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
Keywords
Versions (3)
- 8/23/17 8/23/17 -
- 8/23/17 8/23/17 -
- 9/4/17 9/4/17 -
Uploaded on
August 23, 2017
DOI
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License
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.
Data type
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.
Data type
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.
Data type
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.
Data type
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.
Data type
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.
Data type
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.
Data type
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.
Data type
text
Alias
- UMLS CUI [1]
- C1710066
Description
24-hour clock
Data type
datetime
Alias
- UMLS CUI [1]
- C2697888
- UMLS CUI [2]
- C2697889
Description
if ongoing, please leave blank 24-hour clock
Data type
datetime
Alias
- UMLS CUI [1]
- C2697886
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C1522314
Description
intensity of adverse event
Data type
integer
Alias
- UMLS CUI [1]
- C1710066
Description
relationship to drug
Data type
integer
Alias
- UMLS CUI [1]
- C0277579
Description
change of medication
Data type
integer
Alias
- UMLS CUI [1]
- C0580105
Description
If "Yes", record on Concomitant Medication form.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Description
If intermittent, record number of episodes.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Description
outcome of adverse event
Data type
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])