ID
39430
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 (2)
- 12/11/19 12/11/19 -
- 1/9/20 1/9/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 9, 2020
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 Maintenance 2; Early Withdrawal - Dermatological Neurological Exam; ECG
Description
Dermatological Exam
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C0011627
Description
Date of dermatological exam
Data type
date
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0011627
- UMLS CUI [1,3]
- C0011008
Description
Dermatological Exam not done
Data type
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0011627
- UMLS CUI [1,3]
- C1272696
Description
Upon examination, were any abnormalities present?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0560169
- UMLS CUI [1,3]
- C1704258
Description
Was subject referred to dermatologist?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2585021
- UMLS CUI [1,2]
- C0259831
Description
Reason dermatologist was not consulted
Data type
text
Alias
- UMLS CUI [1,1]
- C0259831
- UMLS CUI [1,2]
- C0009818
- UMLS CUI [1,3]
- C2826287
Description
Date of consult
Data type
date
Alias
- UMLS CUI [1,1]
- C0259831
- UMLS CUI [1,2]
- C0009818
- UMLS CUI [1,3]
- C0011008
Description
What were the findings from consultation?
Data type
text
Alias
- UMLS CUI [1,1]
- C0259831
- UMLS CUI [1,2]
- C0009818
- UMLS CUI [1,3]
- C0243095
Description
Neurological Exam
Alias
- UMLS CUI-1
- C0027853
Description
Neurological Exam
Alias
- UMLS CUI-1
- C0027853
Description
Neurological Test
Data type
integer
Alias
- UMLS CUI [1,1]
- C0039593
- UMLS CUI [1,2]
- C0205494
Description
Neurological abnormalities
Data type
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C1704258
Description
(Only if Abnormal)
Data type
integer
Alias
- UMLS CUI [1]
- C0027853
- UMLS CUI [2]
- C0518690
- UMLS CUI [3]
- C0205161
Description
Was the neurological examination consistent with the diagnosis of Parkinson's disease?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0030567
- UMLS CUI [1,3]
- C0332290
Description
12 Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
Description
Was ECG Performed?
Data type
boolean
Alias
- UMLS CUI [1]
- C0430456
Description
Date and time of ECG
Data type
datetime
Alias
- UMLS CUI [1]
- C2826846
Description
Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
PR Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Duration
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0429025
Description
Uncorrected QT Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C1287082
Description
Method of QTc Calculation
Data type
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Description
Record the RR interval that precedes the measured QT interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1,1]
- C0489636
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0855331
Description
RR interval not available
Data type
integer
Alias
- UMLS CUI [1,1]
- C0489636
- UMLS CUI [1,2]
- C0470187
Description
QTcB (Bazett)
Data type
integer
Alias
- UMLS CUI [1]
- C1882512
Description
QTcB (Bazett) finding
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1,1]
- C1882512
- UMLS CUI [1,2]
- C0243095
Description
QTcF (Fridericia)
Data type
integer
Alias
- UMLS CUI [1]
- C1882513
Description
QTcF (Fridericia) finding
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1,1]
- C1882513
- UMLS CUI [1,2]
- C0243095
Description
QTc Interval, other method of correction
Data type
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
- UMLS CUI [1,3]
- C0205394
Description
Is this a repeat ECG?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Description
Specify reason ECG repeated
Data type
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0392360
Description
Specify other reason ECG repeated
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0392360
- UMLS CUI [1,4]
- C0205394
Description
Result of the ECG
Data type
integer
Alias
- UMLS CUI [1]
- C0438154
Description
Rhythm
Data type
integer
Alias
- UMLS CUI [1]
- C0232187
Description
Specify other rhythm
Data type
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
P-Wave Morphology
Data type
integer
Alias
- UMLS CUI [1]
- C2216025
Description
Specify other ther P-Wave Morphology
Data type
text
Alias
- UMLS CUI [1,1]
- C2216025
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Conduction
Data type
integer
Alias
- UMLS CUI [1]
- C0232217
Description
Specify other conduction
Data type
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Myocardial Infarction
Data type
integer
Alias
- UMLS CUI [1]
- C0027051
Description
Specify other myocardial infarction
Data type
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Depolarisation/Repolarisation (QRS-T)
Data type
integer
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C0948857
Description
Enter Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Other ECG abnormalities
Data type
integer
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
Description
Specify other ECG abnormalities
Data type
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Similar models
Visit Maintenance 2; Early Withdrawal - Dermatological Neurological Exam; ECG
C0011627 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0011627 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0560169 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0259831 (UMLS CUI [1,2])
C0009818 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,3])
C0009818 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0009818 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C0205494 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2])
C0205161 (UMLS CUI [3])
C0030567 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,3])
C2911685 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,3])
C0470187 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0948857 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])