Trial Outcomes & Findings for Efficacy, Safety, and Pharmacokinetic Study of Prophylactic Emicizumab Versus No Prophylaxis in Hemophilia A Participants (NCT NCT03315455)

NCT ID: NCT03315455

Last Updated: 2025-09-16

Results Overview

The number of treated bleeds over the efficacy period was estimated as an annualized bleeding rate (ABR) using a negative binomial regression model, which accounts for different follow-up times. A treated bleed was defined as a bleed that was directly followed by a hemophilia medication reported to be a "treatment for bleed". The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location were counted as one bleed if the second bleed occurred within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure were excluded.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 85 participants
• Primary outcome timeframe: From Baseline to at least 24 weeks
• Results posted on: 2025-09-16

Participant Flow

A total of 76 patients were screened for eligibility, 6 of whom were deemed ineligible, and 70 participants were randomized to this study (Arms A, B, and C). Arm D was added later in a protocol amendment (Version 4) after the study had already started. For Arm D, a total of 16 patients were screened and 15 patients were enrolled.

Participant milestones

Measure	Arm C: No Prophylaxis (Control), Then Emicizumab Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for at least 24 weeks (Control). After 24 weeks, participants had the opportunity to switch to receive emicizumab prophylaxis at 3 mg/kg QW via SC injection for 4 weeks, followed by 6 mg/kg Q4W until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm A: 1.5 mg/kg Emicizumab Prophylaxis QW Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm A received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Overall Study STARTED	14	29	27	15
Overall Study Completed 24 Weeks in the Study	14	29	27	15
Overall Study COMPLETED	1	4	10	0
Overall Study NOT COMPLETED	13	25	17	15

Reasons for withdrawal

Measure	Arm C: No Prophylaxis (Control), Then Emicizumab Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for at least 24 weeks (Control). After 24 weeks, participants had the opportunity to switch to receive emicizumab prophylaxis at 3 mg/kg QW via SC injection for 4 weeks, followed by 6 mg/kg Q4W until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm A: 1.5 mg/kg Emicizumab Prophylaxis QW Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm A received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Overall Study Ongoing in the Study	13	24	17	15
Overall Study Withdrawal by Subject	0	1	0	0

Baseline Characteristics

Efficacy, Safety, and Pharmacokinetic Study of Prophylactic Emicizumab Versus No Prophylaxis in Hemophilia A Participants

Baseline characteristics by cohort

Measure	Arm C: No Prophylaxis (Control), Then Emicizumab n=14 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for at least 24 weeks (Control). After 24 weeks, participants had the opportunity to switch to receive emicizumab prophylaxis at 3 mg/kg QW via SC injection for 4 weeks, followed by 6 mg/kg Q4W until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm A: 1.5 mg/kg Emicizumab Prophylaxis QW n=29 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm A received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=27 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW n=15 Participants Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Total n=85 Participants Total of all reporting groups
Age, Continuous	27.5 Years STANDARD_DEVIATION 10.9 • n=5 Participants	32.2 Years STANDARD_DEVIATION 12.0 • n=7 Participants	28.6 Years STANDARD_DEVIATION 13.5 • n=5 Participants	7.5 Years STANDARD_DEVIATION 2.2 • n=4 Participants	25.9 Years STANDARD_DEVIATION 14.2 • n=21 Participants
Age, Customized <18 Years Old	2 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	15 Participants n=4 Participants	26 Participants n=21 Participants
Age, Customized ≥18 to <65 Years Old	12 Participants n=5 Participants	26 Participants n=7 Participants	20 Participants n=5 Participants	0 Participants n=4 Participants	58 Participants n=21 Participants
Age, Customized ≥65 Years Old	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	29 Participants n=7 Participants	27 Participants n=5 Participants	15 Participants n=4 Participants	85 Participants n=21 Participants
Race/Ethnicity, Customized Asian	14 Participants n=5 Participants	29 Participants n=7 Participants	27 Participants n=5 Participants	15 Participants n=4 Participants	85 Participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	14 Participants n=5 Participants	29 Participants n=7 Participants	27 Participants n=5 Participants	15 Participants n=4 Participants	85 Participants n=21 Participants
Factor VIII (FVIII) Inhibitor Status at Study Entry FVIII Inhibitor Positive	3 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	15 Participants n=4 Participants	30 Participants n=21 Participants
Factor VIII (FVIII) Inhibitor Status at Study Entry FVIII Inhibitor Negative (Non-Inhibitor)	11 Participants n=5 Participants	24 Participants n=7 Participants	20 Participants n=5 Participants	0 Participants n=4 Participants	55 Participants n=21 Participants
Categorical Number of Bleeds (<9 or ≥9) in the Past 24 Weeks Prior to Study Entry <9 Bleeds	3 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	21 Participants n=21 Participants
Categorical Number of Bleeds (<9 or ≥9) in the Past 24 Weeks Prior to Study Entry ≥9 Bleeds	11 Participants n=5 Participants	22 Participants n=7 Participants	21 Participants n=5 Participants	10 Participants n=4 Participants	64 Participants n=21 Participants

PRIMARY outcome

Timeframe: From Baseline to at least 24 weeks

Population: All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.

The number of treated bleeds over the efficacy period was estimated as an annualized bleeding rate (ABR) using a negative binomial regression model, which accounts for different follow-up times. A treated bleed was defined as a bleed that was directly followed by a hemophilia medication reported to be a "treatment for bleed". The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location were counted as one bleed if the second bleed occurred within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure were excluded.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=29 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=14 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=27 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW n=15 Participants Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Model-Based Annualized Bleeding Rate for Treated Bleeds	1.0 Treated bleeds per year Interval 0.53 to 1.85	27.0 Treated bleeds per year Interval 13.29 to 54.91	1.0 Treated bleeds per year Interval 0.5 to 1.84	1.2 Treated bleeds per year Interval 0.48 to 3.13

PRIMARY outcome

Timeframe: From Baseline to at least 24 weeks

Population: All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.

The number of treated bleeds over the efficacy period is presented here as a calculated annualized bleeding rate (ABR) that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. A treated bleed was defined as a bleed that was directly followed by a hemophilia medication reported to be a "treatment for bleed". The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location were counted as one bleed if the second bleed occurred within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure were excluded.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=29 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=14 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=27 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW n=15 Participants Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Mean Calculated Annualized Bleeding Rate for Treated Bleeds	1.4 Treated bleeds per year Interval 0.09 to 6.29	43.7 Treated bleeds per year Interval 31.71 to 58.71	1.5 Treated bleeds per year Interval 0.1 to 6.38	1.2 Treated bleeds per year Interval 0.05 to 5.94

PRIMARY outcome

Timeframe: From Baseline to at least 24 weeks

Population: All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.

The number of treated bleeds over the efficacy period is presented here as a calculated annualized bleeding rate (ABR) that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. A treated bleed was defined as a bleed that was directly followed by a hemophilia medication reported to be a "treatment for bleed". The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location were counted as one bleed if the second bleed occurred within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure were excluded.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=29 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=14 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=27 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW n=15 Participants Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Median Calculated Annualized Bleeding Rate for Treated Bleeds	0.0 Treated bleeds per year Interval 0.0 to 1.23	45.3 Treated bleeds per year Interval 21.74 to 70.49	0.0 Treated bleeds per year Interval 0.0 to 2.26	0.0 Treated bleeds per year Interval 0.0 to 2.08

SECONDARY outcome

Timeframe: From Baseline to at least 24 weeks

Population: All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.

The number of all bleeds over the efficacy period was estimated as an annualized bleeding rate (ABR) using a negative binomial regression model, which accounts for different follow-up times. In this outcome measure, all bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded. As "all bleeds" comprises both treated and non-treated bleeds, the 72-hour rule was implemented separately for treated and non-treated bleeds. For treated bleeds, the 72-hour rule meant that two bleeds of the same type and at the same anatomical location were counted as one bleed if the second bleed occurred within 72 hours from the last treatment for the first bleed. For non-treated bleeds, the 72-hour rule was implemented by calculating a treatment-free period of 72 hours from the bleed itself.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=29 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=14 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=27 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW n=15 Participants Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Model-Based Annualized Bleeding Rate for All Bleeds	1.9 All bleeds per year Interval 1.23 to 2.97	41.1 All bleeds per year Interval 26.37 to 64.19	2.1 All bleeds per year Interval 1.33 to 3.26	3.8 All bleeds per year Interval 2.21 to 6.69

SECONDARY outcome

Timeframe: From Baseline to at least 24 weeks

Population: All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.

The number of all bleeds over the efficacy period is presented here as a calculated annualized bleeding rate (ABR) that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. In this outcome measure, all bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded. As "all bleeds" comprises both treated and non-treated bleeds, the 72-hour rule was implemented separately for treated and non-treated bleeds. For treated bleeds, the 72-hour rule meant that two bleeds of the same type and at the same anatomical location were counted as one bleed if the second bleed occurred within 72 hours from the last treatment for the first bleed. For non-treated bleeds, the 72-hour rule was implemented by calculating a treatment-free period of 72 hours from the bleed itself.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=29 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=14 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=27 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW n=15 Participants Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Mean Calculated Annualized Bleeding Rate for All Bleeds	2.7 All bleeds per year Interval 0.51 to 8.37	53.0 All bleeds per year Interval 39.71 to 69.33	3.1 All bleeds per year Interval 0.67 to 8.94	3.8 All bleeds per year Interval 1.01 to 10.01

SECONDARY outcome

Timeframe: From Baseline to at least 24 weeks

Population: All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.

The number of all bleeds over the efficacy period is presented here as a calculated annualized bleeding rate (ABR) that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. In this outcome measure, all bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded. As "all bleeds" comprises both treated and non-treated bleeds, the 72-hour rule was implemented separately for treated and non-treated bleeds. For treated bleeds, the 72-hour rule meant that two bleeds of the same type and at the same anatomical location were counted as one bleed if the second bleed occurred within 72 hours from the last treatment for the first bleed. For non-treated bleeds, the 72-hour rule was implemented by calculating a treatment-free period of 72 hours from the bleed itself.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=29 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=14 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=27 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW n=15 Participants Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Median Calculated Annualized Bleeding Rate for All Bleeds	1.5 All bleeds per year Interval 0.0 to 4.21	56.7 All bleeds per year Interval 26.09 to 70.81	1.9 All bleeds per year Interval 0.0 to 5.62	2.1 All bleeds per year Interval 0.0 to 5.77

SECONDARY outcome

Timeframe: From Baseline to at least 24 weeks

Population: All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.

The number of treated spontaneous bleeds over the efficacy period was estimated as an annualized bleeding rate (ABR) using a negative binomial regression model, which accounts for different follow-up times. A treated spontaneous bleed was defined as a treated bleed (bleed directly followed by a hemophilia medication reported to be a "treatment for bleed") with no other known contributing factor such as trauma or procedure/surgery. The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location were counted as one bleed if the second bleed occurred within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure were excluded.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=29 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=14 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=27 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW n=15 Participants Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Model-Based Annualized Bleeding Rate for Treated Spontaneous Bleeds	0.4 Treated spontaneous bleeds per year Interval 0.18 to 0.96	23.6 Treated spontaneous bleeds per year Interval 9.28 to 60.03	0.5 Treated spontaneous bleeds per year Interval 0.2 to 1.12	0.6 Treated spontaneous bleeds per year Interval 0.18 to 2.16

SECONDARY outcome

Timeframe: From Baseline to at least 24 weeks

Population: All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.

The number of treated spontaneous bleeds over the efficacy period is presented here as a calculated annualized bleeding rate (ABR) that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. A treated spontaneous bleed was defined as a treated bleed (bleed directly followed by a hemophilia medication reported to be a "treatment for bleed") with no other known contributing factor such as trauma or procedure/surgery. The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location were counted as one bleed if the second bleed occurred within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure were excluded.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=29 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=14 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=27 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW n=15 Participants Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Mean Calculated Annualized Bleeding Rate for Treated Spontaneous Bleeds	0.5 Treated spontaneous bleeds per year Interval 0.0 to 4.66	30.9 Treated spontaneous bleeds per year Interval 20.95 to 43.85	0.6 Treated spontaneous bleeds per year Interval 0.0 to 4.88	0.6 Treated spontaneous bleeds per year Interval 0.0 to 4.92

SECONDARY outcome

Timeframe: From Baseline to at least 24 weeks

Population: All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.

The number of treated spontaneous bleeds over the efficacy period is presented here as a calculated annualized bleeding rate (ABR) that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. A treated spontaneous bleed was defined as a treated bleed (bleed directly followed by a hemophilia medication reported to be a "treatment for bleed") with no other known contributing factor such as trauma or procedure/surgery. The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location were counted as one bleed if the second bleed occurred within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure were excluded.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=29 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=14 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=27 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW n=15 Participants Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Median Calculated Annualized Bleeding Rate for Treated Spontaneous Bleeds	0.0 Treated spontaneous bleeds per year Interval 0.0 to 0.0	21.8 Treated spontaneous bleeds per year Interval 6.48 to 52.18	0.0 Treated spontaneous bleeds per year Interval 0.0 to 0.96	0.0 Treated spontaneous bleeds per year Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: From Baseline to at least 24 weeks

Population: All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.

The number of treated joint bleeds over the efficacy period was estimated as an annualized bleeding rate (ABR) using a negative binomial regression model, which accounts for different follow-up times. A treated joint bleed was defined as a bleed with type reported as "joint" based on at least one of the following symptoms: increasing swelling or warmth of the skin over the joint and/or increasing pain, decreased range of motion, or difficulty using the joint compared with baseline, and the bleed was directly followed by a hemophilia medication reported to be a "treatment for bleed". The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location were counted as one bleed if the second bleed occurred within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure were excluded.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=29 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=14 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=27 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW n=15 Participants Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Model-Based Annualized Bleeding Rate for Treated Joint Bleeds	0.7 Treated joint bleeds per year Interval 0.36 to 1.46	17.7 Treated joint bleeds per year Interval 8.33 to 37.57	0.6 Treated joint bleeds per year Interval 0.28 to 1.22	0.1 Treated joint bleeds per year Interval 0.02 to 0.88

SECONDARY outcome

Timeframe: From Baseline to at least 24 weeks

Population: All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.

The number of treated joint bleeds over the efficacy period is presented here as a calculated annualized bleeding rate (ABR) that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. A treated joint bleed was defined as a bleed with type reported as "joint" based on at least one of the following symptoms: increasing swelling or warmth of the skin over the joint and/or increasing pain, decreased range of motion, or difficulty using the joint compared with baseline, and the bleed was directly followed by a hemophilia medication reported to be a "treatment for bleed". The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location were counted as one bleed if the second bleed occurred within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure were excluded.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=29 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=14 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=27 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW n=15 Participants Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Mean Calculated Annualized Bleeding Rate for Treated Joint Bleeds	1.0 Treated joint bleeds per year Interval 0.02 to 5.57	25.5 Treated joint bleeds per year Interval 16.62 to 37.56	0.8 Treated joint bleeds per year Interval 0.01 to 5.2	0.1 Treated joint bleeds per year Interval 0.0 to 3.93

SECONDARY outcome

Timeframe: From Baseline to at least 24 weeks

Population: All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.

The number of treated joint bleeds over the efficacy period is presented here as a calculated annualized bleeding rate (ABR) that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. A treated joint bleed was defined as a bleed with type reported as "joint" based on at least one of the following symptoms: increasing swelling or warmth of the skin over the joint and/or increasing pain, decreased range of motion, or difficulty using the joint compared with baseline, and the bleed was directly followed by a hemophilia medication reported to be a "treatment for bleed". The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location were counted as one bleed if the second bleed occurred within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure were excluded.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=29 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=14 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=27 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW n=15 Participants Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Median Calculated Annualized Bleeding Rate for Treated Joint Bleeds	0.0 Treated joint bleeds per year Interval 0.0 to 0.0	10.9 Treated joint bleeds per year Interval 8.7 to 50.0	0.0 Treated joint bleeds per year Interval 0.0 to 1.4	0.0 Treated joint bleeds per year Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: From Baseline to at least 24 weeks

Population: All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.

The number of treated target joint bleeds over the efficacy period was estimated as an annualized bleeding rate (ABR) using a negative binomial regression model, which accounts for different follow-up times. A treated target joint bleed was defined as a joint bleed in a target joint, which is a joint location where at least 3 bleeds have occurred over the last 24 weeks prior to study entry or an unresolved target joint (target joint that does not fulfil ≤2 bleeds into this joint within a consecutive 12-month period), and the bleed was directly followed by a hemophilia medication reported to be a "treatment for bleed". The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location were counted as one bleed if the second bleed occurred within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure were excluded.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=29 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=14 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=27 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW n=15 Participants Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Model-Based Annualized Bleeding Rate for Treated Target Joint Bleeds	0.4 Treated target joint bleeds per year Interval 0.18 to 1.09	8.6 Treated target joint bleeds per year Interval 3.15 to 23.42	0.3 Treated target joint bleeds per year Interval 0.12 to 0.85	NA Treated target joint bleeds per year The model-based ABR was not estimable because too few events had occurred.

SECONDARY outcome

Timeframe: From Baseline to at least 24 weeks

Population: All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.

The number of treated target joint bleeds over the efficacy period is presented here as a calculated annualized bleeding rate (ABR) that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. A treated target joint bleed was defined as a joint bleed in a target joint, which is a joint location where at least 3 bleeds have occurred over the last 24 weeks prior to study entry or an unresolved target joint (target joint that does not fulfil ≤2 bleeds into this joint within a consecutive 12-month period), and the bleed was directly followed by a hemophilia medication reported to be a "treatment for bleed". The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location were counted as one bleed if the second bleed occurred within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure were excluded.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=29 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=14 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=27 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW n=15 Participants Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Mean Calculated Annualized Bleeding Rate for Treated Target Joint Bleeds	0.7 Treated target joint bleeds per year Interval 0.0 to 5.06	15.6 Treated target joint bleeds per year Interval 8.83 to 25.47	0.5 Treated target joint bleeds per year Interval 0.0 to 4.76	0.0 Treated target joint bleeds per year Interval 0.0 to 3.69

SECONDARY outcome

Timeframe: From Baseline to at least 24 weeks

Population: All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.

The number of treated target joint bleeds over the efficacy period is presented here as a calculated annualized bleeding rate (ABR) that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. A treated target joint bleed was defined as a joint bleed in a target joint, which is a joint location where at least 3 bleeds have occurred over the last 24 weeks prior to study entry or an unresolved target joint (target joint that does not fulfil ≤2 bleeds into this joint within a consecutive 12-month period), and the bleed was directly followed by a hemophilia medication reported to be a "treatment for bleed". The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location were counted as one bleed if the second bleed occurred within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure were excluded.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=29 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=14 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=27 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW n=15 Participants Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Median Calculated Annualized Bleeding Rate for Treated Target Joint Bleeds	0.0 Treated target joint bleeds per year Interval 0.0 to 0.0	6.5 Treated target joint bleeds per year Interval 0.0 to 19.68	0.0 Treated target joint bleeds per year Interval 0.0 to 1.13	0.0 Treated target joint bleeds per year Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Efficacy periods: At least 24 weeks prior to study entry (mean [min-max] for A+B NIS-Previous Episodic Therapy: 183 [169-221] days); and From Baseline to at least 24 weeks on study (mean [min-max] for A+B NIS-Emicizumab: 363 [324-422] days)

Population: A total of 4 participants, pooled from Arm A and Arm B (2 per Arm), who participated in the NIS BH29768 before entering this study were included for this intraparticipant analysis.

This is an intra-participant comparison of the annualized bleeding rate (ABR) for treated bleeds pre-study versus on-study in the non-interventional study (NIS) population previously treated with episodic therapy in NIS BH29768. The number of treated bleeds over the efficacy period is presented here as a calculated ABR that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. A treated bleed was defined as a bleed that was directly followed by a hemophilia medication reported to be a "treatment for bleed". The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location were counted as one bleed if the second bleed occurred within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure were excluded.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=4 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=4 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Intra-Participant Comparison of the Calculated Annualized Bleeding Rate for Treated Bleeds With Emicizumab Prophylaxis On-Study Versus With Previous Episodic Therapy Pre-Study	0.24 Treated bleeds per year Interval 0.0 to 0.97	13.02 Treated bleeds per year Interval 4.96 to 21.61	—	—

SECONDARY outcome

Timeframe: Efficacy periods: At least 24 weeks prior to study entry (mean [min-max] for A+B NIS-Previous Episodic Therapy: 183 [169-221] days); and From Baseline to at least 24 weeks on study (mean [min-max] for A+B NIS-Emicizumab: 363 [324-422] days)

Population: A total of 4 participants, pooled from Arm A and Arm B (2 per Arm), who participated in the NIS BH29768 before entering this study were included for this intraparticipant analysis.

This is an intra-participant comparison of the annualized bleeding rate (ABR) for all bleeds pre-study versus on-study in the non-interventional study (NIS) population previously treated with episodic therapy in NIS BH29768. The ABR was calculated for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. All bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded. "All bleeds" comprises both treated and non-treated bleeds, and the 72-hour rule was implemented separately for each type. For treated bleeds, the 72-hour rule meant that two bleeds of the same type and at the same anatomical location were counted as one bleed if the second bleed occurred within 72 hours from the last treatment for the first bleed. For non-treated bleeds, the 72-hour rule was calculated as a treatment-free period of 72 hours from the bleed itself.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=4 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=4 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Intra-Participant Comparison of the Calculated Annualized Bleeding Rate for All Bleeds With Emicizumab Prophylaxis On-Study Versus With Previous Episodic Therapy Pre-Study	2.04 All bleeds per year Interval 1.1 to 3.38	39.67 All bleeds per year Interval 15.13 to 92.55	—	—

SECONDARY outcome

Timeframe: Baseline and Week 25

Population: Adult participants randomized to Arms A, B, and C. The number analyzed represents participants who provided responses at Baseline and Week 25.

The Haem-A-QoL questionnaire has been developed and used in hemophilia A participants, assessing very specific aspects of dealing with hemophilia. The questionnaire consists of items pertaining to 10 domains: physical health, sports and leisure, school and work, dealing with hemophilia, family planning, feeling, relationships, treatment, view of yourself, and outlook for the future. The total score for each domain ranges from 0 to 100 with lower scores reflective of better quality of life. Physical Health domain score is reported (range 0 to 100, with lower scores reflective of better physical health). The means were derived via an analysis of covariance (ANCOVA) model and have been adjusted for the following co-variates: baseline score, treatment group, and treatment by baseline interaction term.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=25 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=8 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=21 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Arms A, B, and C: Adjusted Mean Hemophilia A Quality of Life (Haem-A-QoL) Questionnaire Physical Health Domain Score at Week 25 in Participants ≥18 Years of Age	27.85 score on a scale Standard Deviation 19.82	42.53 score on a scale Standard Deviation 14.00	24.20 score on a scale Standard Deviation 16.09	—

SECONDARY outcome

Timeframe: Baseline and Week 25

Population: Adult participants randomized to Arms A, B, and C. The number analyzed represents participants who provided responses at Baseline and Week 25.

The Haem-A-QoL questionnaire has been developed and used in hemophilia A participants, assessing very specific aspects of dealing with hemophilia. The questionnaire consists of items pertaining to 10 domains: physical health, sports and leisure, school and work, dealing with hemophilia, family planning, feeling, relationships, treatment, view of yourself, and outlook for the future. The total score for each domain ranges from 0 to 100 with lower scores reflective of better quality of life. Physical Health domain score is reported (range 0 to 100, with lower scores reflective of better physical health).

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=25 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=8 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=21 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Arms A, B, and C: Change From Baseline to Week 25 in Haem-A-QoL Questionnaire Physical Health Domain Score for Participants ≥18 Years of Age Change from BL to Week 25	-20.20 score on a scale Standard Deviation 19.82	-5.63 score on a scale Standard Deviation 14.00	-22.14 score on a scale Standard Deviation 16.09	—
Arms A, B, and C: Change From Baseline to Week 25 in Haem-A-QoL Questionnaire Physical Health Domain Score for Participants ≥18 Years of Age Absolute Value at Baseline (BL)	50.60 score on a scale Standard Deviation 20.38	51.25 score on a scale Standard Deviation 23.41	42.14 score on a scale Standard Deviation 14.10	—

SECONDARY outcome

Timeframe: Baseline and Week 25

Population: Adult participants randomized to Arms A, B, and C. The number analyzed represents participants who provided responses at Baseline and Week 25.

The Haem-A-QoL questionnaire has been developed and used in hemophilia A participants, assessing very specific aspects of dealing with hemophilia. The questionnaire consists of items pertaining to 10 domains: physical health, sports and leisure, school and work, dealing with hemophilia, family planning, feeling, relationships, treatment, view of yourself, and outlook for the future. The total score for each domain ranges from 0 to 100 with lower scores reflective of better quality of life. Haem-A-QoL Total Score is the average of all domain scores and it ranges from 0 to 100, with lower scores reflective of better quality of life. The means were derived via an analysis of covariance (ANCOVA) model and have been adjusted for the following co-variates: baseline score, treatment group, and treatment by baseline interaction term.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=25 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=8 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=21 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Arms A, B, and C: Adjusted Mean Haem-A-QoL Questionnaire Total Score at Week 25 in Participants ≥18 Years of Age	37.26 score on a scale Standard Deviation 16.17	43.32 score on a scale Standard Deviation 7.47	29.30 score on a scale Standard Deviation 14.60	—

SECONDARY outcome

Timeframe: Baseline and Week 25

Population: Adult participants randomized to Arms A, B, and C. The number analyzed represents participants who provided responses at Baseline and Week 25.

The Haem-A-QoL questionnaire has been developed and used in hemophilia A participants, assessing very specific aspects of dealing with hemophilia. The questionnaire consists of items pertaining to 10 domains: physical health, sports and leisure, school and work, dealing with hemophilia, family planning, feeling, relationships, treatment, view of yourself, and outlook for the future. The total score for each domain ranges from 0 to 100 with lower scores reflective of better quality of life. Haem-A-QoL Total Score is the average of all domain scores and it ranges from 0 to 100, with lower scores reflective of better quality of life.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=25 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=8 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=21 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Arms A, B, and C: Change From Baseline to Week 25 in Haem-A-QoL Questionnaire Total Score for Participants ≥18 Years of Age Value at Baseline (BL)	49.15 score on a scale Standard Deviation 16.04	42.05 score on a scale Standard Deviation 17.89	46.59 score on a scale Standard Deviation 12.58	—
Arms A, B, and C: Change From Baseline to Week 25 in Haem-A-QoL Questionnaire Total Score for Participants ≥18 Years of Age Change from BL to Week 25	-10.14 score on a scale Standard Deviation 16.17	-2.50 score on a scale Standard Deviation 7.47	-17.61 score on a scale Standard Deviation 14.60	—

SECONDARY outcome

Timeframe: Baseline and Week 25

Population: Only adolescents (aged 12-17 years) randomized to Arms A, B, and C were included in this analysis. The number analyzed represents participants who provided responses at Baseline and Week 25.

The Haemo-QoL-SF contains 35 items covering nine dimensions considered relevant for the adolescent's (aged 12-17 years) health-related quality of life (HRQoL). Items are rated with five respective response options: never, seldom, sometimes, often, and always. The score ranges from 0 to 100, and a higher score is indicative of poorer HRQoL. According to the pre-specified statistical analysis plan, no statistical analyses were performed on the protocol-defined endpoints for the Haemo-QoL-SF due to the small number of adolescents randomized to Arms A, B and C.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=3 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=2 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=5 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Arms A, B, and C: Hemophilia-Specific Quality of Life Short Form (Haemo-QoL-SF) Questionnaire Total Score at Baseline and Week 25 in Participants 12 to 17 Years of Age Value at Week 25	32.9 score on a scale Interval 27.9 to 39.3	21.5 score on a scale Interval 13.6 to 29.3	27.6 score on a scale Interval 10.0 to 40.0	—
Arms A, B, and C: Hemophilia-Specific Quality of Life Short Form (Haemo-QoL-SF) Questionnaire Total Score at Baseline and Week 25 in Participants 12 to 17 Years of Age Value at Baseline (BL)	44.5 score on a scale Interval 35.7 to 58.6	44.7 score on a scale Interval 35.0 to 54.3	35.7 score on a scale Interval 20.0 to 50.7	—

SECONDARY outcome

Timeframe: Baseline and Week 25

Population: Participants randomized to Arms A, B, and C. The number analyzed represents participants who provided responses at Baseline and Week 25.

EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L VAS. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. The means were derived via an analysis of covariance (ANCOVA) model and have been adjusted for the following co-variates: baseline score, treatment group, and treatment by baseline interaction term.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=28 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=9 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=25 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Arms A, B, and C: Adjusted Mean European Quality of Life 5-Dimensions-5 Levels Questionnaire (EQ-5D-5L) Questionnaire Visual Analog Scale (VAS) Score at Week 25	81.82 score on a scale Standard Deviation 23.19	78.36 score on a scale Standard Deviation 20.68	85.94 score on a scale Standard Deviation 15.20	—

SECONDARY outcome

Timeframe: Baseline and Week 25

Population: The number analyzed indicates the number of participants who responded to the questionnaire scale at a given timepoint. For the change from baseline analysis, only participants who responded at both Baseline and Week 25 were included.

The European Quality of Life 5-Dimensions-5 Levels Questionnaire (EQ-5D-5L) is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L VAS. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=29 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=10 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=25 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Arms A, B, and C: Change From Baseline in EQ-5D-5L Questionnaire VAS Score at Week 25 Value at Baseline (BL)	74.59 score on a scale Standard Deviation 16.91	84.50 score on a scale Standard Deviation 15.07	78.96 score on a scale Standard Deviation 12.91	—
Arms A, B, and C: Change From Baseline in EQ-5D-5L Questionnaire VAS Score at Week 25 Change from BL to Week 25	4.82 score on a scale Standard Deviation 19.13	-2.00 score on a scale Standard Deviation 13.27	7.40 score on a scale Standard Deviation 16.67	—

SECONDARY outcome

Timeframe: Baseline and Week 25

Population: Participants randomized to Arms A, B, and C. The number analyzed represents participants who provided responses at Baseline and Week 25.

The European Quality of Life 5-Dimensions-5 Levels Questionnaire (EQ-5D-5L) is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L VAS. The EQ-5D-5L health state profile is designed to record the participant's current health state in 5 domains: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Responses from the five domains are used to calculate a single index utility score on a scale of 0 to 1, with higher scores reflective of better quality of life. The means were derived via an analysis of covariance (ANCOVA) model and have been adjusted for the following co-variates: baseline score, treatment group, and treatment by baseline interaction term.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=28 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=9 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=25 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Arms A, B, and C: Adjusted Mean EQ-5D-5L Index Utility Score at Week 25	0.79 score on a scale Standard Deviation 0.27	0.74 score on a scale Standard Deviation 0.35	0.82 score on a scale Standard Deviation 0.17	—

SECONDARY outcome

Timeframe: Baseline and Week 25

Population: Participants randomized to Arms A, B, and C. The number analyzed indicates the number of participants who responded to the questionnaire scale at a given timepoint. For the change from baseline analysis, only participants who responded at both Baseline and Week 25 were included.

The European Quality of Life 5-Dimensions-5 Levels Questionnaire (EQ-5D-5L) is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L VAS. The EQ-5D-5L health state profile is designed to record the participant's current health state in 5 domains: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Responses from the five domains are used to calculate a single index utility score on a scale of 0 to 1, with higher scores reflective of better quality of life.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study n=29 Participants Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=10 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=25 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Arms A, B, and C: Change From Baseline in EQ-5D-5L Index Utility Score at Week 25 Change from BL to Week 25	0.08 score on a scale Standard Deviation 0.22	0.02 score on a scale Standard Deviation 0.09	0.08 score on a scale Standard Deviation 0.21	—
Arms A, B, and C: Change From Baseline in EQ-5D-5L Index Utility Score at Week 25 Value at Baseline (BL)	0.68 score on a scale Standard Deviation 0.27	0.76 score on a scale Standard Deviation 0.27	0.75 score on a scale Standard Deviation 0.20	—

SECONDARY outcome

Timeframe: Baseline and Week 25

Population: This outcome measure was only applicable for participants enrolled in Arm D. The number analyzed for each visit represents the number of participants who responded to the questionnaire.

The Hemophilia-Specific Quality of Life Short Form (Haemo-QoL-SF) questionnaire contains 35 items covering nine dimensions considered relevant for the children's health-related quality of life (HRQoL). Items are rated with five respective response options: never, seldom, sometimes, often, and always. The scores range from 0 to 100, and higher scores are indicative of poorer HRQoL.

Outcome measures

Measure	A+B NIS: Emicizumab Prophylaxis On-Study Only participants with hemophilia A (with or without FVIII inhibitors), pooled from Arm A and Arm B, who previously participated in the NIS BH29768 are included here for analysis. On this study, the participants received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by either 1.5 mg/kg (in Arm A) or 6 mg/kg (in Arm B) via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Control): No Prophylaxis n=6 Participants Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Arm D: Change From Baseline in Haemo-QoL-SF Questionnaire Physical Health and Total Scores at Week 25 in Participants 8 to 12 Years of Age Physical Health Score: Baseline (BL) - Value at Visit	—	67.71 score on a scale Standard Deviation 30.98	—	—
Arm D: Change From Baseline in Haemo-QoL-SF Questionnaire Physical Health and Total Scores at Week 25 in Participants 8 to 12 Years of Age Physical Health Score: Change from BL at Week 25	—	-53.75 score on a scale Standard Deviation 37.66	—	—
Arm D: Change From Baseline in Haemo-QoL-SF Questionnaire Physical Health and Total Scores at Week 25 in Participants 8 to 12 Years of Age Total Score: Baseline (BL) Value at Visit	—	54.40 score on a scale Standard Deviation 19.68	—	—
Arm D: Change From Baseline in Haemo-QoL-SF Questionnaire Physical Health and Total Scores at Week 25 in Participants 8 to 12 Years of Age Total Score: Change from BL at Week 25	—	-23.86 score on a scale Standard Deviation 17.84	—	—

SECONDARY outcome

Timeframe: Baseline (Week 1) and Weeks 17, 29, 37, and 49, every 12 weeks during extension phase, and study completion (up to 48 months)

Proxy assessment of HRQoL and aspects of caregiver burden for all children, regardless of age, were collected using the Adapted Inhib-QoL with Aspects of Caregiver Burden questionnaire. The questionnaire comprises two parts. The first part asks the caregiver for his/her opinion on the child's HRQoL (proxy HRQoL). The second part asks the caregiver to rate how the child's situation is for them (i.e., the impact of the child's disease and treatment on the caregiver). Items are rated with 5 respective response options: never, seldom, sometimes, often, and all the time. Scores range from 0 to 100, with lower scores reflective of better HRQoL. A total score is calculated as the sum of all of the items in the scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline until end of study (up to 85 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline until end of study (up to 85 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline until end of study (up to 85 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline until end of study (up to 85 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline until end of study (up to 85 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline until end of study (up to 85 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline until end of study (up to 85 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline until end of study (up to 85 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Weeks 5, 25, 49, and at study completion (up to 85 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Weeks 5, 25, 49, and at study completion (up to 85 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Weeks 5, 25, 49, and at study completion (up to 85 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Weeks 5, 25, 49, and at study completion (up to 85 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Weeks 5, 25, 49, and at study completion (up to 85 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: QW: Pre-dose at Weeks 1, 5, 9, 13, 17, 21, 25, 33, 41, 49, and every 12 weeks thereafter until study completion; Q4W: Pre-dose at Weeks 1, 5, 9, 13, 17, 21, 25, and every 12 weeks thereafter until study completion (up to 85 months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: QW: Predose at Weeks 1, 2, 3, 4, 5, 7, 9, 13, 17, 21, 25, 33, 41, 49, and every 12 weeks thereafter to study completion; Q4W: Predose at Weeks 1, 2, 3, 4, 5, 7, 9, 13, 17, 21, 25, and every 12 weeks thereafter to study completion (up to 85 months)

Outcome measures

Outcome data not reported

Adverse Events

Arm C (Control): No Prophylaxis

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm A: 1.5 mg/kg Emicizumab Prophylaxis QW

Serious events: 8 serious events

Other events: 27 other events

Deaths: 0 deaths

Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W

Serious events: 4 serious events

Other events: 24 other events

Deaths: 0 deaths

Arm C (Emi): 6 mg/kg Emicizumab Prophylaxis Q4W

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm C (Control): No Prophylaxis n=14 participants at risk Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm A: 1.5 mg/kg Emicizumab Prophylaxis QW n=29 participants at risk Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm A received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=27 participants at risk Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Emi): 6 mg/kg Emicizumab Prophylaxis Q4W n=14 participants at risk After 24 weeks on no prophylaxis, participants were given the opportunity to switch to receive emicizumab prophylaxis at 3 mg/kg QW via SC injection for 4 weeks, followed by 6 mg/kg Q4W until marketing authorization as part of this study or a separate extension study, as long as they derive clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW n=15 participants at risk Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Gastrointestinal disorders Ileal ulcer	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.7% 1/27 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Gastrointestinal disorders Pancreatitis	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
General disorders Mass	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.9% 2/29 • Number of events 3 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.9% 2/29 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Musculoskeletal and connective tissue disorders Haemophilic arthropathy	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Vascular disorders Haemorrhage	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Vascular disorders Shock haemorrhagic	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Blood and lymphatic system disorders Anaemia	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Hepatobiliary disorders Cholelithiasis	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Infections and infestations Infective exacerbation of bronchiectasis	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.7% 1/27 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Injury, poisoning and procedural complications Limb fracture	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.7% 1/27 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.7% 1/27 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Renal and urinary disorders Ureteric dilatation	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Renal and urinary disorders Ureterolithiasis	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.7% 1/27 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).

Other adverse events

Measure	Arm C (Control): No Prophylaxis n=14 participants at risk Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm C did not receive any prophylactic treatment for the first 24 weeks of the study (Control). Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of bleeds during the study.	Arm A: 1.5 mg/kg Emicizumab Prophylaxis QW n=29 participants at risk Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm A received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm B: 6 mg/kg Emicizumab Prophylaxis Q4W n=27 participants at risk Participants ≥12 years old with hemophilia A (with or without FVIII inhibitors) who were randomized to Arm B received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 6 mg/kg via SC injection Q4W for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm C (Emi): 6 mg/kg Emicizumab Prophylaxis Q4W n=14 participants at risk After 24 weeks on no prophylaxis, participants were given the opportunity to switch to receive emicizumab prophylaxis at 3 mg/kg QW via SC injection for 4 weeks, followed by 6 mg/kg Q4W until marketing authorization as part of this study or a separate extension study, as long as they derive clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.	Arm D: 1.5 mg/kg Emicizumab Prophylaxis QW n=15 participants at risk Participants \<12 years old with hemophilia A and FVIII inhibitors who were enrolled to Arm D received prophylactic emicizumab at a dose of 3 mg/kg via SC injection QW for the first 4 weeks, followed by 1.5 mg/kg via SC injection QW for at least 24 weeks. After 24 weeks of treatment, participants were allowed to continue receiving emicizumab until marketing authorization, as part of this study or a separate extension study, as long as they derived clinical benefit. Participants continued to receive standard-of-care treatments on an episodic basis for the treatment of breakthrough bleeds during the study.
Infections and infestations Upper respiratory tract infection	14.3% 2/14 • Number of events 3 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	37.9% 11/29 • Number of events 17 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	37.0% 10/27 • Number of events 22 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	57.1% 8/14 • Number of events 16 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	40.0% 6/15 • Number of events 21 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Infections and infestations Nasopharyngitis	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	10.3% 3/29 • Number of events 5 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	11.1% 3/27 • Number of events 3 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Infections and infestations Pharyngitis	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	11.1% 3/27 • Number of events 3 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.7% 1/15 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Infections and infestations Bronchitis	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.4% 2/27 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.7% 1/15 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Infections and infestations Gingivitis	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.4% 2/27 • Number of events 3 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Infections and infestations Tonsillitis	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.7% 1/27 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	13.3% 2/15 • Number of events 3 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Infections and infestations Herpes zoster	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.7% 1/15 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Infections and infestations Otitis media	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.7% 1/27 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.7% 1/15 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Infections and infestations Rhinitis	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.7% 1/15 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Infections and infestations Laryngitis	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.7% 1/15 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Infections and infestations Viral infection	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Investigations Aspartate aminotransferase increased	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	13.8% 4/29 • Number of events 7 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	22.2% 6/27 • Number of events 10 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	14.3% 2/14 • Number of events 3 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Investigations Alanine aminotransferase increased	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.9% 2/29 • Number of events 5 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	18.5% 5/27 • Number of events 10 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	21.4% 3/14 • Number of events 7 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Investigations Blood uric acid increased	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.9% 2/29 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.4% 2/27 • Number of events 3 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	14.3% 2/14 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.7% 1/15 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Investigations Blood alkaline phosphatase increased	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	33.3% 5/15 • Number of events 8 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Investigations Blood glucose increased	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	10.3% 3/29 • Number of events 7 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.7% 1/27 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Investigations Blood bilirubin increased	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	10.3% 3/29 • Number of events 6 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Investigations Alanine aminotransferase abnormal	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Investigations Bilirubin conjugated increased	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.9% 2/29 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Investigations Blood potassium decreased	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.4% 2/27 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Investigations Weight decreased	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.9% 2/29 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Investigations Aspartate aminotransferase abnormal	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Investigations Blood ketone body increased	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.7% 1/15 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Investigations Differential white blood cell count abnormal	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Investigations Neutrophil count abnormal	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Investigations White blood cell count abnormal	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Investigations White blood cells urine positive	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.7% 1/15 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Gastrointestinal disorders Diarrhoea	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	13.8% 4/29 • Number of events 6 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.4% 2/27 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	21.4% 3/14 • Number of events 4 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Gastrointestinal disorders Constipation	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.9% 2/29 • Number of events 3 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Gastrointestinal disorders Dental caries	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.9% 2/29 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.7% 1/27 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Gastrointestinal disorders Vomiting	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.4% 2/27 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Gastrointestinal disorders Abdominal distension	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	14.3% 2/14 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Gastrointestinal disorders Toothache	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.9% 2/29 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Gastrointestinal disorders Dyspepsia	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.7% 1/15 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Gastrointestinal disorders Mouth ulceration	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
General disorders Injection site reaction	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	13.8% 4/29 • Number of events 7 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	18.5% 5/27 • Number of events 29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
General disorders Pyrexia	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	10.3% 3/29 • Number of events 7 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.7% 1/27 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	20.0% 3/15 • Number of events 4 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
General disorders Influenza like illness	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.9% 2/29 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
General disorders Chest discomfort	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.7% 1/27 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
General disorders Asthenia	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	20.7% 6/29 • Number of events 8 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	14.8% 4/27 • Number of events 4 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	14.3% 2/14 • Number of events 3 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	17.2% 5/29 • Number of events 5 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	11.1% 3/27 • Number of events 3 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Injury, poisoning and procedural complications Contusion	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.7% 1/27 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.4% 2/27 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Injury, poisoning and procedural complications Limb injury	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Nervous system disorders Headache	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	17.2% 5/29 • Number of events 5 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.7% 1/27 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Nervous system disorders Dizziness	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	10.3% 3/29 • Number of events 4 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.7% 1/27 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 3 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Nervous system disorders Head discomfort	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Vascular disorders Hypertension	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	17.2% 5/29 • Number of events 5 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.4% 2/27 • Number of events 3 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	10.3% 3/29 • Number of events 4 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.7% 1/15 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Blood and lymphatic system disorders Anaemia	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	10.3% 3/29 • Number of events 3 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.7% 1/15 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.7% 1/27 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 2 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.7% 1/15 • Number of events 3 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Hepatobiliary disorders Gallbladder polyp	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Hepatobiliary disorders Hepatic steatosis	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Cardiac disorders Palipitations	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.7% 1/27 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Cardiac disorders Sinus bradycardia	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.7% 1/27 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	6.7% 1/15 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Ear and labyrinth disorders Tinnitus	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.4% 1/29 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	3.7% 1/27 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).
Reproductive system and breast disorders Breast hyperplasia	0.00% 0/14 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/29 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/27 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	7.1% 1/14 • Number of events 1 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).	0.00% 0/15 • From the date of randomization or enrollment until the clinical cutoff date (Arms A to C: Emicizumab, up to 223 weeks; Arm D: up to 67 weeks; Arm C [Control] No Prophylaxis: up to 28 weeks) The study is ongoing and adverse event data are still being collected. These results will be updated within 1 year of the final data collection date (i.e., the last patient's last visit).

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER