Table 6.
Severity of adverse events among different groups.
| AEs | Group 1 (n=234) | Group 2 (n=234) | Group 3 (n=234) | P value | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Mild,n(%) | Moderate,n(%) | Severe,n(%) | Mild,n(%) | Moderate,n(%) | Severe,n(%) | Mild,n(%) | Moderate,n(%) | Severe,n(%) | ||
| Local AEs | 22 (9.4) | 39 (16.67) | 10 (4.39) | 21 (8.97) | 5 (2.14) | 3 (1.32) | 16 (6.84) | 25 (10.68) | 9 (3.95) | 0.006 |
| pain | 7 (2.99) | 2 (0.85) | 0 (0) | 4 (1.71) | 1 (0.43) | 0 (0) | 3 (1.28) | 1 (0.43) | 0 (0) | 0.992 |
| induration | 5 (2.14) | 8 (3.42) | 2 (0.88) | 2 (0.85) | 0 (0) | 1 (0.44) | 6 (2.56) | 5 (2.14) | 1 (0.44) | 0.721 |
| redness | 20 (8.55) | 35 (14.96) | 9 (3.95) | 20 (8.55) | 4 (1.71) | 3 (1.32) | 15 (6.41) | 24 (10.26) | 9 (3.95) | 0.006 |
| swelling | 2 (0.85) | 4 (1.71) | 2 (0.88) | 0 (0) | 0 (0) | 1 (0.44) | 1 (0.43) | 0 (0) | 2 (0.88) | 0.485 |
| rash | 1 (0.43) | 1 (0.43) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (0.43) | 0 (0) | 0 (0) | 0.540 |
| skin reactions | 2 (0.85) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | – |
| Systemic AEs | 37 (15.81) | 37 (15.81) | 7 (3.07) | 36 (15.38) | 17 (7.26) | 2 (0.88) | 26 (11.11) | 19 (8.12) | 2 (0.88) | 0.115 |
| fever | 34 (14.53) | 25 (10.68) | 2 (0.88) | 20 (8.55) | 9 (3.85) | 1 (0.44) | 19 (8.12) | 10 (4.27) | 2 (0.88) | 0.720 |
| irritability | 10 (4.27) | 0 (0) | 0 (0) | 10 (4.27) | 0 (0) | 0 (0) | 10 (4.27) | 0 (0) | 0 (0) | 1.000 |
| vomit | 5 (2.14) | 0 (0) | 1 (0.44) | 7 (2.99) | 4 (1.71) | 0 (0) | 4 (1.71) | 1 (0.43) | 0 (0) | 0.839 |
| diarrhea | 7 (2.99) | 14 (5.98) | 5 (2.19) | 8 (3.42) | 5 (2.14) | 1 (0.44) | 6 (2.56) | 12 (5.13) | 1 (0.44) | 0.204 |
| drowsiness | 13 (5.56) | 0 (0) | 0 (0) | 5 (2.14) | 1 (0.43) | 0 (0) | 2 (0.85) | 0 (0) | 0 (0) | 0.843 |
| eating disorder | 5 (2.14) | 2 (0.85) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 3 (1.28) | 0 (0) | 0 (0) | 0.494 |
| Allergic reaction | 1 (0.43) | 1 (0.43) | 0 (0) | 1 (0.43) | 1 (0.43) | 0 (0) | 2 (0.85) | 0 (0) | 0 (0) | 0.651 |
| Others | 18 (7.69) | 27 (11.54) | 14(6.14) | 15 (6.41) | 22 (9.4) | 8 (3.51) | 22 (9.4) | 32 (13.68) | 6 (2.63) | 0.406 |