ID
36916
Description
Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 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 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Baseline Signs And Symptoms for Screening form.
Mots-clés
Versions (1)
- 21/06/2019 21/06/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
21 juin 2019
DOI
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Licence
Creative Commons BY-NC 3.0
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Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201
Baseline Signs And Symptoms for Screening
- StudyEvent: ODM
Description
Non-serious Adverse Event
Alias
- UMLS CUI-1
- C1518404
Description
Non-serious Adverse Event
Type de données
boolean
Alias
- UMLS CUI [1]
- C1518404
Description
Record any baseline events (using standard medical terminology) observed or elicited by the following direct question to the subject: “How do you feel?“ Provide the diagnosis, NOT symptoms where possible. (One baseline event per column)
Type de données
text
Alias
- UMLS CUI [1]
- C0037088
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C2985916
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1518404
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C2697886
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1522314
Description
Outcome
Type de données
integer
Alias
- UMLS CUI [1]
- C1705586
Description
Experience Course
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Description
Number of episodes
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Description
MILD: An event which is easily tolerated MODERATE: An event which is sufficiently discomforting to interfere with daily activity SEVERE: An event which prevents normal everyday activities
Type de données
integer
Alias
- UMLS CUI [1]
- C1710066
Description
NOT RELATED: The event is definitely not related to the study procedures UNLIKELY: There are other more likely causes and the study procedures are not suspected as a cause SUSPECTED (REASONABLE POSSIBILITY): A direct cause and effect relationship between the study procedures and the event has not been demonstrated but there is a reasonable possibility that the study procedures were involved PROBABLE: There probably is a direct cause and effect relationship between the event and the study procedures
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0008976
- UMLS CUI [1,2]
- C2700391
Description
If ‘Yes’, record details in the Concomitant Medication section and/or Healthcare Resource Utilisation form if appropriate
Type de données
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Description
patient withdrawn due to this specific AE
Type de données
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Description
Investigator signature
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C0011008
Similar models
Baseline Signs And Symptoms for Screening
- StudyEvent: ODM
C1518404 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
C2700391 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
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