A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study)

Time required for participants to achieve immune tolerance induction (ITI) success where ITI success is defined as achieving all 3 of the following criteria: confirmed negative titers consisting of 2 consecutive negative inhibitor assessments within 2 weeks (less than \[\<\] 0.6 Bethesda units/milliliter \[mL\] by the Nijmegen-modified Bethesda assay); incremental recovery (IR) greater than or equal to (\>=) 66 percent (%) of the expected IR in 2 consecutive assessments; half-life (t½) \>= 7 hours.

Time frame: Up to 48 Weeks

Population: Participants who are in ITI full analysis set (includes all participants receiving at least 1 infusion of rFVIIIFc) and achieved ITI success

Adherence to treatment is based on prescribed daily dose for the overall study period which is defined as the percentage of administered doses versus the prescribed doses to a patient for the entire study duration.

Time frame: Up to 2 Years

Population: ITI full analysis set

A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Annualized bleeding rate for a patient after the ITT period (for tapering and follow-up period) is defined as the number of bleeding episodes divided by the length of the period after the ITI period in days\* 365.25.

Time frame: Up to 48 weeks (16 weeks Tapering period and 32 weeks follow-up period)

Population: Tapering period full analysis set excluding participants who were observed for less than 90 days in the period.

A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Annualized bleeding rate for a patient during the ITI period is defined as the number of bleeding episodes divided by the length of the ITI period in days\* 365.25.

Time frame: Up to 48 weeks

Population: ITI full analysis set which excludes participants who were observed for less than 90 days during the period

Annualized number of hospitalization days during a period for a patient is defined as the number of hospitalization days divided by the length of the period in days \* 365.25.

Time frame: Up to 48 weeks (16 weeks Tapering period & 32 weeks Follow-up period)

Population: Tapering Period Full analysis set but excluding patients who were observed for less than 90 days in the period.

Annualized number of hospitalization days during a period for a patient is defined as the number of hospitalization days divided by the length of the period in days \* 365.25.

Time frame: Up to 48 weeks

Population: ITI Full analysis set but excluding patients who were observed for less than 90 days in the period.

Annualized rFVIIIFc consumption for a treatment period is the total nominal rFVIIIFc (IU/kg) / length of period in days \* 365.25.

Time frame: Up to 2 Years

Population: ITI Full analysis set

Average number of days missed from school or work per month for a period (counting in non-missing diary days) is defined as number of the missing school/work days in the period divided by number of days with data entry in the period. Number of days per month missed from school or work is reported for those who attend school or have a job.

Time frame: Up to 48 weeks (16 weeks Tapering period & 32 weeks Follow-up period)

Population: Participants of Tapering full analysis set and who attended school or have a job

Average number of days missed from school or work per month for a period (counting in non-missing diary days) is defined as number of the missing school/work days in the period divided by number of days with data entry in the period. Number of days per month missed from school or work is reported for those who attend school or have a job.

Time frame: Up to 48 weeks

Population: Participants of ITI full analysis set and who attend school or have a job

Number of Participants with ITI success who reaches the criteria for relapse (defined as confirmed positive inhibitor titer \>= 0.6 BU/mL or abnormal recovery after tolerance is achieved, and t½ less than \[\<\] 7 hours) evaluated during the Tapering or Follow-Up Periods

Time frame: Up to 48 weeks (16 weeks Tapering period and 32 weeks follow-up period)

Population: Tapering Full analysis set

Number of participants who achieve ITI success where ITI success is defined as achieving all 3 of the following criteria: confirmed negative titers consisting of 2 consecutive negative inhibitor assessments within 2 weeks (\<0.6 Bethesda units/mL by the Nijmegen-modified Bethesda assay); incremental recovery (IR) \>= 66% of the expected IR at 2 consecutive assessments; half-life (t½) \>=7 hours.

Time frame: Up to 48 Weeks

Population: ITI full analysis set

An AE is any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition.

Time frame: Up to 2 Years

Population: ITI full analysis set