On-demand Trial Results: Safety
Six adverse events (3.4%) occurring in 2 subjects were considered by the investigator to be possibly related to treatment with COAGADEX1,2
- Infusion-site erythema (2 mild events), back pain (1 mild event), and fatigue (1 mild event and 1 moderate event) in 1 subject
- Predose infusion-site pain (1 mild event) in 1 subject
Six subjects (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. If symptoms occur, patients should discontinue use of the product immediately, contact their physician, and administer appropriate treatment.
Reference: 1. Austin S, Kavakli K, Norton M, et al. Haemophilia. 2016;22:419-425. 2. Austin S, Norton M, et al. Poster presented at the 9th Annual Scientific Symposium of the Hemostasis and Thrombosis Research Society (HTRS), New Orleans, April 16-18, 2015.