This blog covers the following topics:
- An overview of CTCAE (Common Terminology Criteria for Adverse Events)
- A breakdown of the different grades within the CTCAE classification
- Simple examples to illustrate each grade
Table of Contents
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.
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.
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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
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