Breakdown of disease progression events
Pooled selexipag | Pooled control | |
Patients n | 329 | 320 |
First disease progression events up to end of treatment period#, n (%) | 67 (20.4) | 116 (36.3) |
Hospitalisation for worsening of PAH | 29 (8.8) | 54 (16.9) |
Clinical worsening of PAH¶ | 18 (5.5) | 45 (14.1) |
Death | 14 (4.3) | 13 (4.1) |
Initiation of prostacyclin for worsening of PAH | 6 (1.8) | 4 (1.3) |
Deaths up to end of study, n (%) | 40 (12.2) | 55 (17.2) |
PAH: pulmonary arterial hypertension; 6MWD: 6-min walk distance; WHO FC: World Health Organization functional class. #: end of treatment period was defined as end of double-blind treatment +7 days in GRIPHON and end of main observation period +7 days or end of double-blind treatment +7 days in TRITON. ¶: disease progression in GRIPHON [11] defined as a decrease from baseline of ≥15% in 6MWD (confirmed by a second test on a different day) accompanied by a worsening in WHO FC (for the patients in WHO FC II or III at baseline) or the need for additional PAH therapy (for the patients in WHO FC III or IV at baseline); clinical worsening in TRITON [8] defined as a post-baseline decrease in 6MWD >15% from the highest 6MWD obtained at/after screening and WHO FC III/IV (both conditions confirmed at two consecutive post-baseline visits 1–21 days apart).