Table 4.

Serious TEAEs

	Placebo-controlled period				All apremilast exposure
	Placebo [n = 2084] 622.2 patient-years		Apremilast 30 mg bid [n = 2673] 848.8 patient-years		Apremilast 30 mg bid [n = 4183] 6788.0 patient-years
	n (%)	EAIR/100 patient-years	n (%)	EAIR/100 patient-years	n (%)	EAIR/100 patient-years
Any serious TEAE	55 (2.6)	8.9	58 (2.2)	6.9	392 (9.4)	6.20
Serious TEAEs (≥ 2 patients)
Abdominal pain	0 (0)	0.0	2 (0.1)	0.2	4 (0.1)	0.06
Acute pancreatitis	2 (0.1)	0.3	0 (0)	0.0	4 (0.1)	0.06
Angina pectoris	2 (0.1)	0.3	1 (< 0.1)	0.1	7 (0.2)	0.10
Atrial fibrillation	0 (0)	0.0	2 (0.1)	0.2	7 (0.2)	0.10
Behçet’s syndrome manifestations	2 (0.1)	0.3	1 (< 0.1)	0.1	5 (0.1)	0.07
Congestive cardiac failure	2 (0.1)	0.3	0 (0)	0.0	1 (< 0.1)	0.01
Cholelithiasis	1 (< 0.1)	0.2	2 (0.1)	0.2	8 (0.2)	0.12
Hypertensive crisis	2 (0.1)	0.3	0 (0)	0.0	1 (< 0.1)	0.01
Noncardiac chest pain	2 (0.1)	0.3	0 (0)	0.0	6 (0.1)	0.09
Pneumonia	2 (0.1)	0.3	4 (0.1)	0.5	12 (0.3)	0.18
Pregnancy	0 (0)	0.0	2 (0.1)	0.2	2 (< 0.1)	0.03
Psoriatic arthropathy	3 (0.1)	0.5	2 (0.1)	0.2	14 (0.3)	0.21
Syncope	2 (0.1)	0.3	0 (0)	0.0	2 (< 0.1)	0.03

A TEAE is an adverse event with a start date on or after the date of the first dose of apremilast 30 mg bid and no later than 28 days after the last dose of apremilast 30 mg bid. Each patient is counted once for each applicable category. Patient incidence is 100 times the number (n) of patients reporting the event divided by (m) the number of patients with treatment duration less than or equal to the lower bound of the exposure interval.

bid twice daily, EAIR exposure-adjusted incidence rate, TEAEs treatment-emergent adverse events