ID
36392
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 non serious AE form. It has to be filled in if the subject experiences non serious AE during the study.
Mots-clés
Versions (2)
- 05/09/2017 05/09/2017 -
- 10/05/2019 10/05/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
10 mai 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
Non- Serious Adverse Experiences (non serious AE)
- StudyEvent: ODM
Description
ADVERSE EXPERIENCES (Non-serious)
Alias
- UMLS CUI-1
- C1518404
Description
Record any adverse event (using standard medical terminology) observed or elicited by the following direct question to the subject: “Do you feel different in any way since starting the treatment or since the last visit?” Provide the diagnosis not symptoms where possible. (One adverse event per column) If no adverse events, please mark box and sign form below.
Type de données
boolean
Alias
- UMLS CUI [1]
- C1518404
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]
- C0877248
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]
- C1522314
- UMLS CUI [1,2]
- C0877248
Description
Outcome of AE
Type de données
integer
Alias
- UMLS CUI [1]
- C1705586
Description
Experience Course of AE
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
INTENSITY (Maximum) Definition: MILD: Adverse Event which is easily tolerated. MODERATE: Adverse Event sufficiently discomforting to interfere with daily activity. SEVERE: Adverse Event which prevents normal everyday activities.
Type de données
integer
Alias
- UMLS CUI [1]
- C1710066
Description
Action Taken with Respect to Investigational Drug
Type de données
integer
Alias
- UMLS CUI [1]
- C2826626
Description
Definition: NOT RELATED: The adverse event is definitely not related to the test drug. UNLIKELY: There are more likely causes and the drug is not suspected as a cause. SUSPECTED (REASONABLE POSSIBILITY): A direct cause and effect relationship between the drug and the adverse event has not been demonstrated but there is a reasonable possibility that the event was caused by the drug. PROBABLE: There is probably a direct cause and effect relationship between the adverse event and the study drug.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
If ‘Yes’, please record on Concomitant Medication form.
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 [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Non- Serious Adverse Experiences (non serious AE)
- StudyEvent: ODM
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])