ID
25762
Description
Study ID: 101468/207 Clinical Study ID: SKF-101468/207 Study Title:A double-blind, randomized, placebo-controlled, parallel-group study to investigate the tolerability of a dose-escalating regimen of ropinirole in patients suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome AE Section
Keywords
Versions (1)
- 9/18/17 9/18/17 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 18, 2017
DOI
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License
Creative Commons BY-NC-ND 3.0
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AE Section GSK Ropinirole Restless Legs Syndrome 101468
AE Section GSK Ropinirole Restless Legs Syndrome 101468
- StudyEvent: ODM
Description
Adverse Event - Please note any SERIOUS events should NOT be recorded on this page, but on the SERIOUS ADVERSE EVENT pages provided. Record any Adverse event (using standard medical terminology) observed or elicited as a result of spontaneous reporting by patient 'How are you feeling' (pre-dose) and at subsequent schedules intervals post dose: 'Since you were last asked have you felt unwell or different from usual?'
Alias
- UMLS CUI-1
- C0877248
Description
Adverse Event
Data type
boolean
Alias
- UMLS CUI [1]
- C0877248
Description
Adverse Event: Specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2348235
Description
Onset Date
Data type
date
Measurement units
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0574845
Description
Onset Time
Data type
time
Measurement units
- 24hr:min
Alias
- UMLS CUI [1]
- C0449244
Description
End Date
Data type
date
Measurement units
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0806020
Description
End Time
Data type
time
Measurement units
- 24hr:min
Alias
- UMLS CUI [1]
- C1522314
Description
Adverse Event Outcome
Data type
text
Alias
- UMLS CUI [1]
- C1705586
Description
Event Course
Data type
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Description
Number of Episodes
Data type
float
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Description
Intensity
Data type
text
Description
Action Taken
Data type
text
Alias
- UMLS CUI [1]
- C2826626
Description
Relationship
Data type
text
Alias
- UMLS CUI [1]
- C0439849
Description
Corrective Therapy
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Description
Withdrawal due to Adverse Event
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Description
Adverse Event Date
Data type
date
Alias
- UMLS CUI [1]
- C2697888
Similar models
AE Section GSK Ropinirole Restless Legs Syndrome 101468
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])