TABLE 6.
Incidence of solicited systemic adverse events and solicited systemic adverse drug reactions (Day 0‐Day 6 and Day 21‐Day 27)
| PT | 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 |
| 43 | 46 | 45 | 35 | 248 | |
| Solicited systemic adverse events | 69.4% (56.3‐80.4) | 74.2% (61.5‐84.5) | 71.4% (58.7‐82.1) | 57.4% (44.1‐70.0) | 67.2% (62.2‐72.0) |
| Pyrexia | |||||
| Total | 8 | 17 | 4 | 3 | 86 |
| 12.9% (5.7‐23.9) | 27.4% (16.9‐40.2) | 6.3% (1.8‐15.5) | 4.9% (1.0‐13.7) | 23.3% (19.1‐28.0) | |
| Grade 3 | 4 | 1 | 0 | 0 | 6 |
| 6.5% (1.8‐15.7) | 1.6% (0.0‐8.7) | 0% | 0% | 1.6% (0.6‐3.5) | |
| Headache | |||||
| Total | 21 | 26 | 26 | 20 | 132 |
| 33.9% (22.3‐47.0) | 41.9% (29.5‐55.2) | 41.3% (29.0‐54.4) | 32.8% (21.3‐46.0) | 35.8% (30.9‐40.9) | |
| Grade 3 | 1 | 0 | 0 | 0 | 1 |
| 1.6% (0.0‐8.7) | 0% | 0% | 0% | 0.3% (0.0‐1.5) | |
| Fatigue | |||||
| Total | 36 | 36 | 27 | 27 | 157 |
| 58.1% (44.8‐70.5) | 58.1% (44.8‐70.5) | 42.9% (30.5‐ 56.0) | 44.3% (31.5‐57.6) | 42.5% (37.4‐47.8) | |
| Grade 3 | 1 | 0 | 0 | 0 | 0 |
| 1.6% (0.0‐8.7) | 0% | 0% | 0% | 0% | |
| Arthralgia | |||||
| Total | 18 | 17 | 11 | 8 | 97 |
| 29.0% (18.2‐41.9) | 27.4% (16.9‐40.2) | 17.5% (9.1‐29.1) | 13.1% (5.8‐24.2) | 26.3% (21.9‐31.1) | |
| Grade 3 | 0 | 0 | 0 | 0 | 1 |
| 0% | 0% | 0% | 0% | 0.3% (0.0‐1.5) | |
| Myalgia | |||||
| Total | 23 | 23 | 21 | 21 | 124 |
| 37.1% (25.2‐50.3) | 37.1% (25.2‐50.3) | 33.3% (22.0‐46.3) | 34.4% (22.7‐47.7) | 33.6% (28.8‐38.7) | |
| Grade 3 | 0 | 0 | 0 | 0 | 0 |
| 0% | 0% | 0% | 0% | 0% | |
| Chills | |||||
| Total | 13 | 17 | 7 | 5 | 93 |
| 21.0% (11.7‐33.2) | 27.4% (16.9‐40.2) | 11.1% (4.6‐21.6) | 8.2% (2.7‐18.1) | 25.2% (20.9‐30.0) | |
| Grade 3 | 1 | 0 | 0 | 0 | 1 |
| 1.6% (0.0‐8.7) | 0% | 0% | 0% | 1.3% (0.0‐1.5) | |
| Hyperhidrosis | |||||
| Total | 4 | 7 | 13 | 5 | 44 |
| 6.5% (1.8‐15.7) | 11.3% (4.7‐21.9) | 20.6% (11.5‐32.7) | 8.2% (2.7‐18.1) | 11.9% (8.8‐15.7) | |
| Grade 3 | 0 | 0 | 0 | 0 | 0 |
| 0% | 0% | 0% | 0% | 0% | |
| Solicited systemic adverse drug reactions | 41 | 44 | 45 | 34 | 245 |
| 66.1% (53.0‐77.7) | 71.0% (58.1‐81.8) | 71.4% (58.7‐82.1) | 55.7% (42.4‐68.5) | 66.4% (61.3‐71.2) | |
| Pyrexia | |||||
| Total | 8 | 17 | 4 | 3 | 85 |
| 12.9% (5.7‐23.9) | 27.4% (16.9‐40.2) | 6.3% (1.8‐15.5) | 4.9% (1.0‐13.7) | 23.0% (18.8‐27.7) | |
| Grade 3 | 4 | 1 | 0 | 0 | 6 |
| 6.5% (1.8‐15.7) | 1.6% (0.0‐8.7) | 0% | 0% | 1.6% (0.6‐3.5) | |
| Headache | |||||
| Total | 20 | 25 | 25 | 20 | 131 |
| 32.3% (20.9‐45.3) | 40.3% (28.1‐53.6) | 39.7% (27.6‐52.8) | 32.8% (21.3‐46.0) | 35.5% (30.6‐40.6) | |
| Grade 3 | 1 | 0 | 0 | 0 | 1 |
| 1.6% (0.0‐8.7) | 0% | 0% | 0% | 0.3% (0.0‐1.5) | |
| Fatigue | |||||
| Total | 36 | 34 | 27 | 25 | 156 |
| 58.1% (44.8‐70.5) | 54.8% (41.7‐67.5) | 42.9% (30.5‐ 56.0) | 41.0% (28.6‐54.3) | 42.3% (37.2‐47.5) | |
| Grade 3 | 1 | 0 | 0 | 0 | 0 |
| 1.6% (0.0‐8.7) | 0% | 0% | 0% | 0% | |
| Arthralgia | |||||
| Total | 18 | 17 | 11 | 7 | 96 |
| 29.0% (18.2‐41.9) | 27.4% (16.9‐40.2) | 17.5% (9.1‐29.1) | 11.5% (4.7‐22.2) | 26.0% (21.6‐30.8) | |
| Grade 3 | 0 | 0 | 0 | 0 | 1 |
| 0% | 0% | 0% | 0% | 0.3% (0.0‐1.5) | |
| Myalgia | |||||
| Total | 22 | 23 | 21 | 20 | 122 |
| 35.5% (23.7‐48.7) | 37.1% (25.2‐50.3) | 33.3% (22.0‐46.3) | 32.8% (21.3‐46.0) | 33.1% (28.3‐38.1) | |
| Grade 3 | 0 | 0 | 0 | 0 | 0 |
| 0% | 0% | 0% | 0% | 0% | |
| Chills | |||||
| Total | 12 | 17 | 7 | 5 | 93 |
| 19.4% (10.4‐31.4) | 27.4% (16.9‐40.2) | 11.1% (4.6‐21.6) | 8.2% (2.7‐18.1) | 25.2% (20.9‐30.0) | |
| Grade 3 | 1 | 0 | 0 | 0 | 1 |
| 1.6% (0.0‐8.7) | 0% | 0% | 0% | 0.3% (0.0‐1.5) | |
| Hyperhidrosis | |||||
| Total | 4 | 7 | 13 | 5 | 44 |
| 6.5% (1.8‐15.7) | 11.3% (4.7‐21.9) | 20.6% (11.5‐32.7) | 8.2% (2.7‐18.1) | 11.9% (8.8‐15.7) | |
| Grade 3 | 0 | 0 | 0 | 0 | 0 |
| 0% | 0% | 0% | 0% | 0% | |
Analysis set: Safety analysis set. Period of investigation: Days 0‐6 and Days 21‐27.Item: Adverse event, Adverse drug reaction. MedDRA/J (Ver15.1)