ID

35553

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 Pregnancy Dipstick form. It has to be filled in for Screening (+Baseline), Week 24, Week 52 and fpr early withdrawal.

Nyckelord

Versioner (1)
  1. 2019-03-08 2019-03-08 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

8 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

Engelsk

Pregnancy Dipstick

1 Formulär  
  1. StudyEvent: ODM
    1. Pregnancy Dipstick
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
Patient Number
Beskrivning

Patient Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit type
Beskrivning

Visit type

Datatyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Pregnancy Dipstick
Beskrivning

Pregnancy Dipstick

Alias
UMLS CUI-1
C0430056
Is the patient a female of child-bearing potential?
Beskrivning

child-bearing potential

Datatyp

boolean

Alias
UMLS CUI [1]
C1960468
Pregnancy Dipstick Result
Beskrivning

If patient is of child-bearing potential, please perform a pregnancy dipstick test and record result below. If ’Positive’, please record details on the Pregnancy Notification Form and withdraw the patient.

Datatyp

text

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C0456984
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Similar models

Pregnancy Dipstick

1 Formulär
  1. StudyEvent: ODM
    1. Pregnancy Dipstick
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])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Screening (+Baseline) (1)
CL Item
Week 24  (2)
CL Item
Week 52 (3)
CL Item
Early withdrawal (4)
Item Group
Pregnancy Dipstick
C0430056 (UMLS CUI-1)
child-bearing potential
Item
Is the patient a female of child-bearing potential?
boolean
C1960468 (UMLS CUI [1])
Item
Pregnancy Dipstick Result
text
C0430056 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Pregnancy Dipstick Result
Code List
Pregnancy Dipstick Result
CL Item
Positive (P)
CL Item
Negative (N)
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