ID

35685

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 Laboratory Evaluation form. It has to be filled in for screening, Week 24, Week 52, Early Withdrawal and Follow-up.

Nyckelord

  1. 2019-03-15 2019-03-15 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

15 mars 2019

DOI

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Licens

Creative Commons BY-NC 3.0

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Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS), 101468/192

Laboratory Evaluation

  1. StudyEvent: ODM
    1. Laboratory Evaluation
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 Number
Beskrivning

Patient Number

Datatyp

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beskrivning

Patient Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Visit type
Beskrivning

Visit type

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
LABORATORY EVALUATION
Beskrivning

LABORATORY EVALUATION

Alias
UMLS CUI-1
C0022885
Date of blood sample:
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
Laboratory label
Beskrivning

Laboratory label

Datatyp

text

Alias
UMLS CUI [1]
C4273937
Were any clinically significant abnormalities detected?
Beskrivning

If ’Yes’, please record details in the Adverse Experiences and/or SAE section and repeat at Follow-up

Datatyp

text

Alias
UMLS CUI [1]
C1853129

Similar models

Laboratory Evaluation

  1. StudyEvent: ODM
    1. Laboratory Evaluation
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 Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit type
CL Item
Screening (1)
CL Item
Week 24 (2)
CL Item
Week 52 (3)
CL Item
Early Withdrawal  (4)
CL Item
Follow-up (5)
Item Group
LABORATORY EVALUATION
C0022885 (UMLS CUI-1)
Date of blood sample
Item
Date of blood sample:
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Laboratory label
Item
Laboratory label
text
C4273937 (UMLS CUI [1])
Item
Were any clinically significant abnormalities detected?
text
C1853129 (UMLS CUI [1])
Code List
Were any clinically significant abnormalities detected?
CL Item
Yes (Y)
CL Item
No (N)

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