Serious Adverse Events

Timely reporting of adverse events and adverse drug reactions in clinical trials is required by Food and Drug Administration regulations and policies of the National Cancer Institute and SWOG Cancer Research Network. Such reporting improves both patient care and scientific communication by allowing rapid dissemination of new findings to other investigators studying the drug. Below are links to rules and tools to assist in this important process.

Serious Adverse Event - Expedited Reporting

If you have questions regarding Serious Adverse Events, Serious Adverse Event Reporting or the CTEP-AERS reporting system, contact the SWOG SAE Coordinator (210-614-8808) or nqe/ng/fjbt/qbg/bet.


SWOG

  • Expedited Reporting Requirements
    Section 16.1 of all SWOG protocols contain information pertaining to expedited reporting requirements.
  • Study-Specific SAE Report
    This report lists the SAEs that have been reported on a specified SWOG study. It is available on the Reports page on the CRA Workbench.

 

CTCAE 4.0

  • Introduction
    It is something of an understatement to call CTCAE 4.0 a version change. It is a complete reorganization of NCI’s system of adverse event reporting. The major driving force behind 4.0 was alignment of NCI’s AE classifications with MedDRA, the Medical Dictionary for Regulatory Activities, a standard for adverse event reporting accepted internationally by the pharmaceutical industry and governments. This change required realignment of AEs from long-used CTCAE Categories to MedDRA’s System Organ Classes, adding new AE terms, and eliminating some previously used AEs. The links in this secton are to tools that will aid in the transition to and use of this new method of reporting.

 

National Cancer Institute / Cancer Therapy Evaluation Program

  • Reporting Secondary Malignancy
    Reporting of secondary malignancy, including AML/ALL/MDS will be done via CTEP-AERS.

    If you are reporting in CTCAE v3.0, the event(s) can be reported as "Secondary malignancy-Other (specify)".

    If you are reporting in CTCAE v4.0, the event(s) may be reported as either 1) Leukemia secondary to oncology chemotherapy; 2) Myelodysplastic syndrome; or 3) Treatment related secondary malignancy.

 

Food and Drug Administration