ID
39240
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 (2)
- 2019-12-11 2019-12-11 -
- 2020-01-09 2020-01-09 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
11 december 2019
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
Visit Maintenance 2; Early Withdrawal - Dermatological Neurological Exam; ECG
Beskrivning
Dermatological Exam
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C0011627
Beskrivning
Date of dermatological exam
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0011627
- UMLS CUI [1,3]
- C0011008
Beskrivning
Dermatological Exam not done
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0011627
- UMLS CUI [1,3]
- C1272696
Beskrivning
Upon examination, were any abnormalities present?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0560169
- UMLS CUI [1,3]
- C1704258
Beskrivning
Was subject referred to dermatologist?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2585021
- UMLS CUI [1,2]
- C0259831
Beskrivning
Reason dermatologist was not consulted
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0259831
- UMLS CUI [1,2]
- C0009818
- UMLS CUI [1,3]
- C2826287
Beskrivning
Date of consult
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0259831
- UMLS CUI [1,2]
- C0009818
- UMLS CUI [1,3]
- C0011008
Beskrivning
What were the findings from consultation?
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0259831
- UMLS CUI [1,2]
- C0009818
- UMLS CUI [1,3]
- C0243095
Beskrivning
Neurological Exam
Alias
- UMLS CUI-1
- C0027853
Beskrivning
Neurological Exam
Alias
- UMLS CUI-1
- C0027853
Beskrivning
Neurological Test
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0039593
- UMLS CUI [1,2]
- C0205494
Beskrivning
Neurological abnormalities
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C1704258
Beskrivning
(Only if Abnormal)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0027853
- UMLS CUI [2]
- C0518690
- UMLS CUI [3]
- C0205161
Beskrivning
Was the neurological examination consistent with the diagnosis of Parkinson's disease?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0030567
- UMLS CUI [1,3]
- C0332290
Beskrivning
12 Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
Beskrivning
Was ECG Performed?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0430456
Beskrivning
Date and time of ECG
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826846
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
PR Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0429087
Beskrivning
QRS Duration
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0429025
Beskrivning
Uncorrected QT Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C1287082
Beskrivning
Method of QTc Calculation
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beskrivning
Record the RR interval that precedes the measured QT interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1,1]
- C0489636
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0855331
Beskrivning
RR interval not available
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0489636
- UMLS CUI [1,2]
- C0470187
Beskrivning
QTcB (Bazett)
Datatyp
integer
Alias
- UMLS CUI [1]
- C1882512
Beskrivning
QTcB (Bazett) finding
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1,1]
- C1882512
- UMLS CUI [1,2]
- C0243095
Beskrivning
QTcF (Fridericia)
Datatyp
integer
Alias
- UMLS CUI [1]
- C1882513
Beskrivning
QTcF (Fridericia) finding
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1,1]
- C1882513
- UMLS CUI [1,2]
- C0243095
Beskrivning
QTc Interval, other method of correction
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
- UMLS CUI [1,3]
- C0205394
Beskrivning
Is this a repeat ECG?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Beskrivning
Specify reason ECG repeated
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0392360
Beskrivning
Specify other reason ECG repeated
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0392360
- UMLS CUI [1,4]
- C0205394
Beskrivning
Result of the ECG
Datatyp
integer
Alias
- UMLS CUI [1]
- C0438154
Beskrivning
Rhythm
Datatyp
integer
Alias
- UMLS CUI [1]
- C0232187
Beskrivning
Specify other rhythm
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
P-Wave Morphology
Datatyp
integer
Alias
- UMLS CUI [1]
- C2216025
Beskrivning
Specify other ther P-Wave Morphology
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2216025
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Conduction
Datatyp
integer
Alias
- UMLS CUI [1]
- C0232217
Beskrivning
Specify other conduction
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Myocardial Infarction
Datatyp
integer
Alias
- UMLS CUI [1]
- C0027051
Beskrivning
Specify other myocardial infarction
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Depolarisation/Repolarisation (QRS-T)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C0948857
Beskrivning
Enter Comment
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Other ECG abnormalities
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
Beskrivning
Specify other ECG abnormalities
Datatyp
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])