ID

39233

Beskrivning

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

Nyckelord

Versioner (9)
  1. 2019-12-10 2019-12-10 -
  2. 2019-12-11 2019-12-11 -
  3. 2019-12-11 2019-12-11 -
  4. 2019-12-11 2019-12-11 -
  5. 2019-12-11 2019-12-11 -
  6. 2019-12-11 2019-12-11 -
  7. 2019-12-11 2019-12-11 -
  8. 2019-12-16 2019-12-16 -
  9. 2020-01-09 2020-01-09 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

11 december 2019

DOI

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Licens

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

Engelsk

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 Formulär  
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Study Name
Beskrivning

Study Name

Datatyp

text

Alias
UMLS CUI [1]
C2348560
Subject ID
Beskrivning

Subject ID

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Study Site
Beskrivning

Study Site

Datatyp

text

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

Check-In Review

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

Date of Visit

Datatyp

date

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

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

Datatyp

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?
Beskrivning

Please update the appropriate medical history.

Datatyp

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?
Beskrivning

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

Datatyp

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?
Beskrivning

Please ensure SOOS questionnaire form is completed for this visit.

Datatyp

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
Beskrivning

Please provide a reason

Datatyp

text

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

Did the Investigator review the subject diary?

Datatyp

boolean

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

Was investigational product tolerated?

Datatyp

boolean

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

Will the patient continue in the study?

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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