Table 2 Frequency and distribution of the local adverse events (percents refer to the total number of events within each group)
Local Events | Group I (14 mg) | Group II (70 mg) | Group III (245 mg) | Group IV (490 mg) |
|---|---|---|---|---|
Bleeding | 9 (47.4%) | 22 (57.9%) | 5 (14.7%) | 16 (39.0%) |
Pain in lower abdomen | 0 | 6 (15.8%) | 10 (29.4%) | 8 (19.5%) |
Hematoma | 0 | 3 (7.9%) | 7 (20.6%); g2: 1 (2.9%) | 4 (9.8%); g2: 1 (2.4%) |
Ulcer or superficial necrosis | 0 | 6 (15.8%); g2: 6 (15.8%) | 3 (8.8%); g2: 3 (8.8%) | 6 (14.6%); g2: 4 (9.8%) |
Erythema in situ* | 2 (10.5%) | 0 | 3 (8.8%) | 6 (14.6%) |
Edema in situ* | 4 (21.0%) | 0 | 3 (8.8%) | 1 (2.4%) |
Vaginal burning | 2 (10.5%) | 0 | 2 (5.9%) | 0 |
Spontaneous peeling | 1 (5.3%) | 1 (2.6%); g2: 1 (2.6%) | 0 | 0 |
Pain in situ* | 1 (5.3%) | 0 | 0 | 0 |
Color change at puncture site | 0 | 0 | 1 (2.9%) | 0 |
Total | 19 | 38 | 34 | 41 |