ID

26551

Description

Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

Keywords

Versions (1)
  1. 10/18/17 10/18/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 18, 2017

DOI

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License

Creative Commons BY-NC 3.0
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study conclusion Ropinirole CR Ropinirole IR Monotherapy 101468/168

English

study conclusion Ropinirole CR Ropinirole IR Monotherapy 101468/168

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
STUDY CONCLUSION
Description

STUDY CONCLUSION

Date of subject completion or withdrawal
Description

Date of subject completion or withdrawal

Data type

date

Did the subject withdraw from study as a result of this AE?
Description

Withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C1710677
UMLS CUI [1,2]
C1518404
Primary reason for withdrawal
Description

Primary reason for withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Other, specify
Description

Other primary reason for withdrawal

Data type

text

PREGNANCY INFORMATION
Description

PREGNANCY INFORMATION

Did the subject become pregnant during the study?
Description

If Yes, complete Pregnancy Notification form.

Data type

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0008976
OVERALL COMPLIANCE
Description

OVERALL COMPLIANCE

Did the subject generally take their morning dose of medication within 2 hours of a meal?
Description

Overall compliance

Data type

boolean

INVESTIGATOR’S SIGNATURE
Description

INVESTIGATOR’S SIGNATURE

Investigator’s Signature
Description

I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator’s name (print)
Description

InvestigatorName

Data type

text

Alias
UMLS CUI [1,1]
C0035173
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C1547383
Date
Description

Investigator Signature Date

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

study conclusion Ropinirole CR Ropinirole IR Monotherapy 101468/168

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
STUDY CONCLUSION
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
Item
Did the subject withdraw from study as a result of this AE?
text
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
No (N)
CL Item
Yes (Y)
Item
Primary reason for withdrawal
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Primary reason for withdrawal
Code List
Primary reason for withdrawal
CL Item
Adverse event (record details on the Non-Serious Adverse Event or Serious Adverse Events forms as appropriate) (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Lack of efficacy (5)
CL Item
Sponsor terminated study (6)
CL Item
Non-compliance (17)
CL Item
Other (Z)
Other primary reason for withdrawal
Item
Other, specify
text
Item Group
PREGNANCY INFORMATION
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
pregnancy during study
Code List
Did the subject become pregnant during the study?
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not applicable (Not of childbearing potential or male) (Not applicable)
Item Group
OVERALL COMPLIANCE
Overall compliance
Item
Did the subject generally take their morning dose of medication within 2 hours of a meal?
boolean
Item Group
INVESTIGATOR’S SIGNATURE
Investigator Signature
Item
Investigator’s Signature
text
C2346576 (UMLS CUI [1])
InvestigatorName
Item
Investigator’s name (print)
text
C0035173 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C1547383 (UMLS CUI [1,3])
Investigator Signature Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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