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ID
25684
Beschrijving
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
Trefwoorden
Versies (1)
- 09-09-17 09-09-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
9 september 2017
DOI
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Licentie
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)
GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Serious Adverse Experiences (2) Form (Form 22)
Similar models
GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Serious Adverse Experiences (2) Form (Form 22)
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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
Person Reporting SAE
Item
Person Reporting SAE
text
AEGIS Number
Item
AEGIS Number
integer
Serious Adverse Experience
Item
Serious Adverse Experience
text
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
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
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
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Action Taken with Respect to Investigational Drug
text
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
CL Item
Related (1)
CL Item
Possibly related (2)
CL Item
Probably unrelated (3)
CL Item
Unrelated (4)
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
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
Test
Item
Test
text
Date
Item
Date
date
Value
Item
Value
text
Units
Item
Units
text
Normal Range
Item
Normal Range
text
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