Adverse Event

Acontecimiento Adverso

Adverse Event

Reacción Adversa

Adverse Event

Efecto adverso

Adverse Event
http://www.emea.europa.eu/

Efectos Adversos
http://www.emea.europa.eu/

Adverse Event and

Acontecimientoúnico sugestivo

Serious adverse event

Acontecimiento adverso grave

Adverse reaction/ event
http://www.emea.europa.eu/

Acontecimiento/ Reacción Adversa
http://www.emea.europa.eu/

Adverse event reporting

Comunicación de acontecimientos adversos

Adverse Event Characteristics

Grado e intensidad del acontecimiento adverso

Serious Adverse Event Reporting

Notificación de acontecimientos adversos graves

Adverse Event, n (%)

Acontecimiento adverso, n (%)

Definition of a Serious Adverse Event

Definición de un acontecimiento adverso grave

ADVERSE EVENT DEFINITION AND REPORTING REQUIREMENTS

REQUISITOS DE NOTIFICACIÓN DE ACONTECIMIENTOS ADVERSOS

Adverse Events

Acontecimientos adversos

AE=adverse event; SAE=serious adverse event.

AA = acontecimiento adverso; AAG = acontecimiento adverso grave

Adverse events:

Reacciones adversas:

transient adverse events

acontecimientos adversos transitorios

Treatment-emergent adverse events

Acontecimientos adversos como consecuencia del tratamiento

Adverse Events Definition

Definición de acontecimientos adversos

Renal adverse events:

5 Efectos adversos renales: