ID

25682

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2017-09-09 2017-09-09 -
  2. 2017-09-09 2017-09-09 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

9 september 2017

DOI

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Creative Commons BY-NC 3.0
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GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Serious Adverse Experiences (1) Form (Form 21)

Engelsk

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Serious Adverse Experiences (1) Form (Form 21)

1 Formulär  
General Information
Beskrivning

General Information

Center Number
Beskrivning

Center Number

Datatyp

integer

Patient Number
Beskrivning

Patient Number

Datatyp

integer

Patient Initials
Beskrivning

Patient Initials

Datatyp

text

GSK Receipt Date
Beskrivning

GSK Receipt Date

Datatyp

date

Serious Adverse Experience (SAE)
Beskrivning

Serious Adverse Experience (SAE)

Person Reporting SAE
Beskrivning

Person Reporting SAE

Datatyp

text

AEGIS Number
Beskrivning

AEGIS Number

Datatyp

integer

Serious Adverse Experience
Beskrivning

Serious Adverse Experience

Datatyp

text

Reasons for considering a serious AE
Beskrivning

Reasons for considering a serious AE

Datatyp

text

Specification of other reason for considering a serious AE
Beskrivning

Specification of other reason for considering a serious AE

Datatyp

text

Onset Date and Time
Beskrivning

Onset Date and Time

Datatyp

datetime

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

End Date and Time

Datatyp

datetime

Outcome
Beskrivning

If patient died, please complete Form D

Datatyp

text

Experience Course
Beskrivning

Experience Course

Datatyp

text

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

Number of episodes

Datatyp

integer

Intensity (maximum)
Beskrivning

Intensity

Datatyp

text

Action Taken with Respect to Investigational Drug
Beskrivning

Action Taken with Respect to Investigational Drug

Datatyp

text

Did the SAE abate?
Beskrivning

Abatement

Datatyp

boolean

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

Reintroduction of product

Datatyp

boolean

If yes, did SAE recur?
Beskrivning

Recurrence of SAE

Datatyp

boolean

Relationship to Investigational Drug
Beskrivning

Relationship to Investigational Drug

Datatyp

text

The SAE is probably associated with
Beskrivning

Assessment

Datatyp

text

Please specify Assessment
Beskrivning

Specification of Assessment

Datatyp

text

Corrective Therapy
Beskrivning

Corrective Therapy

Datatyp

text

Was patient withdrawn due to this specific SAE?
Beskrivning

Withdrawal

Datatyp

text

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Similar models

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Serious Adverse Experiences (1) Form (Form 21)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
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