ID

25684

Descripción

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

Palabras clave

Versiones (1)
  1. 9/9/17 9/9/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

9 de septiembre de 2017

DOI

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Licencia

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)

Inglés

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

1 formularios  
General Information
Descripción

General Information

Center Number
Descripción

Center Number

Tipo de datos

integer

Patient Number
Descripción

Patient Number

Tipo de datos

integer

Patient Initials
Descripción

Patient Initials

Tipo de datos

text

GSK Receipt Date
Descripción

GSK Receipt Date

Tipo de datos

date

Serious Adverse Experience (SAE)
Descripción

Serious Adverse Experience (SAE)

Person Reporting SAE
Descripción

Person Reporting SAE

Tipo de datos

text

AEGIS Number
Descripción

AEGIS Number

Tipo de datos

integer

Serious Adverse Experience
Descripción

Serious Adverse Experience

Tipo de datos

text

Reasons for considering a serious AE
Descripción

Reasons for considering a serious AE

Tipo de datos

text

Specification of other reason for considering a serious AE
Descripción

Specification of other reason for considering a serious AE

Tipo de datos

text

Onset Date and Time
Descripción

Onset Date and Time

Tipo de datos

datetime

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

End Date and Time

Tipo de datos

datetime

Outcome
Descripción

If patient died, please complete Form D

Tipo de datos

text

Experience Course
Descripción

Experience Course

Tipo de datos

text

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

Number of episodes

Tipo de datos

integer

Intensity (maximum)
Descripción

Intensity

Tipo de datos

text

Action Taken with Respect to Investigational Drug
Descripción

Action Taken with Respect to Investigational Drug

Tipo de datos

text

Did the SAE abate?
Descripción

Abatement

Tipo de datos

boolean

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

Reintroduction of product

Tipo de datos

boolean

If yes, did SAE recur?
Descripción

Recurrence of SAE

Tipo de datos

boolean

Relationship to Investigational Drug
Descripción

Relationship to Investigational Drug

Tipo de datos

text

The SAE is probably associated with
Descripción

Assessment

Tipo de datos

text

Please specify Assessment
Descripción

Specification of Assessment

Tipo de datos

text

Corrective Therapy
Descripción

Corrective Therapy

Tipo de datos

text

Was patient withdrawn due to this specific SAE?
Descripción

Withdrawal

Tipo de datos

text

Relevant Laboratory Data
Descripción

Relevant Laboratory Data

Test
Descripción

Test

Tipo de datos

text

Date
Descripción

Date

Tipo de datos

date

Value
Descripción

Value

Tipo de datos

text

Units
Descripción

Units

Tipo de datos

text

Normal Range
Descripción

Normal Range

Tipo de datos

text

Summary
Descripción

Summary

Remarks
Descripción

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

Tipo de datos

text

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

Randomizatin code broken

Tipo de datos

boolean

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

Randomization number

Tipo de datos

integer

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

Investigators signature

Tipo de datos

text

Date
Descripción

Date

Tipo de datos

date

SB Medical Monitor´s Signature
Descripción

SB Medical Monitor´s Signature

Tipo de datos

text

Date
Descripción

Date

Tipo de datos

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 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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