Investigator evaluation of hemostatic efficacy, 4-point scale
| Rating . | Treatment of bleeding events . | Treatment during surgery . |
|---|---|---|
| Excellent | Definite pain relief and/or improvement in signs of bleeding (ie, swelling, tenderness, and/or increased range of motion in the case of musculoskeletal hemorrhage) within ∼8 h after the first rVIII-SingleChain injection | Hemostasis clinically not significantly different from normal (eg, achieved hemostasis comparable to that expected during similar surgery in a nonfactor-deficient patient) in the absence of other hemostatic intervention, and estimated blood loss during surgery is not >20% higher than the predicted blood loss for the intended surgery |
| Good | Definite pain relief and/or improvement in signs of bleeding at ∼8 h after the first rVIII-SingleChain injection, but requires 2 injections for complete resolution | Normal or mildly abnormal hemostasis in terms of quantity and/or quality (eg, slight oozing, prolonged time to hemostasis with somewhat increased bleeding compared with a nonfactor-deficient patient in the absence of other hemostatic intervention), or estimated blood loss is >20% but ≤30% higher than the predicted blood loss for intended surgery |
| Moderate | Probable or slight beneficial effect within ∼8 h after the first rVIII-SingleChain injection; requires more than 2 injections for complete resolution | Moderately abnormal hemostasis in terms of quantity and/or quality (eg, moderate hemorrhage that is difficult to control) with estimated blood loss greater than what is defined as “good” |
| Poor/no response | No improvement at all or condition worsens (ie, signs of bleeding) after the first rVIII-SingleChain injection and additional hemostatic intervention is required with another FVIII product, cryoprecipitate, or plasma for complete resolution | Severely abnormal hemostasis in terms of quantity and/or quality (eg, severe hemorrhage that is difficult to control) and/or additional hemostatic intervention required with another FVIII product, cryoprecipitate, or plasma for complete resolution |
| Rating . | Treatment of bleeding events . | Treatment during surgery . |
|---|---|---|
| Excellent | Definite pain relief and/or improvement in signs of bleeding (ie, swelling, tenderness, and/or increased range of motion in the case of musculoskeletal hemorrhage) within ∼8 h after the first rVIII-SingleChain injection | Hemostasis clinically not significantly different from normal (eg, achieved hemostasis comparable to that expected during similar surgery in a nonfactor-deficient patient) in the absence of other hemostatic intervention, and estimated blood loss during surgery is not >20% higher than the predicted blood loss for the intended surgery |
| Good | Definite pain relief and/or improvement in signs of bleeding at ∼8 h after the first rVIII-SingleChain injection, but requires 2 injections for complete resolution | Normal or mildly abnormal hemostasis in terms of quantity and/or quality (eg, slight oozing, prolonged time to hemostasis with somewhat increased bleeding compared with a nonfactor-deficient patient in the absence of other hemostatic intervention), or estimated blood loss is >20% but ≤30% higher than the predicted blood loss for intended surgery |
| Moderate | Probable or slight beneficial effect within ∼8 h after the first rVIII-SingleChain injection; requires more than 2 injections for complete resolution | Moderately abnormal hemostasis in terms of quantity and/or quality (eg, moderate hemorrhage that is difficult to control) with estimated blood loss greater than what is defined as “good” |
| Poor/no response | No improvement at all or condition worsens (ie, signs of bleeding) after the first rVIII-SingleChain injection and additional hemostatic intervention is required with another FVIII product, cryoprecipitate, or plasma for complete resolution | Severely abnormal hemostasis in terms of quantity and/or quality (eg, severe hemorrhage that is difficult to control) and/or additional hemostatic intervention required with another FVIII product, cryoprecipitate, or plasma for complete resolution |