Table 3.

Most Frequent Adverse Events

Variable	Oral Treprostinil (n = 346) [n (%)]	Placebo (n = 344) [n (%)]
Any event reported	342 (98.8)	328 (95.3)
Any event probably or possibly related to study drug	334 (96.5)	219 (63.7)
Study drug–related serious adverse event	27 (7.8)	18 (5.2)
Study drug–related severe adverse event	78 (22.5)	27 (7.8)
Adverse events*
Headache	242 (69.9)	102 (29.7)
Diarrhea	227 (65.6)	68 (19.8)
Flushing	151 (43.6)	26 (7.6)
Nausea	128 (37.0)	58 (16.9)
Vomiting	111 (32.1)	26 (7.6)
Pain in jaw	60 (17.3)	8 (2.3)
Dizziness	52 (15.0)	45 (13.1)
Pain in extremity	48 (13.9)	11 (3.2)
Myalgia	44 (12.7)	23 (6.7)

^*Adverse events listed are those probably or possibly related to study drug that occurred in more than 10% of participants in either study group.