All-Cause Mortality

The risk of death from any cause was five times higher in the placebo group than the treatment group (pooled data for the three United States clinical trials).  The pooled placebo groups had an all-cause mortality rate of 7.8%, and the pooled treatment groups (treatment and cross-over) had an all-cause mortality rate of 1.6% (6 deaths in 77 placebo patients; 8 deaths in 495 treatment patients; p < .00000001).  Specific causes of death are provided in the Table below.

Deaths during or following termination of study drug treatment
(Pooled Data – U.S. Studies)
Patient
ID #		Cause Of DeathGroupDInterval
27206Respiratory failure; massive bleedingPlacebo1252 months post study
12113Respiratory failure; thrombotic microangiopathyDrug*9514 weeks post study
13103PancreatitisDrug1609 months post study
20511Pulmonary hypertension/restrictive lung diseasePlacebo206on study
48817Sudden DeathPlacebo80on study
35712SuicidePlacebo5on study
37495SuicidePlacebo177on study
36571Non-Hodgkin