ID

25784

Description

Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

Keywords

Versions (1)
  1. 9/19/17 9/19/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 19, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

screening prior and concomitant medication Ropinirole CR Ropinirole IR Monotherapy 101468/168

English

screening prior and concomitant medication Ropinirole CR Ropinirole IR Monotherapy 101468/168

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
PRIOR PARKINSON’S MEDICATION
Description

PRIOR PARKINSON’S MEDICATION

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C0030567
Has the subject taken any prior Parkinson’s medication within 30 days prior to the study?
Description

If Yes, record below.

Data type

text

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C0030567
PRIOR PARKINSON’S MEDICATION
Description

PRIOR PARKINSON’S MEDICATION

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C0030567
Drug Name
Description

Trade Name preferred

Data type

text

Alias
UMLS CUI [1]
C2360065
Total Daily Dose
Description

total daily dose

Data type

integer

Alias
UMLS CUI [1]
C2348070
Units
Description

TAB = Tablet MCL = Microlitre ML = Millilitre L = Litre MCG = Microgram MG = Milligram G = Gram

Data type

text

Alias
UMLS CUI [1]
C1519795
Route
Description

IM = Intramuscular IH = Inhalation IV = Intravenous NS = Nasal TP = Topical PO = Oral VG = Vaginal

Data type

text

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Description

indication

Data type

text

Alias
UMLS CUI [1]
C3146298
Start Date
Description

start date

Data type

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Description

stop date

Data type

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Description

medication ongoing

Data type

text

Alias
UMLS CUI [1]
C2826666
PRIOR OR CONCOMITANT MEDICATIONS
Description

PRIOR OR CONCOMITANT MEDICATIONS

Alias
UMLS CUI-1
C2826257
UMLS CUI-3
C2347852
Were any concomitant medications taken by the subject within 30 days prior to the study (excluding parkinson’s medications)?
Description

If Yes, record below.

Data type

text

Alias
UMLS CUI [1]
C2347852
PRIOR OR CONCOMITANT MEDICATIONS
Description

PRIOR OR CONCOMITANT MEDICATIONS

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C2347852
Drug Name
Description

Trade Name preferred

Data type

text

Alias
UMLS CUI [1]
C2360065
Total Daily Dose
Description

total daily dose

Data type

integer

Alias
UMLS CUI [1]
C2348070
Units
Description

TAB = Tablet MCL = Microlitre ML = Millilitre L = Litre MCG = Microgram MG = Milligram G = Gram

Data type

text

Alias
UMLS CUI [1]
C1519795
Route
Description

IM = Intramuscular IH = Inhalation IV = Intravenous NS = Nasal TP = Topical PO = Oral VG = Vaginal

Data type

text

Alias
UMLS CUI [1]
C0013153
Reason for Medication
Description

indication

Data type

text

Alias
UMLS CUI [1]
C3146298
Start Date
Description

start date

Data type

date

Alias
UMLS CUI [1]
C0808070
Stop Date
Description

stop date

Data type

date

Alias
UMLS CUI [1]
C0806020
Ongoing Medication?
Description

medication ongoing

Data type

text

Alias
UMLS CUI [1]
C2826666
Back to the top of the page

Similar models

screening prior and concomitant medication Ropinirole CR Ropinirole IR Monotherapy 101468/168

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
PRIOR PARKINSON’S MEDICATION
C2826257 (UMLS CUI-1)
C0030567 (UMLS CUI-2)
Item
Has the subject taken any prior Parkinson’s medication within 30 days prior to the study?
text
C2826257 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
prior medication due to Parkinson's disease
Code List
Has the subject taken any prior Parkinson’s medication within 30 days prior to the study?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
PRIOR PARKINSON’S MEDICATION
C2826257 (UMLS CUI-1)
C0030567 (UMLS CUI-2)
medication name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
total daily dose
Item
Total Daily Dose
integer
C2348070 (UMLS CUI [1])
units
Item
Units
text
C1519795 (UMLS CUI [1])
route
Item
Route
text
C0013153 (UMLS CUI [1])
indication
Item
Reason for Medication
text
C3146298 (UMLS CUI [1])
start date
Item
Start Date
date
C0808070 (UMLS CUI [1])
stop date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1])
medication ongoing
Code List
Ongoing Medication?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
PRIOR OR CONCOMITANT MEDICATIONS
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-3)
Item
Were any concomitant medications taken by the subject within 30 days prior to the study (excluding parkinson’s medications)?
text
C2347852 (UMLS CUI [1])
concomitant medication
Code List
Were any concomitant medications taken by the subject within 30 days prior to the study (excluding parkinson’s medications)?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
PRIOR OR CONCOMITANT MEDICATIONS
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
medication name
Item
Drug Name
text
C2360065 (UMLS CUI [1])
total daily dose
Item
Total Daily Dose
integer
C2348070 (UMLS CUI [1])
units
Item
Units
text
C1519795 (UMLS CUI [1])
route
Item
Route
text
C0013153 (UMLS CUI [1])
indication
Item
Reason for Medication
text
C3146298 (UMLS CUI [1])
start date
Item
Start Date
date
C0808070 (UMLS CUI [1])
stop date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1])
medication ongoing
Code List
Ongoing Medication?
CL Item
Yes (Y)
CL Item
No (N)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial