ID

25640

Beskrivning

Study part: Serious Adverse Events (SAE). 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. 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. Study ID: 101468/201. Clinical Study ID: 101468/201

Nyckelord

Versioner (2)
  1. 2017-09-08 2017-09-08 -
  2. 2019-05-10 2019-05-10 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

8 september 2017

DOI

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Creative Commons BY-NC 3.0
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Serious Adverse Events (SAE) Ropinirole Restless Legs Syndrome 101468/201

Engelsk

Serious Adverse Experiences (SAE)

1 Formulär  
SERIOUS ADVERSE EVENT (SAE)
Beskrivning

SERIOUS ADVERSE EVENT (SAE)

Alias
UMLS CUI-1
C1519255
Subject number
Beskrivning

Subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Person Reporting SAE
Beskrivning

Person Reporting SAE

Datatyp

text

Alias
UMLS CUI [1]
C0008961
AEGIS Number
Beskrivning

AEGIS Number

Datatyp

integer

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

Serious Adverse Experience

Datatyp

text

Alias
UMLS CUI [1]
C1519255
Specify reason(s) for considering this a serious AE. Mark all that apply- Results in death
Beskrivning

reason death

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0011065
Specify reason(s) for considering this a serious AE. Mark all that apply- life threatening
Beskrivning

reason life threatening

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C2826244
Specify reason(s) for considering this a serious AE. Mark all that apply- results in hospitalisation or prolongation of existing hospitalisation
Beskrivning

reason hospitalization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0019993
Specify reason(s) for considering this a serious AE. Mark all that apply- results in disability/incapacity
Beskrivning

reason disability

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0231170
Specify reason(s) for considering this a serious AE. Mark all that apply- congenital abnormality/birth defect
Beskrivning

reason congenital abnormality

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0000768
Specify reason(s) for considering this a serious AE. Mark all that apply- other (Please specify)
Beskrivning

reason other

Datatyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0205394
Onset Date and Time
Beskrivning

Onset Date and Time

Datatyp

datetime

Alias
UMLS CUI [1]
C2826806
End Date and Time
Beskrivning

End Date and Time

Datatyp

datetime

Alias
UMLS CUI [1]
C2826793
Outcome
Beskrivning

Outcome

Datatyp

integer

Alias
UMLS CUI [1]
C1705586
Event course
Beskrivning

Experience Course

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
No. of episodes
Beskrivning

Number of episodes

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Beskrivning

Intensity

Datatyp

integer

Alias
UMLS CUI [1]
C1710066
Action Taken with Respect to Investigational Drug
Beskrivning

Action Taken with Respect to Investigational Drug

Datatyp

integer

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

SAE abate

Datatyp

boolean

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)?
Beskrivning

dosage change

Datatyp

boolean

Alias
UMLS CUI [1]
C0420247
If yes, did SAE recur?
Beskrivning

Serious Adverse Experiences recurrence

Datatyp

boolean

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

Relationship to Investigational Drug

Datatyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
The SAE is probably associated with:
Beskrivning

Relationship to Investigational Drug

Datatyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Please specify
Beskrivning

specify

Datatyp

text

Alias
UMLS CUI [1]
C1521902
Corrective Therapy
Beskrivning

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

Datatyp

boolean

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

patient withdrawn due to this specific AE

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1518404
RELEVANT LABORATORY DATA
Beskrivning

RELEVANT LABORATORY DATA

Alias
UMLS CUI-1
C0022877
Test
Beskrivning

Test

Datatyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0332307
Date
Beskrivning

Date

Datatyp

text

Alias
UMLS CUI [1]
C0011008
Value
Beskrivning

Value

Datatyp

text

Alias
UMLS CUI [1]
C1522609
Units
Beskrivning

Units

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Normal Range
Beskrivning

Normal Range

Datatyp

text

Alias
UMLS CUI [1]
C0086715
Remarks
Beskrivning

Remarks

Datatyp

text

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

randomisation code broken

Datatyp

boolean

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

Randomisation Number

Datatyp

integer

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

Investigators Signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Please PRINT Name
Beskrivning

name

Datatyp

text

Alias
UMLS CUI [1]
C0027365
SB Medical Monitor’s Signature:
Beskrivning

Medical Monitor’s Signature

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Please PRINT Name
Beskrivning

Name

Datatyp

text

Alias
UMLS CUI [1]
C0027365
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Serious Adverse Experiences (SAE)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
SERIOUS ADVERSE EVENT (SAE)
C1519255 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (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
Specify reason(s) for considering this a serious AE. Mark all that apply- Results in death
boolean
C0392360 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
reason life threatening
Item
Specify reason(s) for considering this a serious AE. Mark all that apply- life threatening
boolean
C0392360 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
reason hospitalization
Item
Specify reason(s) for considering this a serious AE. Mark all that apply- results in hospitalisation or prolongation of existing hospitalisation
boolean
C0392360 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
reason disability
Item
Specify reason(s) for considering this a serious AE. Mark all that apply- results in disability/incapacity
boolean
C0392360 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
reason congenital abnormality
Item
Specify reason(s) for considering this a serious AE. Mark all that apply- congenital abnormality/birth defect
boolean
C0392360 (UMLS CUI [1,1])
C0000768 (UMLS CUI [1,2])
reason other
Item
Specify reason(s) for considering this a serious AE. Mark all that apply- other (Please specify)
text
C0392360 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Onset Date and Time
Item
Onset Date and Time
datetime
C2826806 (UMLS CUI [1])
End Date and Time
Item
End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
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
No. of episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C1710066 (UMLS CUI [1])
Intensity
Code List
Intensity (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)
SAE abate
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
dosage change
Item
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
boolean
C0420247 (UMLS CUI [1])
Serious Adverse Experiences recurrence
Item
If yes, did SAE recur?
boolean
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
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
The SAE is probably associated with:
text
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
undefined item
Code List
The SAE is probably associated with:
CL Item
Protocol design or procedures (Protocol design or procedures)
CL Item
Another condition (eg, condition under study, intercurrent illness) (Another condition (eg, condition under study, intercurrent illness))
CL Item
Another drug (Another drug)
specify
Item
Please specify
text
C1521902 (UMLS CUI [1])
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
patient withdrawn due to this specific AE
Item
Was patient withdrawn due to this specific AE?
boolean
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item Group
RELEVANT LABORATORY DATA
C0022877 (UMLS CUI-1)
Test
Item
Test
text
C0022885 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Date
Item
Date
text
C0011008 (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])
randomisation code broken
Item
If applicable, was randomisation code broken at investigational site?
boolean
C3897778 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
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
Item
Date
date
C0011008 (UMLS CUI [1])
name
Item
Please PRINT Name
text
C0027365 (UMLS CUI [1])
Medical Monitor’s Signature
Item
SB Medical Monitor’s Signature:
text
C2346576 (UMLS CUI [1])
Name
Item
Please PRINT Name
text
C0027365 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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