ID

24328

Beschreibung

Part 1 of Module 12: Wk 52, Follow-Up & Study Conc 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Stichworte

Versionen (1)
  1. 30.07.17 30.07.17 -
Rechteinhaber

glaxoSmithKline

Hochgeladen am

30. Juli 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

  • Neueste
  • Älteste
  • Beliebt
  • Neueste
    • Neueste
    • Älteste
    • Beliebt

Keine Kommentare

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

GSK study: Ropinirole in RLS patients 101468/243 - Week 52

Englisch

GSK study: Ropinirole in RLS patients 101468/243 - Week 52

1 Formulare  
Study medication record since last visit
Beschreibung

Study medication record since last visit

Alias
UMLS CUI-1
C2734539
UMLS CUI-2
C0008972
Study medication record since last visit
Beschreibung

Please complete the study medication record in the Study Medication and Compliance Section at the back of this module.

Datentyp

text

Alias
UMLS CUI [1,1]
C2734539
UMLS CUI [1,2]
C0008972
RLS Rating scale
Beschreibung

RLS Rating scale

Alias
UMLS CUI-1
C0681889
UMLS CUI-2
C0035258
RLS Rating scale
Beschreibung

Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book

Datentyp

text

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
Vital signs
Beschreibung

Vital signs

Alias
UMLS CUI-1
C0518766
Weight in kg
Beschreibung

Weight in kg

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0439209
Weight in lbs
Beschreibung

Weight in lbs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0439219
Weight (without shoes)
Beschreibung

Weight

Datentyp

float

Alias
UMLS CUI [1]
C0005910
Pulse
Beschreibung

after 5min sitting

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Sitting systolic blood pressure
Beschreibung

after 5 minutes sitting

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting diastolic blood pressure
Beschreibung

after 5 minutes sitting

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Laboratory evaluation
Beschreibung

Laboratory evaluation

Alias
UMLS CUI-1
C0022885
Date of blood sample
Beschreibung

Please take a blood sample for routine analysis.

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Please affix the Quest Diagnostics Laboratory label here.
Beschreibung

Laboratory label

Datentyp

text

Alias
UMLS CUI [1]
C4273937
Were any clinically significant abnormalities detected?
Beschreibung

If ’Yes’, please record details in the Adverse Experiences and/or SAE section and repeat at Follow-up

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1704258
Urine dipstick
Beschreibung

Urine dipstick

Alias
UMLS CUI-1
C0430370
What was the result of the urine dipstick performed at this visit?
Beschreibung

Please perform a urine dipstick test for presence of blood or protein. If ’Positive’, please record details in the Adverse Experiences and/or SAE section at the back of this book and repeat at Follow-up. Please send a sample to Quest Diagnostics for further evaluation.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
Pregnancy dipstick
Beschreibung

Pregnancy dipstick

Alias
UMLS CUI-1
C0430056
Is the patient a female of child-bearing potential?
Beschreibung

If ’Yes’, please perform a pregnancy dipstick test and record result below.

Datentyp

boolean

Alias
UMLS CUI [1]
C1960468
Record the result of the pregnancy dipstick, if the patient is a female of child-bearing potential
Beschreibung

If ’Positive’, please record details on the Pregnancy Notification Form.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C0456984
Medical procedures
Beschreibung

Medical procedures

Alias
UMLS CUI-1
C0199171
Medical Procedures
Beschreibung

Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this module

Datentyp

text

Alias
UMLS CUI [1]
C0199171
Concomitant Medication
Beschreibung

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Concomitant Medication
Beschreibung

Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this module

Datentyp

text

Alias
UMLS CUI [1]
C2347852
Adverse reaction
Beschreibung

Adverse reaction

Alias
UMLS CUI-1
C0559546
Adverse reaction
Beschreibung

Please record any adverse experiences observed or elicited by the following direct question to the patient: "Have you felt different in any way since the last visit?" in the Adverse Experience section at the back of this module

Datentyp

text

Alias
UMLS CUI [1]
C0559546
Clinical global impression
Beschreibung

Clinical global impression

Alias
UMLS CUI-1
C3639708
Clinical global impression
Beschreibung

This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by copyright laws and therefore have been excluded.

Datentyp

text

Alias
UMLS CUI [1]
C3639708
Zum Seitenanfang zurückkehren

Ähnliche Modelle

GSK study: Ropinirole in RLS patients 101468/243 - Week 52

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Study medication record since last visit
C2734539 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Study medication record since last visit
Item
Study medication record since last visit
text
C2734539 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Item Group
RLS Rating scale
C0681889 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
RLS Rating scale
Item
RLS Rating scale
text
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Weight in kg
Item
Weight in kg
integer
C0005910 (UMLS CUI [1,1])
C0439209 (UMLS CUI [1,2])
Weight in lbs
Item
Weight in lbs
boolean
C0005910 (UMLS CUI [1,1])
C0439219 (UMLS CUI [1,2])
Weight
Item
Weight (without shoes)
float
C0005910 (UMLS CUI [1])
Pulse rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Sitting systolic blood pressure
Item
Sitting systolic blood pressure
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting diastolic blood pressure
Item
Sitting diastolic blood pressure
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
Laboratory evaluation
C0022885 (UMLS CUI-1)
Date of blood sample
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory label
Item
Please affix the Quest Diagnostics Laboratory label here.
text
C4273937 (UMLS CUI [1])
laboratory results abnormalities
Item
Were any clinically significant abnormalities detected?
boolean
C0005834 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item Group
Urine dipstick
C0430370 (UMLS CUI-1)
Item
What was the result of the urine dipstick performed at this visit?
integer
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
urine dipstick result
Code List
What was the result of the urine dipstick performed at this visit?
CL Item
negative (1)
CL Item
positive (2)
Item Group
Pregnancy dipstick
C0430056 (UMLS CUI-1)
female child-bearing potential
Item
Is the patient a female of child-bearing potential?
boolean
C1960468 (UMLS CUI [1])
Item
Record the result of the pregnancy dipstick, if the patient is a female of child-bearing potential
integer
C0430056 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Pregnancy dipstick result
Code List
Record the result of the pregnancy dipstick, if the patient is a female of child-bearing potential
CL Item
negative (1)
CL Item
positive (2)
Item Group
Medical procedures
C0199171 (UMLS CUI-1)
Medical Procedures
Item
Medical Procedures
text
C0199171 (UMLS CUI [1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant Medication
Item
Concomitant Medication
text
C2347852 (UMLS CUI [1])
Item Group
Adverse reaction
C0559546 (UMLS CUI-1)
Adverse reaction
Item
Adverse reaction
text
C0559546 (UMLS CUI [1])
Item Group
Clinical global impression
C3639708 (UMLS CUI-1)
Clinical global impression
Item
Clinical global impression
text
C3639708 (UMLS CUI [1])
Zum Seitenanfang zurückkehren 

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video