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
Versions (3)
- 09/12/2019 09/12/2019 -
- 09/01/2020 09/01/2020 -
- 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
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
Description
Concomitant Medication Sequence Number
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347852 (Concomitant Agent)
- UMLS CUI [1,2]
- C2348184 (Sequence Number)
Description
(Trade name preferred)
Type de données
text
Alias
- UMLS CUI [1]
- C2347852 (Concomitant Agent)
- UMLS CUI [2]
- C2360065 (Medication name)
- LOINC
- MTHU027854
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
Description
Concomitant Medication - Unit
Type de données
text
Alias
- UMLS CUI [1]
- C2347852 (Concomitant Agent)
- UMLS CUI [2]
- C1519795 (Unit of Measure)
- SNOMED
- 767524001
Description
Concomitant Medication - Indication
Type de données
text
Alias
- UMLS CUI [1]
- C2826696 (Concomitant Medication Use Indication)
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
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)
Description
Concomitant Medication - Taken prior to sudy?
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826667 (Concomitant Medication Previous Occurrence)
Description
Concomitant Medication - Ongoing?
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826666 (Concomitant Medication Ongoing)
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
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
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)
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)
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)
Description
Non-drug therapies
Alias
- UMLS CUI-1
- C0087111 (Therapeutic procedure)
- SNOMED
- 277132007
- LOINC
- LP21090-3
- UMLS CUI-2
- C0033082 (Prescriptions, Non-Drug)
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)
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)
Description
Non-Drug Indication
Type de données
text
Alias
- UMLS CUI [1,1]
- C0033082 (Prescriptions, Non-Drug)
- UMLS CUI [1,2]
- C3146298 (Indication)
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
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
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
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
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
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
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)
Description
Pregnancy
Alias
- UMLS CUI-1
- C0032961 (Pregnancy)
- SNOMED
- 289908002
- LOINC
- LP75920-6
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)
Description
Did the subject become pregnant during the study?
Type de données
boolean
Alias
- UMLS CUI [1]
- C3828490 (Pregnant During the Study)
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)
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
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
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
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)
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
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
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
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
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
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
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
C1514463 (UMLS CUI-2)
C0521116 (UMLS CUI-3)
C2348184 (UMLS CUI [1,2])
C2360065 (UMLS CUI [2])
C2348070 (UMLS CUI [2,1])
C0439810 (UMLS CUI [2,2])
C1519795 (UMLS CUI [2])
C0439673 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
C0439673 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C0869014 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0869014 (UMLS CUI [2,2])
C0033082 (UMLS CUI-2)
C2827774 (UMLS CUI-3)
C0033082 (UMLS CUI-4)
C0033082 (UMLS CUI [1,2])
C2827774 (UMLS CUI [2,1])
C0033082 (UMLS CUI [2,2])
C2348184 (UMLS CUI [1,2])
C2826274 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,2])
C3173309 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0439673 (UMLS CUI [2,2])
C3173309 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C1531784 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0439673 (UMLS CUI [2,2])
C1531784 (UMLS CUI [1,2])
C0033082 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
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])
C0037313 (UMLS CUI-2)
C0034394 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0441471 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0332152 (UMLS CUI [1,2])
C2830004 (UMLS CUI [2])
C0013144 (UMLS CUI [3])
C0013144 (UMLS CUI [2])
C0681841 (UMLS CUI [3])
C0441471 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C0037313 (UMLS CUI [1,2])
C0681841 (UMLS CUI [1,2])
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