RIXUBIS PMS India (RIXUBIS PMS)

TEAE was defined as any event not presented prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. A SAE was defined as any untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death, life-threatening, required in-patient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event that was not immediately life-threatening or resulted in death or required hospitalization but jeopardize the participant or required medical or surgical intervention to prevent any of the above outcomes. Relatedness to study drug was based on physician discretion. Number of participants with serious TEAEs related to RIXUBIS were reported.

Time frame: From start of study drug administration up to End of treatment (EOT) (up to 6 months)

Population: SAS included all enrolled participants having received RIXUBIS at any time during the study.

The ABR was defined as the total number of unique bleeding episodes by participants reported during RIXUBIS treatment for prophylaxis, divided by the RIXUBIS treatment duration for prophylaxis and multiplied by 365.25. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not be associated to a trauma event (spontaneous bleeding). Bleeding occurring at multiple locations related to the same injury (e.g., knee and ankle bleed following a fall) was counted as a single bleeding episode.

Time frame: From start of study drug administration up to EOT (up to 6 months)

Population: The EFAS comprised of all participants for whom all inclusion and none of the exclusion criteria were met. Here Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

Binding antibodies (IgG and IgM) to FIX was determined using validated enzyme-linked immunosorbent assays (ELISAs) employing polyclonal anti-human IgG and IgM antibodies. Number of participants who developed binding antibodies (IgG and IgM) combined data to FIX were reported.

Time frame: From start of study drug administration up to EOT (up to 6 months)

Population: SAS included all enrolled participants having received RIXUBIS at any time during the study.

Citrated plasma was assayed for the presence of antibodies to CHO protein and rFurin, derived from cultures of un-transfected cells. Testing for binding anti-CHO protein and rFurin antibodies was done on citrate-anti-coagulated plasma using an ELISA employing polyclonal anti-human IgG antibodies. Number of participants who developed binding antibodies to CHO proteins and rFurin were reported.

Time frame: From start of study drug administration up to EOT (up to 6 months)

Population: SAS included all enrolled participants having received RIXUBIS at any time during the study.

Clinical laboratory evaluations included clinical chemistry (biochemistry and endocrinology), hematology and urinalysis. Any change in clinical laboratory abnormalities which were deemed clinically significant by the investigator were recorded as TEAEs (defined as any event not presented prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments).

Time frame: From start of study drug administration up to EOT (up to 6 months)

Population: SAS included all enrolled participants having received RIXUBIS at any time during the study.

TEAE was defined as any event not presented prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. Relatedness to study drug was based on physician discretion. Number of participants with TEAEs related to RIXUBIS were reported.

Time frame: From start of study drug administration up to EOT (up to 6 months)

Population: SAS included all enrolled participants having received RIXUBIS at any time during the study.

The success of RIXUBIS for treatment of bleeding episodes was defined by grouping the categories of Excellent/Good of the corresponding hemostatic effectiveness ratings of a 4 point Likert scale (Excellent, Good, Moderate and None) by the participants/legally authorized representative (LAR) (participants less than (\<) 12 years: LAR, participants greater than or equal to (\>=) 12 years: self-assessment) for treatments given at home, or by the investigator for treatments given in the hospital/clinic. The rate of success of RIXUBIS for treatment of bleeding episodes was defined as: The number of successful bleeding episodes/total number of bleeding episodes where the treatment of the bleeding was rated \*100. Rate of success of RIXUBIS for treatment of bleeding episodes, 95% confidence interval (CIs) was calculated using the exact Binomial CI (Clopper-Pearson method).

Time frame: From screening up to EOT (up to 6 months)

Population: The EFAS comprised of all participants for whom all inclusion and none of the exclusion criteria were met. Here Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.