ID
35688
Beschrijving
Study ID: 101468/192 Clinical Study ID: 101468/192 Study Title:A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) 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; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The study consists of 16 visits which are devided in 3 study books: Book 1: Screening (+Baseline), Day 2, Week 1, Week 2 , Week 3 , Week 4, Week 5, Week 6, Week 7, Week 8 Book 2: Week 12, Week 24, Week 36, Week 48, Week 52, Follow-up Book 3: Early withdrawal and Follow-up Each follow-up Visit takes place 7 +/- 3 days after last dose This document contains the study conclusion form. It has to be filled in for the end of study or for early withdrawal.
Trefwoorden
Versies (1)
- 15-03-19 15-03-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
15 maart 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS), 101468/192
Study Conclusion
- StudyEvent: ODM
Beschrijving
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beschrijving
Study Conclusion
Datatype
text
Alias
- UMLS CUI [1,1]
- C1707478
- UMLS CUI [1,2]
- C0008972
Beschrijving
Reason of withdrawal
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0085978
Beschrijving
Other reason
Datatype
text
Alias
- UMLS CUI [1]
- C3840932
Beschrijving
Serious Adverse Experiences
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Person Reporting SAE
Datatype
text
Alias
- UMLS CUI [1]
- C0008961
Beschrijving
AEGIS Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0600091
Beschrijving
Serious Adverse Experience
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Specify reason(s) for considering this a serious AE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0011065
Beschrijving
Specify reason(s) for considering this a serious AE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C2826244
Beschrijving
Specify reason(s) for considering this a serious AE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0019993
Beschrijving
Specify reason(s) for considering this a serious AE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0231170
Beschrijving
Specify reason(s) for considering this a serious AE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0000768
Beschrijving
Specify reason(s) for considering this a serious AE
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0205394
Beschrijving
Other reason, specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C1521902
Beschrijving
day month year 00:00-23:59
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826806
Beschrijving
day month year 00:00-23:59
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826793
Beschrijving
If patient died, STOP: go to SAE section and follow instructions given there
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beschrijving
Experience Course
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschrijving
Number of episodes
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Beschrijving
Action Taken with Respect to Investigational Drug
Datatype
integer
Alias
- UMLS CUI [1]
- C2826626
Beschrijving
SAE abate
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3853704
Beschrijving
dosage change
Datatype
text
Alias
- UMLS CUI [1]
- C0420247
Beschrijving
Serious Adverse Experiences recurrence
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
Beschrijving
Relationship to Investigational Drug
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschrijving
Relationship to Investigational Drug
Datatype
integer
Beschrijving
Another drug
Datatype
text
Alias
- UMLS CUI [1]
- C1115771
Beschrijving
If ‘Yes’, record details in the Concomitant Medication section and/or Healthcare Resource Utilisation form if appropriate
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschrijving
patient withdrawn due to this specific AE
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Beschrijving
Relevant Laboratory Data
Alias
- UMLS CUI-1
- C0022877
Beschrijving
Test
Datatype
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0332307
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Value
Datatype
text
Alias
- UMLS CUI [1]
- C1522609
Beschrijving
Units
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Normal Range
Datatype
text
Alias
- UMLS CUI [1]
- C0086715
Beschrijving
Remarks
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
randomisation code broken
Datatype
text
Alias
- UMLS CUI [1,1]
- C3897778
- UMLS CUI [1,2]
- C1272691
Beschrijving
Randomisation Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschrijving
Investigators Signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Investigator's Name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Medical Monitor’s Signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Medical Monitor's Name
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0807937
- UMLS CUI [1,2]
- C1708968
Similar models
Study Conclusion
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0011065 (UMLS CUI [1,2])
C2826244 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,2])
C0231170 (UMLS CUI [1,2])
C0000768 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0750729 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C1272691 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,2])