CTCAE Explained: An Overview & Criteria

by

This blog covers the following topics:

  1. An overview of CTCAE (Common Terminology Criteria for Adverse Events)
  2. A breakdown of the different grades within the CTCAE classification
  3. Simple examples to illustrate each grade

Introduction

Many healthcare professionals (HCPs) and those involved in pharmacovigilance may not be fully aware of CTCAE or how it is derived.

In this article, we provide an overview of CTCAE, explaining each grade and how to interpret them.

You might wonder why some cases are reported as non-serious, even though they meet the criteria for being serious.

This article will help clarify the value and importance of CTCAE in such situations.

CTCAE: An Overview

The NCI Common Terminology Criteria for Adverse Events (CTCAE) is a standardized system used for reporting and describing Adverse Events (AEs).

It includes a grading scale to assess the severity of each AE.

CTCAE documents are publicly available, meaning anyone can review them to assess reports or incidents that are relevant to their work or cases they are responsible for.

CTCAE and Pharmacovigilance

In pharmacovigilance, particularly in case processing, the CTCAE document plays a crucial role in defining whether an event qualifies as serious.

Many professionals may not be fully aware of this document and its importance.

You might wonder how a reported non-serious event can later be classified as serious. This is where CTCAE becomes essential. Based on the specifics of the report, CTCAE helps determine the appropriate classification.

📢 Recommendations: I recommend two articles: the first discusses the differences between adverse events and adverse reactions, and the second explains what constitutes a serious event, along with the categories used to determine an event as serious.

Grades of Severity: Explained

CTCAE categorizes each condition into five grades, ranging from Grade 1 to Grade 5. These grades are not simply numbers; they represent different levels of severity, ranging from mild to critical, and even death.

Each grade corresponds to the severity of an adverse event (AE). The CTCAE provides detailed clinical descriptions for each grade, which help assess the event’s seriousness, following this general guideline:…

“CTCAE not just a document, it provides a universal language for assessing the impact of treatments.”

Grade 1:

Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention needed.

Example: Hemoglobin (Hgb) <LLN – 10.0 g/dL; <LLN – 6.2 mmol/L; <LLN – 100 g/L

Grade 2:

Moderate; minimal, local, or noninvasive intervention needed; limits age-appropriate instrumental activities of daily living (ADL*).

Example: Hgb <10.0 – 8.0 g/dL; <6.2 – 4.9 mmol/L; <100 – 80g/L

Grade 3:

Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization required; disabling; limits self-care ADL*.

Example: Hgb <8.0 g/dL; <4.9 mmol/L; <80 g/L; transfusion needed

Grade 4:

Life-threatening consequences; urgent intervention required.

Example: Life-threatening consequences; urgent intervention needed.

Grade 5:

Death related to the AE. Note: Death is not applicable for some AEs and is therefore not an option.

Determining the Grade of Your Reported Event in CTCAE

CTCAE terms are based on MedDRA terminology, specifically LLTs (Lowest Level Terms). The CTCAE is structured according to MedDRA coding.

To determine the grade of your event, identify the LLT for the reported verbatim term and search the CTCAE document to find the corresponding severity grade.

Depending on the grade assigned, your case may be upgraded or downgraded, especially if you’re unsure about the seriousness of the event.

Key Takeaways

Not all events need to reach Grade 5.

All terms in CTCAE based on MedDRA LLTs, not PTs (Preferred Terms).

Most events classified as Grade 5 related to death.

Grades vary depending on the severity of the condition.

How can we assist you in case management?

Dealing with a backlog of case corrections? Can it quickly become overwhelming and significantly impact your daily workflow? At Drugvigil, we specialize in subcontracting services aimed at relieving this burden and enhancing your workflow. Let us help streamline your processes and improve efficiency.

Conclusion

We hope this article has provided valuable insights and guidance on understanding CTCAE grades.

As a beginner, you now have a better understanding of how events elevated based on the information, regardless of whether seriousness was initially reported.

If you have any questions or suggestions, we welcome your feedback! Your comments help us improve and grow.

Feel free to share this article with your colleagues and friends!

Acronym:

ADL: Activities of Daily Living

Reference:
  1. Common Terminology Criteria for Adverse Events (CTCAE)’ (no date).

Disclaimer: We write this blog based on our experience and extensive knowledge, supported by references. Please note that we are not responsible for the content on the referenced websites. If you come across any misinformation or misguidance or spelling mistakes, kindly inform us promptly.



Bala Avatar

Meet Bala, the founder of Drugvigil, a service provider specializing in pharmacovigilance. He’s not only an expert in this field, but also a passionate entrepreneur who enjoys creating new opportunities and helping others grow. Despite starting from scratch, he’s determined to develop his company from the ground up. If you’re interested in his work, be sure to show your support and share his message with others.




Just a fancy image. www.drugvigil.com






Comments

2 responses to “CTCAE Explained: An Overview & Criteria”

  1. […] 📢 Recommendation: Recommending an article that explains the medically significant events based on CTCAE grades of seriousness of events. […]

  2. […] 📢 Recommendation: Here what we discussed as what are SUSAR cases and henceforth to explain more in detailing with serious adverse events and categories and characteristics and explaining the assessments of adverse events as serious based on CTCAE documentation. […]

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.