ID
35682
Beskrivning
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 Non-serious adverse event form. It has to be filled in if a non-serious AE occurs during the study.
Nyckelord
Versioner (3)
- 2017-08-24 2017-08-24 -
- 2019-03-06 2019-03-06 -
- 2019-03-15 2019-03-15 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
15 mars 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS), 101468/192
Non-Serious Adverse Events (AE)
- StudyEvent: ODM
Beskrivning
Non-serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Beskrivning
Please mark this box if no adverse experiences occurred during the module.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1518404
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1518404
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1518404
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1518404
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1518404
Beskrivning
If patient died, STOP: go to SAE section and follow instructions given there
Datatyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beskrivning
Experience Course
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beskrivning
Number of episodes
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Beskrivning
MILD: Adverse experience which is easily tolerated MODERATE: Adverse experience sufficiently discomforting to interfere with daily activities SEVERE: Adverse experience which prevents normal everyday activities
Datatyp
integer
Alias
- UMLS CUI [1]
- C1710066
Beskrivning
Action Taken with Respect to Investigational Drug
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826626
Beskrivning
RELATED: There is a direct cause and effect relationship between the adverse experience and the study drug POSSIBLY RELATED: A direct cause and effect relationship between the drug and the adverse experience has not been demonstrated but is possible or likely PROBABLY UNRELATED: Cause and effect relationship between the drug and the adverse experience has not been demonstrated, is improbable but not impossible UNRELATED: The adverse experience is definitely not related to the test drug
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
y If ‘Yes’, record details in the Concomitant Medication section and/ or Healthcare Resource Utilisation form if appropriate
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beskrivning
patient withdrawn due to this specific AE
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Similar models
Non-Serious Adverse Events (AE)
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])