ID

31683

Beskrivning

INFLAMMATORY ARTHRITIS DATA COLLECTION Version 1.0.0 Revised: April 27 th, 2018 www.ichom.org Conditions: Rheumatoid Arthritis | Psoriatic Arthritis | Ankylosing Spondylitis | Juvenile Idiopathic Arthritis This ODM-file contains Clinical Variables to be administered at baseline visit and (a large number of the variables) annually. Please timestamp all variables. Some Standard Set variables are collected at multiple timepoints, and we will ask you to submit these variables in a concatenated VARIABLEID_TIMESTAMP form for future analyses. TEST StudyFor example, VARIABLEID_BASE (baseline); VARIABLEID_6MO (6 month follow-up); VARIABLEID_1YR (1 year follow-up), etc. The following scores are the ones that are integrated into the standard set. There are alternatives for each category: see questionnaire or data collection guide. PAIN: - Numerical Rating Scale (Adult/Paediatric) FATIGUE - Numerical rating Scale (Adult/Paediatric) ACTIVITY LIMITATION: - HAQ-II* (Adult): copyright FORWARD-The National Data Bank for Rheumatic Diseases, arthritis-research.org ; http://bit.ly/HAQIIIA ; Wolfe F, Michaud K, Pincus T. Development and validation of the health assessment questionnaire II: a revised version of the health assessment questionnaire. Arthritis & Rheumatism. 2004;50(10):3296-305. OVERALL EMOTIONAL AND PHYSICAL HEALTH IMPACT - Numerical rating scale (Adult/Paediatric) WORK/SCHOOL/HOUSEWORK ABILITY AND PRODUCTIVITY: - WPAI (Adult): reillyassociates.net/WPAI_General.html, they ask to inform them about publication or presentation of WPAI-data ICHOM was supported by Santeon, Arthritis Research UK, TiH Transparency in Healthcare, Maasstad Ziekenhuis, Karolinska Universitetssjukhuset, Sheba Academic Medical Center Hospital

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www.ichom.org

Nyckelord

Versioner (2)
  1. 21/09/2018 21/09/2018 - Sarah Riepenhausen
  2. 30/04/2020 30/04/2020 - Sarah Riepenhausen
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    ICHOM Inflammatory Arthritis

    Engelsk

    Baseline and Annual Clinical Form

    1 Formulär  
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Indicate the patient's medical record number
    Beskrivning

    This number will not be shared with ICHOM. In the case patient-level data is submitted to ICHOM for benchmarking or research purposes, a separate ICHOM Patient Identifier will be created and cross-linking between the ICHOM Patient Identifier and the medical record number will only be known at the treating institution INCLUSION CRITERIA: All patients TIMING: On all forms REPORTING SOURCE: Administrative or clinical TYPE: Numerical RESPONSE OPTIONS: According to institution

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1269815
    Time Relative to Baseline (e.g. 3 months follow-up, 6 months follow-up, 1 year follow-up, ...)
    Beskrivning

    This Item does not exist in the original standard set, instead it is asked to do the following: Please timestamp all variables. Some Standard Set variables are collected at multiple timepoints, and we will ask you to submit these variables in a concatenated VARIABLEID_TIMESTAMP form for future analyses. For example, VARIABLEID_BASE (baseline); VARIABLEID_6MO (6 month follow-up); VARIABLEID_1YR (1 year follow-up), etc. In this case 6 months, 1, and 2 years should be done, 3 months and 5 years follow-up are recommended, but not essential.

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C1442488
    Baseline Condition Factors
    Beskrivning

    Baseline Condition Factors

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C1442488
    Indicate whether the patient has hypertension and/or uses antihypertensive medication
    Beskrivning

    INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinician TYPE: Single answer

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0020538
    UMLS CUI [2]
    C0003364
    Indicate whether the patient has had a myocardial infarction
    Beskrivning

    INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinician TYPE: Single answer

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0027051
    Indicate whether the patient has had a stroke (excluding transient ischemic attacks)
    Beskrivning

    INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0038454
    UMLS CUI [1,2]
    C0332300
    UMLS CUI [1,3]
    C0007787
    Indicate whether the patient has any other heart disease
    Beskrivning

    INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0018799
    UMLS CUI [1,2]
    C0205394
    Indicate whether the patient has chronic lung disease
    Beskrivning

    INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0746102
    Indicate whether the patient has diabetes mellitus
    Beskrivning

    INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0011849
    Indicate whether the patient has any malignancies
    Beskrivning

    INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0006826
    Indicate whether the patient has depression
    Beskrivning

    INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0011581
    Indicate whether the patient has a fracture
    Beskrivning

    INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0016658
    Indicate whether the patient has stomach ulcers
    Beskrivning

    INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0038358
    Indicate whether the patient has stomach problems
    Beskrivning

    INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0577027
    Indicate whether the patient is obese
    Beskrivning

    Obesity is defined as a BMI ≥30 INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1305855
    UMLS CUI [2]
    C0028754
    Indicate the current diagnosis/diagnoses of inflammatory arthritis 1 = Rheumatoid arthritis
    Beskrivning

    INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0003873
    Indicate the current diagnosis/diagnoses of inflammatory arthritis 2 = Spondyloarthritis
    Beskrivning

    INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0949690
    Indicate the current diagnosis/diagnoses of inflammatory arthritis 3 = Psoriatic arthritis
    Beskrivning

    INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0003872
    Indicate the current diagnosis/diagnoses of inflammatory arthritis 4 = Juvenile idiopathic arthritis
    Beskrivning

    INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3495559
    Indicate the year of inflammatory arthritis diagnosis
    Beskrivning

    INCLUSION CRITERIA: All patients TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Date by YYYY

    Datatyp

    partialDate

    Måttenheter
    • YYYY
    Alias
    UMLS CUI [1]
    C0872146
    UMLS CUI [2,1]
    C0439234
    UMLS CUI [2,2]
    C0011900
    YYYY
    Indicate the presence of rheumatoid factor
    Beskrivning

    INCLUSION CRITERIA: If "1 = Rheumatoid arthritis" or "4 = Juvenile idiopathic arthritis" to IA_DIAG TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer RESPONSE OPTIONS:

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0201660
    Indicate the presence of anti-citrullinated protein antibodies (ACPA)
    Beskrivning

    INCLUSION CRITERIA: If "1 = Rheumatoid arthritis" or "4 = Juvenile idiopathic arthritis" to IA_DIAG TIMING: Baseline REPORTING SOURCE: Clinical TYPE: Single answer

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C4505301
    Treatment-Specific
    Beskrivning

    Treatment-Specific

    Alias
    UMLS CUI-1
    C0087111
    Has the patient suffered from any serious adverse events in the past 12 months?
    Beskrivning

    According to the FDA, a serious adverse event is an undesirable experience associated with the use of a medical product in a patient. The event is serious when the patient outcome is: death; life-threatening; hospitalisation; disability or permanent damage; congenital anomaly/birth defect; required intervention to prevent permanent impairment or damage; other serious (important medical events). INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Single answer

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C4086728
    Which serious adverse event(s) has the patient suffered from in the past 12 months? 1 = Death
    Beskrivning

    INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1705232
    UMLS CUI [1,2]
    C1519255
    Which serious adverse event(s) has the patient suffered from in the past 12 months? 2 = Life-threatening
    Beskrivning

    INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1517874
    Which serious adverse event(s) has the patient suffered from in the past 12 months? 3 = Hospitalization
    Beskrivning

    INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2826664
    Which serious adverse event(s) has the patient suffered from in the past 12 months? 4 = Disability or permanent damage
    Beskrivning

    INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C3640792
    Which serious adverse event(s) has the patient suffered from in the past 12 months? 5 = Congenital anomaly/birth defect
    Beskrivning

    INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2826727
    Which serious adverse event(s) has the patient suffered from in the past 12 months? 6 = Required intervention to prevent permanent impairment or damage
    Beskrivning

    INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C1546955
    Which serious adverse event(s) has the patient suffered from in the past 12 months? 7 = Other serious (important medical events)
    Beskrivning

    INCLUSION CRITERIA: If "1 = Yes" to SAE TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Multiple answer

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C2826256
    What was the disease activity target?
    Beskrivning

    INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Single answer

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0544450
    UMLS CUI [1,2]
    C1521840
    Was the disease activity target reached?
    Beskrivning

    INCLUSION CRITERIA: All patients TIMING: Baseline and annually REPORTING SOURCE: Clinical TYPE: Single answer

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0544450
    UMLS CUI [1,2]
    C1521840
    UMLS CUI [1,3]
    C1550543
    Tillbaka till toppen

    Similar models

    Baseline and Annual Clinical Form

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Patient ID
    Item
    Indicate the patient's medical record number
    integer
    C1269815 (UMLS CUI [1])
    Time Relative to Baseline
    Item
    Time Relative to Baseline (e.g. 3 months follow-up, 6 months follow-up, 1 year follow-up, ...)
    text
    C0439564 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    Item Group
    Baseline Condition Factors
    C0262926 (UMLS CUI-1)
    C1442488 (UMLS CUI-2)
    Item
    Indicate whether the patient has hypertension and/or uses antihypertensive medication
    integer
    C0020538 (UMLS CUI [1])
    C0003364 (UMLS CUI [2])
    High blood pressure
    Code List
    Indicate whether the patient has hypertension and/or uses antihypertensive medication
    CL Item
    No  (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Unknown (999)
    C0439673 (UMLS CUI-1)
    (Comment:en)
    Item
    Indicate whether the patient has had a myocardial infarction
    integer
    C0027051 (UMLS CUI [1])
    High blood pressure
    Code List
    Indicate whether the patient has had a myocardial infarction
    CL Item
    No  (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Unknown (999)
    C0439673 (UMLS CUI-1)
    (Comment:en)
    Item
    Indicate whether the patient has had a stroke (excluding transient ischemic attacks)
    integer
    C0038454 (UMLS CUI [1,1])
    C0332300 (UMLS CUI [1,2])
    C0007787 (UMLS CUI [1,3])
    High blood pressure
    Code List
    Indicate whether the patient has had a stroke (excluding transient ischemic attacks)
    CL Item
    No  (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Unknown (999)
    C0439673 (UMLS CUI-1)
    (Comment:en)
    Item
    Indicate whether the patient has any other heart disease
    integer
    C0018799 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    High blood pressure
    Code List
    Indicate whether the patient has any other heart disease
    CL Item
    No  (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Unknown (999)
    C0439673 (UMLS CUI-1)
    (Comment:en)
    Item
    Indicate whether the patient has chronic lung disease
    integer
    C0746102 (UMLS CUI [1])
    High blood pressure
    Code List
    Indicate whether the patient has chronic lung disease
    CL Item
    No  (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Unknown (999)
    C0439673 (UMLS CUI-1)
    (Comment:en)
    Item
    Indicate whether the patient has diabetes mellitus
    integer
    C0011849 (UMLS CUI [1])
    High blood pressure
    Code List
    Indicate whether the patient has diabetes mellitus
    CL Item
    No  (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Unknown (999)
    C0439673 (UMLS CUI-1)
    (Comment:en)
    Item
    Indicate whether the patient has any malignancies
    integer
    C0006826 (UMLS CUI [1])
    High blood pressure
    Code List
    Indicate whether the patient has any malignancies
    CL Item
    No  (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Unknown (999)
    C0439673 (UMLS CUI-1)
    (Comment:en)
    Item
    Indicate whether the patient has depression
    integer
    C0011581 (UMLS CUI [1])
    High blood pressure
    Code List
    Indicate whether the patient has depression
    CL Item
    No  (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Unknown (999)
    C0439673 (UMLS CUI-1)
    (Comment:en)
    Item
    Indicate whether the patient has a fracture
    integer
    C0016658 (UMLS CUI [1])
    High blood pressure
    Code List
    Indicate whether the patient has a fracture
    CL Item
    No  (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Unknown (999)
    C0439673 (UMLS CUI-1)
    (Comment:en)
    Item
    Indicate whether the patient has stomach ulcers
    integer
    C0038358 (UMLS CUI [1])
    High blood pressure
    Code List
    Indicate whether the patient has stomach ulcers
    CL Item
    No  (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Unknown (999)
    C0439673 (UMLS CUI-1)
    (Comment:en)
    Item
    Indicate whether the patient has stomach problems
    integer
    C0577027 (UMLS CUI [1])
    High blood pressure
    Code List
    Indicate whether the patient has stomach problems
    CL Item
    No  (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Unknown (999)
    C0439673 (UMLS CUI-1)
    (Comment:en)
    Item
    Indicate whether the patient is obese
    integer
    C1305855 (UMLS CUI [1])
    C0028754 (UMLS CUI [2])
    High blood pressure
    Code List
    Indicate whether the patient is obese
    CL Item
    No  (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Unknown (999)
    C0439673 (UMLS CUI-1)
    (Comment:en)
    Inflammatory arthritis diagnosis: Rheumatoid arthritis
    Item
    Indicate the current diagnosis/diagnoses of inflammatory arthritis 1 = Rheumatoid arthritis
    boolean
    C0003873 (UMLS CUI [1])
    Inflammatory arthritis diagnosis: Spondylarthritis
    Item
    Indicate the current diagnosis/diagnoses of inflammatory arthritis 2 = Spondyloarthritis
    boolean
    C0949690 (UMLS CUI [1])
    Inflammatory arthritis diagnosis: Psoriatic Arthritis
    Item
    Indicate the current diagnosis/diagnoses of inflammatory arthritis 3 = Psoriatic arthritis
    boolean
    C0003872 (UMLS CUI [1])
    Inflammatory arthritis diagnosis: Juvenile idiopathic arthritis
    Item
    Indicate the current diagnosis/diagnoses of inflammatory arthritis 4 = Juvenile idiopathic arthritis
    boolean
    C3495559 (UMLS CUI [1])
    Disease duration
    Item
    Indicate the year of inflammatory arthritis diagnosis
    partialDate
    C0872146 (UMLS CUI [1])
    C0439234 (UMLS CUI [2,1])
    C0011900 (UMLS CUI [2,2])
    Item
    Indicate the presence of rheumatoid factor
    integer
    C0201660 (UMLS CUI [1])
    Rheumatoid factor
    Code List
    Indicate the presence of rheumatoid factor
    CL Item
    Negative (0)
    C0205160 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Positive (1)
    C1446409 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Unknown (999)
    C0439673 (UMLS CUI-1)
    (Comment:en)
    Item
    Indicate the presence of anti-citrullinated protein antibodies (ACPA)
    integer
    C4505301 (UMLS CUI [1])
    Rheumatoid factor
    Code List
    Indicate the presence of anti-citrullinated protein antibodies (ACPA)
    CL Item
    Negative (0)
    C0205160 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Positive (1)
    C1446409 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Unknown (999)
    C0439673 (UMLS CUI-1)
    (Comment:en)
    Item Group
    Treatment-Specific
    C0087111 (UMLS CUI-1)
    Item
    Has the patient suffered from any serious adverse events in the past 12 months?
    integer
    C1519255 (UMLS CUI [1,1])
    C4086728 (UMLS CUI [1,2])
    Serious Adverse Events
    Code List
    Has the patient suffered from any serious adverse events in the past 12 months?
    CL Item
    No (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Unknown (999)
    C0439673 (UMLS CUI-1)
    (Comment:en)
    Serious Adverse Events - Classification: Death
    Item
    Which serious adverse event(s) has the patient suffered from in the past 12 months? 1 = Death
    boolean
    C1705232 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Serious Adverse Events - Classification: Life-threatening
    Item
    Which serious adverse event(s) has the patient suffered from in the past 12 months? 2 = Life-threatening
    boolean
    C1519255 (UMLS CUI [1,1])
    C1517874 (UMLS CUI [1,2])
    Serious Adverse Events - Classification: Hospitalization
    Item
    Which serious adverse event(s) has the patient suffered from in the past 12 months? 3 = Hospitalization
    boolean
    C1519255 (UMLS CUI [1,1])
    C2826664 (UMLS CUI [1,2])
    Serious Adverse Events - Classification: Disability or permanent damage
    Item
    Which serious adverse event(s) has the patient suffered from in the past 12 months? 4 = Disability or permanent damage
    boolean
    C1519255 (UMLS CUI [1,1])
    C3640792 (UMLS CUI [1,2])
    Serious Adverse Events - Classification: Congenital anomaly/birth defect
    Item
    Which serious adverse event(s) has the patient suffered from in the past 12 months? 5 = Congenital anomaly/birth defect
    boolean
    C1519255 (UMLS CUI [1,1])
    C2826727 (UMLS CUI [1,2])
    Serious Adverse Events - Classification: Required intervention to prevent permanent impairment or damage
    Item
    Which serious adverse event(s) has the patient suffered from in the past 12 months? 6 = Required intervention to prevent permanent impairment or damage
    boolean
    C1519255 (UMLS CUI [1,1])
    C1546955 (UMLS CUI [1,2])
    Serious Adverse Events - Classification: Other serious (important medical events)
    Item
    Which serious adverse event(s) has the patient suffered from in the past 12 months? 7 = Other serious (important medical events)
    boolean
    C1519255 (UMLS CUI [1,1])
    C2826256 (UMLS CUI [1,2])
    Item
    What was the disease activity target?
    integer
    C0544450 (UMLS CUI [1,1])
    C1521840 (UMLS CUI [1,2])
    Disease activity target
    Code List
    What was the disease activity target?
    CL Item
    Clinical remission (1)
    C0544452 (UMLS CUI-1)
    C0205210 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Low disease activity (2)
    C0544450 (UMLS CUI-1)
    C0205251 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Both (3)
    C0544450 (UMLS CUI-1)
    C0205251 (UMLS CUI-2)
    C0544452 (UMLS CUI-3)
    C0205210 (UMLS CUI-4)
    (Comment:en)
    CL Item
    Unknown (999)
    C0439673 (UMLS CUI-1)
    C1521840 (UMLS CUI-2)
    (Comment:en)
    Item
    Was the disease activity target reached?
    integer
    C0544450 (UMLS CUI [1,1])
    C1521840 (UMLS CUI [1,2])
    C1550543 (UMLS CUI [1,3])
    High blood pressure
    Code List
    Was the disease activity target reached?
    CL Item
    No  (0)
    C1298908 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Yes (1)
    C1705108 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Unknown (999)
    C0439673 (UMLS CUI-1)
    (Comment:en)
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