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ID

42066

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

Mots-clés

  1. 09/12/2019 09/12/2019 -
  2. 09/01/2020 09/01/2020 -
  3. 15/03/2021 15/03/2021 - Dr. rer. medic Philipp Neuhaus
Détendeur de droits

GlaxoSmithKline

Téléchargé le

15 mars 2021

DOI

Pour une demande vous connecter.

Licence

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 (NCT01494532)

    Baseline - PR/ Conmeds; Pregnancy; Sudden Onset of Sleep Questionnaire

    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Study Name
    Description

    Study Name

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2348560 (Study Name)
    Subject ID
    Description

    Subject ID

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Study Site
    Description

    Study Site

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2825164 (Study Site)
    Prior/ Current Concomitant Medications
    Description

    Prior/ Current Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    UMLS CUI-2
    C1514463 (Prior Therapy)
    UMLS CUI-3
    C0521116 (Current (present time))
    SNOMED
    15240007
    Concomitant Medication Sequence Number
    Description

    Concomitant Medication Sequence Number

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C2348184 (Sequence Number)
    Concomitant Medication - Drug Name
    Description

    (Trade name preferred)

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    UMLS CUI [2]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Concomitant Medication - Total daily dose
    Description

    Concomitant Medication - Total daily dose

    Type de données

    float

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    UMLS CUI [2,1]
    C2348070 (Daily Dose)
    UMLS CUI [2,2]
    C0439810 (Total)
    SNOMED
    255619001
    LOINC
    LP21089-5
    Concomitant Medication - Unit
    Description

    Concomitant Medication - Unit

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    UMLS CUI [2]
    C1519795 (Unit of Measure)
    SNOMED
    767524001
    Concomitant Medication - Indication
    Description

    Concomitant Medication - Indication

    Type de données

    text

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

    Concomitant Medication - Start date - Complete Date Unknown

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C2826734 (Concomitant Medication Start Date)
    UMLS CUI [1,2]
    C0439673 (Unknown)
    SNOMED
    261665006
    LOINC
    LA4489-6
    Concomitant Medication - Start date/ time
    Description

    Concomitant Medication - Start date/ time

    Type de données

    datetime

    Alias
    UMLS CUI [1]
    C2826734 (Concomitant Medication Start Date)
    UMLS CUI [2,1]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    UMLS CUI [2,2]
    C2347852 (Concomitant Agent)
    Concomitant Medication - Taken prior to sudy?
    Description

    Concomitant Medication - Taken prior to sudy?

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2826667 (Concomitant Medication Previous Occurrence)
    Concomitant Medication - Ongoing?
    Description

    Concomitant Medication - Ongoing?

    Type de données

    boolean

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

    Concomitant Medication - End date - Complete Date unknown

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C2826744 (Concomitant Medication End Date)
    UMLS CUI [1,2]
    C0439673 (Unknown)
    SNOMED
    261665006
    LOINC
    LA4489-6
    Concomitant Medication - End date/ time
    Description

    Concomitant Medication - End date/ time

    Type de données

    datetime

    Alias
    UMLS CUI [1]
    C2826744 (Concomitant Medication End Date)
    UMLS CUI [2,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [2,2]
    C1522314 (End Time)
    SNOMED
    397898000
    AE/ SAE related?
    Description

    AE/ SAE related?

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1518404 (Non-serious Adverse Event)
    UMLS CUI [1,2]
    C0869014 (Relations)
    UMLS CUI [2,1]
    C1519255 (Serious Adverse Event)
    UMLS CUI [2,2]
    C0869014 (Relations)
    Prior/ current non-drug therapies
    Description

    Prior/ current non-drug therapies

    Alias
    UMLS CUI-1
    C1514463 (Prior Therapy)
    UMLS CUI-2
    C0033082 (Prescriptions, Non-Drug)
    UMLS CUI-3
    C2827774 (Current Therapy)
    UMLS CUI-4
    C0033082 (Prescriptions, Non-Drug)
    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?

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463 (Prior Therapy)
    UMLS CUI [1,2]
    C0033082 (Prescriptions, Non-Drug)
    UMLS CUI [2,1]
    C2827774 (Current Therapy)
    UMLS CUI [2,2]
    C0033082 (Prescriptions, Non-Drug)
    Non-drug therapies
    Description

    Non-drug therapies

    Alias
    UMLS CUI-1
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI-2
    C0033082 (Prescriptions, Non-Drug)
    Non-Drug Sequence Number
    Description

    Non-Drug Sequence Number

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0033082 (Prescriptions, Non-Drug)
    UMLS CUI [1,2]
    C2348184 (Sequence Number)
    Non-Drug Therapy Name
    Description

    Non-Drug Therapy Name

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0033082 (Prescriptions, Non-Drug)
    UMLS CUI [1,2]
    C2826274 (Treatment Name)
    Non-Drug Indication
    Description

    Non-Drug Indication

    Type de données

    text

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

    Non-Drug Therapy - Start Date - Complete Date unknown

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0033082 (Prescriptions, Non-Drug)
    UMLS CUI [1,2]
    C3173309 (Date treatment or therapy started)
    LOINC
    LP262646-5
    UMLS CUI [2,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [2,2]
    C0439673 (Unknown)
    SNOMED
    261665006
    LOINC
    LA4489-6
    Non-Drug Therapy - Start Date
    Description

    Non-Drug Therapy - Start Date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0033082 (Prescriptions, Non-Drug)
    UMLS CUI [1,2]
    C3173309 (Date treatment or therapy started)
    LOINC
    LP262646-5
    Non-Drug Therapy - Taken prior to study?
    Description

    Non-Drug Therapy - Taken prior to study?

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0033082 (Prescriptions, Non-Drug)
    UMLS CUI [1,2]
    C2603343 (Study)
    UMLS CUI [1,3]
    C0332152 (Before)
    SNOMED
    236874000
    Non-Drug Therapy ongoing?
    Description

    Non-Drug Therapy ongoing?

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0033082 (Prescriptions, Non-Drug)
    UMLS CUI [1,2]
    C0549178 (Continuous)
    SNOMED
    255238004
    LOINC
    LA16902-1
    Non-Drug Therapy - End Date - Complete Date unknown
    Description

    Non-Drug Therapy - End Date - Complete Date unknown

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0033082 (Prescriptions, Non-Drug)
    UMLS CUI [1,2]
    C1531784 (Date treatment stopped)
    SNOMED
    413947000
    UMLS CUI [2,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [2,2]
    C0439673 (Unknown)
    SNOMED
    261665006
    LOINC
    LA4489-6
    Non-Drug Therapy - End Date/Time
    Description

    Non-Drug Therapy - End Date/Time

    Type de données

    datetime

    Alias
    UMLS CUI [1,1]
    C0033082 (Prescriptions, Non-Drug)
    UMLS CUI [1,2]
    C1531784 (Date treatment stopped)
    SNOMED
    413947000
    UMLS CUI [2,1]
    C0033082 (Prescriptions, Non-Drug)
    UMLS CUI [2,2]
    C1522314 (End Time)
    SNOMED
    397898000
    Non-Drug Therapy - AE/ SAE related?
    Description

    Non-Drug Therapy - AE/ SAE related?

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0033082 (Prescriptions, Non-Drug)
    UMLS CUI [1,2]
    C0439849 (Relationships)
    SNOMED
    263498003
    LOINC
    LP146886-9
    UMLS CUI [1,3]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [2,1]
    C0033082 (Prescriptions, Non-Drug)
    UMLS CUI [2,2]
    C0439849 (Relationships)
    SNOMED
    263498003
    LOINC
    LP146886-9
    UMLS CUI [2,3]
    C1519255 (Serious Adverse Event)
    Pregnancy
    Description

    Pregnancy

    Alias
    UMLS CUI-1
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    Did a female partner of a male subject become pregnant during the study?
    Description

    Did a female partner of a male subject become pregnant during the study?

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0919624 (Pregnancy of partner)
    Did the subject become pregnant during the study?
    Description

    Did the subject become pregnant during the study?

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3828490 (Pregnant During the Study)
    Sudden Onset of Sleep Questionnaire
    Description

    Sudden Onset of Sleep Questionnaire

    Alias
    UMLS CUI-1
    C1272517 (Sudden onset (contextual qualifier) (qualifier value))
    SNOMED
    385315009
    UMLS CUI-2
    C0037313 (Sleep)
    SNOMED
    258158006
    LOINC
    LA18125-7
    UMLS CUI-3
    C0034394 (Questionnaires)
    Date of event
    Description

    Date of event

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0441471 (Event)
    SNOMED
    272379006
    LOINC
    LP94957-5
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Time of day
    Description

    Time of day

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C0439228 (day)
    SNOMED
    258703001
    1. What were you doing at the time of this event?
    Description

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

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C2828361 (Do (activity))
    UMLS CUI [1,2]
    C0441471 (Event)
    SNOMED
    272379006
    LOINC
    LP94957-5
    UMLS CUI [1,3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    If you were doing something different, specify
    Description

    If you were doing something different, specify

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2828361 (Do (activity))
    UMLS CUI [1,2]
    C0441471 (Event)
    SNOMED
    272379006
    LOINC
    LP94957-5
    UMLS CUI [1,3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,4]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,5]
    C2348235 (Specification)
    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?

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0441471 (Event)
    SNOMED
    272379006
    LOINC
    LP94957-5
    UMLS CUI [1,2]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [2]
    C2830004 (Somnolence)
    LOINC
    LA23818-0
    UMLS CUI [3]
    C0013144 (Drowsiness)
    SNOMED
    79519003
    LOINC
    LA16352-9
    2A. If yes, please explain/clarify:
    Description

    2A. If yes, please explain/clarify:

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2830004 (Somnolence)
    LOINC
    LA23818-0
    UMLS CUI [2]
    C0013144 (Drowsiness)
    SNOMED
    79519003
    LOINC
    LA16352-9
    UMLS CUI [3]
    C0681841 (Explanation)
    LOINC
    LA15331-4
    3. What specifically happened?
    Description

    3. What specifically happened?

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C2348235 (Specification)
    UMLS CUI [1,2]
    C0441471 (Event)
    SNOMED
    272379006
    LOINC
    LP94957-5
    4. How long did this event last?
    Description

    4. How long did this event last?

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0441471 (Event)
    SNOMED
    272379006
    LOINC
    LP94957-5
    UMLS CUI [1,2]
    C0449238 (Duration (temporal concept))
    SNOMED
    762636008
    LOINC
    LP14744-4
    Event duration unit
    Description

    Event duration unit

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0441471 (Event)
    SNOMED
    272379006
    LOINC
    LP94957-5
    UMLS CUI [1,2]
    C0449238 (Duration (temporal concept))
    SNOMED
    762636008
    LOINC
    LP14744-4
    UMLS CUI [1,3]
    C1519795 (Unit of Measure)
    SNOMED
    767524001
    5. Did you suffer any "bad" outcome/problem from this falling asleep event?
    Description

    5. Did you suffer any

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1624730 (Outcome of Event)
    UMLS CUI [1,2]
    C0037313 (Sleep)
    SNOMED
    258158006
    LOINC
    LA18125-7
    Please explain/clarify "bad" outcome/problem
    Description

    Please explain/clarify

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1624730 (Outcome of Event)
    UMLS CUI [1,2]
    C0681841 (Explanation)
    LOINC
    LA15331-4

    Similar models

    Baseline - PR/ Conmeds; Pregnancy; Sudden Onset of Sleep Questionnaire

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    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])
    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])
    C3173309 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [2,1])
    C0439673 (UMLS CUI [2,2])
    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])
    C3173309 (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])
    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
    Pregnancy
    C0032961 (UMLS CUI-1)
    Did a female partner of a male subject become pregnant during the study?
    Item
    Did a female partner of a male subject become pregnant during the study?
    boolean
    C0919624 (UMLS CUI [1])
    Did the subject become pregnant during the study?
    Item
    Did the subject become pregnant during the study?
    boolean
    C3828490 (UMLS CUI [1])
    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])
    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])
    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])
    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])

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