ID

40753

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

Adverse Event

1 forms  
  1. StudyEvent: ODM
    1. Adverse Event
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 (Day 1)
Description

Adverse Event (Day 1)

Alias
UMLS CUI-1
C0877248
Pre-dose - Any Adverse Events?
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439565
Next Day (+12 hrs) 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
Adverse Event (Day 2 - 43; Extra Clinic Visit 1 - 3)
Description

Adverse Event (Day 2 - 43; Extra Clinic Visit 1 - 3)

Alias
UMLS CUI-1
C0877248
Pre-dose - Any Adverse Events?
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439565
+3 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 (+12 hrs) 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
Adverse Event (PK Visit)
Description

Adverse Event (PK Visit)

Alias
UMLS CUI-1
C0877248
Pre-dose - Any Adverse Events?
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439565
+3 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
+12 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
+24hrs - 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
Adverse Event (Last Clinic Visit)
Description

Adverse Event (Last Clinic Visit)

Alias
UMLS CUI-1
C0877248
Pre-dose - Any Adverse Events?
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439565
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Similar models

Adverse Event

1 forms
  1. StudyEvent: ODM
    1. Adverse Event
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 (Day 1)
C0877248 (UMLS CUI-1)
Pre-dose - Any Adverse Events?
Item
Pre-dose - Any Adverse Events?
boolean
C0877248 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
Next Day (+12 hrs) by telephone - Any Adverse Events?
Item
Next Day (+12 hrs) by telephone - Any Adverse Events?
boolean
C0877248 (UMLS CUI [1])
Item Group
Adverse Event (Day 2 - 43; Extra Clinic Visit 1 - 3)
C0877248 (UMLS CUI-1)
Pre-dose - Any Adverse Events?
Item
Pre-dose - Any Adverse Events?
boolean
C0877248 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
+3 hrs - Any Adverse Events?
Item
+3 hrs - Any Adverse Events?
boolean
C0877248 (UMLS CUI [1])
Next Day (+12 hrs) by telephone - Any Adverse Events?
Item
Next Day (+12 hrs) by telephone - Any Adverse Events?
boolean
C0877248 (UMLS CUI [1])
Item Group
Adverse Event (PK Visit)
C0877248 (UMLS CUI-1)
Pre-dose - Any Adverse Events?
Item
Pre-dose - Any Adverse Events?
boolean
C0877248 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
+3 hrs - Any Adverse Events?
Item
+3 hrs - Any Adverse Events?
boolean
C0877248 (UMLS CUI [1])
+12 hrs - Any Adverse Events?
Item
+12 hrs - Any Adverse Events?
boolean
C0877248 (UMLS CUI [1])
+24hrs - Any Adverse Events?
Item
+24hrs - Any Adverse Events?
boolean
C0877248 (UMLS CUI [1])
Item Group
Adverse Event (Last Clinic Visit)
C0877248 (UMLS CUI-1)
Pre-dose - Any Adverse Events?
Item
Pre-dose - Any Adverse Events?
boolean
C0877248 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
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