TABLE 1

Reports of pulmonary arterial hypertension (PAH) in the FDA Adverse Events Reporting System

	T-DM1	Trastuzumab	Pertuzumab	Lapatinib	Total
Total adverse events	3559	27 819	8227	4052	34 189
Reported PAH cases	6	12	2	6	22^#
ROR (95% CI)	3.34 (1.49–7.43)	0.85 (0.48–1.5)	0.48 (0.12–1.92)	2.93 (1.32–6.53)	1.27 (0.83–1.93)

T-DM1: ado-trastuzumab emtansine. ROR: reported odds ratio. ^#: a total number of 22 distinct cases of PAH with HER2-targeted agents as suspected agents were reported: two distinct cases with T-DM1 and trastuzumab listed as potential causes of PAH; one distinct case with trastuzumab and pertuzumab listed as the potential cause of PAH; and one distinct case with pertuzumab and T-DM1 listed as the potential cause of PAH.