ID

25684

Description

Study ID: 101468/191 Clinical Study ID: SKF-101468/191 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Ropinirole in Subjects with Restless Legs Syndrome (RLS) Suffering from Periodic Leg Movements of Sleep (PLMS) 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: Restless Legs Syndrome

Mots-clés

Versions (1)
  1. 09/09/2017 09/09/2017 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

9 septembre 2017

DOI

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Licence

Creative Commons BY-NC 3.0
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GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Serious Adverse Experiences (2) Form (Form 22)

Anglais

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Serious Adverse Experiences (2) Form (Form 22)

1 Formulaires  
General Information
Description

General Information

Center Number
Description

Center Number

Type de données

integer

Patient Number
Description

Patient Number

Type de données

integer

Patient Initials
Description

Patient Initials

Type de données

text

GSK Receipt Date
Description

GSK Receipt Date

Type de données

date

Serious Adverse Experience (SAE)
Description

Serious Adverse Experience (SAE)

Person Reporting SAE
Description

Person Reporting SAE

Type de données

text

AEGIS Number
Description

AEGIS Number

Type de données

integer

Serious Adverse Experience
Description

Serious Adverse Experience

Type de données

text

Reasons for considering a serious AE
Description

Reasons for considering a serious AE

Type de données

text

Specification of other reason for considering a serious AE
Description

Specification of other reason for considering a serious AE

Type de données

text

Onset Date and Time
Description

Onset Date and Time

Type de données

datetime

End Date and Time (if ongoing please leave blank)
Description

End Date and Time

Type de données

datetime

Outcome
Description

If patient died, please complete Form D

Type de données

text

Experience Course
Description

Experience Course

Type de données

text

If experience course intermittent, please fill in no. of episodes
Description

Number of episodes

Type de données

integer

Intensity (maximum)
Description

Intensity

Type de données

text

Action Taken with Respect to Investigational Drug
Description

Action Taken with Respect to Investigational Drug

Type de données

text

Did the SAE abate?
Description

Abatement

Type de données

boolean

If Investgational product was interrupted, stopped or dose reduced: Was investigational product reintroduced (or dose increased)?
Description

Reintroduction of product

Type de données

boolean

If yes, did SAE recur?
Description

Recurrence of SAE

Type de données

boolean

Relationship to Investigational Drug
Description

Relationship to Investigational Drug

Type de données

text

The SAE is probably associated with
Description

Assessment

Type de données

text

Please specify Assessment
Description

Specification of Assessment

Type de données

text

Corrective Therapy
Description

Corrective Therapy

Type de données

text

Was patient withdrawn due to this specific SAE?
Description

Withdrawal

Type de données

text

Relevant Laboratory Data
Description

Relevant Laboratory Data

Test
Description

Test

Type de données

text

Date
Description

Date

Type de données

date

Value
Description

Value

Type de données

text

Units
Description

Units

Type de données

text

Normal Range
Description

Normal Range

Type de données

text

Summary
Description

Summary

Remarks
Description

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

Type de données

text

If applicable, was randomization code broken at investigational side?
Description

Randomizatin code broken

Type de données

boolean

Randomization Number (please do NOT enter the container number)
Description

Randomization number

Type de données

integer

Investigators signature (confirming that the above data are accurate and complete)
Description

Investigators signature

Type de données

text

Date
Description

Date

Type de données

date

SB Medical Monitor´s Signature
Description

SB Medical Monitor´s Signature

Type de données

text

Date
Description

Date

Type de données

date

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Similar models

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Serious Adverse Experiences (2) Form (Form 22)

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
General Information
Center Number
Item
Center Number
integer
Patient Number
Item
Patient Number
integer
Patient Initials
Item
Patient Initials
text
GSK Receipt Date
Item
GSK Receipt Date
date
Item Group
Serious Adverse Experience (SAE)
Person Reporting SAE
Item
Person Reporting SAE
text
AEGIS Number
Item
AEGIS Number
integer
Serious Adverse Experience
Item
Serious Adverse Experience
text
Item
Reasons for considering a serious AE
text
Reasons for considering a serious AE
Code List
Reasons for considering a serious AE
CL Item
results in death (1)
CL Item
life threatening (2)
CL Item
results in hospitalization or prolongation of existing hospitalization (3)
CL Item
Results in disability/incapacity  (4)
CL Item
congenital abnormality/birth defect  (5)
CL Item
Other (please specify below) (6)
Specification of other reason for considering a serious AE
Item
Specification of other reason for considering a serious AE
text
Onset Date and Time
Item
Onset Date and Time
datetime
End Date and Time
Item
End Date and Time (if ongoing please leave blank)
datetime
Item
Outcome
text
Outcome
Code List
Outcome
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
Experience Course
text
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
Item
Intensity (maximum)
text
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
text
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
Reintroduction of product
Item
If Investgational product was interrupted, stopped or dose reduced: Was investigational product reintroduced (or dose increased)?
boolean
Recurrence of SAE
Item
If yes, did SAE recur?
boolean
Item
Relationship to Investigational Drug
text
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
text
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)
Specification of Assessment
Item
Please specify Assessment
text
Item
Corrective Therapy
text
Corrective Therapy
Code List
Corrective Therapy
CL Item
Yes (If "Yes", record details in the Concomitant Medication or Medical Procedures section) (1)
CL Item
No (2)
Withdrawal
Item
Was patient withdrawn due to this specific SAE?
text
Item Group
Relevant Laboratory Data
Test
Item
Test
text
Date
Item
Date
date
Value
Item
Value
text
Units
Item
Units
text
Normal Range
Item
Normal Range
text
Item Group
Summary
Remarks
Item
Remarks
text
Randomizatin code broken
Item
If applicable, was randomization code broken at investigational side?
boolean
Randomization number
Item
Randomization Number (please do NOT enter the container number)
integer
Investigators signature
Item
Investigators signature (confirming that the above data are accurate and complete)
text
Date
Item
Date
date
SB Medical Monitor´s Signature
Item
SB Medical Monitor´s Signature
text
Date
Item
Date
date
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