ID

36391

Description

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.

Keywords

Versions (2)
  1. 9/8/17 9/8/17 -
  2. 5/10/19 5/10/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 10, 2019

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License

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

English

Serious Adverse Experiences (SAE)

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
SERIOUS ADVERSE EVENT (SAE)
Description

SERIOUS ADVERSE EVENT (SAE)

Alias
UMLS CUI-1
C1519255
Person Reporting SAE
Description

Person Reporting SAE

Data type

text

Alias
UMLS CUI [1]
C0008961
AEGIS Number
Description

AEGIS Number

Data type

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0600091
Serious Adverse Event
Description

Serious Adverse Experience

Data type

text

Alias
UMLS CUI [1]
C1519255
Results in death
Description

Specify reason(s) for considering this a serious AE. Mark all that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0011065
Life threatening
Description

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.

Data type

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C2826244
Results in hospitalisation or prolongation of existing hospitalisation
Description

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.

Data type

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0019993
Results in disability/incapacity
Description

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.

Data type

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0231170
Congenital abnormality/birth defect
Description

Specify reason(s) for considering this a serious AE. Mark all that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0000768
If there is an other reason, please specify
Description

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.

Data type

text

Alias
UMLS CUI [1]
C3840932
Onset Date of SAE
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1519255
Onset Time of SAE
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0449244
UMLS CUI [1,2]
C1519255
End Date of SAE
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1519255
End Time of SAE
Description

00:00-23:59

Data type

time

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

NOTE: If subject died, please inform GSK within 24 hours and complete form D

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Event course
Description

Experience Course

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
If SAE is intermittent, please specify number of episodes
Description

Number of episodes

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4086638
Intensity of SAE (maximum)
Description

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.

Data type

integer

Alias
UMLS CUI [1,1]
C1710066
UMLS CUI [1,2]
C1519255
Action Taken with Respect to Investigational Drug
Description

Action Taken with Respect to Investigational Drug

Data type

integer

Alias
UMLS CUI [1]
C2826626
Did the SAE abate?
Description

SAE abate

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3853704
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
Description

dosage change of study medication

Data type

text

Alias
UMLS CUI [1,1]
C0420247
UMLS CUI [1,2]
C0304229
If study medication was reintroduced (or dose increased), did SAE recur?
Description

Serious Adverse Experiences recurrence

Data type

text

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

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.

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
If SAE is "not related" or "unlikely" related to investigational durg, please specify the probably association
Description

Relationship to Investigational Drug, Assessment

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
UMLS CUI [1,4]
C1516048
If there is a SAE association, please specify
Description

Another contition: eg, condition under study, intercurrent illness

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348235
Corrective Therapy
Description

If ‘Yes’, record details in the Concomitant Medication section and/or Healthcare Resource Utilisation form if appropriate

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was patient withdrawn due to this specific AE?
Description

Patient withdrawn due to this specific AE

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
Relevant laboratory data
Description

Relevant laboratory data

Alias
UMLS CUI-1
C0022877
UMLS CUI-2
C1519255
Test
Description

Test

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0332307
Date of test
Description

day month year

Data type

text

Alias
UMLS CUI [1]
C2826247
Value
Description

Value

Data type

text

Alias
UMLS CUI [1]
C1522609
Units
Description

Units

Data type

text

Alias
UMLS CUI [1]
C1519795
Normal Range
Description

Normal Range

Data type

text

Alias
UMLS CUI [1]
C0086715
Remarks
Description

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

Data type

text

Alias
UMLS CUI [1]
C0947611
If applicable, was randomisation code broken at investigational site?
Description

Randomisation code broken

Data type

text

Alias
UMLS CUI [1,1]
C3897778
UMLS CUI [1,2]
C1272691
Randomisation/Study medication number
Description

Randomisation Number

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Investigator’s Signature
Description

Confirming that the above data are accurate and complete

Data type

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Name of investigator
Description

Please PRINT Name

Data type

text

Alias
UMLS CUI [1]
C2826892
GSK Medical Monitor’s Signature
Description

Medical Monitor’s Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Name of GSK Medical Monitor
Description

Please PRINT Name

Data type

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1708968
Date of Medical Monitor’s signature
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C1708968
UMLS CUI [1,2]
C1519316
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Similar models

Serious Adverse Experiences (SAE)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
SERIOUS ADVERSE EVENT (SAE)
C1519255 (UMLS CUI-1)
Person Reporting SAE
Item
Person Reporting SAE
text
C0008961 (UMLS CUI [1])
AEGIS Number
Item
AEGIS Number
integer
C0237753 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Serious Adverse Experience
Item
Serious Adverse Event
text
C1519255 (UMLS CUI [1])
Reason: death
Item
Results in death
boolean
C0566251 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
Reason: life threatening
Item
Life threatening
boolean
C0566251 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Reason: hospitalization
Item
Results in hospitalisation or prolongation of existing hospitalisation
boolean
C0566251 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Reason: disability
Item
Results in disability/incapacity
boolean
C0566251 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
Reason: congenital abnormality
Item
Congenital abnormality/birth defect
boolean
C0566251 (UMLS CUI [1,1])
C0000768 (UMLS CUI [1,2])
Other reason
Item
If there is an other reason, please specify
text
C3840932 (UMLS CUI [1])
Onset Date of SAE
Item
Onset Date of SAE
date
C0574845 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Onset Time of SAE
Item
Onset Time of SAE
time
C0449244 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
End Date of SAE
Item
End Date of SAE
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
End Time of SAE
Item
End Time of SAE
time
C1522314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome of SAE
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Outcome
Code List
Outcome of SAE
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
Event course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Experience Course
Code List
Event course
CL Item
Intermittent (1)
CL Item
Constant (2)
Number of episodes
Item
If SAE is intermittent, please specify number of episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity of SAE (maximum)
integer
C1710066 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Intensity
Code List
Intensity of SAE (maximum)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Action Taken with Respect to Investigational Drug
integer
C2826626 (UMLS CUI [1])
Action Taken with Respect to Investigational Drug
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
Did the SAE abate?
text
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
SAE abate
Code List
Did the SAE abate?
CL Item
Yes (Y)
CL Item
No (N)
Item
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
text
C0420247 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
dosage change of study medication
Code List
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
CL Item
Yes (Y)
CL Item
No (N)
Item
If study medication was reintroduced (or dose increased), did SAE recur?
text
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Serious Adverse Experiences recurrence
Code List
If study medication was reintroduced (or dose increased), did SAE recur?
CL Item
Yes (Y)
CL Item
No (N)
Item
Relationship to Investigational Drug
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Relationship to Investigational Drug
Code List
Relationship to Investigational Drug
CL Item
Not related (1)
CL Item
Dose reduced  (2)
CL Item
Dose increased  (3)
CL Item
Drug interrupted/restarted (4)
CL Item
Drug stopped  (5)
Item
If SAE is "not related" or "unlikely" related to investigational durg, please specify the probably association
integer
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,4])
undefined item
Code List
If SAE is "not related" or "unlikely" related to investigational durg, please specify the probably association
CL Item
Protocol design or procedures (1)
CL Item
Another condition  (2)
CL Item
Another drug (3)
SAE association, Specification
Item
If there is a SAE association, please specify
text
C1519255 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Corrective Therapy
text
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Corrective Therapy
Code List
Corrective Therapy
CL Item
Yes (Y)
CL Item
No (N)
Item
Was patient withdrawn due to this specific AE?
text
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Patient withdrawn due to this specific AE
Code List
Was patient withdrawn due to this specific AE?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Relevant laboratory data
C0022877 (UMLS CUI-1)
C1519255 (UMLS CUI-2)
Test
Item
Test
text
C0022885 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Date of test
Item
Date of test
text
C2826247 (UMLS CUI [1])
Value
Item
Value
text
C1522609 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Normal Range
Item
Normal Range
text
C0086715 (UMLS CUI [1])
Remarks
Item
Remarks
text
C0947611 (UMLS CUI [1])
Item
If applicable, was randomisation code broken at investigational site?
text
C3897778 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Randomisation code broken
Code List
If applicable, was randomisation code broken at investigational site?
CL Item
Yes (Y)
CL Item
No (N)
Randomisation Number
Item
Randomisation/Study medication number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Investigators 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])
Name of investigator
Item
Name of investigator
text
C2826892 (UMLS CUI [1])
Medical Monitor’s Signature
Item
GSK Medical Monitor’s Signature
text
C2346576 (UMLS CUI [1])
Name of GSK Medical Monitor
Item
Name of GSK Medical Monitor
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Date of Medical Monitor’s signature
Item
Date of Medical Monitor’s signature
date
C1708968 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
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