ID
39013
Beschreibung
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
Stichworte
Versionen (2)
- 20.11.19 20.11.19 -
- 09.01.20 09.01.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
20. November 2019
DOI
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Lizenz
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
Beschreibung
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Beschreibung
Demography
Alias
- UMLS CUI-1
- C0011298
Beschreibung
Date of Birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
(mark one)
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Final menses - Complete Date Unknown
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0425932
- UMLS CUI [1,2]
- C0439673
Beschreibung
Date of final menses
Datentyp
date
Alias
- UMLS CUI [1]
- C0425932
Beschreibung
Became sterile - Complete Date Unknown
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0021359
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0439673
Beschreibung
Date became sterile
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0021359
- UMLS CUI [1,2]
- C0011008
Beschreibung
Method of contraception
Datentyp
integer
Alias
- UMLS CUI [1]
- C0700589
Beschreibung
(mark one)
Datentyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
(check all that apply)
Datentyp
integer
Alias
- UMLS CUI [1]
- C3841890
Beschreibung
Central Laboratory
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0745590
- UMLS CUI-3
- C1705822
Beschreibung
Laboratory Test
Datentyp
integer
Alias
- UMLS CUI [1]
- C0022885
Beschreibung
Sample collection date
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
Sample collection time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0005834
Beschreibung
Laboratory Test not done
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1272696
Beschreibung
Central Laboratory - Possible Liver Events
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C0877248
- UMLS CUI-4
- C0332149
Beschreibung
Dermatological Exam
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C0011627
Beschreibung
Date of dermatological exam
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0011627
- UMLS CUI [1,3]
- C0011008
Beschreibung
Dermatological Exam not done
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0011627
- UMLS CUI [1,3]
- C1272696
Beschreibung
Upon examination, were any abnormalities present?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0560169
- UMLS CUI [1,3]
- C1704258
Beschreibung
Was subject referred to dermatologist?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2585021
- UMLS CUI [1,2]
- C0259831
Beschreibung
Reason dermatologist was not consulted
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0259831
- UMLS CUI [1,2]
- C0009818
- UMLS CUI [1,3]
- C2826287
Beschreibung
Date of consult
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0259831
- UMLS CUI [1,2]
- C0009818
- UMLS CUI [1,3]
- C0011008
Beschreibung
What were the findings from consultation?
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0259831
- UMLS CUI [1,2]
- C0009818
- UMLS CUI [1,3]
- C0243095
Beschreibung
Neurological Exam
Alias
- UMLS CUI-1
- C0027853
Beschreibung
Neurological Exam
Alias
- UMLS CUI-1
- C0027853
Beschreibung
Neurological Test
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0039593
- UMLS CUI [1,2]
- C0205494
Beschreibung
Neurological abnormalities
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C1704258
Beschreibung
(Only if Abnormal)
Datentyp
integer
Alias
- UMLS CUI [1]
- C0027853
- UMLS CUI [2]
- C0518690
- UMLS CUI [3]
- C0205161
Beschreibung
Was the neurological examination consistent with the diagnosis of Parkinson's disease?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0030567
- UMLS CUI [1,3]
- C0332290
Beschreibung
12 Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
Beschreibung
Was ECG Performed?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0430456
Beschreibung
Date and time of ECG
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2826846
Beschreibung
Heart rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
PR Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschreibung
QRS Duration
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0429025
Beschreibung
Uncorrected QT Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschreibung
Method of QTc Calculation
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschreibung
Record the RR interval that precedes the measured QT interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1,1]
- C0489636
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0855331
Beschreibung
RR interval not available
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0489636
- UMLS CUI [1,2]
- C0470187
Beschreibung
QTcB (Bazett)
Datentyp
integer
Alias
- UMLS CUI [1]
- C1882512
Beschreibung
QTcB (Bazett) finding
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1,1]
- C1882512
- UMLS CUI [1,2]
- C0243095
Beschreibung
QTcF (Fridericia)
Datentyp
integer
Alias
- UMLS CUI [1]
- C1882513
Beschreibung
QTcF (Fridericia) finding
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1,1]
- C1882513
- UMLS CUI [1,2]
- C0243095
Beschreibung
QTc Interval, other method of correction
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
- UMLS CUI [1,3]
- C0205394
Beschreibung
Is this a repeat ECG?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Beschreibung
Specify reason ECG repeated
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0392360
Beschreibung
Specify other reason ECG repeated
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0392360
- UMLS CUI [1,4]
- C0205394
Beschreibung
Result of the ECG
Datentyp
integer
Alias
- UMLS CUI [1]
- C0438154
Beschreibung
Rhythm
Datentyp
integer
Alias
- UMLS CUI [1]
- C0232187
Beschreibung
Specify other rhythm
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
P-Wave Morphology
Datentyp
integer
Alias
- UMLS CUI [1]
- C2216025
Beschreibung
Specify other ther P-Wave Morphology
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2216025
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
Conduction
Datentyp
integer
Alias
- UMLS CUI [1]
- C0232217
Beschreibung
Specify other conduction
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
Myocardial Infarction
Datentyp
integer
Alias
- UMLS CUI [1]
- C0027051
Beschreibung
Specify other myocardial infarction
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
Depolarisation/Repolarisation (QRS-T)
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C0948857
Beschreibung
Enter Comment
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Other ECG abnormalities
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
Beschreibung
Specify other ECG abnormalities
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Ähnliche Modelle
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])