ID

40751

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2020-04-29 2020-04-29 -
  2. 2020-05-08 2020-05-08 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

8 maj 2020

DOI

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Licens

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

Engelsk

Baseline Signs and Symptoms; Dosing Details

1 Formulär  
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Beskrivning

Patient Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beskrivning

Centre Number

Datatyp

text

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

Baseline Signs and Symptoms

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

Baseline Signs and Symptoms - Onset Date and Time

Datatyp

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
Beskrivning

(If ongoing please leave blank)

Datatyp

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
Beskrivning

Baseline Signs and Symptoms - Outcome

Datatyp

integer

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

Baseline Signs and Symptoms - Event Course

Datatyp

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
Beskrivning

Baseline Signs and Symptoms - Intermittent Course - number of episodes

Datatyp

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)
Beskrivning

Baseline Signs and Symptoms - Intensity (maximum)

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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?
Beskrivning

Baseline Signs and Symptoms - Was subject withdrawn due to this event?

Datatyp

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
Beskrivning

Baseline Signs and Symptoms - Investigator's Signature

Datatyp

text

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

Baseline Signs and Symptoms - Investigator's Signature Date

Datatyp

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)
Beskrivning

Dosing Details (Day 1)

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

Was evening meal eaten before dosing?

Datatyp

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
Beskrivning

Meal finish date and time

Datatyp

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
Beskrivning

Date and time of dosing

Datatyp

datetime

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

Randomisation Number

Datatyp

text

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

Number of Tablets Dispensed

Datatyp

integer

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

Dosing Details - Comments

Datatyp

text

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

Dose Level

Datatyp

text

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

Dose checked and administered by

Datatyp

text

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

Dose checked and witnessed by

Datatyp

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)
Beskrivning

Dosing Details (PK Visit)

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

Was evening meal eaten before dosing?

Datatyp

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
Beskrivning

Meal finish date and time

Datatyp

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
Beskrivning

Date and time of dosing

Datatyp

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
Beskrivning

Number of Tablets Dispensed

Datatyp

integer

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

Dosing Details - Comments

Datatyp

text

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

Dose Level

Datatyp

text

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

Dose checked and administered by

Datatyp

text

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

Dose checked and witnessed by

Datatyp

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)
Beskrivning

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

Was evening meal eaten before dosing?
Beskrivning

Was evening meal eaten before dosing?

Datatyp

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
Beskrivning

Meal finish date and time

Datatyp

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
Beskrivning

Date and time of dosing

Datatyp

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
Beskrivning

Number of Tablets Dispensed

Datatyp

integer

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

Number of Tablets Returned

Datatyp

integer

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

Dosing Details - Comments

Datatyp

text

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

Dose Level

Datatyp

text

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

Dose checked and administered by

Datatyp

text

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

Dose checked and witnessed by

Datatyp

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