ID
41992
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)
- 12/11/19 12/11/19 -
- 12/11/19 12/11/19 -
- 12/11/19 12/11/19 -
- 12/11/19 12/11/19 -
- 12/11/19 12/11/19 -
- 12/11/19 12/11/19 -
- 12/11/19 12/11/19 -
- 12/11/19 12/11/19 -
- 12/16/19 12/16/19 -
- 12/16/19 12/16/19 -
- 1/9/20 1/9/20 -
- 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
Copyright Holder
GlaxoSmithKline
Uploaded on
March 15, 2021
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 (NCT01494532)
Visit 1; Visit 2; Visit 3; Visit 4; Visit 5; Visit 6; Visit 7; Visit 8; Visit Maintenance 1 +2; Early Withdrawal; Follow up; Optional Visit; Unscheduled - PR/Conmeds; SOOS; Vitals
Description
Prior/ Current Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C1514463
- UMLS CUI-3
- C0521116
Description
Concomitant Medication Sequence Number
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348184
Description
(Trade name preferred)
Data type
text
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2]
- C2360065
Description
Concomitant Medication - Total daily dose
Data type
float
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2,1]
- C2348070
- UMLS CUI [2,2]
- C0439810
Description
Concomitant Medication - Unit
Data type
text
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2]
- C1519795
Description
Concomitant Medication - Indication
Data type
text
Alias
- UMLS CUI [1]
- C2826696
Description
Concomitant Medication - Start date - Complete Date Unknown
Data type
integer
Alias
- UMLS CUI [1,1]
- C2826734
- UMLS CUI [1,2]
- C0439673
Description
Concomitant Medication - Start date/ time
Data type
datetime
Alias
- UMLS CUI [1]
- C2826734
- UMLS CUI [2,1]
- C1301880
- UMLS CUI [2,2]
- C2347852
Description
Concomitant Medication - Taken prior to sudy?
Data type
boolean
Alias
- UMLS CUI [1]
- C2826667
Description
Concomitant Medication - Ongoing?
Data type
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Concomitant Medication - End date - Complete Date unknown
Data type
integer
Alias
- UMLS CUI [1,1]
- C2826744
- UMLS CUI [1,2]
- C0439673
Description
Concomitant Medication - End date/ time
Data type
datetime
Alias
- UMLS CUI [1]
- C2826744
- UMLS CUI [2,1]
- C2347852
- UMLS CUI [2,2]
- C1522314
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
Description
Prior/ current non-drug therapies
Alias
- UMLS CUI-1
- C1514463
- UMLS CUI-2
- C0033082
- UMLS CUI-3
- C2827774
- UMLS CUI-4
- C0033082
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
Description
Non-drug therapies
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0033082
Description
Non-Drug Sequence Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0033082
- UMLS CUI [1,2]
- C2348184
Description
Non-Drug Therapy Name
Data type
text
Alias
- UMLS CUI [1,1]
- C0033082
- UMLS CUI [1,2]
- C2826274
Description
Non-Drug Indication
Data type
text
Alias
- UMLS CUI [1,1]
- C0033082
- UMLS CUI [1,2]
- C3146298
Description
Non-Drug Therapy - Start Date - Complete Date unknown
Data type
integer
Alias
- UMLS CUI [1,1]
- C0033082
- UMLS CUI [1,2]
- C3173309
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C0439673
Description
Non-Drug Therapy - Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0033082
- UMLS CUI [1,2]
- C3173309
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
Description
Non-Drug Therapy ongoing?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0033082
- UMLS CUI [1,2]
- C0549178
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
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
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
Description
Sudden Onset of Sleep Questionnaire
Alias
- UMLS CUI-1
- C1272517
- UMLS CUI-2
- C0037313
- UMLS CUI-3
- C0034394
Description
Date of event
Data type
date
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C0011008
Description
Time of day
Data type
integer
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0439228
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
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
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
Description
2A. If yes, please explain/clarify:
Data type
text
Alias
- UMLS CUI [1]
- C2830004
- UMLS CUI [2]
- C0013144
- UMLS CUI [3]
- C0681841
Description
3. What specifically happened?
Data type
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0441471
Description
4. How long did this event last?
Data type
integer
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C0449238
Description
Event duration unit
Data type
integer
Alias
- UMLS CUI [1,1]
- C0441471
- UMLS CUI [1,2]
- C0449238
- UMLS CUI [1,3]
- C1519795
Description
5. Did you suffer any
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1624730
- UMLS CUI [1,2]
- C0037313
Description
Please explain/clarify
Data type
text
Alias
- UMLS CUI [1,1]
- C1624730
- UMLS CUI [1,2]
- C0681841
Description
Vital Signs - Semi supine
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0522019
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
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
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
Description
Heart rate (semi-supine)
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0522019
Description
Systolic Blood pressure (semi-supine)
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0522019
Description
Diastolic Blood pressure (semi-supine)
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0522019
Description
Vital Signs - Standing
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0231472
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
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
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
Description
Heart rate (standing)
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0231472
Description
Systolic Blood pressure (standing)
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0231472
Description
Diastolic Blood pressure (standing)
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0231472
Description
Physical Exam
Alias
- UMLS CUI-1
- C0031809
Description
Date of exam
Data type
date
Alias
- UMLS CUI [1]
- C2826643
Description
Height
Data type
integer
Alias
- UMLS CUI [1]
- C0005890
Description
Height unit
Data type
text
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C0439148
Description
Weight
Data type
float
Alias
- UMLS CUI [1]
- C0005910
Description
Weight unit
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C0439148
Similar models
Visit 1; Visit 2; Visit 3; Visit 4; Visit 5; Visit 6; Visit 7; Visit 8; Visit Maintenance 1 +2; Early Withdrawal; Follow up; Optional Visit; Unscheduled - PR/Conmeds; SOOS; Vitals
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])
C0522019 (UMLS CUI-2)
C0522019 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0522019 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
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])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
C0231472 (UMLS CUI-2)
C0231472 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0231472 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
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])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
C0231472 (UMLS CUI [1,2])
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