ID

35514

Description

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

Keywords

Versions (1)
  1. 3/6/19 3/6/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 6, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194)

English

Adverse Experiences (Non-Serious)

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Centre Number
Description

Study Coordinating Center, Identification number

Data type

integer

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

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Patient Initials
Description

Person Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Adverse Experiences (Non-Serious)
Description

Adverse Experiences (Non-Serious)

Alias
UMLS CUI-1
C1518404
Please mark this box if no adverse experiences occurred during the book.
Description

Non-Serious Adverse Event, No

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1298908
Adverse Experience (please print clearly)
Description

Non-Serious Adverse Event

Data type

text

Alias
UMLS CUI [1]
C1518404
Onset Date and Time
Description

Non-serious Adverse event. Date of onset, Time of onset

Data type

datetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0574845
UMLS CUI [1,3]
C0449244
End Date and Time (If ongoing please leave blank)
Description

Non-serious Adverse event, End Date, End time

Data type

datetime

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1522314
Outcome
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Experience Course
Description

Non-Serious Adverse Event, Course

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0750729
No. of episodes
Description

Non-Serious Adverse Event, Number of episodes

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Description

Non-serious Adverse Event, Symptoms Intensity

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0518690
Action Taken with Respect to Investigational Drug
Description

Non-Serious Adverse Event, Adverse Event Action Taken with Study Treatment

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2826626
Corrective Therapy
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0087111
Was patient withdrawn due to this specific AE?
Description

Non-serious Adverse Event, Withdraw

Data type

boolean

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C2349954
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Similar models

Adverse Experiences (Non-Serious)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Adverse Experiences (Non-Serious)
C1518404 (UMLS CUI-1)
Non-Serious Adverse Event, No
Item
Please mark this box if no adverse experiences occurred during the book.
boolean
C1518404 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
Non-Serious Adverse Event
Item
Adverse Experience (please print clearly)
text
C1518404 (UMLS CUI [1])
Non-serious Adverse event. Date of onset, Time of onset
Item
Onset Date and Time
datetime
C1518404 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0449244 (UMLS CUI [1,3])
Non-serious Adverse event, End Date, End time
Item
End Date and Time (If ongoing please leave blank)
datetime
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Outcome
text
C1518404 (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
C1518404 (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)
Non-Serious Adverse Event, Number of episodes
Item
No. of episodes
integer
C1518404 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
text
C1518404 (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
C1518404 (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)
Non-Serious Adverse Event, Therapeutic procedure
Item
Corrective Therapy
boolean
C1518404 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Non-serious Adverse Event, Withdraw
Item
Was patient withdrawn due to this specific AE?
boolean
C1518404 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
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