Table 3.
Summary of First Clinical Failure Events and First PAH Hospitalizations by WHO Functional Class and Treatment Group (Primary Analysis Set)
| Combination Therapy | Pooled Monotherapy | Ambrisentan Monotherapy | Tadalafil Monotherapy | |||||
|---|---|---|---|---|---|---|---|---|
| (n = 253) | (n = 247) | (n = 126) | (n = 121) | |||||
| Baseline Functional Class | FC II | FC III | FC II | FC III | FC II | FC III | FC II | FC III |
| (n = 76) | (n = 177) | (n = 79) | (n = 168) | (n = 38) | (n = 88) | (n = 41) | (n = 80) | |
| First Clinical Failure Events | ||||||||
| Number (%) of patients with event | 4 (5) | 42 (24) | 17 (22) | 60 (36) | 9 (24) | 34 (39) | 8 (20) | 26 (33) |
| Death | 3 (4) | 6 (3) | 1 (1) | 7 (4) | 0 | 2 (2) | 1 (2) | 5 (6) |
| PAH Hospitalization | 0 | 10 (6) | 8 (10) | 22 (13) | 5 (13) | 13 (15) | 3 (7) | 9 (11) |
| Disease Progression | 0 | 10 (6) | 5 (6) | 11 (7) | 3 (8) | 9 (10) | 2 (5) | 2 (3) |
| ULTCR | 1 (1) | 16 (9) | 3 (4) | 20 (12) | 1 (3) | 10 (11) | 2 (5) | 10 (13) |
| Hazard ratio (95% CI) combination vs. | 0.211 (0.071,0.629) | 0.576 (0.388,0.855) | 0.190 (0.058,0.619) | 0.551 (0.350,0.866) | 0.247 (0.074,0.823) | 0.602 (0.368,0.983) | ||
| First PAH Hospitalizationsa | ||||||||
| Number (%) of patients with event | 0 | 19 (11) | 11 (14) | 33 (20) | 7 (18) | 20 (23) | 4 (10) | 13 (16) |
| Hazard ratio (95% CI) combination vs. | N/A | 0.484 (0.275,0.852) | N/A | 0.435 (0.232,0.815) | N/A | 0.554 (0.273,1.124) | ||
CI Confidence interval, FC Functional class, N/A Not applicable, PAH Pulmonary arterial hypertension, ULTCR Unsatisfactory long-term clinical response, WHO World Health Organization
aPost-hoc analysis