ID

35677

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 concomitant medication form. It has to be filled in if the subject takes concomitant medication during the study.

Nyckelord

  1. 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 :


Inga kommentarer

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

Concomitant Medication

  1. StudyEvent: ODM
    1. Concomitant Medication
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Beskrivning

Centre Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient Initials
Beskrivning

Patient Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Concomitant Medication
Beskrivning

Concomitant Medication

Alias
UMLS CUI-1
C2347852
No new/change in concomitant medication
Beskrivning

Please mark if no new or change in concomitant medication during the module

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C0580105
Drug Name
Beskrivning

Drug Name

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Total Daily Dose
Beskrivning

Total Daily Dose

Datatyp

integer

Alias
UMLS CUI [1]
C2348070
Medical illness/ Diagnosis
Beskrivning

(or symptom in absence of diagnosis)

Datatyp

text

Alias
UMLS CUI [1]
C0011900
Start Date
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1]
C0808070
End Date
Beskrivning

End Date

Datatyp

date

Alias
UMLS CUI [1]
C0806020

Similar models

Concomitant Medication

  1. StudyEvent: ODM
    1. Concomitant Medication
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
No new/change in concomitant medication
Item
No new/change in concomitant medication
boolean
C2347852 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C0580105 (UMLS CUI [1,3])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
integer
C2348070 (UMLS CUI [1])
Diagnosis
Item
Medical illness/ Diagnosis
text
C0011900 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial