ID
25460
Beschrijving
Study ID: 101468/166 Clinical Study ID: SKF-101468/166 Study Title: A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum well-tolerated starting dose of a new formulation of ropinirole in Parkinson's Disease patients not receiving other dopaminergic therapies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Parkinson Disease
Trefwoorden
Versies (3)
- 23-08-17 23-08-17 -
- 23-08-17 23-08-17 -
- 04-09-17 04-09-17 -
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4 september 2017
DOI
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Creative Commons BY-NC 3.0
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visit 2,3,4,5 & ongoing adverse events starting dose of ropinirole Parkinson's Disease 101468/166
visit 2,3,4,5 & ongoing adverse events starting dose of ropinirole Parkinson's Disease 101468/166
Beschrijving
1- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0439568
Beschrijving
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Datatype
integer
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
4- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0439568
Beschrijving
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Datatype
integer
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
12- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0439568
Beschrijving
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Datatype
integer
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
24- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0439568
Beschrijving
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Datatype
integer
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
QUERY FOR ADVERSE EVENTS Study Period Visit 3 (Day 4)
Alias
- UMLS CUI-1
- C0877248
Beschrijving
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Datatype
integer
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
QUERY FOR ADVERSE EVENTS Study Period Visit 4 (Day 8)
Alias
- UMLS CUI-1
- C0877248
Beschrijving
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Datatype
integer
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
QUERY FOR ADVERSE EVENTS Study Period Visit 5 (Day 14)
Alias
- UMLS CUI-1
- C0877248
Beschrijving
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Datatype
integer
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
ADVERSE EVENTS Study Period Ongoing
Alias
- UMLS CUI-1
- C0877248
Beschrijving
ADVERSE EVENT
Alias
- UMLS CUI-1
- C0877248
Beschrijving
If serious, set a tickmark in the field below. Otherwise leave it empty.
Datatype
text
Alias
- UMLS CUI [1]
- C1710066
Beschrijving
24-hour clock
Datatype
datetime
Alias
- UMLS CUI [1]
- C2697888
- UMLS CUI [2]
- C2697889
Beschrijving
if ongoing, please leave blank 24-hour clock
Datatype
datetime
Alias
- UMLS CUI [1]
- C2697886
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C1522314
Beschrijving
intensity of adverse event
Datatype
integer
Alias
- UMLS CUI [1]
- C1710066
Beschrijving
relationship to drug
Datatype
integer
Alias
- UMLS CUI [1]
- C0277579
Beschrijving
change of medication
Datatype
integer
Alias
- UMLS CUI [1]
- C0580105
Beschrijving
If "Yes", record on Concomitant Medication form.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschrijving
If intermittent, record number of episodes.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschrijving
outcome of adverse event
Datatype
integer
Alias
- UMLS CUI [1]
- C1705586
Similar models
visit 2,3,4,5 & ongoing adverse events starting dose of ropinirole Parkinson's Disease 101468/166
C0439568 (UMLS CUI-2)
C0439568 (UMLS CUI-2)
C0439568 (UMLS CUI-2)
C0439568 (UMLS CUI-2)
C2697889 (UMLS CUI [2])
C0877248 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C0087111 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])