ID
25768
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 Serious Adverse Event (SAE)
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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Serious Adverse Event (SAE) GSK Ropinirole Restless Legs Syndrome 101468
Serious Adverse Event (SAE) GSK Ropinirole Restless Legs Syndrome 101468
Beschrijving
Serious Adverse Event - Complete the SAE Pages. Please complete these pages fully and accurately as possible in order to minimise the time you spend dealing with data queries. If the SAE is still ongoing at the time of reporting, please leave 'Event Course' blank and update it later. Sign and date the SAE page. Please ensure that all of the information on the following CRF pages is complete (Demography, significant Medical/Surgical History and Physiology Examination, Study Medication Record, Concomitant Medication, Form D (if applicable). Photocophy the SAE pages and the CRF pages specified above (Do not separate the NCR pages). Fax a copy of the SAE pages and all of the CRF pages specified above to: Your local GSK CRA/Medical Monitor (see Investigator Site File for appropriate fax number). If no photocopier OR fax is available please telephone your local GSK CRA/Medical monitor within 24 hours.
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Investigator's Name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Number
Datatype
text
Alias
- UMLS CUI [1]
- C0237753
Beschrijving
Serious Adverse Event
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Reason
Datatype
text
Alias
- UMLS CUI [1]
- C0566251
Beschrijving
Reason: Specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0566251
- 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
Beschrijving
* If subject died, please inform GSK within 24 hours and complete Form D
Datatype
text
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
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
Alias
- UMLS CUI [1]
- C1710066
Beschrijving
Action taken
Datatype
text
Alias
- UMLS CUI [1]
- C2826626
Beschrijving
Relationship
Datatype
text
Alias
- UMLS CUI [1]
- C0439849
Beschrijving
Assessment
Datatype
text
Alias
- UMLS CUI [1]
- C0220825
Beschrijving
Assessment Specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C2348235
Beschrijving
If 'YES', Please record on Concomitant Medication form
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschrijving
Withdrawal
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Beschrijving
Ablation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0547070
Beschrijving
Retreatment with study medication
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0376495
- UMLS CUI [1,2]
- C0304229
Beschrijving
Recurrence
Datatype
boolean
Alias
- UMLS CUI [1]
- C0034897
Beschrijving
Serious Adverse Event (SAE) - Relevant Laboratory Data (Please provide relevant abnormal laboratory data below)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0587081
Beschrijving
Laboratory Test
Datatype
text
Alias
- UMLS CUI [1]
- C0022885
Beschrijving
Laboratory Test Date
Datatype
date
Maateenheden
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C2826641
Beschrijving
Laboratory Value
Datatype
text
Alias
- UMLS CUI [1]
- C0587081
Beschrijving
Measurement Unit
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Normal Range
Datatype
text
Alias
- UMLS CUI [1]
- C0086715
Beschrijving
Remarks
Datatype
text
Beschrijving
Randomization
Datatype
boolean
Alias
- UMLS CUI [1]
- C0034656
Beschrijving
Randomization Number
Datatype
float
Alias
- UMLS CUI [1]
- C2986235
Beschrijving
Investigator's Name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Date of Report
Datatype
date
Maateenheden
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C1302584
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Serious Adverse Event (SAE) GSK Ropinirole Restless Legs Syndrome 101468
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