ID
24079
Beschreibung
Study ID: 100468 Clinical Study ID: AVA100468 Study Title: An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Avandia XR,Rosiglitazone XR,Avandia Study Indication: Alzheimer's Disease Visit 6
Stichworte
Versionen (1)
- 25.07.17 25.07.17 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
25. Juli 2017
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC-ND 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Visit 6 GSK Rosiglitazone Alzheimer's disease 100468
Visit 6 GSK Rosiglitazone Alzheimer's disease 100468
- StudyEvent: ODM
Beschreibung
Visit Information
Alias
- UMLS CUI-1
- C0545082
Beschreibung
Investigator Instructions
Alias
- UMLS CUI-1
- C1442085
Beschreibung
Subject Continuation
Alias
- UMLS CUI-1
- C0805733
Beschreibung
Subject Continuation
Datentyp
text
Alias
- UMLS CUI [1]
- C0805733
Beschreibung
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datentyp
float
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datentyp
float
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datentyp
float
Maßeinheiten
- beats/minute
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Beschreibung
Neurological Examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0027853
Beschreibung
Central Laboratory (Fasting Samples)
Alias
- UMLS CUI-1
- C1880016
Beschreibung
Pregnancy Test
Alias
- UMLS CUI-1
- C0032976
Beschreibung
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschreibung
Date of ECG
Datentyp
date
Maßeinheiten
- dd-mmm-yy
Alias
- UMLS CUI [1]
- C2826640
Beschreibung
[3] abnormal - clinically significant: Complete an Adverse Event (AE) or Serious Adverse Event (SAE) ge(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.
Datentyp
integer
Alias
- UMLS CUI [1]
- C1623258
Beschreibung
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beschreibung
Adverse Event
Alias
- UMLS CUI-1
- C0877248
Beschreibung
Adverse Event
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschreibung
Physical Examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
Pedal Oedema
Alias
- UMLS CUI-1
- C0574002
Beschreibung
Pedal Oedema: depth
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Beschreibung
Pedal Oedema: Site
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C1515974
Beschreibung
The following scales should be completed at this visit: ADAS-cog, CIBIC+, NPI, DAD
Alias
- UMLS CUI-1
- C0681889
Beschreibung
ADAS-COG
Datentyp
text
Alias
- UMLS CUI [1]
- C3539026
Beschreibung
CIBIC-Plus Summary
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0443172
- UMLS CUI [1,2]
- C0449820
Beschreibung
Neuropsychiatric Inventory (NPI)
Datentyp
text
Alias
- UMLS CUI [1]
- C3539727
Beschreibung
Investigational Product/ Compliance - Dispense Weeks 25 - 32 study medication as specified by the IVRS system. Record start date, container number and number of tablets dispensed below (stop date and tablets returned will be completed when the bottle is returned).
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C1321605
Beschreibung
Investigational Product
Datentyp
text
Alias
- UMLS CUI [1]
- C0304229
Beschreibung
Start Date
Datentyp
date
Maßeinheiten
- dd-mmm-yy
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
Stop Date
Datentyp
date
Maßeinheiten
- dd-mmm-yy
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Dose
Datentyp
integer
Maßeinheiten
- mg
Beschreibung
IP Container Number
Datentyp
text
Alias
- UMLS CUI [1]
- C0180098
Beschreibung
Total number of Tablets Dispensed
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0039225
Beschreibung
Total number of Tablets Returned
Datentyp
float
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0039225
Beschreibung
Discontinuation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0457454
Beschreibung
End of Visit Reminder
Alias
- UMLS CUI-1
- C1709896
- UMLS CUI-2
- C1320303
Ähnliche Modelle
Visit 6 GSK Rosiglitazone Alzheimer's disease 100468
- StudyEvent: ODM
C1442085 (UMLS CUI-2)
C1442085 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,2])
C1321605 (UMLS CUI-2)
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
C1320303 (UMLS CUI [1,2])