ID
36392
Beschrijving
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.
Trefwoorden
Versies (2)
- 05-09-17 05-09-17 -
- 10-05-19 10-05-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
10 mei 2019
DOI
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Licentie
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
Beschrijving
ADVERSE EXPERIENCES (Non-serious)
Alias
- UMLS CUI-1
- C1518404
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1]
- C1518404
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C2985916
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C0877248
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C2697886
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0877248
Beschrijving
Outcome of AE
Datatype
integer
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
Experience Course of AE
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschrijving
Number of episodes
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Beschrijving
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.
Datatype
integer
Alias
- UMLS CUI [1]
- C1710066
Beschrijving
Action Taken with Respect to Investigational Drug
Datatype
integer
Alias
- UMLS CUI [1]
- C2826626
Beschrijving
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.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschrijving
If ‘Yes’, please record on Concomitant Medication form.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschrijving
Patient withdrawn due to this specific AE
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Beschrijving
Investigator signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
day month year
Datatype
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])