ID

22344

Descrizione

A Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Rosiglitazone (Extended Release Tablets) on Cerebral Glucose Utilization and Cognition in Subjects With Mild to Moderate Alzheimer's Disease (AD) Medicine: rosiglitazone, Condition: Alzheimer's Disease, Phase: 2, Clinical Study ID: 49653/461, This form is to be performed in Treatment Phase. Sponsor: GSK Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00265148?term=NCT00265148&rank=1

collegamento

https://clinicaltrials.gov/ct2/show/NCT00265148?term=NCT00265148&rank=1

Keywords

versioni (2)
  1. 30/05/17 30/05/17 -
  2. 30/05/17 30/05/17 -
Caricato su

30 maggio 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Serious Adverse Event Effects of Rosiglitazone on Cerebral Glucose Utilization and Cognition in Subjects With Alzheimer's Disease NCT00265148

Inglese

Serious Adverse Event Effects of Rosiglitazone on Cerebral Glucose Utilization and Cognition in Subjects With Alzheimer's Disease NCT00265148

1 moduli  
Serious Adverse Events (SAE)
Descrizione

Serious Adverse Events (SAE)

Alias
UMLS CUI-1
C1519255
Person Reporting SAE
Descrizione

Name

Tipo di dati

text

Alias
UMLS CUI [1]
C0008961
Serious Adverse Event (Please print clearly) GSK Use
Descrizione

Diagnosis

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0011900
Specify reason(s) for considering this a serious AE. Mark all that apply.
Descrizione

Reason

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1519255
Specify other reason
Descrizione

Specify other reason

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1519255
Onset Date/Time
Descrizione

Onset Date/Time

Tipo di dati

datetime

Alias
UMLS CUI [1]
C2985916
End Date/Time (if ongoing, please leave blank)
Descrizione

End Date/Time

Tipo di dati

datetime

Alias
UMLS CUI [1]
C3899266
Outcome *If subject died, please inform GSK within 24 hours and complete Form D.
Descrizione

Outcome

Tipo di dati

integer

Alias
UMLS CUI [1]
C1705586
Event Course
Descrizione

Course

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
Intensity (maximum)
Descrizione

Intensity

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0522510
UMLS CUI [1,2]
C0877248
Action taken with Respect to Investigational Drug
Descrizione

Action taken

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0441472
UMLS CUI [1,2]
C0013230
Relationship to Investigational Drug
Descrizione

Relationship to Investigational Drug

Tipo di dati

integer

Alias
UMLS CUI [1]
C0013230
Corrective Therapy If ´Yes`, Please record on Concomitant Medication form.
Descrizione

Corrective Therapy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0087111
Was subject withdrawn due to this AE?
Descrizione

Withdrawal

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0877248
Serious Adverse Event
Descrizione

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Did the SAE abate?
Descrizione

SAE Abation

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C3853704
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
Descrizione

Trial medication

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0013227
If yes, did SAE recur?
Descrizione

SAE

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1519255
Assessment
Descrizione

Assessment

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C1516048
The SAE is probably associated with:
Descrizione

sae

Tipo di dati

integer

Alias
UMLS CUI [1]
C1706737
Please specify
Descrizione

Specify SAE

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1519255
Ritorna all'inizio della pagina

Similar models

Serious Adverse Event Effects of Rosiglitazone on Cerebral Glucose Utilization and Cognition in Subjects With Alzheimer's Disease NCT00265148

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Serious Adverse Events (SAE)
C1519255 (UMLS CUI-1)
Name
Item
Person Reporting SAE
text
C0008961 (UMLS CUI [1])
Diagnosis
Item
Serious Adverse Event (Please print clearly) GSK Use
text
C1519255 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Specify reason(s) for considering this a serious AE. Mark all that apply.
integer
C0392360 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Reason
Code List
Specify reason(s) for considering this a serious AE. Mark all that apply.
CL Item
results in Death (1)
CL Item
life threatening (2)
CL Item
requires hospitalization or prolongation of existing hospitalization (3)
CL Item
results in disability/incapacity (4)
CL Item
congenital anomaly/birth defect (5)
CL Item
other (see definition) (6)
Specify other reason
Item
Specify other reason
text
C0392360 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Onset Date/Time
Item
Onset Date/Time
datetime
C2985916 (UMLS CUI [1])
End Date/Time
Item
End Date/Time (if ongoing, please leave blank)
datetime
C3899266 (UMLS CUI [1])
Item
Outcome *If subject died, please inform GSK within 24 hours and complete Form D.
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome *If subject died, please inform GSK within 24 hours and complete Form D.
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
Event Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Course
Code List
Event Course
CL Item
Intermittent  (1)
CL Item
Constant (2)
Item
Intensity (maximum)
integer
C0522510 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Intensity
Code List
Intensity (maximum)
CL Item
Mild (1)
CL Item
Moderate (3)
CL Item
Severe (3)
Item
Action taken with Respect to Investigational Drug
integer
C0441472 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Action taken
Code List
Action taken with Respect to Investigational Drug
CL Item
None (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
CL Item
Drug stopped (5)
Item
Relationship to Investigational Drug
integer
C0013230 (UMLS CUI [1])
trial procedures
Code List
Relationship to Investigational Drug
CL Item
Not related (1)
CL Item
Unlikely (2)
CL Item
Suspected (reasonable possibility) (3)
CL Item
Probable (4)
Corrective Therapy
Item
Corrective Therapy If ´Yes`, Please record on Concomitant Medication form.
boolean
C0087111 (UMLS CUI [1])
Withdrawal
Item
Was subject withdrawn due to this AE?
boolean
C2349954 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
SAE Abation
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
Trial medication
Item
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
boolean
C0013227 (UMLS CUI [1])
SAE
Item
If yes, did SAE recur?
boolean
C1519255 (UMLS CUI [1])
Item Group
Assessment
C1519255 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
Item
The SAE is probably associated with:
integer
C1706737 (UMLS CUI [1])
sae
Code List
The SAE is probably associated with:
CL Item
Protocol design or procedures (but not to study drug) (1)
CL Item
Another condition (eg, condition under study, intercurrent illness) (2)
CL Item
Another drug (3)
Specify SAE
Item
Please specify
text
C0392360 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial