Bleeding episodes were classified as spontaneous if participant records a bleeding event when there is no known contributing factor such as definite trauma/antecedent strenuous activity. In addition, location of bleed (joint, internal, skin/mucosa or muscle) were collected. Annualized spontaneous joint bleeding episodes=(Number of spontaneous joint bleeding episodes during efficacy period (EP)/number of days during EP)*365.25. EP reflects sum of all intervals of time during which participants were treated with rFVIIIFc per treatment regimen excluding major and minor surgical/rehabilitation periods and large injection intervals. Bleeding episodes were summarized by treatment regimen for participants from studies 997HA301/997HA307/997HA309 combined and by age cohort (<6 years and 6 to <12 years old) and treatment regimen for participants from Study 8HA02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.

An exposure day is a 24-hour period in which one or more rFVIIIFc injections are given. The total number of days of exposure to rFVIIIFc were summarized by treatment regimen for participants from studies 997HA301/997HA307/997HA309 combined and by age cohort (<6 years and 6 to <12 years old) and treatment regimen for participants from Study 8HA02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.

Annualized consumption = (total international unit per kilogram [IU/kg] of study treatment received during the efficacy period / total number of days during the efficacy period) multiplied by 365.25. Efficacy period reflects sum of all intervals of time during which participants were treated with rFVIIIFc per treatment regimen excluding major and minor surgical/rehabilitation periods and large injection intervals. Annualized consumption was summarized by treatment regimen for participants from studies 997HA301/997HA307/997HA309 combined and by age cohort (<6 years and 6 to <12 years old) and treatment regimen for participants from Study 8HA02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.

Participants were assessed for response to their rFVIIIFc regimen using following 4-point scale: 1=Excellent:bleeding episodes responded to less than or equal to (<=)usual number of injections/dose of rFVIIIFc or rate of breakthrough bleeding during prophylaxis was <= that usually observed; 2=Effective: most bleeding episodes responded to same number of injections and dose, but some required more injections or higher doses, or there was minor increase in rate of breakthrough; 3=Partially Effective: bleeding episodes most often required more injections and/or higher doses than expected or adequate breakthrough bleeding prevention during prophylaxis required more frequent injections and/or higher doses and 4=Ineffective: routine failure to control hemostasis/hemostatic control require additional agents. Total number of scale responses =total count of scale responses for all participants; multiple responses per participant including those at scheduled and unscheduled visits are counted.

Using eDiary, participant received rating for treatment response to any bleeding episode (BE) using 4-point scale- 1=Excellent: Abrupt pain relief and/or improvement in signs of bleeding within approximately (approx.) 8 hours (h) after initial injection (inj.); 2=Good: Definite pain relief and/or improvement in signs of bleeding within approx. 8h after an injection, but possibly requiring more than 1 injection after 24-48h for complete resolution; 3=Moderate: Probable/slight beneficial effect within 8h after initial injection and requires more than 1 injection and 4=None: No improvement, or condition worsens within approx. 8h after initial injection. This assessment was to be made approx. 8 to 12h from time the injection was given to treat BE and prior to any additional doses of rFVIIIFc given for same bleeding episode. Percentages are based on the number of bleeding episodes for which a response (excellent or good) was provided for the first injection during the efficacy period.

Participants received rFVIIIFc IV as per their assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 international unit per kilogram (IU/kg)-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of greater than (>)3 percent (%), if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level.

Participants who have undergone major surgery or have major surgical/rehabilitation period in study.

Participants with 6 to <12 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of >3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants <12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.

Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of greater than >3 %, if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level.

Participants with 6 to <12 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of >3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants <12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.

Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of greater than >3 %, if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level.

Participants with 6 to <12 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of >3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants <12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.

Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of greater than >3 %, if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level.

Participants with 6 to <12 years old age received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis(TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (i.e. adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of >3%, if bleeding history and/or activity level requires/dosing less frequently). Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). For participants <12 years of age, weekly and episodic treatment regimens were only available once reached at age of 12 years old.

Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of greater than >3 %, if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level.

Participants received rFVIIIFc IV per assigned treatment regimen as follows: Tailored Prophylaxis (TP): 25 IU/kg-65 IU/kg rFVIIIFc every 3-5 days or 2 times/week at approximately 20 IU/kg to 65 IU/kg rFVIIIFc on Day 1 and 40 IU/kg-65 IU/kg rFVIIIFc on Day 4. Weekly P: rFVIIIFc once weekly at approximately 65 IU/kg. Personalized P: If optimal prophylaxis dosing not achieved using TP/WP, Investigator personalized dosing to meet individual participant's needs (options: adding "prevention" dose prior to strenuous activity; targeting FVIII trough level of greater than >3 %, if bleeding history and/or activity level requires/dosing less frequently. Episodic (On demand): individual dose of rFVIIIFc based on clinical condition, type and severity of bleeding event and if indicated, FVIII levels (per investigator and Sponsor decision). The rate of administration determined by participant's comfort level.