On-demand Trial Results: Safety
Only 6 adverse reactions (3.4%) occurring in 2 patients were considered by the investigator to be possibly related to treatment with COAGADEX
- Infusion-site erythema (2 mild events), back pain (1 mild event), and fatigue (1 mild event and 1 moderate event) in 1 patient
- Infusion-site pain (1 mild event) in 1 patient
Six patients (37.5%) experienced a total of 13 serious adverse events (AEs)
- No serious AEs were considered by investigators to be related to COAGADEX
- One serious AE of death occurred due to pneumonia and nosocomial infection
Other safety results
- No thrombotic events or clinical signs of thrombogenicity
- No hypersensitivity reactions to factor X
- No evidence of inhibitors to factor X
- No viral seroconversions were observed
Allergic-type hypersensitivity reactions, including anaphylaxis, are possible with COAGADEX. In clinical studies, the most common adverse reactions with COAGADEX were infusion site erythema, back pain, fatigue, and infusion site pain.
Reference: Austin S, Norton M, et al. Safety and efficacy of FACTOR X, a new high-purity factor X concentrate: a phase 3 study in patients with hereditary factor X deficiency. Poster presented at the 9th Annual Scientific Symposium of the Hemostasis and Thrombosis Research Society (HTRS), New Orleans, April 16-18 2015.