treated for at least 100 EDs. Subjects received a total of 5,313 injections with a median of 59 (range 4 to 145 injections per subject). Control and prevention of bleeding episodes Adult and adolescent subjects (≥12 to 65 years of age) In the adult/adolescent study a total of 848 bleeding episodes were treated with AFSTYLA® and 835 received an efficacy assessment by the investigator. The majority of the bleeding episodes were localised in joints. The median dose per injection used to treat a bleeding episode was 31.7 IU/kg. Of these 848 bleeding episodes, 686 (81.0%) were controlled with a single AFSTYLA® injection and another 107 (13%) were controlled with 2 injections. Fifty-five (6%) of the 848 bleeding episodes required 3 or more injections. For 94% of bleeding episodes the haemostatic efficacy rating evaluated by the investigator was either excellent or good. Efficacy in control of bleeding episodes is summarised in Table 4. Paediatric subjects (0 to <12 years of age) In the paediatric study a total of 347 bleeding episodes were treated with AFSTYLA® all of which received an efficacy assessment by the investigator. The majority of the bleeding episodes were localised in joints. The median dose per injection used to treat a bleeding episode was 27.3 IU/kg. Of the 347 bleeding episodes, 298 (86%) were controlled with a single AFSTYLA® injection and another 34 (10%) were controlled with 2 injections. Fifteen (4%) of the 347 bleeding episodes required 3 or more injections. For 96% of bleeding episodes the haemostatic efficacy rating evaluated by the investigator was either excellent or good. Efficacy in control of bleeding episodes is summarised in Table 4. Table 4: Efficacy* of AFSTYLA® in control of bleeding Adult/Adolescent Paediatric (Study 1001; to 65 3002; 0 to <12 ≥12
treated for at least 100 EDs. Subjects received a total of 5,313 injections with a median of 59 (range 4 to 145 injections per subject). Control and prevention of bleeding episodes Adult and adolescent subjects (≥12 to 65 years of age) In the adult/adolescent study a total of 848 bleeding episodes were treated with AFSTYLA® and 835 received an efficacy assessment by the investigator. The majority of the bleeding episodes were localised in joints. The median dose per injection used to treat a bleeding episode was 31.7 IU/kg. Of these 848 bleeding episodes, 686 (81.0%) were controlled with a single AFSTYLA® injection and another 107 (13%) were controlled with 2 injections. Fifty-five (6%) of the 848 bleeding episodes required 3 or more injections. For 94% of bleeding episodes the haemostatic efficacy rating evaluated by the investigator was either excellent or good. Efficacy in control of bleeding episodes is summarised in Table 4. Paediatric subjects (0 to <12 years of age) In the paediatric study a total of 347 bleeding episodes were treated with AFSTYLA® all of which received an efficacy assessment by the investigator. The majority of the bleeding episodes were localised in joints. The median dose per injection used to treat a bleeding episode was 27.3 IU/kg. Of the 347 bleeding episodes, 298 (86%) were controlled with a single AFSTYLA® injection and another 34 (10%) were controlled with 2 injections. Fifteen (4%) of the 347 bleeding episodes required 3 or more injections. For 96% of bleeding episodes the haemostatic efficacy rating evaluated by the investigator was either excellent or good. Efficacy in control of bleeding episodes is summarised in Table 4. Table 4: Efficacy* of AFSTYLA® in control of bleeding Adult/Adolescent (Study 1001; ≥12 to 65 Paediatric 3002; 0 to <12