Table 1.

Exposure-adjusted event and incidence rates for AESI

FIL200FIL100FIL combined
Number of patients/PYE2267/5302.51647/2782.63691/8085.1
Serious infectionsEAER1.9 (1.5, 2.4)3.2 (2.2, 4.5)2.0 (1.7, 2.4)
EAIRu1.5 (1.1, 1.9)2.7 (1.9, 3.9)1.6 (1.3, 2.0)
EAIR1.5 (1.2, 1.9)2.8 (1.9, 4.0)1.7 (1.4, 2.0)
HZEAER1.6 (1.3, 2.1)1.3 (0.9, 1.8)1.5 (1.2, 1.8)
EAIRu1.5 (1.2, 2.0)1.1 (0.8, 1.5)1.4 (1.1, 1.7)
EAIR1.6 (1.2, 2.0)1.1 (0.8, 1.6)1.4 (1.1, 1.7)
MACEEAER0.3 (0.2, 0.5)0.6 (0.4, 1.0)0.4 (0.3, 0.6)
EAIRu0.3 (0.2, 0.5)0.5 (0.3, 0.8)0.4 (0.2, 0.6)
EAIR0.3 (0.2, 0.5)0.5 (0.3, 0.9)0.4 (0.2, 0.6)
VTEEAER0.3 (0.2, 0.5)0.1 (0.1, 0.4)0.2 (0.2, 0.4)
EAIRu0.2 (0.1, 0.4)0.1 (0.1, 0.4)0.2 (0.1, 0.3)
EAIR0.2 (0.1, 0.4)0.1 (0.1, 0.4)0.2 (0.1, 0.3)
Malignancies excluding NMSCEAER0.8 (0.5, 1.1)0.8 (0.5, 1.2)0.7 (0.2, 2.8)
EAIRu0.6 (0.4, 0.9)0.6 (0.4, 1.0)0.6 (0.4, 0.8)
EAIR0.6 (0.4, 0.9)0.6 (0.4, 1.0)0.6 (0.4, 0.8)
NMSCEAER0.3 (0.2, 0.5)0.2 (0.1, 0.5)0.3 (0.2, 0.4)
EAIRu0.3 (0.2, 0.5)0.2 (0.1, 0.4)0.2 (0.2, 0.4)
EAIR0.3 (0.2, 0.5)0.2 (0.1, 0.4)0.2 (0.2, 0.4)
  • Data are rate (95% CI) unless otherwise stated.