ID

24330

Descripción

GSK study: Ropinirole in RLS patients 101468/243 - Serious Adverse Experience 3 and 4 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 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

Palabras clave

Versiones (1)
  1. 30/7/17 30/7/17 -
Titular de derechos de autor

glaxoSmithKline

Subido en

30 de julio de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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GSK study: Ropinirole in RLS patients 101468/243 - Serious Adverse Experience 3 and 4

Inglés

GSK study: Ropinirole in RLS patients 101468/243 - Serious Adverse Experience 3 and 4

1 formularios  
Serious Adverse Experience
Descripción

Serious Adverse Experience

Alias
UMLS CUI-1
C1519255
Person Reporting Serious Adverse Experience
Descripción

Person Reporting Serious Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0335038
Serious Adverse Experience
Descripción

Serious Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1]
C1519255
Onset Date and Time
Descripción

Onset Date and Time

Tipo de datos

datetime

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

(If ongoing please leave blank)

Tipo de datos

datetime

Alias
UMLS CUI [1]
C2826793
Outcome
Descripción

If patient died, please complete Form D

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1519255
Experience Course
Descripción

serious adverse event course

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0750729
Number of episodes
Descripción

only answer if previous answer was 'intermittent'

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Descripción

Intensity concerning the maximum

Tipo de datos

integer

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

Action Taken with Respect to Investigational Drug

Tipo de datos

integer

Alias
UMLS CUI [1]
C2826626
Relationship to Investigational Drug
Descripción

Relationship to Investigational Drug

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Corrective Therapy
Descripción

If 'Yes', record details in the Concomitant Medication or Medical Procedures section

Tipo de datos

integer

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

Patient withdrawn due to serious adverse event

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1519255
AEGIS number
Descripción

AEGIS number

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0600091
Does the adverse experience result in death?
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1320832
Is the adverse experience life threatening?
Descripción

Adverse experience is life threatening

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1517874
Does the serious adverse experience results in hospitalisation or prolongation of existing hospitalisation?
Descripción

serious adverse experience results in hospitalisation or prolongation of existing hospitalisation?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0019993
Does the serious adverse experience result in disability or incapacity?
Descripción

serious adverse experience result in disability or incapacity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0231170
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C3176592
Does the serious adverse event result in congenital abnormality or birth defect?
Descripción

serious adverse event result in congenital abnormality or birth defect

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1546948
Is there another reason for categorisation to serious adverse experience?
Descripción

other reason for serious adverse event

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3840932
If there is another reason for categorisation to serious adverse experience, please specify.
Descripción

other reason for serious adverse event

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3840932
Did the serious adverse experience abate?
Descripción

abatement of adverse event

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0547047
Was study medication reintroduced (or dose increased)?
Descripción

Only answer if study medication was interrupted, stopped or dose reduced.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1611744
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0580673
If yes, did the serious adverse experience recur?
Descripción

Only answer, if answer to previous question was 'yes'.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034897
The serious adverse event is probably associated with the protocol design or procedures (but not to study drug).
Descripción

SAE association with study protocol or procedures

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1514572
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0199171
Please specify association with study protocol or procedures.
Descripción

specify association with study protocol or procedures

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1514572
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0199171
The serious adverse experience is probably associated with another condition.
Descripción

eg. condition under study, intercurrent illness

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C0205394
If the serious adverse experience is probably associated with another condition, please specify the condition.
Descripción

Specify other condition associated with SAE

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C0205394
The serious adverse experience is associated with another drug.
Descripción

SAE associated with another drug

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0205394
If the serious adverse experience is associated with another drug, please specify.
Descripción

Specify other drug associated with SAE

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0205394
Relevant laboratory test 2
Descripción

Please provide relevant abnormal laboratory data below

Tipo de datos

text

Alias
UMLS CUI [1]
C0022885
Date of laboratory test 2
Descripción

Date of laboratory test 2

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0022885
Value of laboratory test 2
Descripción

laboratory test result 2

Tipo de datos

float

Alias
UMLS CUI [1]
C0587081
Unit of laboratory test 2
Descripción

Unit of laboratory test 2

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0439148
Normal range of laboratory test 2
Descripción

Normal range of laboratory test 2

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0086715
Relevant laboratory test 3
Descripción

Please provide relevant abnormal laboratory data below

Tipo de datos

text

Alias
UMLS CUI [1]
C0022885
Date of laboratory test 3
Descripción

Date of laboratory test 3

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0022885
Value of laboratory test 3
Descripción

laboratory test result 3

Tipo de datos

float

Alias
UMLS CUI [1]
C0587081
Unit of laboratory test 3
Descripción

Unit of laboratory test 3

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0439148
Normal range of laboratory test 3
Descripción

Normal range of laboratory test 3

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0086715
Relevant laboratory test 1
Descripción

Please provide relevant abnormal laboratory data below

Tipo de datos

text

Alias
UMLS CUI [1]
C0022885
Relevant laboratory test 4
Descripción

Please provide relevant abnormal laboratory data below

Tipo de datos

text

Alias
UMLS CUI [1]
C0022885
Date of laboratory test 1
Descripción

Date of laboratory test 1

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0022885
Laboratory test date 4
Descripción

Laboratory test date 4

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0022885
Value of laboratory test 1
Descripción

laboratory test result 1

Tipo de datos

float

Alias
UMLS CUI [1]
C0587081
Laboratory test value 4
Descripción

laboratory test result 4

Tipo de datos

float

Alias
UMLS CUI [1]
C0587081
Unit of laboratory test 1
Descripción

Unit of laboratory test 1

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0439148
Unit of laboratory test 4
Descripción

Unit of laboratory test 4

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0439148
Normal range of laboratory test 1
Descripción

Normal range of laboratory test 1

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0086715
Normal range of laboratory test 4
Descripción

Normal range of laboratory test 4

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0086715
Remarks
Descripción

Remarks (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]
C1519255
UMLS CUI [1,2]
C0947611
If applicable, was randomisation code broken at investigational site?
Descripción

If applicable, was randomisation code broken at investigational site?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3897778
UMLS CUI [1,2]
C1272691
Randomisation Number (please do NOT enter the container number):
Descripción

Randomisation Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2986235
Investigator signature
Descripción

confirming that the above data are accurate and complete

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Investigator signature date
Descripción

Investigator signature date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Please PRINT Name
Descripción

Investigator name

Tipo de datos

text

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

GSK Medical Monitor’s Signature

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C1708968
Date of GSK Medical Monitor’s Signature
Descripción

Date of GSK Medical Monitor’s Signature

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1519316
UMLS CUI [1,3]
C1708968
Please PRINT Name
Descripción

GSK Medical Monitor’s name

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1547383
UMLS CUI [1,2]
C1708968
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Similar models

GSK study: Ropinirole in RLS patients 101468/243 - Serious Adverse Experience 3 and 4

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Serious Adverse Experience
C1519255 (UMLS CUI-1)
Person Reporting Serious Adverse Event
Item
Person Reporting Serious Adverse Experience
text
C1519255 (UMLS CUI [1,1])
C0335038 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Experience
text
C1519255 (UMLS CUI [1])
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 [1,1])
C1519255 (UMLS CUI [1,2])
Serious Adverse Event Outcome
Code List
Outcome
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
Experience Course
integer
C1519255 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
serious adverse event course
Code List
Experience Course
CL Item
intermittent (1)
CL Item
constant (2)
Number of episodes of adverse event
Item
Number of episodes
integer
C1519255 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Intensity of the serious adverse event
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
[1] b [2] b [3] b [4] b (1)
CL Item
[5] b (2)
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
Relationship to Investigational Drug
text
C1519255 (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
Related (5)
CL Item
Possibly related (6)
CL Item
Probably unrelated (7)
CL Item
Unrelated (1)
Item
Corrective Therapy
integer
C1519255 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Corrective therapy to adverse event
Code List
Corrective Therapy
CL Item
yes (1)
CL Item
no (2)
Patient withdrawn due to serious adverse event
Item
Was patient withdrawn due to this specific SAE ?
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
AEGIS number
Item
AEGIS number
text
C0237753 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Adverse event results in death
Item
Does the adverse experience result in death?
boolean
C1320832 (UMLS CUI [1])
Adverse experience is life threatening
Item
Is the adverse experience life threatening?
boolean
C1517874 (UMLS CUI [1])
serious adverse experience results in hospitalisation or prolongation of existing hospitalisation?
Item
Does the serious adverse experience results in hospitalisation or prolongation of existing hospitalisation?
boolean
C1519255 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
serious adverse experience result in disability or incapacity
Item
Does the serious adverse experience result in disability or incapacity?
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C3176592 (UMLS CUI [2,2])
serious adverse event result in congenital abnormality or birth defect
Item
Does the serious adverse event result in congenital abnormality or birth defect?
boolean
C1519255 (UMLS CUI [1,1])
C1546948 (UMLS CUI [1,2])
other reason for serious adverse event
Item
Is there another reason for categorisation to serious adverse experience?
boolean
C1519255 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
other reason for serious adverse event
Item
If there is another reason for categorisation to serious adverse experience, please specify.
text
C1519255 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
abatement of adverse event
Item
Did the serious adverse experience abate?
boolean
C1519255 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
Item
Was study medication reintroduced (or dose increased)?
integer
C0304229 (UMLS CUI [1,1])
C1611744 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0580673 (UMLS CUI [2,2])
study medication
Code List
Was study medication reintroduced (or dose increased)?
CL Item
yes (1)
CL Item
no (2)
CL Item
not applicable (9)
Item
If yes, did the serious adverse experience recur?
integer
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
recur of adverse event
Code List
If yes, did the serious adverse experience recur?
CL Item
yes (1)
CL Item
no (2)
CL Item
not applicable (9)
SAE association with study protocol or procedures
Item
The serious adverse event is probably associated with the protocol design or procedures (but not to study drug).
boolean
C1519255 (UMLS CUI [1,1])
C1514572 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0199171 (UMLS CUI [2,2])
specify association with study protocol or procedures
Item
Please specify association with study protocol or procedures.
text
C1519255 (UMLS CUI [1,1])
C1514572 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0199171 (UMLS CUI [2,2])
SAE associated with another condition
Item
The serious adverse experience is probably associated with another condition.
boolean
C1519255 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Specify other condition associated with SAE
Item
If the serious adverse experience is probably associated with another condition, please specify the condition.
text
C1519255 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
SAE associated with another drug
Item
The serious adverse experience is associated with another drug.
boolean
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Specify other drug associated with SAE
Item
If the serious adverse experience is associated with another drug, please specify.
text
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Relevant laboratory test 2
Item
Relevant laboratory test 2
text
C0022885 (UMLS CUI [1])
Date of laboratory test 2
Item
Date of laboratory test 2
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
laboratory test result 2
Item
Value of laboratory test 2
float
C0587081 (UMLS CUI [1])
Unit of laboratory test 2
Item
Unit of laboratory test 2
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Normal range of laboratory test 2
Item
Normal range of laboratory test 2
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Relevant laboratory test 3
Item
Relevant laboratory test 3
text
C0022885 (UMLS CUI [1])
Date of laboratory test 3
Item
Date of laboratory test 3
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
laboratory test result 3
Item
Value of laboratory test 3
float
C0587081 (UMLS CUI [1])
Unit of laboratory test 3
Item
Unit of laboratory test 3
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Normal range of laboratory test 3
Item
Normal range of laboratory test 3
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Relevant laboratory test 1
Item
Relevant laboratory test 1
text
C0022885 (UMLS CUI [1])
Relevant laboratory test 4
Item
Relevant laboratory test 4
text
C0022885 (UMLS CUI [1])
Date of laboratory test 1
Item
Date of laboratory test 1
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Laboratory test date 4
Item
Laboratory test date 4
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
laboratory test result 1
Item
Value of laboratory test 1
float
C0587081 (UMLS CUI [1])
laboratory test result 4
Item
Laboratory test value 4
float
C0587081 (UMLS CUI [1])
Unit of laboratory test 1
Item
Unit of laboratory test 1
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Unit of laboratory test 4
Item
Unit of laboratory test 4
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Normal range of laboratory test 1
Item
Normal range of laboratory test 1
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Normal range of laboratory test 4
Item
Normal range of laboratory test 4
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
SAE Remarks
Item
Remarks
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
If applicable, was randomisation code broken at investigational site?
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 Number (please do NOT enter the container number):
integer
C2986235 (UMLS CUI [1])
investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Investigator signature date
Item
Investigator signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
Please PRINT Name
text
C2826892 (UMLS CUI [1])
GSK Medical Monitor’s Signature
Item
GSK Medical Monitor’s Signature
text
C1519316 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Date of GSK Medical Monitor’s Signature
Item
Date of GSK Medical Monitor’s Signature
date
C0011008 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,3])
GSK Medical Monitor’s name
Item
Please PRINT Name
text
C1547383 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
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