (99)
    ESR numeric result
    Item
    ESR numeric result
    integer
    C1176468 (UMLS CUI [1,1])
    C2347373 (UMLS CUI [1,2])
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