ID

26381

Beschreibung

Study Part: Baseline Signs and Symptoms Week 1 Pre-dose (Visit 1). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Stichworte

Versionen (1)
  1. 16.10.17 16.10.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

16. Oktober 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.

Baseline Signs and Symptoms Week 1 Pre-dose (Visit 1) Ropinirole Parkinson Disease 101468/165

Englisch

Baseline Signs and Symptoms Week 1 Pre-dose (Visit 1)

1 Formulare  
BASELINE SIGNS AND SYMPTOMS
Beschreibung

BASELINE SIGNS AND SYMPTOMS

Alias
UMLS CUI-1
C0037088
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C1830427
Centre Number
Beschreibung

Centre Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Onset Date and Time
Beschreibung

Onset Date and Time

Datentyp

datetime

Alias
UMLS CUI [1]
C2826806
End Date and Time
Beschreibung

End Date and Time

Datentyp

datetime

Alias
UMLS CUI [1]
C2826793
Outcome
Beschreibung

Outcome

Datentyp

text

Alias
UMLS CUI [1]
C1705586
Event Course
Beschreibung

Event Course

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
No. of Episodes
Beschreibung

number of episodes

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Beschreibung

Intensity

Datentyp

text

Alias
UMLS CUI [1]
C1710066
Relationship to study procedures performed prior to randomisation
Beschreibung

Relationship to study drug

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0013227
Corrective Therapy
Beschreibung

Corrective Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was subject withdrawn due to this event?
Beschreibung

subject withdrawn

Datentyp

boolean

Alias
UMLS CUI [1]
C0422727
Investigator’s Signature
Beschreibung

Investigator Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date:
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Baseline Signs and Symptoms Week 1 Pre-dose (Visit 1)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
BASELINE SIGNS AND SYMPTOMS
C0037088 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Onset Date and Time
Item
Onset Date and Time
datetime
C2826806 (UMLS CUI [1])
End Date and Time
Item
End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Outcome
text
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Resolved (Resolved)
CL Item
Ongoing (Ongoing)
CL Item
Died (Died)
Item
Event Course
text
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Event Course
Code List
Event Course
CL Item
Intermittent (Intermittent)
CL Item
Constant (Constant)
number of episodes
Item
No. of Episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
text
C1710066 (UMLS CUI [1])
Intensity
Code List
Intensity (maximum)
CL Item
Mild (Mild)
CL Item
Moderate (Moderate)
CL Item
Severe (Severe)
Item
Relationship to study procedures performed prior to randomisation
text
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Relationship to study drug
Code List
Relationship to study procedures performed prior to randomisation
CL Item
Not related (Not related)
CL Item
Unlikely (Unlikely)
CL Item
Suspected (Suspected)
CL Item
Probable (Probable)
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
subject withdrawn
Item
Was subject withdrawn due to this event?
boolean
C0422727 (UMLS CUI [1])
Investigator Signature
Item
Investigator’s Signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date:
date
C0011008 (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