ID

35557

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 Significant Medical/ Surgical History,Physical Examination form. It has to be filled in for screening (Baseline).

Palavras-chave

Versões (1)
  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

Inglês

Significant Medical/ Surgical History,Physical Examination

1 Formulários  
Administrative data
Descrição

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Descrição

Centre Number

Tipo de dados

integer

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

Patient Initials

Tipo de dados

text

Alias
UMLS CUI [1]
C2986440
Patient Number
Descrição

Patient Number

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Descrição

day month year

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Significant medical/surgical history and physical examination
Descrição

Significant medical/surgical history and physical examination

Alias
UMLS CUI-1
C0262926
Is the patient suffering from or has he/she suffered from any significant medical or surgical condition since the last visit of the previous study (excluding RLS)?
Descrição

If you tick Yes , please list one diagnosis per line in the following items. (Please print clearly). Only in the absence of a diagnosis, record the signs and symptoms on separate lines.

Tipo de dados

text

Alias
UMLS CUI [1]
C0009488
Diagnosis
Descrição

Diagnosis

Tipo de dados

text

Alias
UMLS CUI [1]
C0011900
Year of first diagnosis
Descrição

Year of first diagnosis

Tipo de dados

partialDate

Alias
UMLS CUI [1,1]
C0439234
UMLS CUI [1,2]
C0011900
Medical condition
Descrição

Medical condition

Tipo de dados

integer

Alias
UMLS CUI [1]
C0012634
Comment for SB
Descrição

Comment

Tipo de dados

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Significant Medical/ Surgical History,Physical Examination

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Significant medical/surgical history and physical examination
C0262926 (UMLS CUI-1)
Item
Is the patient suffering from or has he/she suffered from any significant medical or surgical condition since the last visit of the previous study (excluding RLS)?
text
C0009488 (UMLS CUI [1])
Comorbidity
Code List
Is the patient suffering from or has he/she suffered from any significant medical or surgical condition since the last visit of the previous study (excluding RLS)?
CL Item
Yes (Y)
CL Item
No (N)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Year of first diagnosis
Item
Year of first diagnosis
partialDate
C0439234 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Medical condition
integer
C0012634 (UMLS CUI [1])
Medical condition
Code List
Medical condition
CL Item
Past (1)
CL Item
Ongoing (2)
CL Item
Past + Ongoing (3)
Comment
Item
Comment for SB
text
C0947611 (UMLS CUI [1])
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