ID

24980

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)
  1. 8/22/17 8/22/17 -
  2. 8/23/17 8/23/17 -
  3. 9/4/17 9/4/17 -
Uploaded on

August 23, 2017

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Creative Commons BY-NC 3.0
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nausea VAS determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

English

nausea VAS determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Initials
Description

patient's initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Patient No.
Description

patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Date of Visit
Description

date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Prior to morning dose Study Period Visit 2 (Day1)
Description

Prior to morning dose Study Period Visit 2 (Day1)

Alias
UMLS CUI-1
C0027497
UMLS CUI-2
C0439565
Time of completion
Description

time of documentation

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0920316
Mark a vertical line ( I) on the scale to indicate the degree of nausea that you are experiencing.
Description

Instead of markering a vertical line, write down a number here. 0= Normal 10= Severe nausea, about to vomit

Data type

integer

Alias
UMLS CUI [1]
C1319170
4-hrs post morning dose
Description

4-hrs post morning dose

Alias
UMLS CUI-1
C0027497
UMLS CUI-2
C0439568
Time of completion
Description

time of documentation

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0920316
Mark a vertical line ( I) on the scale to indicate the degree of nausea that you are experiencing.
Description

Instead of markering a vertical line, write down a number here. 0= Normal 10= Severe nausea, about to vomit

Data type

integer

Alias
UMLS CUI [1]
C1319170
6-hrs post morning dose
Description

6-hrs post morning dose

Alias
UMLS CUI-1
C0027497
UMLS CUI-2
C0439568
Time of completion
Description

time of documentation

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0920316
Mark a vertical line ( I) on the scale to indicate the degree of nausea that you are experiencing.
Description

Instead of markering a vertical line, write down a number here. 0= Normal 10= Severe nausea, about to vomit

Data type

integer

Alias
UMLS CUI [1]
C1319170
8-hrs post morning dose
Description

8-hrs post morning dose

Alias
UMLS CUI-1
C0027497
UMLS CUI-2
C0439568
Time of completion
Description

time of documentation

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0920316
Mark a vertical line ( I) on the scale to indicate the degree of nausea that you are experiencing.
Description

Instead of markering a vertical line, write down a number here. 0= Normal 10= Severe nausea, about to vomit

Data type

integer

Alias
UMLS CUI [1]
C1319170
10-hrs post morning dose
Description

10-hrs post morning dose

Alias
UMLS CUI-1
C0027497
UMLS CUI-2
C0439568
Time of completion
Description

time of documentation

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0920316
Mark a vertical line ( I) on the scale to indicate the degree of nausea that you are experiencing.
Description

Instead of markering a vertical line, write down a number here. 0= Normal 10= Severe nausea, about to vomit

Data type

integer

Alias
UMLS CUI [1]
C1319170
12-hrs post morning dose
Description

12-hrs post morning dose

Alias
UMLS CUI-1
C0027497
UMLS CUI-2
C0439568
Time of completion
Description

time of documentation

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0920316
Mark a vertical line ( I) on the scale to indicate the degree of nausea that you are experiencing.
Description

Instead of markering a vertical line, write down a number here. 0= Normal 10= Severe nausea, about to vomit

Data type

integer

Alias
UMLS CUI [1]
C1319170
24-hrs post morning dose
Description

24-hrs post morning dose

Alias
UMLS CUI-1
C0027497
UMLS CUI-2
C0439568
Time of completion
Description

time of documentation

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0920316
Mark a vertical line ( I) on the scale to indicate the degree of nausea that you are experiencing.
Description

Instead of markering a vertical line, write down a number here. 0= Normal 10= Severe nausea, about to vomit

Data type

integer

Alias
UMLS CUI [1]
C1319170
Prior to morning dose Study Period Visit 3 (Day 4)
Description

Prior to morning dose Study Period Visit 3 (Day 4)

Alias
UMLS CUI-1
C0027497
UMLS CUI-2
C0439565
Time of completion
Description

time of documentation

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0920316
Mark a vertical line ( I) on the scale to indicate the degree of nausea that you are experiencing.
Description

Instead of markering a vertical line, write down a number here. 0= Normal 10= Severe nausea, about to vomit

Data type

integer

Alias
UMLS CUI [1]
C1319170
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Similar models

nausea VAS determination of the maximum well-tolerated starting dose of ropinirole in Parkinson's Disease 101468/166

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
patient's initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
patient number
Item
Patient No.
integer
C1830427 (UMLS CUI [1])
date of visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Prior to morning dose Study Period Visit 2 (Day1)
C0027497 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
time of documentation
Item
Time of completion
time
C0040223 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
nausea and vomiting status
Item
Mark a vertical line ( I) on the scale to indicate the degree of nausea that you are experiencing.
integer
C1319170 (UMLS CUI [1])
Item Group
4-hrs post morning dose
C0027497 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of documentation
Item
Time of completion
time
C0040223 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
nausea and vomiting status
Item
Mark a vertical line ( I) on the scale to indicate the degree of nausea that you are experiencing.
integer
C1319170 (UMLS CUI [1])
Item Group
6-hrs post morning dose
C0027497 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of documentation
Item
Time of completion
time
C0040223 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
nausea and vomiting status
Item
Mark a vertical line ( I) on the scale to indicate the degree of nausea that you are experiencing.
integer
C1319170 (UMLS CUI [1])
Item Group
8-hrs post morning dose
C0027497 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of documentation
Item
Time of completion
time
C0040223 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
nausea and vomiting status
Item
Mark a vertical line ( I) on the scale to indicate the degree of nausea that you are experiencing.
integer
C1319170 (UMLS CUI [1])
Item Group
10-hrs post morning dose
C0027497 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of documentation
Item
Time of completion
time
C0040223 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
nausea and vomiting status
Item
Mark a vertical line ( I) on the scale to indicate the degree of nausea that you are experiencing.
integer
C1319170 (UMLS CUI [1])
Item Group
12-hrs post morning dose
C0027497 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of documentation
Item
Time of completion
time
C0040223 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
nausea and vomiting status
Item
Mark a vertical line ( I) on the scale to indicate the degree of nausea that you are experiencing.
integer
C1319170 (UMLS CUI [1])
Item Group
24-hrs post morning dose
C0027497 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
time of documentation
Item
Time of completion
time
C0040223 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
nausea and vomiting status
Item
Mark a vertical line ( I) on the scale to indicate the degree of nausea that you are experiencing.
integer
C1319170 (UMLS CUI [1])
Item Group
Prior to morning dose Study Period Visit 3 (Day 4)
C0027497 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
time of documentation
Item
Time of completion
time
C0040223 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
nausea and vomiting status
Item
Mark a vertical line ( I) on the scale to indicate the degree of nausea that you are experiencing.
integer
C1319170 (UMLS CUI [1])
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