Table 5. Median adverse event rate by CHMP criteria.
Adverse event | IC patients (%) | VICT controls (%) | PNV controls (%) |
Local | |||
Ecchymosis | 3.1 (2.0 to 4.2; n = 2) | 0.0 (0.0 to 0.0; n = 1) | – |
Induration | 18.9 (10.2 to 30.0; n = 5) | 11.0 (6.3 to 15.0; n = 3) | – |
System ic | |||
Fever | 7.1 (0.0 to 23.3; n = 14) | 5.0 (0.0 to 16.7; n = 5) | 10.2 (10.0 to 10.3; n = 2) |
Malaise | 23.6 (0.8 to 44.0; n = 8) | 12.0 (0.0 to 25.9; n = 5) | 22.1 (20.0 to 24.1; n = 2) |
Shivering | 10.2 (10.2 to 10.2; n = 1) | 16.3 (16.3 to 16.3; n = 1) | – |
Values in parentheses show the reported range of adverse events and number of studies; IC = immunocompromised; VICT = vaccinated immunocompetent; PNV = placebo or no vaccination.