The BSPS15 criterion identified 28 (21%) of sertraline-treated patients and 4 (6%) of placebo-treated patients as responders.

The median survival time for sipuleucel-T patients was 25.8 months comparing to 21.7 months for placebo-treated patients.

The median survival time for patients treated with sipuleucel-T was 25.9 months comparing to 21.4 months for placebo-treated patients.

The median survival time for patients treated with sipuleucel-T was 19.0 months comparing to 15.3 months for placebo-treated patients, but did not reach statistical significance.

In addition, more serious cardiovascular events were observed at a rate of 2.4% in patients treated with sipuleucel-T vs 1.8% in placebo-treated patients.

Values for placebo-treated patients regressed towards baseline during the follow-up period in all analyses performed.

Over the course of the study, patients taking the experimental drug gained an average of 6 pounds more than the placebo-treated patients.

Analysis of initial efficacy showed a 35% reduction of the percentage of days with ulcerative oral mucositis in the AG013-treated patients versus the placebo-treated patients.

Close to 30% of the patients treated with AG013 were full responders while all placebo-treated patients developed ulcerative oral mucositis.

There were no data on quality of life, but patients treated with riluzole remained in a more moderately affected health state significantly longer than placebo-treated patients.