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ID

39225

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 (12)
  1. 12/11/19 12/11/19 -
  2. 12/11/19 12/11/19 -
  3. 12/11/19 12/11/19 -
  4. 12/11/19 12/11/19 -
  5. 12/11/19 12/11/19 -
  6. 12/11/19 12/11/19 -
  7. 12/11/19 12/11/19 -
  8. 12/11/19 12/11/19 -
  9. 12/16/19 12/16/19 -
  10. 12/16/19 12/16/19 -
  11. 1/9/20 1/9/20 -
  12. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
Copyright Holder

GlaxoSmithKline

Uploaded on

December 11, 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

    Visit 1; Visit 2; Visit 3; Visit 4; Visit 5 - PR/Conmeds; SOOS; Vitals

    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
    Prior/ Current Concomitant Medications
    Description

    Prior/ Current Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    UMLS CUI-2
    C1514463
    UMLS CUI-3
    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
    Prior/ current non-drug therapies
    Description

    Prior/ current non-drug therapies

    Alias
    UMLS CUI-1
    C1514463
    UMLS CUI-2
    C0033082
    UMLS CUI-3
    C2827774
    UMLS CUI-4
    C0033082
    Did the subject participate in any Non-Drug therapies prior to screening and/or during the study?
    Description

    Did the subject participate in any Non-Drug therapies prior to screening and/or during the study?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0033082
    UMLS CUI [2,1]
    C2827774
    UMLS CUI [2,2]
    C0033082
    Non-drug therapies
    Description

    Non-drug therapies

    Alias
    UMLS CUI-1
    C0087111
    UMLS CUI-2
    C0033082
    Non-Drug Sequence Number
    Description

    Non-Drug Sequence Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0033082
    UMLS CUI [1,2]
    C2348184
    Non-Drug Therapy Name
    Description

    Non-Drug Therapy Name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0033082
    UMLS CUI [1,2]
    C2826274
    Non-Drug Indication
    Description

    Non-Drug Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0033082
    UMLS CUI [1,2]
    C3146298
    Non-Drug Therapy - Start Date - Complete Date unknown
    Description

    Non-Drug Therapy - Start Date - Complete Date unknown

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0033082
    UMLS CUI [1,2]
    C1531783
    UMLS CUI [2,1]
    C0011008
    UMLS CUI [2,2]
    C0439673
    Non-Drug Therapy - Start Date
    Description

    Non-Drug Therapy - Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0033082
    UMLS CUI [1,2]
    C1531783
    Non-Drug Therapy - Taken prior to study?
    Description

    Non-Drug Therapy - Taken prior to study?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0033082
    UMLS CUI [1,2]
    C2603343
    UMLS CUI [1,3]
    C0332152
    Non-Drug Therapy ongoing?
    Description

    Non-Drug Therapy ongoing?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0033082
    UMLS CUI [1,2]
    C0549178
    Non-Drug Therapy - End Date - Complete Date unknown
    Description

    Non-Drug Therapy - End Date - Complete Date unknown

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0033082
    UMLS CUI [1,2]
    C1531784
    UMLS CUI [2,1]
    C0011008
    UMLS CUI [2,2]
    C0439673
    Non-Drug Therapy - End Date/Time
    Description

    Non-Drug Therapy - End Date/Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0033082
    UMLS CUI [1,2]
    C1531784
    UMLS CUI [2,1]
    C0033082
    UMLS CUI [2,2]
    C1522314
    Non-Drug Therapy - AE/ SAE related?
    Description

    Non-Drug Therapy - AE/ SAE related?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0033082
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0877248
    UMLS CUI [2,1]
    C0033082
    UMLS CUI [2,2]
    C0439849
    UMLS CUI [2,3]
    C1519255
    Sudden Onset of Sleep Questionnaire
    Description

    Sudden Onset of Sleep Questionnaire

    Alias
    UMLS CUI-1
    C1272517
    UMLS CUI-2
    C0037313
    UMLS CUI-3
    C0034394
    Date of event
    Description

    Date of event

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0441471
    UMLS CUI [1,2]
    C0011008
    Time of day
    Description

    Time of day

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0439228
    1. What were you doing at the time of this event?
    Description

    1. What were you doing at the time of this event?

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2828361
    UMLS CUI [1,2]
    C0441471
    UMLS CUI [1,3]
    C0040223
    If you were doing something different, specify
    Description

    If you were doing something different, specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2828361
    UMLS CUI [1,2]
    C0441471
    UMLS CUI [1,3]
    C0040223
    UMLS CUI [1,4]
    C0205394
    UMLS CUI [1,5]
    C2348235
    2. Prior to this event, did you experience any sleepiness or drowsiness?
    Description

    2. Prior to this event, did you experience any sleepiness or drowsiness?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0441471
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [2]
    C2830004
    UMLS CUI [3]
    C0013144
    2A. If yes, please explain/clarify:
    Description

    2A. If yes, please explain/clarify:

    Data type

    text

    Alias
    UMLS CUI [1]
    C2830004
    UMLS CUI [2]
    C0013144
    UMLS CUI [3]
    C0681841
    3. What specifically happened?
    Description

    3. What specifically happened?

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348235
    UMLS CUI [1,2]
    C0441471
    4. How long did this event last?
    Description

    4. How long did this event last?

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0441471
    UMLS CUI [1,2]
    C0449238
    Event duration unit
    Description

    Event duration unit

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0441471
    UMLS CUI [1,2]
    C0449238
    UMLS CUI [1,3]
    C1519795
    5. Did you suffer any "bad" outcome/problem from this falling asleep event?
    Description

    5. Did you suffer any

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1624730
    UMLS CUI [1,2]
    C0037313
    Please explain/clarify "bad" outcome/problem
    Description

    Please explain/clarify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1624730
    UMLS CUI [1,2]
    C0681841
    Vital Signs - Semi supine
    Description

    Vital Signs - Semi supine

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0522019
    Vital signs not done (semi-supine)
    Description

    Vital signs not done (semi-supine)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0522019
    UMLS CUI [1,3]
    C1272696
    Please provide a reason for vital signs not done (semi-supine)
    Description

    Please provide a reason for vital signs not done (semi-supine)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0522019
    UMLS CUI [1,3]
    C2826287
    Date/Time vitals performed (semi-supine)
    Description

    Date/Time vitals performed (semi-supine)

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0522019
    UMLS CUI [1,3]
    C0040223
    UMLS CUI [2,1]
    C0518766
    UMLS CUI [2,2]
    C0522019
    UMLS CUI [2,3]
    C0011008
    Heart rate (semi-supine)
    Description

    Heart rate (semi-supine)

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0522019
    beats/min
    Systolic Blood pressure (semi-supine)
    Description

    Systolic Blood pressure (semi-supine)

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0522019
    mm[Hg]
    Diastolic Blood pressure (semi-supine)
    Description

    Diastolic Blood pressure (semi-supine)

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0522019
    mm[Hg]
    Vital Signs - Standing
    Description

    Vital Signs - Standing

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0231472
    Vital signs not done (standing)
    Description

    Vital signs not done (standing)

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0231472
    UMLS CUI [1,3]
    C1272696
    Please provide a reason for vital signs not done (standing)
    Description

    Please provide a reason for vital signs not done (standing)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0231472
    UMLS CUI [1,3]
    C2826287
    Date/Time vitals performed (standing)
    Description

    Date/Time vitals performed (standing)

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0231472
    UMLS CUI [1,3]
    C0040223
    UMLS CUI [2,1]
    C0518766
    UMLS CUI [2,2]
    C0231472
    UMLS CUI [2,3]
    C0011008
    Heart rate (standing)
    Description

    Heart rate (standing)

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0231472
    beats/min
    Systolic Blood pressure (standing)
    Description

    Systolic Blood pressure (standing)

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0231472
    mm[Hg]
    Diastolic Blood pressure (standing)
    Description

    Diastolic Blood pressure (standing)

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0231472
    mm[Hg]
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    Similar models

    Visit 1; Visit 2; Visit 3; Visit 4; Visit 5 - PR/Conmeds; SOOS; Vitals

    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
    Prior/ Current Concomitant Medications
    C2347852 (UMLS CUI-1)
    C1514463 (UMLS CUI-2)
    C0521116 (UMLS CUI-3)
    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])
    Item Group
    Prior/ current non-drug therapies
    C1514463 (UMLS CUI-1)
    C0033082 (UMLS CUI-2)
    C2827774 (UMLS CUI-3)
    C0033082 (UMLS CUI-4)
    Did the subject participate in any Non-Drug therapies prior to screening and/or during the study?
    Item
    Did the subject participate in any Non-Drug therapies prior to screening and/or during the study?
    boolean
    C1514463 (UMLS CUI [1,1])
    C0033082 (UMLS CUI [1,2])
    C2827774 (UMLS CUI [2,1])
    C0033082 (UMLS CUI [2,2])
    Item Group
    Non-drug therapies
    C0087111 (UMLS CUI-1)
    C0033082 (UMLS CUI-2)
    Non-Drug Sequence Number
    Item
    Non-Drug Sequence Number
    integer
    C0033082 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Non-Drug Therapy Name
    Item
    Non-Drug Therapy Name
    text
    C0033082 (UMLS CUI [1,1])
    C2826274 (UMLS CUI [1,2])
    Non-Drug Indication
    Item
    Non-Drug Indication
    text
    C0033082 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Item
    Non-Drug Therapy - Start Date - Complete Date unknown
    integer
    C0033082 (UMLS CUI [1,1])
    C1531783 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [2,1])
    C0439673 (UMLS CUI [2,2])
    Non-Drug Therapy - Start Date - Complete Date unknown
    Code List
    Non-Drug Therapy - Start Date - Complete Date unknown
    CL Item
    Complete Date Unknown (1)
    Non-Drug Therapy - Start Date
    Item
    Non-Drug Therapy - Start Date
    date
    C0033082 (UMLS CUI [1,1])
    C1531783 (UMLS CUI [1,2])
    Non-Drug Therapy - Taken prior to study?
    Item
    Non-Drug Therapy - Taken prior to study?
    boolean
    C0033082 (UMLS CUI [1,1])
    C2603343 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    Non-Drug Therapy ongoing?
    Item
    Non-Drug Therapy ongoing?
    boolean
    C0033082 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Item
    Non-Drug Therapy - End Date - Complete Date unknown
    integer
    C0033082 (UMLS CUI [1,1])
    C1531784 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [2,1])
    C0439673 (UMLS CUI [2,2])
    Non-Drug Therapy - Stop Date - Complete Date unknown
    Code List
    Non-Drug Therapy - End Date - Complete Date unknown
    CL Item
    Complete Date Unknown (1)
    Non-Drug Therapy - End Date/Time
    Item
    Non-Drug Therapy - End Date/Time
    datetime
    C0033082 (UMLS CUI [1,1])
    C1531784 (UMLS CUI [1,2])
    C0033082 (UMLS CUI [2,1])
    C1522314 (UMLS CUI [2,2])
    Non-Drug Therapy - AE/ SAE related?
    Item
    Non-Drug Therapy - AE/ SAE related?
    boolean
    C0033082 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0877248 (UMLS CUI [1,3])
    C0033082 (UMLS CUI [2,1])
    C0439849 (UMLS CUI [2,2])
    C1519255 (UMLS CUI [2,3])
    Item Group
    Sudden Onset of Sleep Questionnaire
    C1272517 (UMLS CUI-1)
    C0037313 (UMLS CUI-2)
    C0034394 (UMLS CUI-3)
    Date of event
    Item
    Date of event
    date
    C0441471 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Time of day
    integer
    C0040223 (UMLS CUI [1,1])
    C0439228 (UMLS CUI [1,2])
    Time of day
    Code List
    Time of day
    CL Item
    Morning (1)
    CL Item
    Afternoon (2)
    CL Item
    Early evening (3)
    CL Item
    Late evening (4)
    CL Item
    Night (5)
    Item
    1. What were you doing at the time of this event?
    integer
    C2828361 (UMLS CUI [1,1])
    C0441471 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    1. What were you doing at the time of this event?
    Code List
    1. What were you doing at the time of this event?
    CL Item
    Eating (1)
    CL Item
    Driving (2)
    CL Item
    Passenger in car (3)
    CL Item
    Talking (4)
    CL Item
    Other (5)
    If you were doing something different, specify
    Item
    If you were doing something different, specify
    text
    C2828361 (UMLS CUI [1,1])
    C0441471 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    C2348235 (UMLS CUI [1,5])
    2. Prior to this event, did you experience any sleepiness or drowsiness?
    Item
    2. Prior to this event, did you experience any sleepiness or drowsiness?
    boolean
    C0441471 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C2830004 (UMLS CUI [2])
    C0013144 (UMLS CUI [3])
    2A. If yes, please explain/clarify:
    Item
    2A. If yes, please explain/clarify:
    text
    C2830004 (UMLS CUI [1])
    C0013144 (UMLS CUI [2])
    C0681841 (UMLS CUI [3])
    3. What specifically happened?
    Item
    3. What specifically happened?
    text
    C2348235 (UMLS CUI [1,1])
    C0441471 (UMLS CUI [1,2])
    4. How long did this event last?
    Item
    4. How long did this event last?
    integer
    C0441471 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    Item
    Event duration unit
    integer
    C0441471 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    C1519795 (UMLS CUI [1,3])
    Event duration unit
    Code List
    Event duration unit
    CL Item
    Seconds (1)
    CL Item
    Minutes (2)
    CL Item
    Hours (3)
    5. Did you suffer any
    Item
    5. Did you suffer any "bad" outcome/problem from this falling asleep event?
    boolean
    C1624730 (UMLS CUI [1,1])
    C0037313 (UMLS CUI [1,2])
    Please explain/clarify
    Item
    Please explain/clarify "bad" outcome/problem
    text
    C1624730 (UMLS CUI [1,1])
    C0681841 (UMLS CUI [1,2])
    Item Group
    Vital Signs - Semi supine
    C0518766 (UMLS CUI-1)
    C0522019 (UMLS CUI-2)
    Item
    Vital signs not done (semi-supine)
    integer
    C0518766 (UMLS CUI [1,1])
    C0522019 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Vital signs not done (semi-supine)
    Code List
    Vital signs not done (semi-supine)
    CL Item
    Not done (1)
    Please provide a reason for vital signs not done (semi-supine)
    Item
    Please provide a reason for vital signs not done (semi-supine)
    text
    C0518766 (UMLS CUI [1,1])
    C0522019 (UMLS CUI [1,2])
    C2826287 (UMLS CUI [1,3])
    Date/Time vitals performed (semi-supine)
    Item
    Date/Time vitals performed (semi-supine)
    datetime
    C0518766 (UMLS CUI [1,1])
    C0522019 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    C0518766 (UMLS CUI [2,1])
    C0522019 (UMLS CUI [2,2])
    C0011008 (UMLS CUI [2,3])
    Heart rate (semi-supine)
    Item
    Heart rate (semi-supine)
    integer
    C0018810 (UMLS CUI [1,1])
    C0522019 (UMLS CUI [1,2])
    Systolic Blood pressure (semi-supine)
    Item
    Systolic Blood pressure (semi-supine)
    integer
    C0871470 (UMLS CUI [1,1])
    C0522019 (UMLS CUI [1,2])
    Diastolic Blood pressure (semi-supine)
    Item
    Diastolic Blood pressure (semi-supine)
    integer
    C0428883 (UMLS CUI [1,1])
    C0522019 (UMLS CUI [1,2])
    Item Group
    Vital Signs - Standing
    C0518766 (UMLS CUI-1)
    C0231472 (UMLS CUI-2)
    Item
    Vital signs not done (standing)
    integer
    C0518766 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Vital signs not done (standing)
    Code List
    Vital signs not done (standing)
    CL Item
    Not done (1)
    Please provide a reason for vital signs not done (standing)
    Item
    Please provide a reason for vital signs not done (standing)
    text
    C0518766 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    C2826287 (UMLS CUI [1,3])
    Date/Time vitals performed (standing)
    Item
    Date/Time vitals performed (standing)
    datetime
    C0518766 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    C0518766 (UMLS CUI [2,1])
    C0231472 (UMLS CUI [2,2])
    C0011008 (UMLS CUI [2,3])
    Heart rate (standing)
    Item
    Heart rate (standing)
    integer
    C0018810 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Systolic Blood pressure (standing)
    Item
    Systolic Blood pressure (standing)
    integer
    C0871470 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Diastolic Blood pressure (standing)
    Item
    Diastolic Blood pressure (standing)
    integer
    C0428883 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
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