ID

39233

Beschrijving

Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo Study Indication: Parkinson's Disease

Trefwoorden

Versies (9)
  1. 10-12-19 10-12-19 -
  2. 11-12-19 11-12-19 -
  3. 11-12-19 11-12-19 -
  4. 11-12-19 11-12-19 -
  5. 11-12-19 11-12-19 -
  6. 11-12-19 11-12-19 -
  7. 11-12-19 11-12-19 -
  8. 16-12-19 16-12-19 -
  9. 09-01-20 09-01-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

11 december 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease

Engels

Visit 1; Visit 2; Visit 3; Visit 4; Visit 5; Visit 6; Visit 7; Visit 8; Maintenance 1 +2; Early Withdrawal; Follow up- Check In

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Study Name
Beschrijving

Study Name

Datatype

text

Alias
UMLS CUI [1]
C2348560
Subject ID
Beschrijving

Subject ID

Datatype

text

Alias
UMLS CUI [1]
C2348585
Study Site
Beschrijving

Study Site

Datatype

text

Alias
UMLS CUI [1]
C2825164
Check-In Review
Beschrijving

Check-In Review

Alias
UMLS CUI-1
C4321547
UMLS CUI-2
C0699752
Date of Visit
Beschrijving

Date of Visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Are there any changes in the concomitant medications, including non-drug therapies?
Beschrijving

Please ensure Concomitant Medication or Non-Drug Therapy record is added/updated as needed.

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0443172
UMLS CUI [2]
C0033082
Are there any changes in the medical history, including cardiovascular risk factors, medical conditions and smoking history?
Beschrijving

Please update the appropriate medical history.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0392747
UMLS CUI [2]
C0850624
UMLS CUI [3]
C0012634
UMLS CUI [4]
C1519384
Did the patient experience any adverse events since the last visit?
Beschrijving

Please ensure that an Adverse Event with a start date occurring between the previous and current visit dates is entered.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1711239
Did the patient complete the Sudden Onset of Sleep questionnaire?
Beschrijving

Please ensure SOOS questionnaire form is completed for this visit.

Datatype

boolean

Alias
UMLS CUI [1,1]
C1272517
UMLS CUI [1,2]
C0037313
UMLS CUI [1,3]
C0034394
UMLS CUI [1,4]
C0205197
Please provide a reason
Beschrijving

Please provide a reason

Datatype

text

Alias
UMLS CUI [1]
C0392360
Did the Investigator review the subject diary?
Beschrijving

Did the Investigator review the subject diary?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0035173
UMLS CUI [1,2]
C3166277
UMLS CUI [1,3]
C3890583
Was investigational product tolerated?
Beschrijving

Was investigational product tolerated?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0013220
Will the patient continue in the study?
Beschrijving

Will the patient continue in the study?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C2603343
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Similar models

Visit 1; Visit 2; Visit 3; Visit 4; Visit 5; Visit 6; Visit 7; Visit 8; Maintenance 1 +2; Early Withdrawal; Follow up- Check In

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study Name
Item
Study Name
text
C2348560 (UMLS CUI [1])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Study Site
Item
Study Site
text
C2825164 (UMLS CUI [1])
Item Group
Check-In Review
C4321547 (UMLS CUI-1)
C0699752 (UMLS CUI-2)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Are there any changes in the concomitant medications, including non-drug therapies?
Item
Are there any changes in the concomitant medications, including non-drug therapies?
boolean
C2347852 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
C0033082 (UMLS CUI [2])
Are there any changes in the medical history, including cardiovascular risk factors, medical conditions and smoking history?
Item
Are there any changes in the medical history, including cardiovascular risk factors, medical conditions and smoking history?
boolean
C0262926 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0850624 (UMLS CUI [2])
C0012634 (UMLS CUI [3])
C1519384 (UMLS CUI [4])
Did the patient experience any adverse events since the last visit?
Item
Did the patient experience any adverse events since the last visit?
boolean
C0877248 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1711239 (UMLS CUI [1,4])
Did the patient complete the Sudden Onset of Sleep questionnaire?
Item
Did the patient complete the Sudden Onset of Sleep questionnaire?
boolean
C1272517 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0034394 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
Please provide a reason
Item
Please provide a reason
text
C0392360 (UMLS CUI [1])
Did the Investigator review the subject diary?
Item
Did the Investigator review the subject diary?
boolean
C0035173 (UMLS CUI [1,1])
C3166277 (UMLS CUI [1,2])
C3890583 (UMLS CUI [1,3])
Was investigational product tolerated?
Item
Was investigational product tolerated?
boolean
C0304229 (UMLS CUI [1,1])
C0013220 (UMLS CUI [1,2])
Will the patient continue in the study?
Item
Will the patient continue in the study?
boolean
C0805733 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
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