ID

40751

Description

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Keywords

Versions (2)
  1. 4/29/20 4/29/20 -
  2. 5/8/20 5/8/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 8, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218

English

Baseline Signs and Symptoms; Dosing Details

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Baseline Signs and Symptoms
Description

Baseline Signs and Symptoms

Alias
UMLS CUI-1
C0037088
UMLS CUI-2
C1442488
Baseline Signs and Symptoms - Onset Date and Time
Description

Baseline Signs and Symptoms - Onset Date and Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1442488
UMLS CUI [2,1]
C0574845
UMLS CUI [2,2]
C0449244
Baseline Signs and Symptoms - End Date and Time
Description

(If ongoing please leave blank)

Data type

datetime

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1442488
UMLS CUI [2,1]
C0806020
UMLS CUI [2,2]
C1522314
Baseline Signs and Symptoms - Outcome
Description

Baseline Signs and Symptoms - Outcome

Data type

integer

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1442488
UMLS CUI [2]
C1547647
Baseline Signs and Symptoms - Event Course
Description

Baseline Signs and Symptoms - Event Course

Data type

integer

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1442488
UMLS CUI [2,1]
C0750729
UMLS CUI [2,2]
C0441471
Baseline Signs and Symptoms - Intermittent Course - number of episodes
Description

Baseline Signs and Symptoms - Intermittent Course - number of episodes

Data type

integer

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1442488
UMLS CUI [2,1]
C0750729
UMLS CUI [2,2]
C0205267
UMLS CUI [3]
C4086638
Baseline Signs and Symptoms - Intensity (maximum)
Description

Baseline Signs and Symptoms - Intensity (maximum)

Data type

integer

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1442488
UMLS CUI [2,1]
C0518690
UMLS CUI [2,2]
C0806909
Baseline Signs and Symptoms - Relationship to study procedures performed prior to randomisation
Description

Baseline Signs and Symptoms - Relationship to study procedures performed prior to randomisation

Data type

integer

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1442488
UMLS CUI [2]
C1510821
UMLS CUI [3]
C0034656
Baseline Signs and Symptoms - Corrective Therapy
Description

If ‘Yes’, Please record on Prior Medication form.

Data type

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1442488
UMLS CUI [2]
C0087111
Baseline Signs and Symptoms - Was subject withdrawn due to this event?
Description

Baseline Signs and Symptoms - Was subject withdrawn due to this event?

Data type

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1442488
UMLS CUI [2,1]
C0422727
UMLS CUI [2,2]
C0877248
Baseline Signs and Symptoms - Investigator's Signature
Description

Baseline Signs and Symptoms - Investigator's Signature

Data type

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1442488
UMLS CUI [2]
C2346576
Baseline Signs and Symptoms - Investigator's Signature Date
Description

Baseline Signs and Symptoms - Investigator's Signature Date

Data type

date

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1442488
UMLS CUI [2,1]
C2346576
UMLS CUI [2,2]
C0011008
Dosing Details (Day 1)
Description

Dosing Details (Day 1)

Alias
UMLS CUI-1
C0678766
UMLS CUI-2
C1522508
Was evening meal eaten before dosing?
Description

Was evening meal eaten before dosing?

Data type

boolean

Alias
UMLS CUI [1,1]
C0439550
UMLS CUI [1,2]
C1998602
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0332152
Meal finish date and time
Description

Meal finish date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C1998602
UMLS CUI [2,2]
C1522314
Date and time of dosing
Description

Date and time of dosing

Data type

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Randomisation Number
Description

Randomisation Number

Data type

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Number of Tablets Dispensed
Description

Number of Tablets Dispensed

Data type

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Dosing Details - Comments
Description

Dosing Details - Comments

Data type

text

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C1522508
UMLS CUI [1,3]
C0947611
Dose Level
Description

Dose Level

Data type

text

Alias
UMLS CUI [1]
C0178602
Dose checked and administered by
Description

Dose checked and administered by

Data type

text

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C0178602
UMLS CUI [2]
C2348343
Dose checked and witnessed by
Description

Dose checked and witnessed by

Data type

text

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0682356
UMLS CUI [2,2]
C0178602
Dosing Details (PK Visit)
Description

Dosing Details (PK Visit)

Alias
UMLS CUI-1
C0678766
UMLS CUI-2
C1522508
Was evening meal eaten before dosing?
Description

Was evening meal eaten before dosing?

Data type

boolean

Alias
UMLS CUI [1,1]
C0439550
UMLS CUI [1,2]
C1998602
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0332152
Meal finish date and time
Description

Meal finish date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C1998602
UMLS CUI [2,2]
C1522314
Date and time of dosing
Description

Date and time of dosing

Data type

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Number of Tablets Dispensed
Description

Number of Tablets Dispensed

Data type

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Dosing Details - Comments
Description

Dosing Details - Comments

Data type

text

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C1522508
UMLS CUI [1,3]
C0947611
Dose Level
Description

Dose Level

Data type

text

Alias
UMLS CUI [1]
C0178602
Dose checked and administered by
Description

Dose checked and administered by

Data type

text

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C0178602
UMLS CUI [2]
C2348343
Dose checked and witnessed by
Description

Dose checked and witnessed by

Data type

text

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0682356
UMLS CUI [2,2]
C0178602
Dosing Details (Day 3 - 43; Extra Clinic Visit 1 - 3)
Description

Dosing Details (Day 3 - 43; Extra Clinic Visit 1 - 3)

Was evening meal eaten before dosing?
Description

Was evening meal eaten before dosing?

Data type

boolean

Alias
UMLS CUI [1,1]
C0439550
UMLS CUI [1,2]
C1998602
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0332152
Meal finish date and time
Description

Meal finish date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C1998602
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C1998602
UMLS CUI [2,2]
C1522314
Date and time of dosing
Description

Date and time of dosing

Data type

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Number of Tablets Dispensed
Description

Number of Tablets Dispensed

Data type

integer

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Number of Tablets Returned
Description

Number of Tablets Returned

Data type

integer

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0039225
Dosing Details - Comments
Description

Dosing Details - Comments

Data type

text

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C1522508
UMLS CUI [1,3]
C0947611
Dose Level
Description

Dose Level

Data type

text

Alias
UMLS CUI [1]
C0178602
Dose checked and administered by
Description

Dose checked and administered by

Data type

text

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C0178602
UMLS CUI [2]
C2348343
Dose checked and witnessed by
Description

Dose checked and witnessed by

Data type

text

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0682356
UMLS CUI [2,2]
C0178602
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Similar models

Baseline Signs and Symptoms; Dosing Details

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item Group
Baseline Signs and Symptoms
C0037088 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
Baseline Signs and Symptoms - Onset Date and Time
Item
Baseline Signs and Symptoms - Onset Date and Time
datetime
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0574845 (UMLS CUI [2,1])
C0449244 (UMLS CUI [2,2])
Baseline Signs and Symptoms - End Date and Time
Item
Baseline Signs and Symptoms - End Date and Time
datetime
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0806020 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Item
Baseline Signs and Symptoms - Outcome
integer
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C1547647 (UMLS CUI [2])
Baseline Signs and Symptoms - Outcome
Code List
Baseline Signs and Symptoms - Outcome
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
Baseline Signs and Symptoms - Event Course
integer
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0750729 (UMLS CUI [2,1])
C0441471 (UMLS CUI [2,2])
Baseline Signs and Symptoms - Event Course
Code List
Baseline Signs and Symptoms - Event Course
CL Item
Intermittent (1)
CL Item
Constant (2)
Baseline Signs and Symptoms - Intermittent Course - number of episodes
Item
Baseline Signs and Symptoms - Intermittent Course - number of episodes
integer
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0750729 (UMLS CUI [2,1])
C0205267 (UMLS CUI [2,2])
C4086638 (UMLS CUI [3])
Item
Baseline Signs and Symptoms - Intensity (maximum)
integer
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
Baseline Signs and Symptoms - Intensity (maximum)
Code List
Baseline Signs and Symptoms - Intensity (maximum)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Baseline Signs and Symptoms - Relationship to study procedures performed prior to randomisation
integer
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C1510821 (UMLS CUI [2])
C0034656 (UMLS CUI [3])
Baseline Signs and Symptoms - Relationship to study procedures performed prior to randomisation
Code List
Baseline Signs and Symptoms - Relationship to study procedures performed prior to randomisation
CL Item
Not related (1)
CL Item
Unlikely (2)
CL Item
Suspected (reasonable possibility) (3)
CL Item
Probable (4)
Baseline Signs and Symptoms - Corrective Therapy
Item
Baseline Signs and Symptoms - Corrective Therapy
boolean
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2])
Baseline Signs and Symptoms - Was subject withdrawn due to this event?
Item
Baseline Signs and Symptoms - Was subject withdrawn due to this event?
boolean
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0422727 (UMLS CUI [2,1])
C0877248 (UMLS CUI [2,2])
Baseline Signs and Symptoms - Investigator's Signature
Item
Baseline Signs and Symptoms - Investigator's Signature
text
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C2346576 (UMLS CUI [2])
Baseline Signs and Symptoms - Investigator's Signature Date
Item
Baseline Signs and Symptoms - Investigator's Signature Date
date
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C2346576 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Item Group
Dosing Details (Day 1)
C0678766 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Was evening meal eaten before dosing?
Item
Was evening meal eaten before dosing?
boolean
C0439550 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Meal finish date and time
Item
Meal finish date and time
datetime
C1998602 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1998602 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Date and time of dosing
Item
Date and time of dosing
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Number of Tablets Dispensed
Item
Number of Tablets Dispensed
integer
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Dosing Details - Comments
Item
Dosing Details - Comments
text
C0678766 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Dose Level
Item
Dose Level
text
C0178602 (UMLS CUI [1])
Dose checked and administered by
Item
Dose checked and administered by
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C2348343 (UMLS CUI [2])
Dose checked and witnessed by
Item
Dose checked and witnessed by
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0682356 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Item Group
Dosing Details (PK Visit)
C0678766 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Was evening meal eaten before dosing?
Item
Was evening meal eaten before dosing?
boolean
C0439550 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Meal finish date and time
Item
Meal finish date and time
datetime
C1998602 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1998602 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Date and time of dosing
Item
Date and time of dosing
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Number of Tablets Dispensed
Item
Number of Tablets Dispensed
integer
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Dosing Details - Comments
Item
Dosing Details - Comments
text
C0678766 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Dose Level
Item
Dose Level
text
C0178602 (UMLS CUI [1])
Dose checked and administered by
Item
Dose checked and administered by
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C2348343 (UMLS CUI [2])
Dose checked and witnessed by
Item
Dose checked and witnessed by
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0682356 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Item Group
Dosing Details (Day 3 - 43; Extra Clinic Visit 1 - 3)
Was evening meal eaten before dosing?
Item
Was evening meal eaten before dosing?
boolean
C0439550 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Meal finish date and time
Item
Meal finish date and time
datetime
C1998602 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1998602 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
Date and time of dosing
Item
Date and time of dosing
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Number of Tablets Dispensed
Item
Number of Tablets Dispensed
integer
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Number of Tablets Returned
Item
Number of Tablets Returned
integer
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Dosing Details - Comments
Item
Dosing Details - Comments
text
C0678766 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Dose Level
Item
Dose Level
text
C0178602 (UMLS CUI [1])
Dose checked and administered by
Item
Dose checked and administered by
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C2348343 (UMLS CUI [2])
Dose checked and witnessed by
Item
Dose checked and witnessed by
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0682356 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
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