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42066

Beskrivning

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

Nyckelord

Versioner (3)
  1. 2019-12-09 2019-12-09 -
  2. 2020-01-09 2020-01-09 -
  3. 2021-03-15 2021-03-15 - Dr. rer. medic Philipp Neuhaus
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

15 mars 2021

DOI

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Licens

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)

    Engelsk

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

    1 Formulär  
    Administrative
    Beskrivning

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Study Name
    Beskrivning

    Study Name

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348560
    Subject ID
    Beskrivning

    Subject ID

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Study Site
    Beskrivning

    Study Site

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2825164
    Prior/ Current Concomitant Medications
    Beskrivning

    Prior/ Current Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    UMLS CUI-2
    C1514463
    UMLS CUI-3
    C0521116
    Concomitant Medication Sequence Number
    Beskrivning

    Concomitant Medication Sequence Number

    Datatyp

    text

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

    (Trade name preferred)

    Datatyp

    text

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

    Concomitant Medication - Total daily dose

    Datatyp

    float

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

    Concomitant Medication - Unit

    Datatyp

    text

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

    Concomitant Medication - Indication

    Datatyp

    text

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

    Concomitant Medication - Start date - Complete Date Unknown

    Datatyp

    integer

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

    Concomitant Medication - Start date/ time

    Datatyp

    datetime

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

    Concomitant Medication - Taken prior to sudy?

    Datatyp

    boolean

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

    Concomitant Medication - Ongoing?

    Datatyp

    boolean

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

    Concomitant Medication - End date - Complete Date unknown

    Datatyp

    integer

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

    Concomitant Medication - End date/ time

    Datatyp

    datetime

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

    AE/ SAE related?

    Datatyp

    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
    Beskrivning

    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?
    Beskrivning

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

    Datatyp

    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
    Beskrivning

    Non-drug therapies

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

    Non-Drug Sequence Number

    Datatyp

    integer

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

    Non-Drug Therapy Name

    Datatyp

    text

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

    Non-Drug Indication

    Datatyp

    text

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

    Non-Drug Therapy - Start Date - Complete Date unknown

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0033082
    UMLS CUI [1,2]
    C3173309
    UMLS CUI [2,1]
    C0011008
    UMLS CUI [2,2]
    C0439673
    Non-Drug Therapy - Start Date
    Beskrivning

    Non-Drug Therapy - Start Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0033082
    UMLS CUI [1,2]
    C3173309
    Non-Drug Therapy - Taken prior to study?
    Beskrivning

    Non-Drug Therapy - Taken prior to study?

    Datatyp

    boolean

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

    Non-Drug Therapy ongoing?

    Datatyp

    boolean

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

    Non-Drug Therapy - End Date - Complete Date unknown

    Datatyp

    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
    Beskrivning

    Non-Drug Therapy - End Date/Time

    Datatyp

    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?
    Beskrivning

    Non-Drug Therapy - AE/ SAE related?

    Datatyp

    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
    Pregnancy
    Beskrivning

    Pregnancy

    Alias
    UMLS CUI-1
    C0032961
    Did a female partner of a male subject become pregnant during the study?
    Beskrivning

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

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0919624
    Did the subject become pregnant during the study?
    Beskrivning

    Did the subject become pregnant during the study?

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3828490
    Sudden Onset of Sleep Questionnaire
    Beskrivning

    Sudden Onset of Sleep Questionnaire

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

    Date of event

    Datatyp

    date

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

    Time of day

    Datatyp

    integer

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

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

    Datatyp

    integer

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

    If you were doing something different, specify

    Datatyp

    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?
    Beskrivning

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

    Datatyp

    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:
    Beskrivning

    2A. If yes, please explain/clarify:

    Datatyp

    text

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

    3. What specifically happened?

    Datatyp

    text

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

    4. How long did this event last?

    Datatyp

    integer

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

    Event duration unit

    Datatyp

    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?
    Beskrivning

    5. Did you suffer any

    Datatyp

    boolean

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

    Please explain/clarify

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1624730
    UMLS CUI [1,2]
    C0681841
    Tillbaka till toppen

    Similar models

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

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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])
    C3173309 (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])
    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])
    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
    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])
    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])
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