ID
36015
Descripción
Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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 a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the SAE form. It has to be filled in if the subject experience a SAE during the study trial.
Palabras clave
Versiones (1)
- 9/4/19 9/4/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
9 de abril de 2019
DOI
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Licencia
Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198
Serious Adverse Event (SAE)
- StudyEvent: ODM
Descripción
Serious Adverse Event (SAE)
Alias
- UMLS CUI-1
- C1519255
Descripción
(Please print clearly)
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0335038
- UMLS CUI [1,2]
- C1519255
Descripción
GSK use
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0600091
- UMLS CUI [1,2]
- C0679918
- UMLS CUI [1,3]
- C1519255
Descripción
(Please print clearly). Please specify reason(s) for considering this a SAE in the itemgroup "SAE, reason".
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519255
Descripción
Comment for GSK
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0008961
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Descripción
00:00-23:9
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1519255
Descripción
day month year (If ongoing please leave blank)
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
Descripción
00:00-23:59 If ongoing please leave blank)
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1519255
Descripción
If subject died, please inform GSK within 24 h and complete Form D
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1624730
- UMLS CUI [1,2]
- C1519255
Descripción
Event Course SAE
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0750729
- UMLS CUI [1,2]
- C1519255
Descripción
Number of episodes
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C4086638
- UMLS CUI [1,2]
- C1519255
Descripción
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
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Descripción
Action Taken
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1547656
Descripción
If study medication was interrupted, stopped or dose reduced
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3854006
- UMLS CUI [1,2]
- C0580673
- UMLS CUI [2,1]
- C3854006
- UMLS CUI [2,2]
- C1611744
Descripción
SAE recur
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034897
- UMLS CUI [1,2]
- C1519255
Descripción
If you tick "Not related" or "Unlikely" please fill in the itemgroup "Assessment". Not related: The event is definitely not related to the study procedured 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
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0439849
- UMLS CUI [1,2]
- C3854006
Descripción
If "Yes", record details in the Concomitant Medication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C1519255
Descripción
Subject withdrawn
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0422727
Descripción
SAE abate
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3853704
- UMLS CUI [1,2]
- C1519255
Descripción
SAE, reason
Alias
- UMLS CUI-1
- C0392360
- UMLS CUI-2
- C1519255
Descripción
Results in death
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C1519255
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1517874
Descripción
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 ofa pre-existing condition that did not worsen from baseline is not considered anAE.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0019993
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0745041
Descripción
NOTE: The term disability means a substantial disruption ofa 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 consitute a substantial disruption.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Descripción
Congenital anomaly/birth defect
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C1519255
Descripción
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.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1519255
Descripción
Other reason, specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1521902
Descripción
Assessment
Alias
- UMLS CUI-1
- C0220825
Descripción
The SAE is probably associated with:
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0332281
- UMLS CUI [1,2]
- C0184661
Descripción
The SAE is probably associated with:
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0332281
- UMLS CUI [1,2]
- C2707304
Descripción
The SAE is probably associated with:
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0332281
- UMLS CUI [1,2]
- C1115771
Descripción
Please specify
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1521902
Descripción
Relevant Laboratory Data
Alias
- UMLS CUI-1
- C0022877
Descripción
Laboratory Test
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3891717
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0011008
Descripción
Laboratory Value
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0587081
Descripción
Units
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519795
Descripción
Normal Range
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0587081
Descripción
Details SAE
Alias
- UMLS CUI-1
- C1522508
- UMLS CUI-2
- C1519255
Descripción
Please provide a brief narrative description of the SAE, attaching extra pages eg. hospital discharge summary if necessary
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1519255
Descripción
Randomization code broken
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0443289
Descripción
Randomisation/Study Medication Number
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0600091
Descripción
(confirming that the above data are accurate and complete)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Descripción
Print name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1555464
- UMLS CUI [1,2]
- C0027365
Descripción
GSK Medical Monitor's Signature
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C1708968
- UMLS CUI [1,3]
- C0008961
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C1708968
- UMLS CUI [1,3]
- C0008961
Descripción
Print Name of Medical Monitor
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Similar models
Serious Adverse Event (SAE)
- StudyEvent: ODM
C1519255 (UMLS CUI [1,2])
C0679918 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0008961 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0580673 (UMLS CUI [1,2])
C3854006 (UMLS CUI [2,1])
C1611744 (UMLS CUI [2,2])
C1519255 (UMLS CUI [1,2])
C3854006 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0019993 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
C0231170 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,2])
C2707304 (UMLS CUI [1,2])
C1115771 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0443289 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0027365 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C1708968 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C1708968 (UMLS CUI [1,2])
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