Table 14Time from Randomization to First Critical Event Committee–Confirmed Morbidity or Mortality Event up to 7 Days After Last Study Drug Intake, Full Analysis Set

SubgroupSelexipag (n/N)Placebo (n/N)Hazard Ratio (99% CI)P Value for Interaction
PAH therapy at baseline0.95
ERA monotherapy23/9429/760.66 (0.32 to 1.35)
PDE5 inhibitor monotherapy54/18984/1850.58 (0.37 to 0.91)
ERA and PDE5 inhibitor47/17980/1970.63 (0.39 to 1.01)
No PAH-specific therapy31/11249/1240.57 (0.32 to 1.03)
WHO FC at baseline0.78
Class I/II52/27874/2600.63 (0.40 to 1.00)
Class III/IV103/296168/3220.60 (0.43 to 0.83)

CEC = Critical Event Committee; CI = confidence interval; ERA = endothelin receptor antagonist; FAS = full analysis set; FC = functional class; MM = morbidity/mortality; PAH = pulmonary arterial hypertension; PDE5 = phosphodiesterase type 5; WHO = World Health Organization.

Note: The data in this table appear to include the events that occurred before the protocol amendment.

Source: Clinical Study Report.8

From: 3, Results

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