ID

25467

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 (2)
  1. 8/24/17 8/24/17 -
  2. 9/4/17 9/4/17 -
Uploaded on

September 4, 2017

DOI

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License

Creative Commons BY-NC 3.0
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study period ongoing concomitant medication starting dose of ropinirole Parkinson's Disease 101468/166

English

study period ongoing concomitant medication starting dose of ropinirole 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
CONCOMITANT MEDICATIONS
Description

CONCOMITANT MEDICATIONS

Alias
UMLS CUI-1
C2347852
Has the patient taken any new and/or changed concomitant medications since taking the first dose of study drug?
Description

Record .fill concomitant medication(s) (other than study drug) taken by the patient since taking the first dose of study drug through Day 14.

Data type

integer

Alias
UMLS CUI [1]
C2347852
CONCOMITANT MEDICATIONS
Description

CONCOMITANT MEDICATIONS

Alias
UMLS CUI-1
C2347852
MEDICATION
Description

Use generic name.

Data type

text

Alias
UMLS CUI [1]
C2347852
DATE STARTED
Description

start date of concomitant medication

Data type

date

Alias
UMLS CUI [1]
C2826734
DATE STOPPED
Description

stop date of concomitant medication

Data type

text

Alias
UMLS CUI [1]
C2826744
DATE STOPPED
Description

If not "continued" above, record the date.

Data type

date

Alias
UMLS CUI [1]
C2826744
TOTAL DAILY DOSE
Description

total daily dose of concomitant medication

Data type

integer

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C2347852
ROUTE
Description

If "other", specify.

Data type

text

Alias
UMLS CUI [1]
C0013153
INDICATION
Description

indication for medication

Data type

text

Alias
UMLS CUI [1]
C2826696
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Similar models

study period ongoing concomitant medication starting dose of ropinirole 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])
Item Group
CONCOMITANT MEDICATIONS
C2347852 (UMLS CUI-1)
Item
Has the patient taken any new and/or changed concomitant medications since taking the first dose of study drug?
integer
C2347852 (UMLS CUI [1])
concomitant medication
Code List
Has the patient taken any new and/or changed concomitant medications since taking the first dose of study drug?
CL Item
Yes (1)
CL Item
No (2)
Item Group
CONCOMITANT MEDICATIONS
C2347852 (UMLS CUI-1)
concomitant medication
Item
MEDICATION
text
C2347852 (UMLS CUI [1])
start date of concomitant medication
Item
DATE STARTED
date
C2826734 (UMLS CUI [1])
Item
DATE STOPPED
text
C2826744 (UMLS CUI [1])
stop date of medication
Code List
DATE STOPPED
CL Item
Continuing (Continuing)
CL Item
Not Continuing (Not Continuing)
stop date of concomitant medication
Item
DATE STOPPED
date
C2826744 (UMLS CUI [1])
total daily dose of concomitant medication
Item
TOTAL DAILY DOSE
integer
C2348070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item
ROUTE
text
C0013153 (UMLS CUI [1])
route of medication administration
Code List
ROUTE
CL Item
IV (IV)
CL Item
PR (PR)
CL Item
IM (IM)
CL Item
Sublingual (Sublingual)
CL Item
PO (PO)
CL Item
Inhaled (Inhaled)
CL Item
SC (SC)
CL Item
Topical (Topical)
CL Item
Other, Specify (Other)
indication for medication
Item
INDICATION
text
C2826696 (UMLS CUI [1])
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