Table 5.

Grade 2 and 3 adverse events. Adverse events that were possibly, probably, or definitely related to applicator placement or radiation therapy as reported at each follow-up visit

	1 month	6 months	1 year
Grade 2 events
Number of patients	68a	59	37
Induration/firmness	4 (5.9%)	3 (5.1%)	1 (2.7%)
Erythema	4 (5.9%)	0	1 (2.7)d
Seroma	1 (1.5%)	2 (3.4%)c	1 (2.7%)
Rash/desquamation – moist	3 (4.4%)b	0	0
Breast tenderness	1 (1.5%)	1 (1.7%)	0
Hypopigmentation	2 (2.9%)	0	0
Palpable mass	2 (2.9%)	0	0
Field contracture – slight indent in skin	0	0	1 (2.7%)
Field contracture – significant	0	1 (1.7%)	0
Infection	1 (1.5%)	0	0
Grade 3 eventse
Field contracture – significant	1 (1.5%)	0	0
Fibrosis connective tissue	0	0	1 (2.7%)c

^aNotes: One of the 69 treated patients did not complete the 1-month follow-up visit due to an acute myocardial infarction and subsequent death; no treatment-related adverse events occurred in this patient;

^bIncludes three unscheduled visits around 1 month post-treatment;

^cIncludes one unscheduled visit around 6 months post-treatment;

^dIncludes one unscheduled visit around 1 year post-treatment;

^eOne patient had Grade 3 diarrhea that was related to a Clostridium difficile infection due to a prophylactic antibiotic.