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ID

39166

Description

Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

Keywords

Versions (3)
  1. 12/3/19 12/3/19 -
  2. 12/6/19 12/6/19 -
  3. 1/9/20 1/9/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 6, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease

    English

    Screening - Medical History; PD Stage Prior Med; PR/ Conmeds

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Study Name
    Description

    Study Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348560
    Subject ID
    Description

    Subject ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Study Site
    Description

    Study Site

    Data type

    text

    Alias
    UMLS CUI [1]
    C2825164
    General Medical History - Cardiovascular Risk Factors
    Description

    General Medical History - Cardiovascular Risk Factors

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0850624
    Cardiovascular Risk Factor
    Description

    Cardiovascular Risk Factor

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0850624
    Cardiovascular Risk Factor Status
    Description

    Cardiovascular Risk Factor Status

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0850624
    UMLS CUI [1,2]
    C0449438
    Family history - Cardiovascular Risk Factors
    Description

    Family history - Cardiovascular Risk Factors

    Alias
    UMLS CUI-1
    C0241889
    UMLS CUI-2
    C0850624
    Is there a family history of premature coronary artery disease in women < 65 years or men < 55 years in first degree relatives only; e.g. biological mother or father, biological brother or sister, biological son or daughter (half siblings are considered first degree relatives)?
    Description

    Family history | Premature coronary artery disease | Gender | Age | First Degree Relative | Mother (person); Natural parent | Father (person); Natural parent | Brothers; Natural parent | Sister; Natural parent | Natural parent; Natural parent | Daughter; Natural parent

    Data type

    text

    Alias
    UMLS CUI [1]
    C0241889
    UMLS CUI [2]
    C1867743
    UMLS CUI [3]
    C0079399
    UMLS CUI [4]
    C0001779
    UMLS CUI [5]
    C1517194
    UMLS CUI [6,1]
    C0026591
    UMLS CUI [6,2]
    C0337465
    UMLS CUI [7,1]
    C0015671
    UMLS CUI [7,2]
    C0337465
    UMLS CUI [8]
    C0337527
    UMLS CUI [9]
    C0337514
    UMLS CUI [10]
    C0037683
    UMLS CUI [11]
    C0011011
    Medical Conditions
    Description

    Medical Conditions

    Alias
    UMLS CUI-1
    C0012634
    Medical Condition
    Description

    Medical Condition

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0012634
    Medical Condition Status
    Description

    Medical Condition Status

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0449438
    Tobacco Use
    Description

    Tobacco Use

    Alias
    UMLS CUI-1
    C0543414
    What is the subject's tobacco use history?
    Description

    What is the subject's tobacco use history?

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0841002
    Provide average tobacco used per week in units, using the measurement below
    Description

    1 cigar = 7 cigarettes 1 gram (0.03 oz) of tobacco = 1 cigarette

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0543414
    UMLS CUI [1,2]
    C0585296
    Parkinson's Disease History
    Description

    Parkinson's Disease History

    Alias
    UMLS CUI-1
    C0030567
    UMLS CUI-2
    C0262926
    A modified Hoehn and Yahr stage is to be obtained while 'Off'
    Description

    A modified Hoehn and Yahr stage is to be obtained while 'Off'

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0451215
    UMLS CUI [2]
    C1518544
    Pre-study Parkinson's Disease Medication
    Description

    Pre-study Parkinson's Disease Medication

    Alias
    UMLS CUI-1
    C0030567
    UMLS CUI-2
    C0013227
    UMLS CUI-3
    C0332152
    UMLS CUI-4
    C2347804
    Pre-study Parkinson's Disease Medication - Drug Sequence Number
    Description

    Pre-study Parkinson's Disease Medication - Drug Sequence Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0030567
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0332152
    UMLS CUI [1,4]
    C2347804
    UMLS CUI [2,1]
    C0013227
    UMLS CUI [2,2]
    C2348184
    Pre-study Parkinson's Disease Medication - Drug Name
    Description

    Trade name preferred

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0030567
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0332152
    UMLS CUI [1,4]
    C2347804
    UMLS CUI [2]
    C0013227
    Pre-study Parkinson's Disease Medication - Total daily dose
    Description

    Pre-study Parkinson's Disease Medication - Total daily dose

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0030567
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0332152
    UMLS CUI [1,4]
    C2347804
    UMLS CUI [2,1]
    C2348070
    UMLS CUI [2,2]
    C0439810
    Pre-study Parkinson's Disease Medication - Unit
    Description

    Pre-study Parkinson's Disease Medication - Unit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0030567
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0332152
    UMLS CUI [1,4]
    C2347804
    UMLS CUI [2]
    C1519795
    Pre-study Parkinson's Disease Medication - Indication
    Description

    Pre-study Parkinson's Disease Medication - Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0030567
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0332152
    UMLS CUI [1,4]
    C2347804
    UMLS CUI [2]
    C3146298
    Pre-study Parkinson's Disease Medication - Start Date - Complete Date Unknown
    Description

    Pre-study Parkinson's Disease Medication - Start Date - Complete Date Unknown

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0030567
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0332152
    UMLS CUI [1,4]
    C2347804
    UMLS CUI [2,1]
    C0808070
    UMLS CUI [2,2]
    C0439673
    Pre-study Parkinson's Disease Medication - Start date/time
    Description

    Pre-study Parkinson's Disease Medication - Start date/time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0030567
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0332152
    UMLS CUI [1,4]
    C2347804
    UMLS CUI [2]
    C0808070
    UMLS CUI [3]
    C1301880
    Pre-study Parkinson's Disease Medication - Taken prior to study?
    Description

    Pre-study Parkinson's Disease Medication - Taken prior to study?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030567
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0332152
    UMLS CUI [1,4]
    C2347804
    UMLS CUI [2,1]
    C0030567
    UMLS CUI [2,2]
    C0013227
    UMLS CUI [2,3]
    C2603343
    UMLS CUI [2,4]
    C0332152
    Pre-study Parkinson's Disease Medication - Ongoing?
    Description

    Pre-study Parkinson's Disease Medication - Ongoing?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030567
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0332152
    UMLS CUI [1,4]
    C2347804
    UMLS CUI [2]
    C0549178
    Pre-study Parkinson's Disease Medication - End Date - Complete Date Unknown
    Description

    Pre-study Parkinson's Disease Medication - End Date - Complete Date Unknown

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0030567
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0332152
    UMLS CUI [1,4]
    C2347804
    UMLS CUI [2,1]
    C0806020
    UMLS CUI [2,2]
    C0439673
    Pre-study Parkinson's Disease Medication - End date/time
    Description

    Pre-study Parkinson's Disease Medication - End date/time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0030567
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C0332152
    UMLS CUI [1,4]
    C2347804
    UMLS CUI [2,1]
    C0806020
    UMLS CUI [2,2]
    C1522314
    Prior/ Current Concomitant Medications
    Description

    Prior/ Current Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    UMLS CUI-3
    C1514463
    UMLS CUI-5
    C0521116
    Concomitant Medication Sequence Number
    Description

    Concomitant Medication Sequence Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C2348184
    Concomitant Medication - Drug Name
    Description

    (Trade name preferred)

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347852
    UMLS CUI [2]
    C2360065
    Concomitant Medication - Total daily dose
    Description

    Concomitant Medication - Total daily dose

    Data type

    float

    Alias
    UMLS CUI [1]
    C2347852
    UMLS CUI [2,1]
    C2348070
    UMLS CUI [2,2]
    C0439810
    Concomitant Medication - Unit
    Description

    Concomitant Medication - Unit

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347852
    UMLS CUI [2]
    C1519795
    Concomitant Medication - Indication
    Description

    Concomitant Medication - Indication

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826696
    Concomitant Medication - Start date - Complete Date Unknown
    Description

    Concomitant Medication - Start date - Complete Date Unknown

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2826734
    UMLS CUI [1,2]
    C0439673
    Concomitant Medication - Start date/ time
    Description

    Concomitant Medication - Start date/ time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C2826734
    UMLS CUI [2,1]
    C1301880
    UMLS CUI [2,2]
    C2347852
    Concomitant Medication - Taken prior to sudy?
    Description

    Concomitant Medication - Taken prior to sudy?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826667
    Concomitant Medication - Ongoing?
    Description

    Concomitant Medication - Ongoing?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    Concomitant Medication - End date - Complete Date unknown
    Description

    Concomitant Medication - End date - Complete Date unknown

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2826744
    UMLS CUI [1,2]
    C0439673
    Concomitant Medication - End date/ time
    Description

    Concomitant Medication - End date/ time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C2826744
    UMLS CUI [2,1]
    C2347852
    UMLS CUI [2,2]
    C1522314
    AE/ SAE related?
    Description

    AE/ SAE related?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0869014
    UMLS CUI [2,1]
    C1519255
    UMLS CUI [2,2]
    C0869014
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    Similar models

    Screening - Medical History; PD Stage Prior Med; PR/ Conmeds

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Study Name
    Item
    Study Name
    text
    C2348560 (UMLS CUI [1])
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Study Site
    Item
    Study Site
    text
    C2825164 (UMLS CUI [1])
    Item Group
    General Medical History - Cardiovascular Risk Factors
    C0262926 (UMLS CUI-1)
    C0850624 (UMLS CUI-2)
    Item
    Cardiovascular Risk Factor
    integer
    C0850624 (UMLS CUI [1])
    Cardiovascular Risk Factor
    Code List
    Cardiovascular Risk Factor
    CL Item
    Angina Pectoris (1)
    CL Item
    Myocardial Infarction (2)
    CL Item
    Stroke  (3)
    CL Item
    Diabetes (4)
    CL Item
    Hypertension (5)
    CL Item
    Hyperlipidemia (6)
    Item
    Cardiovascular Risk Factor Status
    integer
    C0850624 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Cardiovascular Risk Factor Status
    Code List
    Cardiovascular Risk Factor Status
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical History (3)
    CL Item
    Not Assessed (4)
    Item Group
    Family history - Cardiovascular Risk Factors
    C0241889 (UMLS CUI-1)
    C0850624 (UMLS CUI-2)
    Item
    Is there a family history of premature coronary artery disease in women < 65 years or men < 55 years in first degree relatives only; e.g. biological mother or father, biological brother or sister, biological son or daughter (half siblings are considered first degree relatives)?
    text
    C0241889 (UMLS CUI [1])
    C1867743 (UMLS CUI [2])
    C0079399 (UMLS CUI [3])
    C0001779 (UMLS CUI [4])
    C1517194 (UMLS CUI [5])
    C0026591 (UMLS CUI [6,1])
    C0337465 (UMLS CUI [6,2])
    C0015671 (UMLS CUI [7,1])
    C0337465 (UMLS CUI [7,2])
    C0337527 (UMLS CUI [8])
    C0337514 (UMLS CUI [9])
    C0037683 (UMLS CUI [10])
    C0011011 (UMLS CUI [11])
    undefined item
    Code List
    Is there a family history of premature coronary artery disease in women < 65 years or men < 55 years in first degree relatives only; e.g. biological mother or father, biological brother or sister, biological son or daughter (half siblings are considered first degree relatives)?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Unknown (U)
    Item Group
    Medical Conditions
    C0012634 (UMLS CUI-1)
    Item
    Medical Condition
    integer
    C0012634 (UMLS CUI [1])
    Medical Condition
    Code List
    Medical Condition
    CL Item
    Blood and lymphatic system disorders (1)
    CL Item
    Cardiac disorders (2)
    CL Item
    Ear and labyrinth disorders (3)
    CL Item
    Endocrine disorders (4)
    CL Item
    Eye disorders (5)
    CL Item
    Gastrointestinal disorders (6)
    CL Item
    Hepatobiliary disorders (7)
    CL Item
    Immune system disorders (8)
    CL Item
    Metabolism and nutrition disorders (9)
    CL Item
    Musculoskeletal and connective tissue disorders  (10)
    CL Item
    Neoplasms benign, malignant and unspecified (including cysts and polyps) (11)
    CL Item
    Nervous system disorders (12)
    CL Item
    Psychiatric disorders (13)
    CL Item
    Renal and urinary disorders (14)
    CL Item
    Reproductive system and breast disorders (15)
    CL Item
    Respiratory, thoracic and mediastinal disorders (16)
    CL Item
    Skin and subcutaneous tissue disorders (17)
    CL Item
    Vascular disorders (18)
    CL Item
    Infections and infestations (19)
    CL Item
    Congenital, familial and genetic disorders (20)
    CL Item
    General disorders and administration site conditions (21)
    CL Item
    Injury, poisoning and procedural complications (22)
    CL Item
    Investigations (23)
    Item
    Medical Condition Status
    integer
    C0012634 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Medical Condition Status
    Code List
    Medical Condition Status
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical History (3)
    CL Item
    Not Assessed (4)
    Item Group
    Tobacco Use
    C0543414 (UMLS CUI-1)
    Item
    What is the subject's tobacco use history?
    integer
    C0841002 (UMLS CUI [1])
    What is the subject's tobacco use history?
    Code List
    What is the subject's tobacco use history?
    CL Item
    Never used tobacco (1)
    CL Item
    Current tobacco user (2)
    CL Item
    Former tobacco user (3)
    Provide average tobacco used per week in units, using the measurement below
    Item
    Provide average tobacco used per week in units, using the measurement below
    integer
    C0543414 (UMLS CUI [1,1])
    C0585296 (UMLS CUI [1,2])
    Item Group
    Parkinson's Disease History
    C0030567 (UMLS CUI-1)
    C0262926 (UMLS CUI-2)
    Item
    A modified Hoehn and Yahr stage is to be obtained while 'Off'
    integer
    C0451215 (UMLS CUI [1])
    C1518544 (UMLS CUI [2])
    A modified Hoehn and Yahr stage is to be obtained while 'Off'
    Code List
    A modified Hoehn and Yahr stage is to be obtained while 'Off'
    CL Item
    0 (1)
    CL Item
    1 (2)
    CL Item
    1.5 (3)
    CL Item
    2 (4)
    CL Item
    2.5 (5)
    CL Item
    3 (6)
    CL Item
    4 (7)
    CL Item
    5 (8)
    Item Group
    Pre-study Parkinson's Disease Medication
    C0030567 (UMLS CUI-1)
    C0013227 (UMLS CUI-2)
    C0332152 (UMLS CUI-3)
    C2347804 (UMLS CUI-4)
    Pre-study Parkinson's Disease Medication - Drug Sequence Number
    Item
    Pre-study Parkinson's Disease Medication - Drug Sequence Number
    integer
    C0030567 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    C2347804 (UMLS CUI [1,4])
    C0013227 (UMLS CUI [2,1])
    C2348184 (UMLS CUI [2,2])
    Pre-study Parkinson's Disease Medication - Drug Name
    Item
    Pre-study Parkinson's Disease Medication - Drug Name
    text
    C0030567 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    C2347804 (UMLS CUI [1,4])
    C0013227 (UMLS CUI [2])
    Pre-study Parkinson's Disease Medication - Total daily dose
    Item
    Pre-study Parkinson's Disease Medication - Total daily dose
    float
    C0030567 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    C2347804 (UMLS CUI [1,4])
    C2348070 (UMLS CUI [2,1])
    C0439810 (UMLS CUI [2,2])
    Pre-study Parkinson's Disease Medication - Unit
    Item
    Pre-study Parkinson's Disease Medication - Unit
    text
    C0030567 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    C2347804 (UMLS CUI [1,4])
    C1519795 (UMLS CUI [2])
    Pre-study Parkinson's Disease Medication - Indication
    Item
    Pre-study Parkinson's Disease Medication - Indication
    text
    C0030567 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    C2347804 (UMLS CUI [1,4])
    C3146298 (UMLS CUI [2])
    Item
    Pre-study Parkinson's Disease Medication - Start Date - Complete Date Unknown
    integer
    C0030567 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    C2347804 (UMLS CUI [1,4])
    C0808070 (UMLS CUI [2,1])
    C0439673 (UMLS CUI [2,2])
    Complete Date Unknown
    Code List
    Pre-study Parkinson's Disease Medication - Start Date - Complete Date Unknown
    CL Item
    Complete Date Unknown (1)
    Pre-study Parkinson's Disease Medication - Start date/time
    Item
    Pre-study Parkinson's Disease Medication - Start date/time
    datetime
    C0030567 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    C2347804 (UMLS CUI [1,4])
    C0808070 (UMLS CUI [2])
    C1301880 (UMLS CUI [3])
    Pre-study Parkinson's Disease Medication - Taken prior to study?
    Item
    Pre-study Parkinson's Disease Medication - Taken prior to study?
    boolean
    C0030567 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    C2347804 (UMLS CUI [1,4])
    C0030567 (UMLS CUI [2,1])
    C0013227 (UMLS CUI [2,2])
    C2603343 (UMLS CUI [2,3])
    C0332152 (UMLS CUI [2,4])
    Pre-study Parkinson's Disease Medication - Ongoing?
    Item
    Pre-study Parkinson's Disease Medication - Ongoing?
    boolean
    C0030567 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    C2347804 (UMLS CUI [1,4])
    C0549178 (UMLS CUI [2])
    Item
    Pre-study Parkinson's Disease Medication - End Date - Complete Date Unknown
    integer
    C0030567 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    C2347804 (UMLS CUI [1,4])
    C0806020 (UMLS CUI [2,1])
    C0439673 (UMLS CUI [2,2])
    Pre-study Parkinson's Disease Medication - End Date - Complete Date Unknown
    Code List
    Pre-study Parkinson's Disease Medication - End Date - Complete Date Unknown
    CL Item
    Complete Date Unknown (1)
    Pre-study Parkinson's Disease Medication - End date/time
    Item
    Pre-study Parkinson's Disease Medication - End date/time
    datetime
    C0030567 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    C2347804 (UMLS CUI [1,4])
    C0806020 (UMLS CUI [2,1])
    C1522314 (UMLS CUI [2,2])
    Item Group
    Prior/ Current Concomitant Medications
    C2347852 (UMLS CUI-1)
    C1514463 (UMLS CUI-3)
    C0521116 (UMLS CUI-5)
    Concomitant Medication Sequence Number
    Item
    Concomitant Medication Sequence Number
    text
    C2347852 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Concomitant Medication - Drug Name
    Item
    Concomitant Medication - Drug Name
    text
    C2347852 (UMLS CUI [1])
    C2360065 (UMLS CUI [2])
    Concomitant Medication - Total daily dose
    Item
    Concomitant Medication - Total daily dose
    float
    C2347852 (UMLS CUI [1])
    C2348070 (UMLS CUI [2,1])
    C0439810 (UMLS CUI [2,2])
    Concomitant Medication - Unit
    Item
    Concomitant Medication - Unit
    text
    C2347852 (UMLS CUI [1])
    C1519795 (UMLS CUI [2])
    Concomitant Medication - Indication
    Item
    Concomitant Medication - Indication
    text
    C2826696 (UMLS CUI [1])
    Item
    Concomitant Medication - Start date - Complete Date Unknown
    integer
    C2826734 (UMLS CUI [1,1])
    C0439673 (UMLS CUI [1,2])
    Concomitant Medication - Start date - Complete Date Unknown
    Code List
    Concomitant Medication - Start date - Complete Date Unknown
    CL Item
    Complete Date Unknown (1)
    Concomitant Medication - Start date/ time
    Item
    Concomitant Medication - Start date/ time
    datetime
    C2826734 (UMLS CUI [1])
    C1301880 (UMLS CUI [2,1])
    C2347852 (UMLS CUI [2,2])
    Concomitant Medication - Taken prior to sudy?
    Item
    Concomitant Medication - Taken prior to sudy?
    boolean
    C2826667 (UMLS CUI [1])
    Concomitant Medication - Ongoing?
    Item
    Concomitant Medication - Ongoing?
    boolean
    C2826666 (UMLS CUI [1])
    Item
    Concomitant Medication - End date - Complete Date unknown
    integer
    C2826744 (UMLS CUI [1,1])
    C0439673 (UMLS CUI [1,2])
    Concomitant Medication - End date - Complete Date unknown
    Code List
    Concomitant Medication - End date - Complete Date unknown
    CL Item
    Complete Date Unknown (1)
    Concomitant Medication - End date/ time
    Item
    Concomitant Medication - End date/ time
    datetime
    C2826744 (UMLS CUI [1])
    C2347852 (UMLS CUI [2,1])
    C1522314 (UMLS CUI [2,2])
    AE/ SAE related?
    Item
    AE/ SAE related?
    boolean
    C1518404 (UMLS CUI [1,1])
    C0869014 (UMLS CUI [1,2])
    C1519255 (UMLS CUI [2,1])
    C0869014 (UMLS CUI [2,2])
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