ID

36015

Beschreibung

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.

Stichworte

Versionen (1)
  1. 09.04.19 09.04.19 -
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GlaxoSmithKline

Hochgeladen am

9. April 2019

DOI

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

Englisch

Serious Adverse Event (SAE)

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Beschreibung

Subject No.

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Beschreibung

Panel ID

Datentyp

text

Alias
UMLS CUI [1]
C3846158
GSK Receipt Date
Beschreibung

day month year

Datentyp

date

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

Serious Adverse Event (SAE)

Alias
UMLS CUI-1
C1519255
Person Reporting SAE
Beschreibung

(Please print clearly)

Datentyp

text

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

GSK use

Datentyp

text

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

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

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Comment for GSK
Beschreibung

Comment for GSK

Datentyp

text

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

day month year

Datentyp

date

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

00:00-23:9

Datentyp

time

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

day month year (If ongoing please leave blank)

Datentyp

date

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

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

Datentyp

time

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

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

Datentyp

integer

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

Event Course SAE

Datentyp

integer

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

Number of episodes

Datentyp

integer

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

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

Datentyp

integer

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

Action Taken

Datentyp

integer

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

If study medication was interrupted, stopped or dose reduced

Datentyp

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?
Beschreibung

SAE recur

Datentyp

text

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

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

Datentyp

integer

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

If "Yes", record details in the Concomitant Medication

Datentyp

text

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

Subject withdrawn

Datentyp

text

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

SAE abate

Datentyp

text

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

SAE, reason

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

Results in death

Datentyp

boolean

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

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]
C1517874
Requires hospitalisation or prolongation of existing hospitalization
Beschreibung

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.

Datentyp

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
Beschreibung

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.

Datentyp

boolean

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

Congenital anomaly/birth defect

Datentyp

boolean

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

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

boolean

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

Other reason, specification

Datentyp

text

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

Assessment

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

The SAE is probably associated with:

Datentyp

boolean

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

The SAE is probably associated with:

Datentyp

boolean

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

The SAE is probably associated with:

Datentyp

boolean

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

Please specify

Datentyp

text

Alias
UMLS CUI [1]
C1521902
Relevant Laboratory Data
Beschreibung

Relevant Laboratory Data

Alias
UMLS CUI-1
C0022877
Laboratory Test
Beschreibung

Laboratory Test

Datentyp

text

Alias
UMLS CUI [1]
C3891717
Date of test
Beschreibung

day month year

Datentyp

date

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

Laboratory Value

Datentyp

float

Alias
UMLS CUI [1]
C0587081
Units
Beschreibung

Units

Datentyp

text

Alias
UMLS CUI [1]
C1519795
Normal Range
Beschreibung

Normal Range

Datentyp

text

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

Details SAE

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

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

Datentyp

text

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

Randomization code broken

Datentyp

text

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

Randomisation/Study Medication Number

Datentyp

text

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

(confirming that the above data are accurate and complete)

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Beschreibung

day month year

Datentyp

date

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

Print name

Datentyp

text

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

GSK Medical Monitor's Signature

Datentyp

text

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

day month year

Datentyp

date

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

Print Name of Medical Monitor

Datentyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1708968
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Ähnliche Modelle

Serious Adverse Event (SAE)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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