What is a CTCAE grade?

Grades. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.

What is CTCAE used for?

CTCAE is an internationally accepted standard for defining and categorizing adverse events. It allows us to talk to our patients in a more useful way, and it also allows us to speak the same language as cutting-edge oncology researchers around the world.

What is latest version of CTCAE?

The current version 5.0 was released on November 27, 2017. Many clinical trials, now extending beyond oncology, encode their observations based on the CTCAE system. It uses a range of grades from 1 to 5.

What is considered a Serious Adverse Event?

Serious adverse event or serious suspected adverse reaction: Death. A life-threatening adverse event. Inpatient hospitalization, or prolonged of existing hospitalization. A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.

What are the 4 elements you should try to get when reporting an adverse event to patient safety?

The minimum dataset required to consider information as a reportable AE is indeed minimal, namely (1) an identifiable patient, (2) an identifiable reporter, (3) product exposure, and (4) an event.

What should happen after an adverse event?

After an adverse event, Five A’s: Acknowledgment, Apology, All the Facts, Assurance and Appropriate Compensation, serve to meet the essential needs of patients and their families.

What the difference between a side effect and an adverse reaction?

To many people, adverse events and side effects mean the same thing and are used interchangeably, which is incorrect. Adverse events are unintended pharmacologic effects that occur when a medication is administered correctly while a side effect is a secondary unwanted effect that occurs due to drug therapy.