Table 2—

Patient disposition

Subjects860
 Total in previous controlled study423 (49)
 Randomised to receive treprostinil in previous study205
 Randomised to receive placebo in previous study218
De novo patients437 (51)
Completed#331 (38)
Prematurely discontinued506 (59)
Ongoing as of December 1, 200323 (3)
Reason for premature discontinuation
  Death136 (16; 27)
  Transplantation11 (1; 2)
  Clinical deterioration/rescue therapy117 (14; 23)
  Withdrew consent29 (3; 6)
  Adverse event199 (23; 39)
  Protocol violation10 (1; 2)
  Lost to follow-up4 (<1; 1)
  • Data are presented as n, n (%) or n (% total; % discontinuations). #: transitioned to commercial drug.