Annualised Spontaneous Bleeding Rate 0 (0–2.4) 11.73 (2.8–36.5) 0 (0–2.2) 31.76 (0–42.7) (AsBR) Median (IQR*) Number of subjects with zero 63 (43.2%) 1 (3.7%) 21 (26.3%) 0 bleeding episodes requiring treatment * IQR = interquartile range, 25th percentile to 75th percentile. Control and prevention of bleeding episodes in the perioperative setting Thirteen subjects in the adult/adolescent study underwent a total of 16 surgical procedures. Overall, investigators assessed haemostatic efficacy of AFSTYLA® in surgical prophylaxis as excellent in 15 of 16 surgeries and as good in 1 of 16 surgeries (see Table 6). Median factor consumption on the day of surgery was 89.4 IU/kg (range 40.5–108.6 IU/kg). Table 6: Efficacy of AFSTYLA® in surgical prophylaxis Factor Consumption (IU/kg) Procedure Efficacy Evaluation* (pre- and intra-operatively) Extraction of wisdom Excellent 51.09 Abdominal hernia repair Excellent 47.89 Elbow replacement Excellent 108.58 Ankle arthroplasty Excellent 76.83 Knee replacement (5) Excellent (4), Good (1) 92.49 100.9 67.26 105.79 86.09 Cholecystectomy Excellent 105.95 and Lengthening of the Achilles Excellent tendon combined with: Straightening of the right toes Circumcision (3) Excellent (3) 99.04 92.74 81.5 Open reduction internal fixation Excellent 89.36 (ORIF) right ankle Hardware removal, right ankle Excellent 40.45
Annualised Spontaneous Bleeding Rate (AsBR) Median (IQR*) 0 (0–2.4) 11.73 (2.8–36.5) 0 (0–2.2) 31.76 (0–42.7) Number of subjects with zero bleeding episodes requiring treatment 63 (43.2%) 1 (3.7%) 21 (26.3%) 0 * IQR = interquartile range, 25th percentile to 75th percentile. Control and prevention of bleeding episodes in the perioperative setting Thirteen subjects in the adult/adolescent study underwent a total of 16 surgical procedures. Overall, investigators assessed haemostatic efficacy of AFSTYLA® in surgical prophylaxis as excellent in 15 of 16 surgeries and as good in 1 of 16 surgeries (see Table 6). Median factor consumption on the day of surgery was 89.4 IU/kg (range 40.5–108.6 IU/kg). Table 6: Efficacy of AFSTYLA® in surgical prophylaxis Procedure Efficacy Evaluation* Factor Consumption (IU/kg) (pre- and intra-operatively) Extraction of wisdom Excellent 51.09 Abdominal hernia repair Excellent 47.89 Elbow replacement Excellent 108.58 Ankle arthroplasty Excellent 76.83 Knee replacement (5) Excellent (4), Good (1) 92.49 100.9 67.26 105.79 86.09 Cholecystectomy and Lengthening of the Achilles tendon combined with: Straightening of the right toes Excellent Excellent 105.95 Circumcision (3) Excellent (3) 99.04 92.74 81.5 Open reduction internal fixation (ORIF) right ankle Excellent 89.36 Hardware removal, right ankle Excellent 40.45
auspar-lonoctocog-alfa-rch-180123-pi.docx