Breast Cancer NCT00103181 Toxicity - NSABP PROTOCOL B-39: ADVERSE EVENT FORM FOR RADIATION THERAPY - 2295182v3.0

This paper worksheet may be completed to facilitate the entry of the adverse event information in NSABP Coordinator Online. Partially completed forms may be saved in Coordinator Online. DO NOT SUBMIT THIS WORKSHEET VIA FAX OR MAIL. For Protocol B-39, Form AE collects only adverse events that are possibly, probably, or definitely related to whole breast irradiation (WBI) or partial breast irradiation (PBI), regardless of whether these adverse events are expected or unexpected. Do not report adverse events resulting from chemotherapy, hormonal therapy or any other systemic cancer therapy. Complete Form AE at the end of each Reporting Period, as defined below. The Reporting Period Start Date should not lapse or overlap with the Reporting Period End Date of the prior Form AE. If the patient has a breast cancer recurrence or second primary cancer, please use the date of the cancer event as the reporting period end date. No additional AE forms will be required for this patient. If patient did not start RT, do not submit Form AE. If patient started radiation therapy (RT), use Form AE to report adverse events that are POSSIBLY, PROBABLY, or DEFINITELY RELATED to radiation therapy.