The purpose of this survey is to understand the following items observed in the actual clinical use of RIXUBIS. 1. Unexpected adverse drug reactions 2. Occurrence of adverse drug reactions in the actual clinical use 3. Factors that may affect safety and effectiveness 4. Occurrence of Factor IX (FIX) inhibitor development in patients with coagulation FIX deficiency 5. Safety and effectiveness for hemophilia B patients who received routine prophylactic therapy, on-demand therapy and perioperative therapy
Study Type
OBSERVATIONAL
Enrollment
6
Seki-shi, Japan
Seki-shi, Gifu, Japan
Maebashi-shi, Japan
Maebashi, Gunma, Japan
Nobeoka-shi, Japan
Nobeoka-shi, Miyazaki, Japan
Niigata-shi, Japan
Niigata, Niigata, Japan
Osaka-shi, Japan
Number of Participants Who Discontinued the Use of Nonacog Gamma (Genetical Recombination)
Number of participants who discontinued the use of Nonacog Gamma (Genetical Recombination) was reported in this outcome measure.
Time frame: Throughout the study period, approximately 4 ½ years
Number of Participants Who Developed a Factor IX (FIX) Inhibitor
Number of participants who developed a Factor IX (FIX) Inhibitor was reported in this outcome measure.
Time frame: Throughout the study period, approximately 4 ½ years
Annual Bleed Rate (ABR): Number of Times of Bleeding During the Study
Annual bleed rate (ABR) was defined as the number of times of bleeding during the study. ABR was reported in this outcome measure.
Time frame: Throughout the study period, approximately 4 ½ years
Number of Doses to Treat A Bleed of Participants on An On-Demand Regimen
Number of doses to treat a bleed of participants on an on-demand regimen was reported in this outcome measure.
Time frame: At bleed resolution throughout the study period of approximately 4 ½ years
Hemostatic Effectiveness of Rixubis for Participants on An On-Demand Regimen Based on a 4-Point Ordinal Scale (Excellent, Moderate, Good, Poor)
Number of participants in hemostatic effectiveness of Rixubis with a 4-point ordinal scale (Excellent, Moderate, Good, Poor) for an on-demand regimen was reported in this outcome measure. The definition of each scale was following: Excellent; After a single infusion, complete disappearance of pain and objective decrease of bleeding symptom (swelling, tenderness, and increase in range of motion in musculoskeletal bleeding case) were observed. Good; After a single infusion, there were definitive relief of pain and improvement of bleeding symptom. Fair; After a single infusion, there were a probable or slight relief of pain and a mild improvement of bleeding signs. Poor; Improvement was not observed or symptom was aggravated.
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Osaka, Osaka, Japan
Time frame: At bleed resolution throughout the study period of approximately 4 ½ years
Hemostatic Effectiveness of Rixubis in Surgery-Perioperative and Postoperative Based on a 4-Point Ordinal Scale (Excellent, Moderate, Good, Poor) for Participants Who Received Perioperative Therapy During the Study
Number of participants in hemostatic effectiveness of Rixubis with a 4-point ordinal scale (Excellent, Moderate, Good, Poor) for perioperative therapy was reported in this outcome measure. The definition of each scale was following: Excellent; Amount of bleeding is smaller than expected. Good; Amount of bleeding is within the expected range. Fair; Amount of bleeding is greater than expected, with use of additional concomitant medication. Poor; Hemostasis difficulty.
Time frame: Assessed at the time of discharge from recovery room; and at 24 to 72 hours postoperatively
Number of Participants Who Experienced Adverse Events of Shock or Anaphylaxis
Number of participants who experienced adverse events of shock or anaphylaxis was reported in this outcome measure.
Time frame: Throughout the study period, approximately 4 ½ years
Number of Participants Who Experienced Adverse Events of Thromboembolism
Number of participants who experienced adverse events of thromboembolism was reported in this outcome measure.
Time frame: Throughout the study period, approximately 4 ½ years