ID
39013
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 (2)
- 20/11/2019 20/11/2019 -
- 09/01/2020 09/01/2020 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
20 novembre 2019
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
Screening - Consent Demographics; Central Laboratory; Dermatological Neurological Exam; ECG
Description
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Description
Subject ID
Type de données
text
Alias
- UMLS CUI [1]
- C2348585
Description
Visit date
Type de données
date
Alias
- UMLS CUI [1]
- C1320303
Description
Date of Informed Consent
Type de données
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0011008
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of Birth
Type de données
date
Alias
- UMLS CUI [1]
- C0421451
Description
(mark one)
Type de données
text
Alias
- UMLS CUI [1]
- C0079399
Description
Final menses - Complete Date Unknown
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0425932
- UMLS CUI [1,2]
- C0439673
Description
Date of final menses
Type de données
date
Alias
- UMLS CUI [1]
- C0425932
Description
Became sterile - Complete Date Unknown
Type de données
text
Alias
- UMLS CUI [1,1]
- C0021359
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0439673
Description
Date became sterile
Type de données
date
Alias
- UMLS CUI [1,1]
- C0021359
- UMLS CUI [1,2]
- C0011008
Description
Method of contraception
Type de données
integer
Alias
- UMLS CUI [1]
- C0700589
Description
(mark one)
Type de données
integer
Alias
- UMLS CUI [1]
- C0015031
Description
(check all that apply)
Type de données
integer
Alias
- UMLS CUI [1]
- C3841890
Description
Central Laboratory
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0745590
- UMLS CUI-3
- C1705822
Description
Laboratory Test
Type de données
integer
Alias
- UMLS CUI [1]
- C0022885
Description
Sample collection date
Type de données
date
Alias
- UMLS CUI [1]
- C1302413
Description
Sample collection time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0005834
Description
Laboratory Test not done
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1272696
Description
Central Laboratory - Possible Liver Events
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C0877248
- UMLS CUI-4
- C0332149
Description
Dermatological Exam
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C0011627
Description
Date of dermatological exam
Type de données
date
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0011627
- UMLS CUI [1,3]
- C0011008
Description
Dermatological Exam not done
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0011627
- UMLS CUI [1,3]
- C1272696
Description
Upon examination, were any abnormalities present?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0560169
- UMLS CUI [1,3]
- C1704258
Description
Was subject referred to dermatologist?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2585021
- UMLS CUI [1,2]
- C0259831
Description
Reason dermatologist was not consulted
Type de données
text
Alias
- UMLS CUI [1,1]
- C0259831
- UMLS CUI [1,2]
- C0009818
- UMLS CUI [1,3]
- C2826287
Description
Date of consult
Type de données
date
Alias
- UMLS CUI [1,1]
- C0259831
- UMLS CUI [1,2]
- C0009818
- UMLS CUI [1,3]
- C0011008
Description
What were the findings from consultation?
Type de données
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
Type de données
text
Alias
- UMLS CUI [1,1]
- C0039593
- UMLS CUI [1,2]
- C0205494
Description
Neurological abnormalities
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C1704258
Description
(Only if Abnormal)
Type de données
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?
Type de données
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?
Type de données
boolean
Alias
- UMLS CUI [1]
- C0430456
Description
Date and time of ECG
Type de données
datetime
Alias
- UMLS CUI [1]
- C2826846
Description
Heart rate
Type de données
integer
Unités de mesure
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
PR Interval
Type de données
integer
Unités de mesure
- ms
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Duration
Type de données
integer
Unités de mesure
- ms
Alias
- UMLS CUI [1]
- C0429025
Description
Uncorrected QT Interval
Type de données
integer
Unités de mesure
- ms
Alias
- UMLS CUI [1]
- C1287082
Description
Method of QTc Calculation
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Description
Record the RR interval that precedes the measured QT interval
Type de données
integer
Unités de mesure
- ms
Alias
- UMLS CUI [1,1]
- C0489636
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0855331
Description
RR interval not available
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0489636
- UMLS CUI [1,2]
- C0470187
Description
QTcB (Bazett)
Type de données
integer
Alias
- UMLS CUI [1]
- C1882512
Description
QTcB (Bazett) finding
Type de données
integer
Unités de mesure
- ms
Alias
- UMLS CUI [1,1]
- C1882512
- UMLS CUI [1,2]
- C0243095
Description
QTcF (Fridericia)
Type de données
integer
Alias
- UMLS CUI [1]
- C1882513
Description
QTcF (Fridericia) finding
Type de données
integer
Unités de mesure
- ms
Alias
- UMLS CUI [1,1]
- C1882513
- UMLS CUI [1,2]
- C0243095
Description
QTc Interval, other method of correction
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
- UMLS CUI [1,3]
- C0205394
Description
Is this a repeat ECG?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Description
Specify reason ECG repeated
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0392360
Description
Specify other reason ECG repeated
Type de données
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
Type de données
integer
Alias
- UMLS CUI [1]
- C0438154
Description
Rhythm
Type de données
integer
Alias
- UMLS CUI [1]
- C0232187
Description
Specify other rhythm
Type de données
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
P-Wave Morphology
Type de données
integer
Alias
- UMLS CUI [1]
- C2216025
Description
Specify other ther P-Wave Morphology
Type de données
text
Alias
- UMLS CUI [1,1]
- C2216025
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Conduction
Type de données
integer
Alias
- UMLS CUI [1]
- C0232217
Description
Specify other conduction
Type de données
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Myocardial Infarction
Type de données
integer
Alias
- UMLS CUI [1]
- C0027051
Description
Specify other myocardial infarction
Type de données
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Depolarisation/Repolarisation (QRS-T)
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C0948857
Description
Enter Comment
Type de données
text
Alias
- UMLS CUI [1]
- C0947611
Description
Other ECG abnormalities
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
Description
Specify other ECG abnormalities
Type de données
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Similar models
Screening - Consent Demographics; Central Laboratory; Dermatological Neurological Exam; ECG
C0011008 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0745590 (UMLS CUI-2)
C1705822 (UMLS CUI-3)
C0005834 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C0023884 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0332149 (UMLS CUI-4)
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
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])
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])