ID

24783

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. 8/17/17 8/17/17 -
  2. 9/4/17 9/4/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 17, 2017

DOI

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License

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

English

prior medication 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
PRIOR MEDICATIONS FOR TREATMENT OF PARKINSON'S DISEASE
Description

PRIOR MEDICATIONS FOR TREATMENT OF PARKINSON'S DISEASE

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C0030567
MEDICATION
Description

medication

Data type

integer

Alias
UMLS CUI [1]
C0013227
MEDICATION
Description

If not "none" above, specify. Use Generic Name.

Data type

text

Alias
UMLS CUI [1]
C0013227
DATE STARTED
Description

start date of medication

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
DATE STOPPED
Description

stop date of medication

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
DATE STOPPED
Description

If not "continued" above, record the date.

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
TOTAL DAILY DOSE
Description

total daily dose of medication

Data type

integer

Alias
UMLS CUI [1]
C2348070
ROUTE
Description

If "other", specify.

Data type

text

Alias
UMLS CUI [1]
C0013153
INDICATION
Description

indication for medication

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
PRIOR MEDICATIONS - NON-PARKINSON'S DISEASE
Description

PRIOR MEDICATIONS - NON-PARKINSON'S DISEASE

Alias
UMLS CUI-1
C2826257
MEDICATION
Description

medication

Data type

integer

Alias
UMLS CUI [1]
C0013227
MEDICATION
Description

If not "none" above, specify. Use Generic Name.

Data type

text

Alias
UMLS CUI [1]
C0013227
DATE STARTED
Description

start date of medication

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
DATE STOPPED
Description

stop date of medication

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
DATE STOPPED
Description

If not "continued" above, record the date.

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
TOTAL DAILY DOSE
Description

total daily dose of medication

Data type

integer

Alias
UMLS CUI [1]
C2348070
ROUTE
Description

If "other", specify.

Data type

text

Alias
UMLS CUI [1]
C0013153
INDICATION
Description

indication for medication

Data type

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
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Similar models

prior medication 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])
Item Group
PRIOR MEDICATIONS FOR TREATMENT OF PARKINSON'S DISEASE
C2826257 (UMLS CUI-1)
C0030567 (UMLS CUI-2)
Item
MEDICATION
integer
C0013227 (UMLS CUI [1])
medication
Code List
MEDICATION
CL Item
none (0)
CL Item
yes, specify (1)
medication
Item
MEDICATION
text
C0013227 (UMLS CUI [1])
start date of medication
Item
DATE STARTED
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
DATE STOPPED
text
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
stop date of medication
Code List
DATE STOPPED
CL Item
Continuing (Continuing)
CL Item
Not Continuing (Not Continuing)
stop date of medication
Item
DATE STOPPED
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
total daily dose of medication
Item
TOTAL DAILY DOSE
integer
C2348070 (UMLS CUI [1])
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
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
PRIOR MEDICATIONS - NON-PARKINSON'S DISEASE
C2826257 (UMLS CUI-1)
Item
MEDICATION
integer
C0013227 (UMLS CUI [1])
medication
Code List
MEDICATION
CL Item
none (0)
CL Item
yes, specify (1)
medication
Item
MEDICATION
text
C0013227 (UMLS CUI [1])
start date of medication
Item
DATE STARTED
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
DATE STOPPED
text
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
stop date of medication
Code List
DATE STOPPED
CL Item
Continuing (Continuing)
CL Item
Not Continuing (Not Continuing)
stop date of medication
Item
DATE STOPPED
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
total daily dose of medication
Item
TOTAL DAILY DOSE
integer
C2348070 (UMLS CUI [1])
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
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
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