ID

25459

Beschreibung

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

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Versionen (3)
  1. 22.08.17 22.08.17 -
  2. 23.08.17 23.08.17 -
  3. 04.09.17 04.09.17 -
Hochgeladen am

4. September 2017

DOI

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visit 2 & 3 nausea VAS starting dose of ropinirole Parkinson's Disease 101468/166

Englisch

visit 2 & 3 nausea VAS starting dose of ropinirole Parkinson's Disease 101468/166

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Initials
Beschreibung

patient's initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Patient No.
Beschreibung

patient number

Datentyp

integer

Alias
UMLS CUI [1]
C1830427
Date of Visit
Beschreibung

date of visit

Datentyp

date

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

Prior to morning dose Study Period Visit 2 (Day1)

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

time of documentation

Datentyp

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.
Beschreibung

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

Datentyp

integer

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

4-hrs post morning dose

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

time of documentation

Datentyp

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.
Beschreibung

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

Datentyp

integer

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

6-hrs post morning dose

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

time of documentation

Datentyp

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.
Beschreibung

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

Datentyp

integer

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

8-hrs post morning dose

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

time of documentation

Datentyp

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.
Beschreibung

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

Datentyp

integer

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

10-hrs post morning dose

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

time of documentation

Datentyp

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.
Beschreibung

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

Datentyp

integer

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

12-hrs post morning dose

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

time of documentation

Datentyp

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.
Beschreibung

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

Datentyp

integer

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

24-hrs post morning dose

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

time of documentation

Datentyp

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.
Beschreibung

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

Datentyp

integer

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

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

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

time of documentation

Datentyp

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.
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1]
C1319170
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Ähnliche Modelle

visit 2 & 3 nausea VAS starting dose of ropinirole Parkinson's Disease 101468/166

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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