ID

36397

Description

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the study conclusion form. In this Pregnancy information and Investigators’s Statement are included. The document has to be filled in for the end of study.

Keywords

Versions (3)
  1. 9/5/17 9/5/17 -
  2. 5/10/19 5/10/19 -
  3. 5/10/19 5/10/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 10, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

English

Study Conclusion (Pregnancy information, Investigators’s Statement)

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

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Did the subject complete the study as planned?
Description

study subject participation status

Data type

text

Alias
UMLS CUI [1]
C2348568
If subject did not complete the study as planned, mark one most appropriate category
Description

Reason, no completion as planned

Data type

integer

Alias
UMLS CUI [1]
C1709849
If other reason, please specify
Description

Other reason

Data type

text

Alias
UMLS CUI [1]
C3840932
Comments on reason for withdrawal
Description

reason for withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0008976
Date of withdrawal
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2349954
Time of withdrawal
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C2349954
Date of final dose
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1531784
Time of final dose
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0013227
Pregnancy Information
Description

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did subject become pregnant during the study?
Description

Pregnancy during study

Data type

text

Alias
UMLS CUI [1]
C0549206
Did the female partner of a male subject become pregnant during the study?
Description

Pregnant Partner in relationship

Data type

text

Alias
UMLS CUI [1,1]
C0549206
UMLS CUI [1,2]
C0682323
Statement investigator
Description

Statement investigator

Alias
UMLS CUI-1
C1710187
UMLS CUI-2
C2826892
Check all Adverse Event forms are up to date and complete
Description

Tick when done

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1283174
Check that the Concomitant Medication form is up to date
Description

Tick when done

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1283174
Check that all appropriate pages are signed (thus indicating completion) and dated
Description

Tick when done

Data type

boolean

Alias
UMLS CUI [1,1]
C0805732
UMLS CUI [1,2]
C1283174
Check that laboratory results are included
Description

Tick when done

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1283174
Investigator signature
Description

I certify to the best of my knowledge, that the observations and findings are recorded correctly and completely in this CRF.

Data type

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Description

day month year

Data type

date

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

Study Conclusion (Pregnancy information, Investigators’s Statement)

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
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Item
Did the subject complete the study as planned?
text
C2348568 (UMLS CUI [1])
study subject participation status
Code List
Did the subject complete the study as planned?
CL Item
Yes (Y)
CL Item
No (N)
Item
If subject did not complete the study as planned, mark one most appropriate category
integer
C1709849 (UMLS CUI [1])
reason
Code List
If subject did not complete the study as planned, mark one most appropriate category
CL Item
Adverse event (complete adverse event form)  (1)
CL Item
Insufficient therapeutic effect  (2)
CL Item
Deviation from protocol (including non-compliance)  (3)
CL Item
Lost to Follow-Up  (4)
CL Item
Other (5)
Other reason
Item
If other reason, please specify
text
C3840932 (UMLS CUI [1])
reason for withdrawal
Item
Comments on reason for withdrawal
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Date of withdrawal
Item
Date of withdrawal
date
C0011008 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Time of withdrawal
Item
Time of withdrawal
time
C0040223 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Date of final dose
Item
Date of final dose
date
C1531784 (UMLS CUI [1])
Time of final dose
Item
Time of final dose
time
C1522314 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did subject become pregnant during the study?
text
C0549206 (UMLS CUI [1])
Pregnancy during study
Code List
Did subject become pregnant during the study?
CL Item
Not applicable (Not of child bearing potential or male) (X)
CL Item
No (N)
CL Item
Yes (Y)
Item
Did the female partner of a male subject become pregnant during the study?
text
C0549206 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
Pregnant Partner in relationship
Code List
Did the female partner of a male subject become pregnant during the study?
CL Item
Not applicable (Subject is female, female partner not of childbearing potential or female partner) (X)
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Statement investigator
C1710187 (UMLS CUI-1)
C2826892 (UMLS CUI-2)
Adverse Event
Item
Check all Adverse Event forms are up to date and complete
boolean
C0877248 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
Concomitant Medication
Item
Check that the Concomitant Medication form is up to date
boolean
C2347852 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
Completion
Item
Check that all appropriate pages are signed (thus indicating completion) and dated
boolean
C0805732 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
Laboratory results
Item
Check that laboratory results are included
boolean
C1254595 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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