ID

27543

Description

Study Part: Diary Card. An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Keywords

Versions (1)
  1. 11/20/17 11/20/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 20, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Diary Card Ropinirole Parkinson Disease 101468/165

English

Diary Card

1 forms  
  1. StudyEvent: ODM
    1. Diary Card
DOSES
Description

DOSES

Alias
UMLS CUI-1
C0178602
DATE
Description

DATE

Data type

date

Alias
UMLS CUI [1]
C0011008
DOSING TIME
Description

DOSING TIME

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0178602
TOTAL ROPINIROLE DOSE
Description

dose ropinirole

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0244821
mg
NUMBER OF TABLETS
Description

NUMBER OF TABLETS

Data type

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0304229
TABLET STRENGTH
Description

TABLET STRENGTH

Data type

text

Measurement units
  • mg
Alias
UMLS CUI [1]
C1705922
mg
COMMENTS
Description

COMMENTS

Data type

text

Alias
UMLS CUI [1]
C0947611
ADVERSE EVENTS
Description

ADVERSE EVENTS

Alias
UMLS CUI-1
C0877248
Symptom
Description

Symptom

Data type

text

Alias
UMLS CUI [1]
C1457887
Start date & time
Description

Start date & time

Data type

datetime

Alias
UMLS CUI [1]
C3897500
Stop date & time
Description

date and time

Data type

datetime

Alias
UMLS CUI [1]
C3899266
CONMEDICATIONS
Description

CONMEDICATIONS

Alias
UMLS CUI-1
C2347852
Drug Name (Trade Name Preferred)
Description

Drug Name

Data type

text

Alias
UMLS CUI [1]
C2360065
SINGLE Dose/ Unit
Description

dose

Data type

text

Alias
UMLS CUI [1]
C3174092
Frequency of this Dose
Description

dose frequency

Data type

text

Alias
UMLS CUI [1]
C2826654
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Start Date/Time
Description

Start date and time

Data type

datetime

Alias
UMLS CUI [1]
C3897500
End Date/Time
Description

End date and time

Data type

datetime

Alias
UMLS CUI [1]
C3899266
Continuing at end of Study?
Description

Continuing at end of Study

Data type

boolean

Alias
UMLS CUI [1,1]
C1553904
UMLS CUI [1,2]
C2983670
Was this medication checked with the study doctor?
Description

study doctor

Data type

boolean

Alias
UMLS CUI [1]
C1710470
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Similar models

Diary Card

1 forms
  1. StudyEvent: ODM
    1. Diary Card
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
DOSES
C0178602 (UMLS CUI-1)
DATE
Item
DATE
date
C0011008 (UMLS CUI [1])
DOSING TIME
Item
DOSING TIME
time
C0040223 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
dose ropinirole
Item
TOTAL ROPINIROLE DOSE
float
C3174092 (UMLS CUI [1,1])
C0244821 (UMLS CUI [1,2])
NUMBER OF TABLETS
Item
NUMBER OF TABLETS
integer
C0805077 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
TABLET STRENGTH
Item
TABLET STRENGTH
text
C1705922 (UMLS CUI [1])
COMMENTS
Item
COMMENTS
text
C0947611 (UMLS CUI [1])
Item Group
ADVERSE EVENTS
C0877248 (UMLS CUI-1)
Symptom
Item
Symptom
text
C1457887 (UMLS CUI [1])
Start date & time
Item
Start date & time
datetime
C3897500 (UMLS CUI [1])
date and time
Item
Stop date & time
datetime
C3899266 (UMLS CUI [1])
Item Group
CONMEDICATIONS
C2347852 (UMLS CUI-1)
Drug Name
Item
Drug Name (Trade Name Preferred)
text
C2360065 (UMLS CUI [1])
dose
Item
SINGLE Dose/ Unit
text
C3174092 (UMLS CUI [1])
dose frequency
Item
Frequency of this Dose
text
C2826654 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Start date and time
Item
Start Date/Time
datetime
C3897500 (UMLS CUI [1])
End date and time
Item
End Date/Time
datetime
C3899266 (UMLS CUI [1])
Continuing at end of Study
Item
Continuing at end of Study?
boolean
C1553904 (UMLS CUI [1,1])
C2983670 (UMLS CUI [1,2])
study doctor
Item
Was this medication checked with the study doctor?
boolean
C1710470 (UMLS CUI [1])
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