ID
40761
Description
Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome
Keywords
Versions (1)
- 5/8/20 5/8/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 8, 2020
DOI
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License
Creative Commons BY-NC 4.0
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Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218
Pregnancy Information; Study Conclusion, Investigator's Statement (Follow-Up)
Description
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Description
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Description
Did the subject complete the study as planned?
Data type
boolean
Alias
- UMLS CUI [1]
- C2348577
Description
If the subject did not complete the study as planned, mark the most appropriate category
Data type
integer
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C2826287
Description
Other reason for not completing the study as planned
Data type
text
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C2826287
- UMLS CUI [1,3]
- C0205394
Description
Comments on reason for withdrawal:
Data type
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C2349954
- UMLS CUI [1,3]
- C0566251
Description
Date of Withdrawal:
Data type
date
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0011008
Description
Time of Withdrawal:
Data type
time
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0040223
Description
Date of Final Dose:
Data type
date
Alias
- UMLS CUI [1]
- C1762893
Description
Time of Final Dose:
Data type
time
Alias
- UMLS CUI [1]
- C0946444
Description
Investigator's Statement
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1710187
Description
Check all Adverse Event forms are up to date and complete
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0920316
- UMLS CUI [1,3]
- C0205197
Description
Check that the Concomitant Medication form is up to date
Data type
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0920316
- UMLS CUI [1,3]
- C0237400
Description
Check that all appropriate pages are signed (thus indicating completion) and dated
Data type
integer
Alias
- UMLS CUI [1,1]
- C0805732
- UMLS CUI [1,2]
- C1283174
Description
Check that laboratory results are included
Data type
integer
Alias
- UMLS CUI [1,1]
- C1254595
- UMLS CUI [1,2]
- C0920316
Description
I certify that the observations and findings are recorded correctly and completely in this CRF.
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator's Signature Date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
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Pregnancy Information; Study Conclusion, Investigator's Statement (Follow-Up)
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C0205394 (UMLS CUI [1,3])
C2349954 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
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C0205197 (UMLS CUI [1,3])
C0920316 (UMLS CUI [1,2])
C0237400 (UMLS CUI [1,3])
C1283174 (UMLS CUI [1,2])
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C0011008 (UMLS CUI [1,2])