TABLE 5.
Incidence of solicited local adverse events (Day 0‐Day 6 and Day 21‐Day 27)
| No. of subjects with the event | |||||
|---|---|---|---|---|---|
| Incidence(%)(Confidenceinterval) | |||||
| Phase II | Phase III | ||||
| MA group | HA group | MB group | HB group | MA group | |
| Number of analyzed subjects | 62 | 62 | 63 | 61 | 369 |
| Solicited local adverse events | 54 | 52 | 52 | 48 | 330 |
| 87.1% (76.1‐94.3) | 83.9% (72.3‐92.0) | 82.5% (70.9‐90.9) | 78.7% (66.3‐88.1) | 89.4% (85.8‐92.4) | |
| Pain | |||||
| Total | 53 | 52 | 49 | 45 | 320 |
| 85.5% (74.2‐93.1) | 83.9% (72.3‐92.0) | 77.8% (65.5‐87.3) | 73.8% (60.9‐84.2) | 86.7% (82.8‐90.0) | |
| Grade 3 | 0 | 0 | 0 | 0 | 0 |
| 0% | 0% | 0% | 0% | 0% | |
| Erythema | |||||
| Total | 18 | 19 | 10 | 12 | 126 |
| 29.0% (18.2‐41.9) | 30.6% (19.6‐43.7) | 15.9% (7.9‐27.3) | 19.7% (10.6‐31.8) | 34.1% (29.3‐39.2) | |
| Grade 3 | 1 | 0 | 1 | 0 | 8 |
| 1.6% (0.0‐8.7) | 0% | 1.6% (0.0‐8.5) | 0% | 2.2% (0.9‐4.2) | |
| Swelling | |||||
| Total | 17 | 15 | 8 | 10 | 106 |
| 27.4% (16.9‐40.2) | 24.2% (14.2‐36.7) | 12.7% (5.6‐23.5) | 16.4% (8.2‐28.1) | 28.7% (24.2‐33.6) | |
| Grade 3 | 1 | 0 | 0 | 0 | 4 |
| 1.6% (0.0‐8.7) | 0% | 0% | 0% | 1.1% (0.3‐2.8) | |
| Induration | |||||
| Total | 17 | 14 | 10 | 11 | 82 |
| 27.4% (16.9‐40.2) | 22.6% (12.9‐35.0) | 15.9% (7.9‐27.3) | 18.0%（9.4‐30.0) | 22.2% (18.1‐26.8) | |
| Grade 3 | 1 | 0 | 0 | 0 | 0 |
| 1.6% (0.0‐8.7) | 0% | 0% | 0% | 0% | |
Analysis set: Safety analysis set. Period of investigation: Day 0‐Day 6 and Day 21 ‐Day 27.Item: Adverse event. MedDRA/J (Ver15.1). MA group; 3.75 μg HA + AS03. HA group; 7.5 μg HA + AS03. MB group; 3.75 μg HA + 1/2 AS03. HB group; 7.5 μg HA + 1/2 AS03.