Table 7 Summary of adverse events
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 %) |