CTC-AE+ 3.1

CTC-AE+ serves as a comprehensive reference tool for the Common Terminology Criteria for Adverse Events (CTCAE) list, specifically tailored for oncology. It includes a browsable database of adverse event (AE) terms frequently encountered in cancer treatments and features a portable Adverse Event Logger designed to track adverse events throughout clinical studies.

The CTC-AE 4 and CTC-AE 5 versions have evolved from the earlier Common Toxicity Criteria (CTC) vocabulary. Each AE term is meticulously defined and paired with a grading scale that indicates the severity of the event. This structured organization, based on System Organ Classes (SOCs) from the Medical Dictionary for Regulatory Activities (MedDRA), facilitates a standardized approach to AE reporting.

Adverse events are prevalent among patients undergoing cancer treatment, making it essential to systematically monitor these occurrences, particularly with the introduction of new therapeutic agents and multimodal interventions. The CTCAE aims to establish a consistent terminology for the designation, reporting, and grading of AEs within oncology research.

CTC-AE serves several purposes:

• Standardizes AE reporting within the National Cancer Institute (NCI) oncology research community across collaborative groups and treatment modalities.
• Facilitates the evaluation of novel cancer therapies, treatment strategies, and supportive care interventions.
• Assists in recognizing AEs and determining their severity grading.
• Supports safety data monitoring and regulatory documentation.
• Defines parameters for oncology research protocols, such as eligibility criteria, dose-limiting toxicity, maximum tolerated dose, and dose modification guidelines.

KARNOFSKY and ECOG:

Furthermore, CTC-AE+ integrates the two most widely used performance scoring systems. These serve as references and provide guided algorithms for incorporating event details into patient records when necessary.

ADVERSE EVENT LOGGER:

The Adverse Event Logger is a structured local database that assists investigators in tracking all adverse events associated with patients in clinical trials. This tool allows for the management of multiple clinical studies, patients per trial, and events per patient. Events can be selected from the CTC-AE 4 and CTC-AE 5 databases or entered as customized entries from Karnofsky and ECOG score tables.

For user convenience, data can be exported as an Excel CSV file for integration with various analysis software systems.

IMPORTANT NOTE:

This application adheres strictly to EU GDPR compliance, ensuring that no clinical study or patient information is stored outside the device or uploaded to remote cloud resources.