ID
25768
Beskrivning
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)
Nyckelord
Versioner (1)
- 2017-09-18 2017-09-18 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
18 september 2017
DOI
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Licens
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
Beskrivning
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
Beskrivning
Investigator's Name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Number
Datatyp
text
Alias
- UMLS CUI [1]
- C0237753
Beskrivning
Serious Adverse Event
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Reason
Datatyp
text
Alias
- UMLS CUI [1]
- C0566251
Beskrivning
Reason: Specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C2348235
Beskrivning
Onset Date
Datatyp
date
Måttenheter
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0574845
Beskrivning
Onset Time
Datatyp
time
Måttenheter
- 24hr:min
Alias
- UMLS CUI [1]
- C0449244
Beskrivning
End Date
Datatyp
date
Måttenheter
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C0806020
Beskrivning
End Time
Datatyp
time
Måttenheter
- 24hr:min
Beskrivning
* If subject died, please inform GSK within 24 hours and complete Form D
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1519255
Beskrivning
Event Course
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beskrivning
Number of Episodes
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Beskrivning
Intensity
Datatyp
text
Alias
- UMLS CUI [1]
- C1710066
Beskrivning
Action taken
Datatyp
text
Alias
- UMLS CUI [1]
- C2826626
Beskrivning
Relationship
Datatyp
text
Alias
- UMLS CUI [1]
- C0439849
Beskrivning
Assessment
Datatyp
text
Alias
- UMLS CUI [1]
- C0220825
Beskrivning
Assessment Specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C2348235
Beskrivning
If 'YES', Please record on Concomitant Medication form
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beskrivning
Withdrawal
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Beskrivning
Ablation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0547070
Beskrivning
Retreatment with study medication
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0376495
- UMLS CUI [1,2]
- C0304229
Beskrivning
Recurrence
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0034897
Beskrivning
Serious Adverse Event (SAE) - Relevant Laboratory Data (Please provide relevant abnormal laboratory data below)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0587081
Beskrivning
Laboratory Test
Datatyp
text
Alias
- UMLS CUI [1]
- C0022885
Beskrivning
Laboratory Test Date
Datatyp
date
Måttenheter
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C2826641
Beskrivning
Laboratory Value
Datatyp
text
Alias
- UMLS CUI [1]
- C0587081
Beskrivning
Measurement Unit
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Normal Range
Datatyp
text
Alias
- UMLS CUI [1]
- C0086715
Beskrivning
Remarks
Datatyp
text
Beskrivning
Randomization
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0034656
Beskrivning
Randomization Number
Datatyp
float
Alias
- UMLS CUI [1]
- C2986235
Beskrivning
Investigator's Name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Date of Report
Datatyp
date
Måttenheter
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C1302584
Similar models
Serious Adverse Event (SAE) GSK Ropinirole Restless Legs Syndrome 101468
C0019994 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0587081 (UMLS CUI-2)