ID
35553
Descrição
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.
Palavras-chave
Versões (1)
- 08/03/2019 08/03/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
8 de março de 2019
DOI
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Licença
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
Pregnancy Dipstick
- StudyEvent: ODM
Descrição
Pregnancy Dipstick
Alias
- UMLS CUI-1
- C0430056
Descrição
child-bearing potential
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C1960468
Descrição
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.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C0456984
Similar models
Pregnancy Dipstick
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
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