ID

35557

Description

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).

Mots-clés

Versions (1)
  1. 08/03/2019 08/03/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

8 mars 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

  • Plus récent
  • Plus ancien
  • Favori
  • Plus récent
    • Plus récent
    • Plus ancien
    • Favori

Aucun commentaire

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

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

Anglais

Significant Medical/ Surgical History,Physical Examination

1 Formulaires  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Description

Centre Number

Type de données

integer

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

Patient Initials

Type de données

text

Alias
UMLS CUI [1]
C2986440
Patient Number
Description

Patient Number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

day month year

Type de données

date

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

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)?
Description

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.

Type de données

text

Alias
UMLS CUI [1]
C0009488
Diagnosis
Description

Diagnosis

Type de données

text

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

Year of first diagnosis

Type de données

partialDate

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

Medical condition

Type de données

integer

Alias
UMLS CUI [1]
C0012634
Comment for SB
Description

Comment

Type de données

text

Alias
UMLS CUI [1]
C0947611
Retour au début de la page

Similar models

Significant Medical/ Surgical History,Physical Examination

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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