ID

26381

Description

Study Part: Baseline Signs and Symptoms Week 1 Pre-dose (Visit 1). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Keywords

Versions (1)
  1. 10/16/17 10/16/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 16, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Baseline Signs and Symptoms Week 1 Pre-dose (Visit 1) Ropinirole Parkinson Disease 101468/165

English

Baseline Signs and Symptoms Week 1 Pre-dose (Visit 1)

1 forms  
BASELINE SIGNS AND SYMPTOMS
Description

BASELINE SIGNS AND SYMPTOMS

Alias
UMLS CUI-1
C0037088
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C1830427
Centre Number
Description

Centre Number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Onset Date and Time
Description

Onset Date and Time

Data type

datetime

Alias
UMLS CUI [1]
C2826806
End Date and Time
Description

End Date and Time

Data type

datetime

Alias
UMLS CUI [1]
C2826793
Outcome
Description

Outcome

Data type

text

Alias
UMLS CUI [1]
C1705586
Event Course
Description

Event Course

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
No. of Episodes
Description

number of episodes

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Description

Intensity

Data type

text

Alias
UMLS CUI [1]
C1710066
Relationship to study procedures performed prior to randomisation
Description

Relationship to study drug

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0013227
Corrective Therapy
Description

Corrective Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was subject withdrawn due to this event?
Description

subject withdrawn

Data type

boolean

Alias
UMLS CUI [1]
C0422727
Investigator’s Signature
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date:
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Baseline Signs and Symptoms Week 1 Pre-dose (Visit 1)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
BASELINE SIGNS AND SYMPTOMS
C0037088 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Onset Date and Time
Item
Onset Date and Time
datetime
C2826806 (UMLS CUI [1])
End Date and Time
Item
End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Outcome
text
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Resolved (Resolved)
CL Item
Ongoing (Ongoing)
CL Item
Died (Died)
Item
Event Course
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Event Course
Code List
Event Course
CL Item
Intermittent (Intermittent)
CL Item
Constant (Constant)
number of episodes
Item
No. of Episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
text
C1710066 (UMLS CUI [1])
Intensity
Code List
Intensity (maximum)
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
Item
Relationship to study procedures performed prior to randomisation
text
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Relationship to study drug
Code List
Relationship to study procedures performed prior to randomisation
CL Item
Not related (Not related)
CL Item
Unlikely (Unlikely)
CL Item
Suspected (Suspected)
CL Item
Probable (Probable)
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
subject withdrawn
Item
Was subject withdrawn due to this event?
boolean
C0422727 (UMLS CUI [1])
Investigator Signature
Item
Investigator’s Signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date:
date
C0011008 (UMLS CUI [1])
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