Table.5 Summary of solicited and unsolicited adverse reactions occurred within 28Â days during the study period
Adverse reaction* | 0–14 group (n = 270) | 0–21 group (n = 270) | 0–28 group (n = 269) | P |
|---|---|---|---|---|
Solicited adverse reactions within 0–7 days |  |  |  | |
 Local reactions | 7 (2.6) | 9 (3.3) | 4 (1.5) | 0.418 |
  Pain | 4 (1.5) | 7 (2.6) | 2 (0.7) | 0.263 |
  Swelling | 2 (0.7) | 0 (0.0) | 2 (0.7) | 0.479 |
  Pruritus | 1 (0.4) | 2 (0.7) | 0 (0.0) | 0.777 |
 Systemic reactions | 1 (0.4) | 2 (0.7) | 3 (1.1) | 0.545 |
  Diarrhea | 0 (0.0) | 1 (0.4) | 1 (0.4) | 0.777 |
  Fatigue | 1 (0.4) | 1 (0.4) | 2 (0.7) | 0.702 |
Unsolicited adverse reactions within 8–28 days |  |  |  | |
 Local reactions | 1 (0.4) | 1 (0.4) | 1(0.4) | 1.000 |
  Rash | 1 (0.4) | 1 (0.4) | 1(0.4) | 1.000 |
 Systemic reactions | 2 (0.7) | 1 (0.4) | 2(0.7) | 0.876 |
  Cough | 1 (0.4) | 1 (0.4) | 1(0.4) | 1.000 |
  Headache | 1 (0.4) | 0 (0.0) | 1(0.4) | 0.777 |