ID

24455

Beschreibung

Module 19B - GSK study: Ropinirole in RLS patients 101468/243 - Evening Visits for Orthostatic Vital Signs, Week 48 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. 01.08.17 01.08.17 -
Rechteinhaber

glaxoSmithKline

Hochgeladen am

1. August 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 :

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 - Evening Visits for Orthostatic Vital Signs, Week 48

Englisch

GSK study: Ropinirole in RLS patients 101468/243 - Evening Visits for Orthostatic Vital Signs, Week 48

1 Formulare  
Orthostatic vital signs - instructions
Beschreibung

Orthostatic vital signs - instructions

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1442085
Orthostatic vital signs - instructions
Beschreibung

ONLY TAKE ORTHOSTATIC VITAL SIGNS IF A DOSE INCREASE OCCURS Instructions: Semi-supine measurements will be made after the patient has been resting semi-supine for at least 10 minutes and erect measurements will be taken after the patient has been standing for a period of 1 minute. • The blood pressure cuff must be placed on the same arm throughout the study. • Ideally, the same study nurse/medical professional should conduct all the blood pressure/pulse measurements for each clinic visit and each patient throughout the study. • Pre-dose orthostatic measurements will commence approximately 30 minutes prior to dosing and each set will be separated by 10 minutes rest in the semi-supine position. • Two sets of stable, consecutive pre-dose semi-supine and erect blood pressure measurements as well as two sets of pulse rate measurements will be taken. Stable is defined as three measurements within +15mmHg of the lowest measurement. • One set of orthostatic blood pressure and pulse measurements will be taken 2 hours post dose.

Datentyp

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1442085
Pre-Dose Reading
Beschreibung

Pre-Dose Reading

Alias
UMLS CUI-1
C1522609
UMLS CUI-2
C0439565
Pre-dose reading
Beschreibung

Pre-dose reading

Datentyp

integer

Alias
UMLS CUI [1,1]
C1522609
UMLS CUI [1,2]
C0439565
Time vitals taken
Beschreibung

Pre-Dose Reading: after 10 min in semi-supine position. 40 min prior to dosing.

Datentyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Semi-supine systolic blood pressure
Beschreibung

Pre-Dose Reading: after 10 min in semi-supine position. 40 min prior to dosing.

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Semi-supine diastolic blood pressure
Beschreibung

Pre-Dose Reading: after 10 min in semi-supine position. 40 min prior to dosing.

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Beschreibung

Pre-Dose Reading: after 10 min in semi-supine position. 40 min prior to dosing.

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Time vitals taken
Beschreibung

Pre-Dose Reading: after erect for 1 min. 40 min prior to dosing.

Datentyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Erect systolic blood pressure
Beschreibung

Pre-Dose Reading: after erect for 1 min. 40 min prior to dosing.

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Erect diastolic blood pressure
Beschreibung

Pre-Dose Reading: after erect for 1 min. 40 min prior to dosing.

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Beschreibung

Pre-Dose Reading: after erect for 1 min. 40 min prior to dosing.

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Time of dose
Beschreibung

Time of dose

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0040223
Time of dose
Beschreibung

Time of dose

Datentyp

time

Maßeinheiten
  • Hr : Min
Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0040223
Hr : Min
Dose level
Beschreibung

Dose level

Datentyp

text

Alias
UMLS CUI [1]
C0178602
2 hours Post-Dose Reading 1
Beschreibung

2 hours Post-Dose Reading 1

Alias
UMLS CUI-1
C1522609
UMLS CUI-2
C0439572
Time vitals taken
Beschreibung

Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

Datentyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Semi-supine systolic blood pressure
Beschreibung

Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Semi-supine diastolic blood pressure
Beschreibung

Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Pulse
Beschreibung

Post-Dose Reading 1: after 10 min in semi-supine position. 2 hours post-dose.

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Time vitals taken
Beschreibung

Post-Dose Reading 1: after erect for 1 min. 2 hours post-dose.

Datentyp

time

Erect systolic blood pressure
Beschreibung

Post-Dose Reading 1: after erect for 1 min. 2 hours post-dose. in mmHg; systolic/diastolic

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Erect diastolic blood-pressure
Beschreibung

Post-Dose Reading 1: after erect for 1 min. 2 hours post-dose.

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Pulse
Beschreibung

Pre-Dose Reading 1: after erect for 1 min. 2 hours post-dose.

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Zum Seitenanfang zurückkehren

Ähnliche Modelle

GSK study: Ropinirole in RLS patients 101468/243 - Evening Visits for Orthostatic Vital Signs, Week 48

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Orthostatic vital signs - instructions
C0518766 (UMLS CUI-1)
C1442085 (UMLS CUI-2)
Orthostatic vital signs - instructions
Item
Orthostatic vital signs - instructions
text
C0518766 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
Item Group
Pre-Dose Reading
C1522609 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Pre-dose reading
Item
Pre-dose reading
integer
C1522609 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
Time vitals taken
Item
Time vitals taken
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Semi-supine Systolic blood pressure
Item
Semi-supine systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Semi-supine diastolic blood pressure
Item
Semi-supine diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Time vitals taken
Item
Time vitals taken
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Erect systolic blood pressure
Item
Erect systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Erect diastolic blood pressure
Item
Erect diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Item Group
Time of dose
C0013227 (UMLS CUI-1)
C0040223 (UMLS CUI-2)
Time of dose
Item
Time of dose
time
C0013227 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dose level
Item
Dose level
text
C0178602 (UMLS CUI [1])
Item Group
2 hours Post-Dose Reading 1
C1522609 (UMLS CUI-1)
C0439572 (UMLS CUI-2)
Time vitals taken
Item
Time vitals taken
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Semi-supine systolic blood pressure
Item
Semi-supine systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Semi-supine diastolic blood pressure
Item
Semi-supine diastolic blood pressure
integer
C0871470 (UMLS CUI [1])
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Time vitals taken
Item
Time vitals taken
time
Erect systolic blood pressure
Item
Erect systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Erect diastolic blood-pressure
Item
Erect diastolic blood-pressure
integer
C0428883 (UMLS CUI [1])
Pulse Rate
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

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