ID
25762
Beschrijving
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
Trefwoorden
Versies (1)
- 18-09-17 18-09-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
18 september 2017
DOI
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Licentie
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
Beschrijving
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
Beschrijving
Adverse Event
Datatype
boolean
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Adverse Event: Specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2348235
Beschrijving
Onset Date
Datatype
date
Maateenheden
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0574845
Beschrijving
Onset Time
Datatype
time
Maateenheden
- 24hr:min
Alias
- UMLS CUI [1]
- C0449244
Beschrijving
End Date
Datatype
date
Maateenheden
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
End Time
Datatype
time
Maateenheden
- 24hr:min
Alias
- UMLS CUI [1]
- C1522314
Beschrijving
Adverse Event Outcome
Datatype
text
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
Event Course
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschrijving
Number of Episodes
Datatype
float
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Beschrijving
Intensity
Datatype
text
Beschrijving
Action Taken
Datatype
text
Alias
- UMLS CUI [1]
- C2826626
Beschrijving
Relationship
Datatype
text
Alias
- UMLS CUI [1]
- C0439849
Beschrijving
Corrective Therapy
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschrijving
Withdrawal due to Adverse Event
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Beschrijving
Adverse Event Date
Datatype
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])