ID
24079
Description
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
Mots-clés
Versions (1)
- 25/07/2017 25/07/2017 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
25 juillet 2017
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC-ND 3.0
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Visit 6 GSK Rosiglitazone Alzheimer's disease 100468
Visit 6 GSK Rosiglitazone Alzheimer's disease 100468
- StudyEvent: ODM
Description
Visit Information
Alias
- UMLS CUI-1
- C0545082
Description
Investigator Instructions
Alias
- UMLS CUI-1
- C1442085
Description
Subject Continuation
Alias
- UMLS CUI-1
- C0805733
Description
Subject Continuation
Type de données
text
Alias
- UMLS CUI [1]
- C0805733
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Weight
Type de données
float
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Type de données
float
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Type de données
float
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Type de données
float
Unités de mesure
- beats/minute
Alias
- UMLS CUI [1]
- C0018810
Description
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Description
Neurological Examination
Type de données
text
Alias
- UMLS CUI [1]
- C0027853
Description
Central Laboratory (Fasting Samples)
Alias
- UMLS CUI-1
- C1880016
Description
Pregnancy Test
Alias
- UMLS CUI-1
- C0032976
Description
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
Date of ECG
Type de données
date
Unités de mesure
- dd-mmm-yy
Alias
- UMLS CUI [1]
- C2826640
Description
[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.
Type de données
integer
Alias
- UMLS CUI [1]
- C1623258
Description
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Description
Adverse Event
Alias
- UMLS CUI-1
- C0877248
Description
Adverse Event
Type de données
text
Alias
- UMLS CUI [1]
- C0877248
Description
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Description
Physical Examination
Type de données
text
Alias
- UMLS CUI [1]
- C0031809
Description
Pedal Oedema
Alias
- UMLS CUI-1
- C0574002
Description
Pedal Oedema: depth
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Description
Pedal Oedema: Site
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C1515974
Description
The following scales should be completed at this visit: ADAS-cog, CIBIC+, NPI, DAD
Alias
- UMLS CUI-1
- C0681889
Description
ADAS-COG
Type de données
text
Alias
- UMLS CUI [1]
- C3539026
Description
CIBIC-Plus Summary
Type de données
text
Alias
- UMLS CUI [1,1]
- C0443172
- UMLS CUI [1,2]
- C0449820
Description
Neuropsychiatric Inventory (NPI)
Type de données
text
Alias
- UMLS CUI [1]
- C3539727
Description
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
Description
Investigational Product
Type de données
text
Alias
- UMLS CUI [1]
- C0304229
Description
Start Date
Type de données
date
Unités de mesure
- dd-mmm-yy
Alias
- UMLS CUI [1]
- C0808070
Description
Stop Date
Type de données
date
Unités de mesure
- dd-mmm-yy
Alias
- UMLS CUI [1]
- C0806020
Description
Dose
Type de données
integer
Unités de mesure
- mg
Description
IP Container Number
Type de données
text
Alias
- UMLS CUI [1]
- C0180098
Description
Total number of Tablets Dispensed
Type de données
float
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0039225
Description
Total number of Tablets Returned
Type de données
float
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0039225
Description
Discontinuation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0457454
Description
End of Visit Reminder
Alias
- UMLS CUI-1
- C1709896
- UMLS CUI-2
- C1320303
Similar models
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])