ID
39420
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 (3)
- 03.12.19 03.12.19 -
- 06.12.19 06.12.19 -
- 09.01.20 09.01.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
9. Januar 2020
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease (NCT01494532)
Baseline - Consent; Central Laboratory; Diary; ECG
- StudyEvent: ODM
Beschreibung
Randomisation
Alias
- UMLS CUI-1
- C0034656
Beschreibung
Was the subject able to be randomised?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0034656
Beschreibung
Randomisation Number
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschreibung
Date of Randomisation
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0011008
Beschreibung
Electronically Transferred Lab Data
Alias
- UMLS CUI-1
- C0745590
- UMLS CUI-2
- 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
Possible Liver Events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0332149
Beschreibung
Diary - Target Day 1
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C1521840
- UMLS CUI-3
- C0439228
Beschreibung
Diary - Target Day 2
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C1521840
- UMLS CUI-3
- C0439228
Beschreibung
Target Day 2 - Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C0011008
Beschreibung
Target Day 2 - Time of awakening
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C1720052
- UMLS CUI [1,4]
- C0040223
Beschreibung
State you woke up in, following your overnight sleep
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C1720052
- UMLS CUI [1,4]
- C1442792
Beschreibung
Time you took your study medication
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [1,4]
- C0040223
Beschreibung
Diary Day 2
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C0439228
Beschreibung
Timepoint
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348792
Beschreibung
State
Datentyp
integer
Alias
- UMLS CUI [1]
- C1442792
Beschreibung
Troublesome dyskinesia
Datentyp
integer
Alias
- UMLS CUI [1]
- C0013384
Beschreibung
Target Day 3
Alias
- UMLS CUI-1
- C1521840
- UMLS CUI-2
- C0439228
Beschreibung
Target Day 3 - Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C0011008
Beschreibung
Target Day 3 - Time of awakening
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C1720052
- UMLS CUI [1,4]
- C0040223
Beschreibung
State you woke up in, following your overnight sleep
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C1720052
- UMLS CUI [1,4]
- C1442792
Beschreibung
Time you took your study medication
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1521840
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C0013227
- UMLS CUI [1,4]
- C0040223
Beschreibung
Diary Day 3
Alias
- UMLS CUI-1
- C3890583
- UMLS CUI-2
- C0439228
Beschreibung
Timepoint
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348792
Beschreibung
Troublesome dyskinesia
Datentyp
integer
Alias
- UMLS CUI [1]
- C0013384
Beschreibung
12 Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
Beschreibung
ECG Information
Alias
- UMLS CUI-1
- C1623258
- UMLS CUI-2
- C1533716
Beschreibung
ECG Sequence Number
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2348184
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
Baseline - Consent; Central Laboratory; Diary; ECG
- StudyEvent: ODM
C0237753 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1705822 (UMLS CUI-2)
C0005834 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C0877248 (UMLS CUI-2)
C0332149 (UMLS CUI-3)
C0877248 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
C0005834 (UMLS CUI [2])
C1521840 (UMLS CUI-2)
C0439228 (UMLS CUI-3)
C0439228 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1521840 (UMLS CUI-2)
C0439228 (UMLS CUI-3)
C0439228 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0439228 (UMLS CUI [1,2])
C1720052 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0439228 (UMLS CUI [1,2])
C1720052 (UMLS CUI [1,3])
C1442792 (UMLS CUI [1,4])
C0439228 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0439228 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0439228 (UMLS CUI [1,2])
C1720052 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0439228 (UMLS CUI [1,2])
C1720052 (UMLS CUI [1,3])
C1442792 (UMLS CUI [1,4])
C0439228 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C2348184 (UMLS CUI [1,2])
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])