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†
Due to data collection limitations, data must be interpreted cautiously

- 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
Time Point | Orenitram n=346 n (%) |
Placebo n=344 n (%) |
Cox Hazard Ratio (95% CI) P-Value (Orenitram-Placebo) |
Log-Rank P-Value* |
---|---|---|---|---|
Deaths at end of randomized treatment |
17 (4.9%) | 18 (5.2%) | 1 (0.52-1.95) P=0.99 |
P=0.98 |
Deaths in OLE | 13 (3.8%) | 24 (7%) | ||
Deaths in randomized study and OLE† |
30 (8.7%) | 42 (12.2%) | 0.80 (0.50-1.28) P=0.36 |
P=0.43 |
Deaths in early discontinuation participants |
8 (2.3%) | 18 (5.2%) | ||
Total deaths at study closure |
38 (11%) | 60 (17.4%) | 0.63 (0.42-0.95) P=0.03 |
P=0.03 |
Due to data collection limitations, data must be interpreted cautiously
- 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