ID

36015

Beschrijving

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.

Trefwoorden

Versies (1)
  1. 09-04-19 09-04-19 -
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GlaxoSmithKline

Geüploaded op

9 april 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

Engels

Serious Adverse Event (SAE)

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Beschrijving

Subject No.

Datatype

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Beschrijving

Panel ID

Datatype

text

Alias
UMLS CUI [1]
C3846158
GSK Receipt Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C2985846
Serious Adverse Event (SAE)
Beschrijving

Serious Adverse Event (SAE)

Alias
UMLS CUI-1
C1519255
Person Reporting SAE
Beschrijving

(Please print clearly)

Datatype

text

Alias
UMLS CUI [1,1]
C0335038
UMLS CUI [1,2]
C1519255
AEGIS number
Beschrijving

GSK use

Datatype

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0679918
UMLS CUI [1,3]
C1519255
Serious Adverse Event
Beschrijving

(Please print clearly). Please specify reason(s) for considering this a SAE in the itemgroup "SAE, reason".

Datatype

text

Alias
UMLS CUI [1]
C1519255
Comment for GSK
Beschrijving

Comment for GSK

Datatype

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0008961
SAE onset Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1519255
SAE onset Time
Beschrijving

00:00-23:9

Datatype

time

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1519255
SAE end Date
Beschrijving

day month year (If ongoing please leave blank)

Datatype

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
SAE end Time
Beschrijving

00:00-23:59 If ongoing please leave blank)

Datatype

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C1519255
Outcome SAE
Beschrijving

If subject died, please inform GSK within 24 h and complete Form D

Datatype

integer

Alias
UMLS CUI [1,1]
C1624730
UMLS CUI [1,2]
C1519255
Event Course SAE
Beschrijving

Event Course SAE

Datatype

integer

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C1519255
If event course, please note number of episodes
Beschrijving

Number of episodes

Datatype

integer

Alias
UMLS CUI [1,1]
C4086638
UMLS CUI [1,2]
C1519255
SAE intensity (maximum)
Beschrijving

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

Datatype

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1519255
Action Taken with Respect to Investigational Drug
Beschrijving

Action Taken

Datatype

integer

Alias
UMLS CUI [1]
C1547656
Was study medication reintroduced (or dose increased)?
Beschrijving

If study medication was interrupted, stopped or dose reduced

Datatype

text

Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C0580673
UMLS CUI [2,1]
C3854006
UMLS CUI [2,2]
C1611744
If study medication reintroduced, did SAE recur?
Beschrijving

SAE recur

Datatype

text

Alias
UMLS CUI [1,1]
C0034897
UMLS CUI [1,2]
C1519255
Relationship to Investigational Drug
Beschrijving

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

Datatype

integer

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C3854006
Corrective Therapy
Beschrijving

If "Yes", record details in the Concomitant Medication

Datatype

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1519255
Was subject withdrawn due to this specific SAE?
Beschrijving

Subject withdrawn

Datatype

text

Alias
UMLS CUI [1]
C0422727
Did the SAE abate?
Beschrijving

SAE abate

Datatype

text

Alias
UMLS CUI [1,1]
C3853704
UMLS CUI [1,2]
C1519255
SAE, reason
Beschrijving

SAE, reason

Alias
UMLS CUI-1
C0392360
UMLS CUI-2
C1519255
Results in death
Beschrijving

Results in death

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C1519255
Life threatening
Beschrijving

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.

Datatype

boolean

Alias
UMLS CUI [1]
C1517874
Requires hospitalisation or prolongation of existing hospitalization
Beschrijving

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.

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0019993
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0745041
Results in disability/incapacity
Beschrijving

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.

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0231170
Congenital anomaly/birth defect
Beschrijving

Congenital anomaly/birth defect

Datatype

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C1519255
Other reason
Beschrijving

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.

Datatype

boolean

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1519255
If other reason, please specify
Beschrijving

Other reason, specification

Datatype

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
Assessment
Beschrijving

Assessment

Alias
UMLS CUI-1
C0220825
Protocol design or procedures (but not to study drug)
Beschrijving

The SAE is probably associated with:

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332281
UMLS CUI [1,2]
C0184661
Another condition (eg. condition under study intercurrent illness)
Beschrijving

The SAE is probably associated with:

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332281
UMLS CUI [1,2]
C2707304
Another drug
Beschrijving

The SAE is probably associated with:

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332281
UMLS CUI [1,2]
C1115771
If there is an association, Please specify
Beschrijving

Please specify

Datatype

text

Alias
UMLS CUI [1]
C1521902
Relevant Laboratory Data
Beschrijving

Relevant Laboratory Data

Alias
UMLS CUI-1
C0022877
Laboratory Test
Beschrijving

Laboratory Test

Datatype

text

Alias
UMLS CUI [1]
C3891717
Date of test
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0011008
Laboratory Value
Beschrijving

Laboratory Value

Datatype

float

Alias
UMLS CUI [1]
C0587081
Units
Beschrijving

Units

Datatype

text

Alias
UMLS CUI [1]
C1519795
Normal Range
Beschrijving

Normal Range

Datatype

text

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0587081
Details SAE
Beschrijving

Details SAE

Alias
UMLS CUI-1
C1522508
UMLS CUI-2
C1519255
Remarks SAE
Beschrijving

Please provide a brief narrative description of the SAE, attaching extra pages eg. hospital discharge summary if necessary

Datatype

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1519255
If applicable, was randomization code broken at investigational site?
Beschrijving

Randomization code broken

Datatype

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0443289
Randomisation/Study Medication Number
Beschrijving

Randomisation/Study Medication Number

Datatype

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0600091
Investigator's Signature
Beschrijving

(confirming that the above data are accurate and complete)

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Print name
Beschrijving

Print name

Datatype

text

Alias
UMLS CUI [1,1]
C1555464
UMLS CUI [1,2]
C0027365
GSK Medical Monitor's Signature
Beschrijving

GSK Medical Monitor's Signature

Datatype

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C1708968
UMLS CUI [1,3]
C0008961
Date of Medical Monitor's signature
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C1708968
UMLS CUI [1,3]
C0008961
Print Name of Medical Monitor
Beschrijving

Print Name of Medical Monitor

Datatype

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1708968
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Similar models

Serious Adverse Event (SAE)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID
text
C3846158 (UMLS CUI [1])
GSK Receipt Date
Item
GSK Receipt Date
date
C2985846 (UMLS CUI [1])
Item Group
Serious Adverse Event (SAE)
C1519255 (UMLS CUI-1)
Person Reporting SAE
Item
Person Reporting SAE
text
C0335038 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
AEGIS number
Item
AEGIS number
text
C0600091 (UMLS CUI [1,1])
C0679918 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Serious Adverse Event
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Comment for GSK
Item
Comment for GSK
text
C0947611 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
SAE onset Date
Item
SAE onset Date
date
C0574845 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE onset Time
Item
SAE onset Time
time
C0449244 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE end Date
Item
SAE end Date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE end Time
Item
SAE end Time
time
C1522314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome SAE
integer
C1624730 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Outcome
Code List
Outcome SAE
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
Event Course SAE
integer
C0750729 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Event Course
Code List
Event Course SAE
CL Item
Intermittent (1)
CL Item
Constant (2)
Number of episodes
Item
If event course, please note number of episodes
integer
C4086638 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
SAE intensity (maximum)
integer
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Intensity (maximum)
Code List
SAE intensity (maximum)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Action Taken with Respect to Investigational Drug
integer
C1547656 (UMLS CUI [1])
Action Taken
Code List
Action Taken with Respect to Investigational Drug
CL Item
None (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
CL Item
Drug stopped (5)
Item
Was study medication reintroduced (or dose increased)?
text
C3854006 (UMLS CUI [1,1])
C0580673 (UMLS CUI [1,2])
C3854006 (UMLS CUI [2,1])
C1611744 (UMLS CUI [2,2])
Study medication reintroduced
Code List
Was study medication reintroduced (or dose increased)?
CL Item
Yes (Y)
CL Item
No (N)
Item
If study medication reintroduced, did SAE recur?
text
C0034897 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE recur
Code List
If study medication reintroduced, did SAE recur?
CL Item
Yes (Y)
CL Item
No (N)
Item
Relationship to Investigational Drug
integer
C0439849 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Relationship
Code List
Relationship to Investigational Drug
CL Item
Not related (1)
CL Item
Unlikely (2)
CL Item
Suspected (reasonable possibility) (3)
CL Item
Probable (4)
Item
Corrective Therapy
text
C0087111 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Corrective Therapy
Code List
Corrective Therapy
CL Item
Yes (Y)
CL Item
No (N)
Item
Was subject withdrawn due to this specific SAE?
text
C0422727 (UMLS CUI [1])
Subject withdrawn
Code List
Was subject withdrawn due to this specific SAE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Did the SAE abate?
text
C3853704 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Did the SAE abate?
Code List
Did the SAE abate?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
SAE, reason
C0392360 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Results in death
Item
Results in death
boolean
C0011065 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Life threatening
Item
Life threatening
boolean
C1517874 (UMLS CUI [1])
Requires hospitalisation or prolongation of existing hospitalization
Item
Requires hospitalisation or prolongation of existing hospitalization
boolean
C1519255 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
Results in disability/incapacity
Item
Results in disability/incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
Congenital anomaly/birth defect
Item
Congenital anomaly/birth defect
boolean
C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other reason
Item
Other reason
boolean
C3840932 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other reason, specification
Item
If other reason, please specify
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Assessment
C0220825 (UMLS CUI-1)
Association with protocol design
Item
Protocol design or procedures (but not to study drug)
boolean
C0332281 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
Association with another condition
Item
Another condition (eg. condition under study intercurrent illness)
boolean
C0332281 (UMLS CUI [1,1])
C2707304 (UMLS CUI [1,2])
Association with another drug
Item
Another drug
boolean
C0332281 (UMLS CUI [1,1])
C1115771 (UMLS CUI [1,2])
Please specify
Item
If there is an association, Please specify
text
C1521902 (UMLS CUI [1])
Item Group
Relevant Laboratory Data
C0022877 (UMLS CUI-1)
Laboratory Test
Item
Laboratory Test
text
C3891717 (UMLS CUI [1])
Date of test
Item
Date of test
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory Value
Item
Laboratory Value
float
C0587081 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Normal Range
Item
Normal Range
text
C0086715 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item Group
Details SAE
C1522508 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Remarks SAE
Item
Remarks SAE
text
C0678257 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
If applicable, was randomization code broken at investigational site?
text
C0034656 (UMLS CUI [1,1])
C0443289 (UMLS CUI [1,2])
Randomization code broken
Code List
If applicable, was randomization code broken at investigational site?
CL Item
Yes (Y)
CL Item
No (N)
Randomisation/Study Medication Number
Item
Randomisation/Study Medication Number
text
C0034656 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Print name
Item
Print name
text
C1555464 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
GSK Medical Monitor's Signature
Item
GSK Medical Monitor's Signature
text
C1519316 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
Date of Medical Monitor's signature
Item
Date of Medical Monitor's signature
date
C1519316 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
Print Name of Medical Monitor
Item
Print Name of Medical Monitor
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
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