ID

35685

Beschrijving

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.

Trefwoorden

  1. 15-03-19 15-03-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

15 maart 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

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
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Beschrijving

Centre Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient Number
Beschrijving

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschrijving

Patient Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1320303
Visit type
Beschrijving

Visit type

Datatype

text

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

LABORATORY EVALUATION

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

day month year

Datatype

date

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

Laboratory label

Datatype

text

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

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

Datatype

text

Alias
UMLS CUI [1]
C1853129

Similar models

Laboratory Evaluation

  1. StudyEvent: ODM
    1. Laboratory Evaluation
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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)

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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