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Table 7 Summary of adverse events

From: The safety and effectiveness of volumetric magnetic resonance-guided high-intensity focused ultrasound treatment of symptomatic uterine fibroids: early clinical experience in China

Adverse event Peking (N = 58) Xi’an (N = 49) Overall (N = 107)
Total number of adverse events 224 142 366
Patients with at least one SAE 1 (1.7 %) 5 (10.2 %) 6 (5.6 %)
Total number of serious AEs 2 (0.9 %) 8 (5.7 %) 10 (2.7 %)
 Pregnancy 1 (1.7 %) 3 (6.1 %) 4 (3.7 %)
 Termination of pregnancy 1 (1.7 %) 3 (6.1 %) 4 (3.7 %)
 Ductal carcinoma 0 (0.0 %) 1 (2.0 %) 1 (0.9 %)
 Fibroid surgery 0 (0.0 %) 1 (2.0 %) 1 (0.9 %)
Patients with at least one AE 45 (77.6 %) 38 (77.6 %) 83 (77.6 %)
Total number of related AEs 52 (23.2 %) 107 (74.8 %) 159 (43.3 %)
 Abdominal/pelvic pain 30 (51.7 %) 30 (61.2 %) 60 (56.1 %)
 Skin heating/pain 25 (43.1 %) 10 (20.4 %) 35 (32.7 %)
 Leg pain 15 (25.9 %) 5 (10.2 %) 20 (18.7 %)
 Back pain 11 (19.0 %) 2 (4.1 %) 13 (12.1 %)
 Abdominal distension 3 (5.2 %) 1 (2.0 %) 4 (3.7 %)
 Buttock pain 4 (6.9 %) 0 (0.0 %) 4 (3.7 %)
 Leg numbness 3 (5.2 %) 0 (0.0 %) 3 (2.8 %)
 Skin redness 1 (1.7 %) 2 (4.1 %) 3 (2.8 %)
 1st degree skin burn 1 (1.7 %) 0 (0.0 %) 1 (0.9 %)
 Leg edema/pain 1 (1.7 %) 0 (0.0 %) 1 (0.9 %)
 Pubic bone pain 0 (0.0 %) 1 (2.0 %) 1 (0.9 %)
 Skin edema 1 (1.7 %) 0 (0.0 %) 1 (0.9 %)