ID
24978
Description
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
Mots-clés
Versions (3)
- 23/08/2017 23/08/2017 -
- 23/08/2017 23/08/2017 -
- 04/09/2017 04/09/2017 -
Téléchargé le
23 août 2017
DOI
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Licence
Creative Commons BY-NC 3.0 Legacy
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adverse events determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166
adverse events determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166
Description
1- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0439568
Description
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Type de données
integer
Alias
- UMLS CUI [1]
- C0877248
Description
4- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0439568
Description
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Type de données
integer
Alias
- UMLS CUI [1]
- C0877248
Description
12- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0439568
Description
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Type de données
integer
Alias
- UMLS CUI [1]
- C0877248
Description
24- HOUR POST-DOSE QUERY FOR ADVERSE EVENTS
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0439568
Description
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Type de données
integer
Alias
- UMLS CUI [1]
- C0877248
Description
QUERY FOR ADVERSE EVENTS
Alias
- UMLS CUI-1
- C0877248
Description
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Type de données
integer
Alias
- UMLS CUI [1]
- C0877248
Description
QUERY FOR ADVERSE EVENTS
Alias
- UMLS CUI-1
- C0877248
Description
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Type de données
integer
Alias
- UMLS CUI [1]
- C0877248
Description
QUERY FOR ADVERSE EVENTS
Alias
- UMLS CUI-1
- C0877248
Description
If YES, please record in the Adverse Events section below. Spontaneously reported or observed Adverse Events should be recorded in the Adverse Events section.
Type de données
integer
Alias
- UMLS CUI [1]
- C0877248
Description
ADVERSE EVENTS
Alias
- UMLS CUI-1
- C0877248
Description
ADVERSE EVENT
Alias
- UMLS CUI-1
- C0877248
Description
If serious, set a tickmark in the field below. Otherwise leave it empty.
Type de données
text
Alias
- UMLS CUI [1]
- C1710066
Description
24-hour clock
Type de données
datetime
Alias
- UMLS CUI [1]
- C2697888
- UMLS CUI [2]
- C2697889
Description
if ongoing, please leave blank 24-hour clock
Type de données
datetime
Alias
- UMLS CUI [1]
- C2697886
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C1522314
Description
intensity of adverse event
Type de données
integer
Alias
- UMLS CUI [1]
- C1710066
Description
relationship to drug
Type de données
integer
Alias
- UMLS CUI [1]
- C0277579
Description
change of medication
Type de données
integer
Alias
- UMLS CUI [1]
- C0580105
Description
If "Yes", record on Concomitant Medication form.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Description
If intermittent, record number of episodes.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Description
outcome of adverse event
Type de données
integer
Alias
- UMLS CUI [1]
- C1705586
Similar models
adverse events determination of the maximum well-tolerated starting dose of ropinirole in 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])