Vital Status SubstudyOrenitram was associated with a positive impact on survival1*
Orenitram was associated with a 37% reduction in risk of death vs placebo at study closure (P=0.03)1†
- P-value was calculated with log-rank test stratified by background PAH therapy and baseline 6MWD category.
- Hazard ratio, 95% CI, and P-value were calculated with proportional hazard model with treatment, background PAH therapy, and baseline 6MWD as explanatory variables.
View vital status substudy
In FREEDOM-EV, vital status was collected throughout the study from patients who agreed to be followed. This included patients who discontinued early and those who transitioned to the OLE study1
- When vital status was collected, cause of death was not specified1
- Due to the collection of vital status occurring after some participants had exited the study and some investigative sites had closed, vital status was collected for 89% of patients (43 Orenitram, 31 placebo patients unknown)1
- At the time of study closure, 11% of patients in the Orenitram group died vs 17.4% of patients in the placebo group (P=0.03)1
- FREEDOM-EV study closed after the occurrence of approximately 205 adjudicated events.1
- FREEDOM-EV OLE study is ongoing. Data as of October 2018.
Summary of Deaths (All Causes)1
|Cox Hazard Ratio
|Deaths at end
|17 (4.9%)||18 (5.2%)||1 (0.52-1.95)
|Deaths in OLE||13 (3.8%)||24 (7%)|
study and OLE†
|30 (8.7%)||42 (12.2%)||0.80 (0.50-1.28)
|Deaths in early
|8 (2.3%)||18 (5.2%)|
|Total deaths at
|38 (11%)||60 (17.4%)||0.63 (0.42-0.95)
- P-values were stratified by background therapy and baseline 6MWD.
- In the Orenitram group, 213 of 346 patients transitioned to the OLE. In the placebo group, 258 of 344 patients transitioned to the OLE.1