ID

24330

Beschrijving

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

Trefwoorden

Versies (1)
  1. 30-07-17 30-07-17 -
Houder van rechten

glaxoSmithKline

Geüploaded op

30 juli 2017

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

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

Engels

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

1 Formulieren  
Serious Adverse Experience
Beschrijving

Serious Adverse Experience

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

Person Reporting Serious Adverse Event

Datatype

text

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

Serious Adverse Event

Datatype

text

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

Onset Date and Time

Datatype

datetime

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

(If ongoing please leave blank)

Datatype

datetime

Alias
UMLS CUI [1]
C2826793
Outcome
Beschrijving

If patient died, please complete Form D

Datatype

integer

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

serious adverse event course

Datatype

integer

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

only answer if previous answer was 'intermittent'

Datatype

integer

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

Intensity concerning the maximum

Datatype

integer

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

Action Taken with Respect to Investigational Drug

Datatype

integer

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

Relationship to Investigational Drug

Datatype

text

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

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

Datatype

integer

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

Patient withdrawn due to serious adverse event

Datatype

boolean

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

AEGIS number

Datatype

text

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

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

Datatype

boolean

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

Adverse experience is life threatening

Datatype

boolean

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

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

Datatype

boolean

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

serious adverse experience result in disability or incapacity

Datatype

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?
Beschrijving

serious adverse event result in congenital abnormality or birth defect

Datatype

boolean

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

other reason for serious adverse event

Datatype

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.
Beschrijving

other reason for serious adverse event

Datatype

text

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

abatement of adverse event

Datatype

boolean

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

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

Datatype

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?
Beschrijving

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

Datatype

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).
Beschrijving

SAE association with study protocol or procedures

Datatype

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.
Beschrijving

specify association with study protocol or procedures

Datatype

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.
Beschrijving

eg. condition under study, intercurrent illness

Datatype

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.
Beschrijving

Specify other condition associated with SAE

Datatype

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.
Beschrijving

SAE associated with another drug

Datatype

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.
Beschrijving

Specify other drug associated with SAE

Datatype

text

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

Please provide relevant abnormal laboratory data below

Datatype

text

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

Date of laboratory test 2

Datatype

date

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

laboratory test result 2

Datatype

float

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

Unit of laboratory test 2

Datatype

text

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

Normal range of laboratory test 2

Datatype

text

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

Please provide relevant abnormal laboratory data below

Datatype

text

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

Date of laboratory test 3

Datatype

date

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

laboratory test result 3

Datatype

float

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

Unit of laboratory test 3

Datatype

text

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

Normal range of laboratory test 3

Datatype

text

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

Please provide relevant abnormal laboratory data below

Datatype

text

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

Please provide relevant abnormal laboratory data below

Datatype

text

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

Date of laboratory test 1

Datatype

date

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

Laboratory test date 4

Datatype

date

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

laboratory test result 1

Datatype

float

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

laboratory test result 4

Datatype

float

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

Unit of laboratory test 1

Datatype

text

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

Unit of laboratory test 4

Datatype

text

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

Normal range of laboratory test 1

Datatype

text

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

Normal range of laboratory test 4

Datatype

text

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

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

If applicable, was randomisation code broken at investigational site?

Datatype

boolean

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

Randomisation Number

Datatype

integer

Alias
UMLS CUI [1]
C2986235
Investigator signature
Beschrijving

confirming that the above data are accurate and complete

Datatype

text

Alias
UMLS CUI [1]
C2346576
Investigator signature date
Beschrijving

Investigator signature date

Datatype

date

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

Investigator name

Datatype

text

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

GSK Medical Monitor’s Signature

Datatype

text

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

Date of GSK Medical Monitor’s Signature

Datatype

date

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

GSK Medical Monitor’s name

Datatype

text

Alias
UMLS CUI [1,1]
C1547383
UMLS CUI [1,2]
C1708968
Terug naar het begin van de pagina

Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial