ID

27231

Beschreibung

Study ID: 101468/188 Clinical Study ID: SKF-101468/188 Study Title:A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of 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: Parkinson Disease Module: Baseline Signs and Symptoms

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Versionen (1)
  1. 03.11.17 03.11.17 -
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GlaxoSmithKline

Hochgeladen am

3. November 2017

DOI

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GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/188

Englisch

Baseline Signs and Symptoms

1 Formulare  
Baseline Signs and Symptoms
Beschreibung

Baseline Signs and Symptoms

Alias
UMLS CUI-1
C0037088
UMLS CUI-2
C1442488
Baseline event
Beschreibung

Record any baseline events (using standard medical terminology) observed or elicited by the following direct question to patient: “Have you felt different in any way in the last 7 days or since the last visit?” Provide the diagnosis, not symptoms where possible. One baseline event per column.

Datentyp

text

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1442488
UMLS CUI [2]
C0037088
Onset Date and Time
Beschreibung

Baseline event

Datentyp

datetime

Alias
UMLS CUI [1]
C0808070
UMLS CUI [2]
C1301880
UMLS CUI [3,1]
C0441471
UMLS CUI [3,2]
C1442488
End Date and Time
Beschreibung

If ongoing please leave blank

Datentyp

datetime

Alias
UMLS CUI [1]
C0806020
UMLS CUI [2]
C1522314
UMLS CUI [3,1]
C0441471
UMLS CUI [3,2]
C1442488
Outcome
Beschreibung

Baseline event

Datentyp

integer

Alias
UMLS CUI [1]
C1705586
UMLS CUI [2,1]
C0441471
UMLS CUI [2,2]
C1442488
Event Course
Beschreibung

Baseline event

Datentyp

integer

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C1442488
Intensity (maximum)
Beschreibung

Baseline event

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C1442488
Relationship to study procedures performed prior to randomization
Beschreibung

Baseline event

Datentyp

integer

Alias
UMLS CUI [1,1]
C1510821
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C1442488
Corrective Therapy
Beschreibung

If "Yes", record details in Prior and Concomitant Medication section if appropriate.

Datentyp

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2,1]
C0441471
UMLS CUI [2,2]
C1442488
Was patient withdrawn due to this specific event?
Beschreibung

Baseline event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C1442488
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Ähnliche Modelle

Baseline Signs and Symptoms

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Baseline Signs and Symptoms
C0037088 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
Baseline event
Item
Baseline event
text
C0441471 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2])
Onset Date and Time
Item
Onset Date and Time
datetime
C0808070 (UMLS CUI [1])
C1301880 (UMLS CUI [2])
C0441471 (UMLS CUI [3,1])
C1442488 (UMLS CUI [3,2])
End Date and Time
Item
End Date and Time
datetime
C0806020 (UMLS CUI [1])
C1522314 (UMLS CUI [2])
C0441471 (UMLS CUI [3,1])
C1442488 (UMLS CUI [3,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
C0441471 (UMLS CUI [2,1])
C1442488 (UMLS CUI [2,2])
Outcome
Code List
Outcome
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (If patient died, STOP: go to SAE section and follow instructions given there.) (3)
Item
Event Course
integer
C0750729 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
Event Course
Code List
Event Course
CL Item
Intermittent (-> No. of episodes) (1)
CL Item
Constant (2)
Item
Intensity (maximum)
integer
C0518690 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
Intensity (maximum)
Code List
Intensity (maximum)
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Relationship to study procedures performed prior to randomization
integer
C1510821 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
Relationship to study procedures performed prior to randomization
Code List
Relationship to study procedures performed prior to randomization
CL Item
Related (1)
CL Item
Possibly related (2)
CL Item
Probably unrelated (3)
CL Item
Unrelated (4)
Corrective Therapy
Item
Corrective Therapy
boolean
C0087111 (UMLS CUI [1])
C0441471 (UMLS CUI [2,1])
C1442488 (UMLS CUI [2,2])
Patient withdrawn due to event
Item
Was patient withdrawn due to this specific event?
boolean
C0422727 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
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