Table 3.

Overall summary of exposure adjusted incidence rates of treatment emergent adverse events

	Fevipiprant 150 mg (N = 1092) Exp. = 1100.8 PY n IR	Fevipiprant 450 mg (N = 1084) Exp. = 1080.2 PY n IR	Placebo (N = 361) Exp. = 364.1 PY n IR
Patients with AE(s)	716 65.0	686 63.5	245 67.3
SAE(s)	87 7.9	64 5.9	33 9.1
SAE(s) with an outcome of death	3 0.3	1 0.1	1 0.3
Discontinued study treatment due to any AE(s)	30 2.7	37 3.4	9 2.5
Discontinued study treatment due to any SAE(s)	15 1.4	13 1.2	3 0.8

IR (incidence rate per 100 patient years) = n/(sum of patient exposure) × 100

A patient with multiple AEs is counted only once in the AE category for that treatment

AE adverse event; n number of patients with events; PY person years; SAE serious adverse event