ID

35515

Beschreibung

Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from 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: Restless Legs Syndrome

Stichworte

Versionen (1)
  1. 06.03.19 06.03.19 -
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GlaxoSmithKline

Hochgeladen am

6. März 2019

DOI

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Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)

Englisch

Serious Adverse Experience (SAE)

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Beschreibung

Study Coordinating Center, Identification number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Patient Number
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Patient Initials
Beschreibung

Person Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Serious Adverse Experience (SAE)
Beschreibung

Serious Adverse Experience (SAE)

Alias
UMLS CUI-1
C1519255
Person Reporting SAE (Please print clearly)
Beschreibung

Serious Adverse Event, Reporter

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0335038
Serious Adverse Experience (please print clearly)
Beschreibung

Serious Adverse Event

Datentyp

text

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

Serious Adverse event. Date of onset, Time of onset

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0574845
UMLS CUI [1,3]
C0449244
End Date and Time (If ongoing please leave blank)
Beschreibung

Serious Adverse event, End Date, End time

Datentyp

datetime

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

If patient died, STOP: go to SAE section and follow instructions given there

Datentyp

text

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

Serious Adverse Event, Course

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0750729
No. of episodes
Beschreibung

Serious Adverse Event, Number of episodes

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Beschreibung

Serious Adverse Event, Symptoms Intensity

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
Action Taken with Respect to Investigational Drug
Beschreibung

Serious Adverse Event, Adverse Event Action Taken with Study Treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826626
Relationship to Investigational Drug
Beschreibung

Serious Adverse Event, Experimental drug, Causations

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0085978
Corrective Therapy
Beschreibung

If ‘Yes’, record details in the Concomitant Medication section and/ or Healthcare Resource Utilisation form if appropriate

Datentyp

boolean

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

Serious Adverse Event, Withdraw

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2349954
Specify reason(s) for considering this a serious AE. Mark all that apply.
Beschreibung

Serious Adverse Event, Reason and Justification

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0566251
Did the SAE abate?
Beschreibung

Serious Adverse Event, Abate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3853704
Was study medication reintroduced (or dose increased)?
Beschreibung

Serious Adverse Event, Experimental Drug, Drug dose altered

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0420247
If yes, did SAE recur?
Beschreibung

Serious Adverse Event, Experimental Drug, Drug dose altered, Recurrence

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0420247
UMLS CUI [1,4]
C0034897
Was study medication reintroduced (or dose increased)?
Beschreibung

Serious Adverse Event, Experimental Drug, Drug dose altered

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0420247
The SAE is probably associated with:
Beschreibung

Serious Adverse Event, Association

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0004083
Relevant Laboratory Data
Beschreibung

Relevant Laboratory Data

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

Serious Adverse Event, Laboratory Procedures

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0022885
Date
Beschreibung

Serious Adverse Event, Laboratory Procedures, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C0011008
Value
Beschreibung

Serious Adverse Event, Laboratory Procedures, Numerical value

Datentyp

float

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C1522609
Units
Beschreibung

Serious Adverse Event, Laboratory Procedures, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C1519795
Normal Range
Beschreibung

Serious Adverse Event, Laboratory Procedures, Normal Range

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C0086715
Serious Adverse Event Conclusion
Beschreibung

Serious Adverse Event Conclusion

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1707478
Remarks
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

Serious Adverse Event, Randomization, Revealed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034656
UMLS CUI [1,3]
C0443289
Randomisation Number (please do NOT enter the container number)
Beschreibung

Serious Adverse Event, Randomization, Numbers

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0034656
UMLS CUI [1,3]
C0237753
Investigator’s Signature
Beschreibung

Serious Adverse Event, Investigator Signature

Datentyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2346576
Date
Beschreibung

Serious Adverse Event, Investigator Signature, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2346576
UMLS CUI [1,3]
C0011008
Please PRINT Name
Beschreibung

Serious Adverse Event, Investigator Name

Datentyp

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2826892
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Ähnliche Modelle

Serious Adverse Experience (SAE)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Study Coordinating Center, Identification number
Item
Centre Number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Patient Number
integer
C2348585 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Serious Adverse Experience (SAE)
C1519255 (UMLS CUI-1)
Serious Adverse Event, Reporter
Item
Person Reporting SAE (Please print clearly)
text
C1519255 (UMLS CUI [1,1])
C0335038 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Experience (please print clearly)
text
C1519255 (UMLS CUI [1])
Serious Adverse event. Date of onset, Time of onset
Item
Onset Date and Time
datetime
C1519255 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
Serious Adverse event, End Date, End time
Item
End Date and Time (If ongoing please leave blank)
datetime
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Outcome
text
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-serious Adverse Event, Adverse Event Outcome
Code List
Outcome
CL Item
Resolved  (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
Experience Course
text
C1519255 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Non-Serious Adverse Event, Course
Code List
Experience Course
CL Item
Intermittent (1)
CL Item
Constant (2)
Serious Adverse Event, Number of episodes
Item
No. of episodes
integer
C1519255 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Non-serious Adverse Event, Symptoms 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
C1519255 (UMLS CUI [1,1])
C2826626 (UMLS CUI [1,2])
Non-Serious Adverse Event, Adverse Event Action Taken with Study Treatment
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)
Item
Relationship to Investigational Drug
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
Non-Serious Adverse Event, Adverse Event Action Taken with Study Treatment
Code List
Relationship to Investigational Drug
CL Item
Related (1)
CL Item
Possibly related (2)
CL Item
Probably unrelated  (3)
CL Item
Unrelated (4)
Serious Adverse Event, Therapeutic procedure
Item
Corrective Therapy
boolean
C1519255 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Serious Adverse Event, Withdraw
Item
Was patient withdrawn due to this specific AE?
boolean
C1519255 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Item
Specify reason(s) for considering this a serious AE. Mark all that apply.
text
C1519255 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Serious Adverse Event, Reason and Justification
Code List
Specify reason(s) for considering this a serious AE. Mark all that apply.
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)
Serious Adverse Event, Abate
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
Serious Adverse Event, Experimental Drug, Drug dose altered
Item
Was study medication reintroduced (or dose increased)?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0420247 (UMLS CUI [1,3])
Serious Adverse Event, Experimental Drug, Drug dose altered, Recurrence
Item
If yes, did SAE recur?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0420247 (UMLS CUI [1,3])
C0034897 (UMLS CUI [1,4])
Serious Adverse Event, Experimental Drug, Drug dose altered
Item
Was study medication reintroduced (or dose increased)?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0420247 (UMLS CUI [1,3])
Item
The SAE is probably associated with:
text
C1519255 (UMLS CUI [1,1])
C0004083 (UMLS CUI [1,2])
Serious Adverse Event, Association
Code List
The SAE is probably associated with:
CL Item
Protocol design or procedures (but not to study drug) (1)
CL Item
Another condition (eg, condition under study, intercurrent illness) (2)
CL Item
Another drug (3)
Item Group
Relevant Laboratory Data
C1519255 (UMLS CUI-1)
C0587081 (UMLS CUI-2)
Serious Adverse Event, Laboratory Procedures
Item
Test
text
C1519255 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Serious Adverse Event, Laboratory Procedures, Date in time
Item
Date
date
C1519255 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Serious Adverse Event, Laboratory Procedures, Numerical value
Item
Value
float
C1519255 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C1522609 (UMLS CUI [1,3])
Serious Adverse Event, Laboratory Procedures, Unit of Measure
Item
Units
text
C1519255 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Serious Adverse Event, Laboratory Procedures, Normal Range
Item
Normal Range
text
C1519255 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0086715 (UMLS CUI [1,3])
Item Group
Serious Adverse Event Conclusion
C1519255 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
Serious Adverse Event, Comment
Item
Remarks
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Serious Adverse Event, Randomization, Revealed
Item
If applicable, was randomisation code broken at investigational site?
boolean
C1519255 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0443289 (UMLS CUI [1,3])
Serious Adverse Event, Randomization, Numbers
Item
Randomisation Number (please do NOT enter the container number)
integer
C1519255 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Serious Adverse Event, Investigator Signature
Item
Investigator’s Signature
text
C1519255 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Serious Adverse Event, Investigator Signature, Date in time
Item
Date
date
C1519255 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Serious Adverse Event, Investigator Name
Item
Please PRINT Name
date
C1519255 (UMLS CUI [1,1])
C2826892 (UMLS CUI [1,2])
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