TABLE 1

Demographic and clinical characteristics in the overall population and in the subgroups defined post hoc according to completion of clinical assessment either pre- or post-riociguat approval

TotalPre-riociguat approvalPost-riociguat approval#
Subjects, n1035548
Age years, mean±sd55.6±14.357.9±14.752.9±13.5
Sex, n (%)
Male61 (59)27 (49)34 (71)
Female42 (41)28 (51)14 (29)
Duration of follow-up days, mean±sd1604.5±925.91922.5±1082.71240.1±509.6
Charlson comorbidity index, mean±sd1.8±1.71.6±1.82.0±1.6

#: post hoc defined subgroups, whereby 21 patients whose pulmonary endarterectomy surgery occurred before the approval of riociguat in the USA but whose observation period extended beyond the riociguat approval date were reassigned from the pre-riociguat approval subgroup to the post-riociguat approval subgroup. : identified within ≤12 months prior to the index date and excluding the category of “chronic pulmonary disease”.