Adverse Drug Events

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The Basics on Adverse Event Monitoring, Assessment and ...

www.bumc.bu.edu

there is a reasonable possibility that the drug caused the adverse event….. _ – ZReasonable possibility: evidence to suggest a causal relationship between the drug and the adverse event. (21 CFR 312.32) •Adverse reaction: Subset of suspected adverse reactions – ^Any adverse event caused by a drug. (FDA Guidance, 12/12) 17 Adverse event

Assessment, Drug, Events, Monitoring, Adverse, Assessment and, On adverse event monitoring

DRUG NAME: Rituximab - BC Cancer

www.bccancer.bc.ca

The table includes adverse events that presented during drug treatment but may not necessarily have a causal relationship with the drug. Because clinical trials are conducted under very specific conditions, the adverse event rates observed may not reflect the rates observed in clinical practice. Adverse events are generally included if they

Drug, Events, Adverse, Adverse event

Adverse Drug Events

The Basics on Adverse Event Monitoring, Assessment and ...

DRUG NAME: Rituximab - BC Cancer

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