What safety data exist for Saltikva?

Zero serious adverse events have been attributed to Saltikva®. The Phase 2 reports 41 serious adverse events. One (dehydration) was first attributed to Saltikva; on review, the principal investigator and the independent DSMC attributed it, like the rest, to chemotherapy. One patient had persistent diarrhea with stool tests negative for Salmonella, and no clinical late-onset Salmonella infection was identified in protocol follow-up. The Phase 1 paper reports two patients with adverse events judged possibly attributable. Saltikva is investigational and has not been approved by the FDA or any other regulator.