ID

25338

Beschreibung

Study ID: 101468/191 Clinical Study ID: SKF-101468/191 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Ropinirole in Subjects with Restless Legs Syndrome (RLS) Suffering from Periodic Leg Movements of Sleep (PLMS) 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: Restless Legs Syndrome

Stichworte

Versionen (2)
  1. 01.09.17 01.09.17 -
  2. 01.09.17 01.09.17 -
Hochgeladen am

1. September 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 Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 12 Day (Form 16)

Englisch

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 12 Day (Form 16)

1 Formulare  
General Information
Beschreibung

General Information

Center Number
Beschreibung

Center Number

Datentyp

integer

Patient Number
Beschreibung

Patient Number

Datentyp

integer

Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Visit Date
Beschreibung

Visit Date

Datentyp

date

Investigational Product Record since last visit
Beschreibung

Investigational Product Record since last visit

Please complete the investigational product record in the Investigational Product and Compliance Section at the back of this book. Please complete the Investigational Product Interruption record in the Investigational Product and Compliance Section at the back of this book.
Beschreibung

Investigational Product Record since last visit

Datentyp

boolean

RSL Rating Scale
Beschreibung

RSL Rating Scale

INVESTIGATOR: Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
Beschreibung

RSL Rating Scale

Datentyp

boolean

Vital Signs
Beschreibung

Vital Signs

Weight (without shoes)
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg/lbs
kg/lbs
Pulse (after 5 minutes sitting)
Beschreibung

Pulse

Datentyp

integer

Maßeinheiten
  • beats/min
beats/min
Sitting Blood Pressure (after 5 minutes sitting) systolic
Beschreibung

Sitting Blood Pressure systolic

Datentyp

integer

Maßeinheiten
  • mmHg
mmHg
Sitting Blood pressure (after 5 minutes sitting) diastolic
Beschreibung

Sitting Blood pressure diastolic

Datentyp

integer

Maßeinheiten
  • mmHg
mmHg
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
Beschreibung

Medical Procedures

Datentyp

boolean

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

Concomitant Medication

Datentyp

boolean

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 Week 8 Visit?" in the Adverse Experience section at the back of this book.
Beschreibung

Adverse Experiences

Datentyp

boolean

Laboratory Evaluation
Beschreibung

Laboratory Evaluation

Date of blood sample
Beschreibung

Date of blood sample

Datentyp

date

Were any clinically significant abnormalities detected?
Beschreibung

Results

Datentyp

text

Pregnancy Dipstick
Beschreibung

Pregnancy Dipstick

Is the patient a female of childbearing potential?
Beschreibung

Pregnancy Dipstick

Datentyp

text

Results pregnancy dipstick
Beschreibung

Results pregnancy dipstick

Datentyp

text

Zum Seitenanfang zurückkehren

Ähnliche Modelle

GSK Ropinirole in Subjects with Restless Legs Syndrome 101468/191 Week 12 Day (Form 16)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
General Information
Center Number
Item
Center Number
integer
Patient Number
Item
Patient Number
integer
Patient Initials
Item
Patient Initials
text
Visit Date
Item
Visit Date
date
Item Group
Investigational Product Record since last visit
Investigational Product Record since last visit
Item
Please complete the investigational product record in the Investigational Product and Compliance Section at the back of this book. Please complete the Investigational Product Interruption record in the Investigational Product and Compliance Section at the back of this book.
boolean
Item Group
RSL Rating Scale
RSL Rating Scale
Item
INVESTIGATOR: Please complete the appropriate RLS Rating Scale from the RLS Rating Scale Book.
boolean
Item Group
Vital Signs
Weight
Item
Weight (without shoes)
float
Pulse
Item
Pulse (after 5 minutes sitting)
integer
Sitting Blood Pressure systolic
Item
Sitting Blood Pressure (after 5 minutes sitting) systolic
integer
Sitting Blood pressure diastolic
Item
Sitting Blood pressure (after 5 minutes sitting) diastolic
integer
Medical Procedures
Item
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
boolean
Concomitant Medication
Item
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
boolean
Adverse Experiences
Item
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 Week 8 Visit?" in the Adverse Experience section at the back of this book.
boolean
Item Group
Laboratory Evaluation
Date of blood sample
Item
Date of blood sample
date
Item
Were any clinically significant abnormalities detected?
text
Results
Code List
Were any clinically significant abnormalities detected?
CL Item
No (1)
CL Item
Yes -> If "Positive", please record details in the Pregnancy Information section on the Study Conclusion page at the back of this book. (2)
Item Group
Pregnancy Dipstick
Item
Is the patient a female of childbearing potential?
text
Pregnancy Dipstick
Code List
Is the patient a female of childbearing potential?
CL Item
No (1)
CL Item
Yes -> If "Yes", please perform a pregnancy dipstick test and record results below. (2)
Item
Results pregnancy dipstick
text
Results pregnancy dipstick
Code List
Results pregnancy dipstick
CL Item
Negative (1)
CL Item
Positive -> If "Posititve", please record details in the Pregnancy Information section on the Study Conclusion page at the end of this book. (2)
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