Subjects | 860 | |
Total in previous controlled study | 423 (49) | |
Randomised to receive treprostinil in previous study | 205 | |
Randomised to receive placebo in previous study | 218 | |
De novo patients | 437 (51) | |
Completed# | 331 (38) | |
Prematurely discontinued | 506 (59) | |
Ongoing as of December 1, 2003 | 23 (3) | |
Reason for premature discontinuation | ||
Death | 136 (16; 27) | |
Transplantation | 11 (1; 2) | |
Clinical deterioration/rescue therapy | 117 (14; 23) | |
Withdrew consent | 29 (3; 6) | |
Adverse event | 199 (23; 39) | |
Protocol violation | 10 (1; 2) | |
Lost to follow-up | 4 (<1; 1) |
Data are presented as n, n (%) or n (% total; % discontinuations). #: transitioned to commercial drug.