ID

40515

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

April 29, 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

Dose Level 1, Day1 - Vital Signs Post Dose; Adverse Event

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
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
+2 hrs - Any Adverse Events?
Description

If "Yes" record all details on an Adverse Event page at back of CRF.

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Next Day (+12hrs) by telephone - Any Adverse Events?
Description

If "Yes" record all details on an Adverse Event page at back of CRF.

Data type

boolean

Alias
UMLS CUI [1]
C0877248
In the Investigator’s opinion, is it safe for the patient to continue dosing at home?
Description

Y - Ensure patient returns home with their study medication and diary card N - Select a dosing strategy from options below and tick the relevant box

Data type

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C4534363
If it is not safe for the patient to continue dosing at home, select a dosing strategy from options below and tick the relevant
Description

If it is not safe for the patient to continue dosing at home, select a dosing strategy from options below and tick the relevant

Data type

integer

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C2603343
UMLS CUI [1,3]
C4534363
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0679199
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Similar models

Dose Level 1, Day1 - Vital Signs Post Dose; Adverse Event

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
Adverse Event
C0877248 (UMLS CUI-1)
+2 hrs - Any Adverse Events?
Item
+2 hrs - Any Adverse Events?
boolean
C0877248 (UMLS CUI [1])
Next Day (+12hrs) by telephone - Any Adverse Events?
Item
Next Day (+12hrs) by telephone - Any Adverse Events?
boolean
C0877248 (UMLS CUI [1])
In the Investigator’s opinion, is it safe for the patient to continue dosing at home?
Item
In the Investigator’s opinion, is it safe for the patient to continue dosing at home?
boolean
C0805733 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C4534363 (UMLS CUI [1,3])
Item
If it is not safe for the patient to continue dosing at home, select a dosing strategy from options below and tick the relevant
integer
C0805733 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
C4534363 (UMLS CUI [1,3])
C0178602 (UMLS CUI [2,1])
C0679199 (UMLS CUI [2,2])
If it is not safe for the patient to continue dosing at home, select a dosing strategy from options below and tick the relevant
Code List
If it is not safe for the patient to continue dosing at home, select a dosing strategy from options below and tick the relevant
CL Item
TRY AGAIN: Patient will receive the next days dose in the clinic. Complete an Extra Clinic Visit section of the CRF for this visit. (1)
CL Item
MTD DETERMINED: No further attempts at this dose level will be made. Complete Last Clinic Visit section in the CRF. (2)
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