ID

27235

Beschreibung

Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Parkinson Disease Module: Serious Adverse Experience

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  1. 03.11.17 03.11.17 -
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GlaxoSmithKline

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3. November 2017

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GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188

Englisch

Serious Adverse Experience

1 Formulare  
Serious Adverse Experience (SAE)
Beschreibung

Serious Adverse Experience (SAE)

Alias
UMLS CUI-1
C1519255
Person Reporting SAE
Beschreibung

Person Reporting SAE

Datentyp

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C1519255
AEGIS Number
Beschreibung

AEGIS Number

Datentyp

integer

Alias
UMLS CUI [1]
C0600091
Serious Adverse Experience
Beschreibung

Serious Adverse Experience

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Reasons for considering a serious AE
Beschreibung

Reasons for considering a serious AE

Datentyp

integer

Alias
UMLS CUI [1]
C1519255
Onset Date and Time SAE
Beschreibung

Onset Date and Time SAE

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C1301880
End Date and Time (if ongoing please leave blank) SAE
Beschreibung

End Date and Time SAE

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Outcome SAE
Beschreibung

If patient died, please complete Form D

Datentyp

integer

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

Experience Course

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0750729
If experience course intermittent, please fill in no. of episodes
Beschreibung

Number of episodes

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C4086638
Intensity SAE
Beschreibung

Intensity SAE

Datentyp

integer

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

Action Taken with Respect to Investigational Drug

Datentyp

integer

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C1519255
Did the SAE abate?
Beschreibung

Abatement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0547047
If Investgational product was interrupted, stopped or dose reduced: Was investigational product reintroduced (or dose increased)?
Beschreibung

Reintroduction of product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0376495
UMLS CUI [1,2]
C0304229
UMLS CUI [2]
C1519255
If yes, did SAE recur?
Beschreibung

Recurrence of SAE

Datentyp

boolean

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

Relationship to Investigational Drug

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
The SAE is probably associated with
Beschreibung

SAE association

Datentyp

integer

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1710056
Please specify association
Beschreibung

SAE association

Datentyp

text

Alias
UMLS CUI [1,1]
C0085978
UMLS CUI [1,2]
C1710056
Corrective Therapy SAE
Beschreibung

(If "Yes", record details in the Concomitant Medication or Medical Procedures section)

Datentyp

boolean

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

Withdrawal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
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]
C1519255
UMLS CUI [1,2]
C0947611
If applicable, was randomisation code broken at investigational site?
Beschreibung

randomisation code broken

Datentyp

boolean

Alias
UMLS CUI [1]
C0034656
UMLS CUI [2]
C1519255
Randomisation Number
Beschreibung

Randomisation Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
UMLS CUI [2]
C1519255
Investigator’s Signature
Beschreibung

Investigator’s Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
UMLS CUI [2]
C1519255
Relevant Laboratory Data
Beschreibung

Relevant Laboratory Data

Alias
UMLS CUI-1
C0587081
UMLS CUI-2
C1519255
Test
Beschreibung

Test

Datentyp

text

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

Date of test

Datentyp

date

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

Value of test

Datentyp

text

Alias
UMLS CUI [1,1]
C1522609
UMLS CUI [1,2]
C0587081
Units of test
Beschreibung

Units of test

Datentyp

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0587081
Normal Range of test
Beschreibung

Normal Range of test

Datentyp

text

Alias
UMLS CUI [1,1]
C0086715
UMLS CUI [1,2]
C0587081
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Ähnliche Modelle

Serious Adverse Experience

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Serious Adverse Experience (SAE)
C1519255 (UMLS CUI-1)
Person Reporting SAE
Item
Person Reporting SAE
text
C0008961 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
AEGIS Number
Item
AEGIS Number
integer
C0600091 (UMLS CUI [1])
Serious Adverse Experience
Item
Serious Adverse Experience
text
C1519255 (UMLS CUI [1])
Item
Reasons for considering a serious AE
integer
C1519255 (UMLS CUI [1])
Reasons for considering a serious AE
Code List
Reasons for considering a serious AE
CL Item
fatal (1)
CL Item
life threatening (2)
CL Item
disabling/incapacitating (3)
CL Item
results in hospitalisation (excluding elective surgery or routine clinical procedures) (4)
CL Item
hospitalisation prolonged (5)
CL Item
congenital abnormality (6)
CL Item
cancer (7)
CL Item
overdose (8)
CL Item
Investigator considers serious or a significant hazard, contraindication, side effect or precaution (9)
Onset Date and Time SAE
Item
Onset Date and Time SAE
datetime
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
End Date and Time SAE
Item
End Date and Time (if ongoing please leave blank) SAE
datetime
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Outcome SAE
integer
C1705586 (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
Experience Course
integer
C1519255 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Experience Course
Code List
Experience Course
CL Item
Intermittend -> Please fill in No. of episodes below (1)
CL Item
Constant (2)
Number of episodes
Item
If experience course intermittent, please fill in no. of episodes
integer
C1519255 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity SAE
integer
C1710066 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Intensity
Code List
Intensity SAE
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Action Taken with Respect to Investigational Drug
integer
C2826626 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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)
Abatement
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
Reintroduction of product
Item
If Investgational product was interrupted, stopped or dose reduced: Was investigational product reintroduced (or dose increased)?
boolean
C0376495 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Recurrence of SAE
Item
If yes, did SAE recur?
boolean
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Item
Relationship to Investigational Drug
integer
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 (1)
CL Item
Possibly related (2)
CL Item
Probably unrelated (3)
CL Item
Unrelated (4)
Item
The SAE is probably associated with
integer
C0085978 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Assessment
Code List
The SAE is probably associated with
CL Item
Protocol design or procedures (but not to study drug) -> please specify below (1)
CL Item
Another condition (e.g condition under study, intercurrent illness) -> please specify below (2)
CL Item
Another drug (please specify below) (3)
SAE association
Item
Please specify association
text
C0085978 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Corrective Therapy SAE
Item
Corrective Therapy SAE
boolean
C1519255 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Withdrawal
Item
Was patient withdrawn due to this specific SAE?
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Remarks SAE
Item
Remarks SAE
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
randomisation code broken
Item
If applicable, was randomisation code broken at investigational site?
boolean
C0034656 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
Investigator’s Signature
Item
Investigator’s Signature
text
C2346576 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Item Group
Relevant Laboratory Data
C0587081 (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
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Value of test
Item
Value of test
text
C1522609 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Units of test
Item
Units of test
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Normal Range of test
Item
Normal Range of test
text
C0086715 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
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