ID
36391
Beschreibung
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 SAE form. It has to be filled in if the subject experiences SAE during the study.
Stichworte
Versionen (2)
- 08.09.17 08.09.17 -
- 10.05.19 10.05.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
10. Mai 2019
DOI
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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
Serious Adverse Experiences (SAE)
- StudyEvent: ODM
Beschreibung
SERIOUS ADVERSE EVENT (SAE)
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Person Reporting SAE
Datentyp
text
Alias
- UMLS CUI [1]
- C0008961
Beschreibung
AEGIS Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0600091
Beschreibung
Serious Adverse Experience
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Specify reason(s) for considering this a serious AE. Mark all that apply
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0011065
Beschreibung
Specify reason(s) for considering this a serious AE. Mark all that apply. NOTE: The term ‘life-threatening’ in the definition of ‘serious’ refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C2826244
Beschreibung
Specify reason(s) for considering this a serious AE. Mark all that apply. NOTE: In general, hospitalisation signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician’s office or out-patient setting. Complications that occur during hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils any other serious criteria, the event is serious. When in doubt as to whether “hospitalisation” occurred or was necessary, the AE should be considered serious. Hospitalisation for elective treatment of a preexisting condition that did not worsen from baseline is not considered an AE.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0019993
Beschreibung
Specify reason(s) for considering this a serious AE. Mark all that apply. NOTE: The term disability means a substantial disruption of a person’s ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and accidental trauma (e.g. sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0231170
Beschreibung
Specify reason(s) for considering this a serious AE. Mark all that apply
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0000768
Beschreibung
Specify reason(s) for considering this a serious AE. Mark all that apply. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or development of drug dependency or drug abuse.
Datentyp
text
Alias
- UMLS CUI [1]
- C3840932
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1519255
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1519255
Beschreibung
NOTE: If subject died, please inform GSK within 24 hours and complete form D
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschreibung
Experience Course
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschreibung
Number of episodes
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C4086638
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1710066
- UMLS CUI [1,2]
- C1519255
Beschreibung
Action Taken with Respect to Investigational Drug
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826626
Beschreibung
SAE abate
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3853704
Beschreibung
dosage change of study medication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0420247
- UMLS CUI [1,2]
- C0304229
Beschreibung
Serious Adverse Experiences recurrence
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschreibung
Relationship to Investigational Drug, Assessment
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
- UMLS CUI [1,4]
- C1516048
Beschreibung
Another contition: eg, condition under study, intercurrent illness
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348235
Beschreibung
If ‘Yes’, record details in the Concomitant Medication section and/or Healthcare Resource Utilisation form if appropriate
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschreibung
Patient withdrawn due to this specific AE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Beschreibung
Relevant laboratory data
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C1519255
Beschreibung
Test
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0332307
Beschreibung
day month year
Datentyp
text
Alias
- UMLS CUI [1]
- C2826247
Beschreibung
Value
Datentyp
text
Alias
- UMLS CUI [1]
- C1522609
Beschreibung
Units
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Normal Range
Datentyp
text
Alias
- UMLS CUI [1]
- C0086715
Beschreibung
Please provide a brief narrative description of the SAE, attaching extra pages eg. hospital discharge summary if necessary
Datentyp
text
Alias
- UMLS CUI [1]
- C0947611
Beschreibung
Randomisation code broken
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3897778
- UMLS CUI [1,2]
- C1272691
Beschreibung
Randomisation Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschreibung
Confirming that the above data are accurate and complete
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
Please PRINT Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Medical Monitor’s Signature
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Please PRINT Name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1708968
- UMLS CUI [1,2]
- C1519316
Ähnliche Modelle
Serious Adverse Experiences (SAE)
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0011065 (UMLS CUI [1,2])
C2826244 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,2])
C0231170 (UMLS CUI [1,2])
C0000768 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0034897 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C1272691 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])