ID
25460
Descrizione
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
Keywords
versioni (3)
- 23/08/17 23/08/17 -
- 23/08/17 23/08/17 -
- 04/09/17 04/09/17 -
Caricato su
4 settembre 2017
DOI
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Licenza
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
Descrizione
1- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0439568
Descrizione
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0877248
Descrizione
4- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0439568
Descrizione
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0877248
Descrizione
12- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0439568
Descrizione
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0877248
Descrizione
24- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS Study Period Visit 2 (Day 1)
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0439568
Descrizione
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0877248
Descrizione
QUERY FOR ADVERSE EVENTS Study Period Visit 3 (Day 4)
Alias
- UMLS CUI-1
- C0877248
Descrizione
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0877248
Descrizione
QUERY FOR ADVERSE EVENTS Study Period Visit 4 (Day 8)
Alias
- UMLS CUI-1
- C0877248
Descrizione
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0877248
Descrizione
QUERY FOR ADVERSE EVENTS Study Period Visit 5 (Day 14)
Alias
- UMLS CUI-1
- C0877248
Descrizione
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0877248
Descrizione
ADVERSE EVENTS Study Period Ongoing
Alias
- UMLS CUI-1
- C0877248
Descrizione
ADVERSE EVENT
Alias
- UMLS CUI-1
- C0877248
Descrizione
If serious, set a tickmark in the field below. Otherwise leave it empty.
Tipo di dati
text
Alias
- UMLS CUI [1]
- C1710066
Descrizione
24-hour clock
Tipo di dati
datetime
Alias
- UMLS CUI [1]
- C2697888
- UMLS CUI [2]
- C2697889
Descrizione
if ongoing, please leave blank 24-hour clock
Tipo di dati
datetime
Alias
- UMLS CUI [1]
- C2697886
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C1522314
Descrizione
intensity of adverse event
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C1710066
Descrizione
relationship to drug
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0277579
Descrizione
change of medication
Tipo di dati
integer
Alias
- UMLS CUI [1]
- C0580105
Descrizione
If "Yes", record on Concomitant Medication form.
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Descrizione
If intermittent, record number of episodes.
Tipo di dati
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Descrizione
outcome of adverse event
Tipo di dati
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])