ID
39013
Beschrijving
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
Trefwoorden
Versies (2)
- 20-11-19 20-11-19 -
- 09-01-20 09-01-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
20 november 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
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
Beschrijving
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Beschrijving
Demography
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Date of Birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
(mark one)
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Final menses - Complete Date Unknown
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0425932
- UMLS CUI [1,2]
- C0439673
Beschrijving
Date of final menses
Datatype
date
Alias
- UMLS CUI [1]
- C0425932
Beschrijving
Became sterile - Complete Date Unknown
Datatype
text
Alias
- UMLS CUI [1,1]
- C0021359
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0439673
Beschrijving
Date became sterile
Datatype
date
Alias
- UMLS CUI [1,1]
- C0021359
- UMLS CUI [1,2]
- C0011008
Beschrijving
Method of contraception
Datatype
integer
Alias
- UMLS CUI [1]
- C0700589
Beschrijving
(mark one)
Datatype
integer
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
(check all that apply)
Datatype
integer
Alias
- UMLS CUI [1]
- C3841890
Beschrijving
Central Laboratory
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0745590
- UMLS CUI-3
- C1705822
Beschrijving
Laboratory Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0022885
Beschrijving
Sample collection date
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Sample collection time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0005834
Beschrijving
Laboratory Test not done
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C1272696
Beschrijving
Central Laboratory - Possible Liver Events
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0023884
- UMLS CUI-3
- C0877248
- UMLS CUI-4
- C0332149
Beschrijving
Dermatological Exam
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C0011627
Beschrijving
Date of dermatological exam
Datatype
date
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0011627
- UMLS CUI [1,3]
- C0011008
Beschrijving
Dermatological Exam not done
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0011627
- UMLS CUI [1,3]
- C1272696
Beschrijving
Upon examination, were any abnormalities present?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0560169
- UMLS CUI [1,3]
- C1704258
Beschrijving
Was subject referred to dermatologist?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2585021
- UMLS CUI [1,2]
- C0259831
Beschrijving
Reason dermatologist was not consulted
Datatype
text
Alias
- UMLS CUI [1,1]
- C0259831
- UMLS CUI [1,2]
- C0009818
- UMLS CUI [1,3]
- C2826287
Beschrijving
Date of consult
Datatype
date
Alias
- UMLS CUI [1,1]
- C0259831
- UMLS CUI [1,2]
- C0009818
- UMLS CUI [1,3]
- C0011008
Beschrijving
What were the findings from consultation?
Datatype
text
Alias
- UMLS CUI [1,1]
- C0259831
- UMLS CUI [1,2]
- C0009818
- UMLS CUI [1,3]
- C0243095
Beschrijving
Neurological Exam
Alias
- UMLS CUI-1
- C0027853
Beschrijving
Neurological Exam
Alias
- UMLS CUI-1
- C0027853
Beschrijving
Neurological Test
Datatype
text
Alias
- UMLS CUI [1,1]
- C0039593
- UMLS CUI [1,2]
- C0205494
Beschrijving
Neurological abnormalities
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C1704258
Beschrijving
(Only if Abnormal)
Datatype
integer
Alias
- UMLS CUI [1]
- C0027853
- UMLS CUI [2]
- C0518690
- UMLS CUI [3]
- C0205161
Beschrijving
Was the neurological examination consistent with the diagnosis of Parkinson's disease?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0030567
- UMLS CUI [1,3]
- C0332290
Beschrijving
12 Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Was ECG Performed?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0430456
Beschrijving
Date and time of ECG
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826846
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
Method of QTc Calculation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschrijving
Record the RR interval that precedes the measured QT interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1,1]
- C0489636
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0855331
Beschrijving
RR interval not available
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0489636
- UMLS CUI [1,2]
- C0470187
Beschrijving
QTcB (Bazett)
Datatype
integer
Alias
- UMLS CUI [1]
- C1882512
Beschrijving
QTcB (Bazett) finding
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1,1]
- C1882512
- UMLS CUI [1,2]
- C0243095
Beschrijving
QTcF (Fridericia)
Datatype
integer
Alias
- UMLS CUI [1]
- C1882513
Beschrijving
QTcF (Fridericia) finding
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1,1]
- C1882513
- UMLS CUI [1,2]
- C0243095
Beschrijving
QTc Interval, other method of correction
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
- UMLS CUI [1,3]
- C0205394
Beschrijving
Is this a repeat ECG?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Beschrijving
Specify reason ECG repeated
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0392360
Beschrijving
Specify other reason ECG repeated
Datatype
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0392360
- UMLS CUI [1,4]
- C0205394
Beschrijving
Result of the ECG
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
Rhythm
Datatype
integer
Alias
- UMLS CUI [1]
- C0232187
Beschrijving
Specify other rhythm
Datatype
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
P-Wave Morphology
Datatype
integer
Alias
- UMLS CUI [1]
- C2216025
Beschrijving
Specify other ther P-Wave Morphology
Datatype
text
Alias
- UMLS CUI [1,1]
- C2216025
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Conduction
Datatype
integer
Alias
- UMLS CUI [1]
- C0232217
Beschrijving
Specify other conduction
Datatype
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Myocardial Infarction
Datatype
integer
Alias
- UMLS CUI [1]
- C0027051
Beschrijving
Specify other myocardial infarction
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Depolarisation/Repolarisation (QRS-T)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C0948857
Beschrijving
Enter Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Other ECG abnormalities
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
Beschrijving
Specify other ECG abnormalities
Datatype
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])