TABLE 4

Clinical worsening events during PATENT-2

Former riociguatFormer placeboTotal
2.5 mg maximum1.5 mg maximum
Patients23156109396
Patients with clinical worsening#49 (21)11 (20)24 (22)84 (21)
 Heart/lung transplantation1 (0.4)1 (2)02 (1)
 Hospitalisation due to PH25 (11)5 (9)11 (10)41 (10)
 Start of new PH treatment34 (15)9 (16)17 (16)60 (15)
 Decrease in 6MWD due to PH6 (3)1 (2)3 (3)10 (3)
 Persistent worsening in WHO FC due to PH4 (2)01 (1)5 (1)
 Died14 (6)4 (7)9 (8)27 (7)
  • Data are presented as n or n (%). PH: pulmonary hypertension; 6MWD: 6-min walking distance; WHO: World Health Organization; FC: functional class. #: one patient can experience more than one type of event. The mean treatment duration was 95 weeks.