ID
36392
Descrição
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.
Palavras-chave
Versões (2)
- 05/09/2017 05/09/2017 -
- 10/05/2019 10/05/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
10 de maio de 2019
DOI
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Licença
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
Descrição
ADVERSE EXPERIENCES (Non-serious)
Alias
- UMLS CUI-1
- C1518404
Descrição
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.
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C1518404
Descrição
day month year
Tipo de dados
date
Alias
- UMLS CUI [1]
- C2985916
Descrição
00:00-23:59
Tipo de dados
time
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C0877248
Descrição
day month year
Tipo de dados
date
Alias
- UMLS CUI [1]
- C2697886
Descrição
00:00-23:59
Tipo de dados
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0877248
Descrição
Outcome of AE
Tipo de dados
integer
Alias
- UMLS CUI [1]
- C1705586
Descrição
Experience Course of AE
Tipo de dados
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Descrição
Number of episodes
Tipo de dados
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Descrição
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.
Tipo de dados
integer
Alias
- UMLS CUI [1]
- C1710066
Descrição
Action Taken with Respect to Investigational Drug
Tipo de dados
integer
Alias
- UMLS CUI [1]
- C2826626
Descrição
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.
Tipo de dados
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Descrição
If ‘Yes’, please record on Concomitant Medication form.
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Descrição
Patient withdrawn due to this specific AE
Tipo de dados
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Descrição
Investigator signature
Tipo de dados
text
Alias
- UMLS CUI [1]
- C2346576
Descrição
day month year
Tipo de dados
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])