guardian TM 7: Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02938585
• Collaborator: (none)
• Enrollment: 68
• Locations: 11
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site: 6.2
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This trial is conducted in China. The aim of this trial is to evaluate the clinical efficacy of turoctocog alfa in treatment of bleeding episodes in Chinese patients with severe haemophilia A (FVIII≤1%).

Condition or Disease	Intervention/Treatment	Phase
Congenital Bleeding Disorder; Haemophilia A	Drug: turoctocog alfa; Drug: turoctocog alfa	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A
• Actual Study Start Date: Dec 12, 2016
• Actual Primary Completion Date: Mar 16, 2018
• Actual Study Completion Date: Dec 12, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prophylactic treatment	Drug: turoctocog alfa; The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur.
Experimental: On-demand treatment	Drug: turoctocog alfa; Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)

Outcome Measures

Primary Outcome Measures

1. Haemostatic Effect of Turoctocog Alfa (Treatment of Bleeds): 6 Months [Month 0-6]

   The haemostatic effect of turoctocog alfa when used for treatment of bleeding episodes in both prophylaxis and on-demand regimen was evaluated during month 0-6. The effect was assessed on a four-point scale for haemostatic response, excellent, good, moderate and none.

Secondary Outcome Measures

1. Haemostatic Effect of Turoctocog Alfa (Treatment of Bleeds): 24 Months [Month 0-24]

   The haemostatic effect of turoctocog alfa when used for treatment of bleeding episodes in both prophylaxis and on-demand regimen was evaluated during month 0-24. The effect was assessed on a four-point scale for haemostatic response, excellent, good, moderate and none.

2. Incidence Rate of Inhibitory Antibodies Against FVIII (≥0.6 BU): 6 Months [Month 0-6]

   This endpoint presented 'percentage of participants with inhibitory antibodies against FVIII (≥0.6 BU)' in both prophylaxis and on-demand regimen, evaluated during month 0-6.

3. Incidence Rate of Inhibitory Antibodies Against FVIII (≥0.6 BU): 24 Months [Month 0-24]

   This endpoint presented 'percentage of participants with inhibitory antibodies against FVIII (≥0.6 BU)' in both prophylaxis and on-demand regimen, evaluated during month 0-24.

4. Number of Bleeds (Total Bleeds Assessed as Annual Bleeding Rate) Per Participant: 6 Months [Month 0-6]

   Number of bleeds (total bleeds assessed as annual bleeding rate) per participant in the prophylaxis regimen was evaluated during month 0-6. The annualised bleeding rate was analysed by a negative binomial model.

5. Number of Bleeds (Total Bleeds Assessed as Annual Bleeding Rate) Per Participant: 24 Months [Month 0-24]

   Number of bleeds (total bleeds assessed as annual bleeding rate) per participant in the prophylaxis regimen was evaluated during month 0-24. The annualised bleeding rate was analysed by a negative binomial model.

6. Consumption of Turoctocog Alfa for Bleeding Treatment: Average Dose to Treat a Bleed (6 Months) [Month 0-6]

   Average dose of turoctocog alfa used to treat a bleed in both prophylaxis and on-demand regimen was evaluated during month 0-6.

7. Consumption of Turoctocog Alfa for Bleeding Treatment: Average Dose to Treat a Bleed (24 Months) [Month 0-24]

   Average dose of turoctocog alfa used to treat a bleed in both prophylaxis and on-demand regimen was evaluated during month 0-24.

8. Consumption of Turoctocog Alfa for Bleeding Treatment: Number of Injections Per Bleed (6 Months) [Month 0-6]

   Number of turoctocog alfa injections consumed to treat a bleeding episode in both prophylaxis and on-demand regimen was evaluated during month 0-6.

9. Consumption of Turoctocog Alfa for Bleeding Treatment: Number of Injections Per Bleed (24 Months) [Month 0-24]

   Number of turoctocog alfa injections consumed to treat a bleeding episode in both prophylaxis and on-demand regimen was evaluated during month 0-24.

10. Consumption of Turoctocog Alfa for Bleeding Treatment: IU/kg Per Bleed (6 Months) [Month 0-6]

    Consumption of turoctocog alfa IU/kg BW per bleed in both prophylaxis and on-demand regimen was evaluated during month 0-6.

11. Consumption of Turoctocog Alfa for Bleeding Treatment: IU/kg Per Bleed (24 Months) [Month 0-24]

    Consumption of turoctocog alfa IU/kg BW per bleed in both prophylaxis and on-demand regimen was evaluated during month 0-24.

12. Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: Average Preventive Dose (6 Months) [Month 0-6]

    Average preventive dose of turoctocog alfa consumed per participant in the prophylaxis regimen was evaluated during month 0-6.

13. Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: Average Preventive Dose (24 Months) [Month 0-24]

    Average preventive dose of turoctocog alfa consumed per participant in the prophylaxis regimen was evaluated during month 0-24.

14. Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Month (6 Months) [Month 0-6]

    Preventive dose of turoctocog alfa (IU/kg body weight (BW) per month) per participant in the prophylaxis regimen was evaluated during month 0-6.

15. Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Month (24 Months) [Month 0-24]

    Preventive dose of turoctocog alfa (IU/kg body weight (BW) per month) per participant in the prophylaxis regimen was evaluated during month 0-24.

16. Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Year (6 Months) [Month 0-6]

    Preventive dose of turoctocog alfa (IU/kg body weight per year) per participant in the prophylaxis regimen was evaluated during month 0-6.

17. Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Year (24 Months) [Month 0-24]

    Preventive dose of turoctocog alfa (IU/kg body weight (BW) per year) per participant in the prophylaxis regimen was evaluated during month 0-24.

18. Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Month (6 Months) [Month 0-6]

    Total consumption of turoctocog alfa (IU/kg body weight per month) per participant in both prophylaxis and on-demand regimen was evaluated during month 0-6.

19. Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Month (24 Months) [Month 0-24]

    Total consumption of turoctocog alfa (IU/kg body weight per month) per participant in both prophylaxis and on-demand regimen was evaluated during month 0-24.

20. Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Year (6 Months) [Month 0-6]

    Total consumption of turoctocog alfa (IU/kg body weight per year) per participant in both prophylaxis and on-demand regimen was evaluated during month 0-6.

21. Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Year (24 Months) [Month 0-24]

    Total consumption of turoctocog alfa (IU/kg body weight per year) per participant in both prophylaxis and on-demand regimen was evaluated during month 0-24.

22. Frequency of Adverse Events (6 Months) [Month 0-6]

    Frequency of adverse events (AEs) are presented as rate of events, which was calculated as the number of AEs per patient years. All presented AEs are treatment emergent (TEAEs), which were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.

23. Frequency of Adverse Events (24 Months) [Month 0-24]

    Frequency of adverse events (AEs) are presented as rate of events, which was calculated as the number of AEs per patient years. All presented AEs are treatment emergent (TEAEs), which were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.

24. Frequency of Serious Adverse Events (6 Months) [Month 0-6]

    Frequency of serious adverse events (SAEs) are presented as rate of events, which was calculated as the number of SAEs per patient years. All presented SAEs are treatment emergent, which were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.

25. Frequency of Serious Adverse Events (24 Months) [Month 0-24]

    Frequency of serious adverse events (SAEs) are presented as rate of events, which was calculated as the number of SAEs per patient years. All presented SAEs are treatment emergent, which were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.

26. Haemostatic Effect of Turoctocog Alfa (Surgery): 6 Months [Month 0-6]

    The haemostatic effect of turoctocog alfa when used for surgery was evaluated during month 0-6. The effect was assessed on a four-point scale for haemostatic response (excellent, good, moderate and none) and assessed by the investigator/surgeon on the day of surgery (day 1) and on the last day in the post-operative period the participant was at the trial/surgery site.

27. Haemostatic Effect of Turoctocog Alfa (Surgery): 24 Months [Month 0-24]

    The haemostatic effect of turoctocog alfa when used for surgery was evaluated during month 0-24. The effect was assessed on a four-point scale for haemostatic response (excellent, good, moderate and none) and assessed by the investigator/surgeon on the day of surgery (day 1) and on the last day in the post-operative period the participant was at the trial/surgery site. Haemostatic response of 'not applicable' indicated that turoctocog alfa was not used.

28. Loss of Blood (Surgery): 6 Months [Month 0-6]

    Loss of blood was evaluated during month 0-6: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first.

29. Loss of Blood (Surgery): 24 Months [Month 0-24]

    Loss of blood was evaluated during month 0-24: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first.

30. Requirements for Transfusion (Surgery): 6 Months [Month 0-6]

    Surgeries required transfusion was evaluated during month 0-6: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first.

31. Requirements for Transfusion (Surgery): 24 Months [Month 0-24]

    Surgeries required transfusion was evaluated during month 0-24: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first.

32. Adverse Events (Surgery): 6 Months [Month 0-6]

    TEAEs during surgery were recorded during month 0-6: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first. TEAEs were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.

33. Adverse Events (Surgery): 24 Months [Month 0-24]

    TEAEs during surgery were recorded during month 0-24: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first. TEAEs were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.

34. Serious Adverse Events (Surgery): 6 Months [Month 0-6]

    Treatment emergent serious adverse events occurred during surgery were recorded from month 0 to month 6: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant is at the trial/surgery site whatever comes first. Treatment emergent events were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.

35. Serious Adverse Events (Surgery): 24 Months [Month 0-24]

    Treatment emergent serious adverse events occurred during surgery were recorded from month 0 to month 24: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant is at the trial/surgery site whatever comes first. Treatment emergent events were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.

36. Change in Total Scores for Reported Health-related Quality of Life (for Participants): Month 6 [Month 0, Month 6]

    Reported results are baseline (month 0) and change from baseline (at month 6) of end of disease and age specific HRQOL. HRQOL was collected through use of the patient reported outcome (PRO) instruments, HAEMO-QOL (for children (8-12 years)/adolescents (13-16 years)) and HAEM-A-QOL (for adults (>=17 years)). HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. HAEM-A-QOL assessment included questions on physical health, feeling, view of yourself, sports and leisure, work and school, dealing with haemophilia, treatment, future, family planning, and partnership and sexuality. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Observed mean of the means of all the questions for HAEMO-QOL and HAEM-A-QOL, respectively are presented.

37. Change in Total Scores for Reported Health-related Quality of Life (for Participants): Month 24 [Month 0, Month 24]

    Reported results are baseline (month 0) and change from baseline (at month 24) of end of disease and age specific HRQOL. HRQOL was collected through use of the patient reported outcome (PRO) instruments, HAEM-A-QOL (for adults (>=17 years)) and HAEMO-QOL (for children (8-12 years)/adolescents (13-16 years)). HAEM-A-QOL assessment included questions on physical health, feeling, view of yourself, sports and leisure, work and school, dealing with haemophilia, treatment, future, family planning, and partnership and sexuality. HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Observed mean of the means of all the questions for HAEM-A-QOL and HAEMO-QOL, respectively are presented.

38. Change in Total Scores for Reported Health-related Quality of Life (for Parents): Month 6 [Month 0, Month 6]

    Reported results are baseline (month 0) and change from baseline (at month 6) of end of disease and age specific health related quality of life (HRQOL). HRQOL was collected through use of the PRO instrument, HAEMO-QOL (for parents of the children (4-7 years and 8-12 years)/adolescents (13-16 years)). HAEMO-QOL assessment included questions on physical health, feeling, view of himself, family, friends, perceived support, other persons, nursery School or Kindergarten, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Observed mean of the means of all the questions for HAEMO-QOL are presented.

39. Change in Total Scores for Reported Health-related Quality of Life (for Parents): Month 24 [Month 0, Month 24]

    Reported results are baseline (month 0) and change from baseline (at month 24) of end of disease and age specific health related quality of life (HRQOL). HRQOL was collected through use of the PRO instrument, HAEMO-QOL (for parents of the children (4-7 years and 8-12 years)/adolescents (13-16 years)). HAEMO-QOL assessment included questions on physical health, feeling, view of himself, family, friends, perceived support, other persons, nursery School or Kindergarten, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Observed mean of the means of all the questions for HAEMO-QOL are presented.

40. Incremental Recovery of FVIII [Days 1-2]

    Blood samples for the evaluation of incremental recovery of FVIII were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. The incremental recovery was calculated as (FVIII: coagulant (C) activity measured in plasma 30 minutes after dosing - FVIII:C activity measured in plasma immediately before dosing)/(dose injected at time 0 minute), where the dose was expressed as IU FVIII product per kg body weight. The results are based on the chromogenic assay.

41. Area Under the Curve (AUC0-inf) [Days 1-2]

    Blood samples for the evaluation of AUC0-inf were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. AUC0-inf was defined as the area under the concentration versus time from time curve zero to infinity. The results are based on the chromogenic assay.

42. Half-life (t½) [Days 1-2]

    Blood samples for the evaluation of t½ were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. The results are based on the chromogenic assay.

43. Clearance (CL) [Days 1-2]

    Blood samples for the evaluation of CL were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. The results are based on the chromogenic assay.

44. Highest Measured FVIII Activity in the Profile (Cmax) [Days 1-2]

    Blood samples for the evaluation of Cmax were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. The results are based on the chromogenic assay.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male patients

• Age from 0 years

• With the diagnosis of severe congenital haemophilia A (FVIII≤1%)

• History of exposure days (ED) to any FVIII products fulfilling the criteria of previously treated patients:

• Patients of 12 years or above: 100 exposures days (ED) or more

• Patients below 12 years: 50 exposure days (ED) or more

Exclusion Criteria:

• Inhibitors to factor VIII (≥0.6 BU) at screening as assessed by central laboratory

• Known history of FVIII inhibitors

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Beijing	Beijing	China	100045
2	Novo Nordisk Investigational Site	Chonqqing	Chongqing	China	400014
3	Novo Nordisk Investigational Site	Fuzhou	Fujian	China	350001
4	Novo Nordisk Investigational Site	Guangzhou	Guangdong	China	510515
5	Novo Nordisk Investigational Site	Guiyang	Guizhou	China	550004
6	Novo Nordisk Investigational Site	Wuhan	Hubei	China	430030
7	Novo Nordisk Investigational Site	Xining	Qinghai	China	810007
8	Novo Nordisk Investigational Site	Shanghai	Shanghai	China	200025
9	Novo Nordisk Investigational Site	Tianjing	Tianjin	China	300020
10	Novo Nordisk Investigational Site	Kunming	Yunnan	China	650032
11	Novo Nordisk Investigational Site	Hangzhou	Zhejiang	China	310003

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jul 21, 2017
• Statistical Analysis Plan - Nov 1, 2018

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02938585
• Other Study ID Numbers: NN7008-4028; U1111-1150-0765; CTR20160811; 2013-004791-35
• First Posted: Oct 19, 2016
• Last Update Posted: Jul 27, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders; Hemorrhage; Factor VIII

Study Results

Participant Flow

Recruitment Details	The trial was conducted at 10 sites in mainland China.
Pre-assignment Detail	Study design: This was an open-label and non-randomised trial. Participants with severe haemophilia A were administered a prophylaxis (preventive) or on-demand regimen of turoctocog alfa (trial product) at the investigator's discretion.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Period Title: Overall Study
STARTED	9	33	11	15
Exposed to Prophylaxis Regimen	9	31	11	12
Exposed to On-demand Regimen	1	7	1	8
COMPLETED	9	32	11	10
NOT COMPLETED	0	1	0	5

Baseline Characteristics

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)	Total
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Total of all reporting groups
Overall Participants	9	33	11	15	68
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	4.00 (1.12)	8.70 (1.91)	14.55 (1.92)	31.00 (11.20)	13.94 (10.99)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%
Male	9 100%	33 100%	11 100%	15 100%	68 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	9 100%	33 100%	11 100%	15 100%	68 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	9 100%	33 100%	11 100%	15 100%	68 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Haemostatic Effect of Turoctocog Alfa (Treatment of Bleeds): 6 Months
Description	The haemostatic effect of turoctocog alfa when used for treatment of bleeding episodes in both prophylaxis and on-demand regimen was evaluated during month 0-6. The effect was assessed on a four-point scale for haemostatic response, excellent, good, moderate and none.
Time Frame	Month 0-6

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	6	20	6	15
Measure Bleeding episodes	48	245	28	290
Excellent	35	156	20	190
Good	12	73	8	87
Moderate	1	15	0	13
None	0	0	0	0
Missing	0	1	0	0

2. Secondary Outcome

Title	Haemostatic Effect of Turoctocog Alfa (Treatment of Bleeds): 24 Months
Description	The haemostatic effect of turoctocog alfa when used for treatment of bleeding episodes in both prophylaxis and on-demand regimen was evaluated during month 0-24. The effect was assessed on a four-point scale for haemostatic response, excellent, good, moderate and none.
Time Frame	Month 0-24

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	7	24	8	15
Measure Bleeding episodes	65	405	53	402
Excellent	45	275	42	272
Good	18	103	11	116
Moderate	2	26	0	14
None	0	0	0	0
Missing	0	1	0	0

3. Secondary Outcome

Title	Incidence Rate of Inhibitory Antibodies Against FVIII (≥0.6 BU): 6 Months
Description	This endpoint presented 'percentage of participants with inhibitory antibodies against FVIII (≥0.6 BU)' in both prophylaxis and on-demand regimen, evaluated during month 0-6.
Time Frame	Month 0-6

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants, from both prophylaxis and on-demand regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	9	33	11	15
Number [Percentage of participants]	0 0%	0 0%	0 0%	0 0%

4. Secondary Outcome

Title	Incidence Rate of Inhibitory Antibodies Against FVIII (≥0.6 BU): 24 Months
Description	This endpoint presented 'percentage of participants with inhibitory antibodies against FVIII (≥0.6 BU)' in both prophylaxis and on-demand regimen, evaluated during month 0-24.
Time Frame	Month 0-24

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants, from both prophylaxis and on-demand regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	9	33	11	15
Number [Percentage of participants]	0 0%	0 0%	0 0%	0 0%

5. Secondary Outcome

Title	Number of Bleeds (Total Bleeds Assessed as Annual Bleeding Rate) Per Participant: 6 Months
Description	Number of bleeds (total bleeds assessed as annual bleeding rate) per participant in the prophylaxis regimen was evaluated during month 0-6. The annualised bleeding rate was analysed by a negative binomial model.
Time Frame	Month 0-6

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from the prophylaxis regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	8	26	10	7
Number (95% Confidence Interval) [Bleeding episodes/year]	4.36	4.11	2.34	10.67

6. Secondary Outcome

Title	Number of Bleeds (Total Bleeds Assessed as Annual Bleeding Rate) Per Participant: 24 Months
Description	Number of bleeds (total bleeds assessed as annual bleeding rate) per participant in the prophylaxis regimen was evaluated during month 0-24. The annualised bleeding rate was analysed by a negative binomial model.
Time Frame	Month 0-24

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from the prophylaxis regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	9	31	11	12
Number (95% Confidence Interval) [Bleeding episodes/year]	2.28	2.63	1.97	4.97

7. Secondary Outcome

Title	Consumption of Turoctocog Alfa for Bleeding Treatment: Average Dose to Treat a Bleed (6 Months)
Description	Average dose of turoctocog alfa used to treat a bleed in both prophylaxis and on-demand regimen was evaluated during month 0-6.
Time Frame	Month 0-6

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	6	20	6	15
Measure doses	69	361	60	400
Mean (Standard Deviation) [IU/kg BW]	42.96 (5.35)	36.69 (14.04)	46.79 (5.31)	20.29 (6.48)

8. Secondary Outcome

Title	Consumption of Turoctocog Alfa for Bleeding Treatment: Average Dose to Treat a Bleed (24 Months)
Description	Average dose of turoctocog alfa used to treat a bleed in both prophylaxis and on-demand regimen was evaluated during month 0-24.
Time Frame	Month 0-24

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	7	24	8	15
Measure doses	94	624	95	565
Mean (Standard Deviation) [IU/kg BW]	43.99 (6.95)	36.00 (12.32)	43.58 (6.93)	21.07 (7.49)

9. Secondary Outcome

Title	Consumption of Turoctocog Alfa for Bleeding Treatment: Number of Injections Per Bleed (6 Months)
Description	Number of turoctocog alfa injections consumed to treat a bleeding episode in both prophylaxis and on-demand regimen was evaluated during month 0-6.
Time Frame	Month 0-6

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	6	20	6	15
Measure bleeding episodes	48	245	28	290
Mean (Standard Deviation) [Injections]	1.31 (0.59)	1.22 (0.61)	1.07 (0.26)	1.29 (0.89)

10. Secondary Outcome

Title	Consumption of Turoctocog Alfa for Bleeding Treatment: Number of Injections Per Bleed (24 Months)
Description	Number of turoctocog alfa injections consumed to treat a bleeding episode in both prophylaxis and on-demand regimen was evaluated during month 0-24.
Time Frame	Month 0-24

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	7	24	8	15
Measure bleeding episodes	65	405	53	402
Mean (Standard Deviation) [Injections]	1.34 (0.62)	1.30 (0.88)	1.09 (0.30)	1.33 (1.21)

11. Secondary Outcome

Title	Consumption of Turoctocog Alfa for Bleeding Treatment: IU/kg Per Bleed (6 Months)
Description	Consumption of turoctocog alfa IU/kg BW per bleed in both prophylaxis and on-demand regimen was evaluated during month 0-6.
Time Frame	Month 0-6

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	6	20	6	15
Measure bleeding episodes	48	245	28	290
Mean (Standard Deviation) [IU/kg BW]	56.60 (25.32)	42.37 (26.54)	48.82 (15.05)	26.20 (17.55)

12. Secondary Outcome

Title	Consumption of Turoctocog Alfa for Bleeding Treatment: IU/kg Per Bleed (24 Months)
Description	Consumption of turoctocog alfa IU/kg BW per bleed in both prophylaxis and on-demand regimen was evaluated during month 0-24.
Time Frame	Month 0-24

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	7	24	8	15
Measure bleeding episodes	65	405	53	402
Mean (Standard Deviation) [IU/kg BW]	59.01 (28.61)	44.75 (34.15)	45.07 (15.33)	27.44 (22.52)

13. Secondary Outcome

Title	Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: Average Preventive Dose (6 Months)
Description	Average preventive dose of turoctocog alfa consumed per participant in the prophylaxis regimen was evaluated during month 0-6.
Time Frame	Month 0-6

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from the prophylaxis regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	8	26	10	7
Measure doses	530	1689	661	484
Mean (Standard Deviation) [IU/kg BW]	47.05 (9.21)	39.46 (7.12)	35.40 (7.41)	37.28 (5.22)

14. Secondary Outcome

Title	Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: Average Preventive Dose (24 Months)
Description	Average preventive dose of turoctocog alfa consumed per participant in the prophylaxis regimen was evaluated during month 0-24.
Time Frame	Month 0-24

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from the prophylaxis regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	9	31	11	12
Measure doses	2314	6729	2794	1999
Mean (Standard Deviation) [IU/kg BW]	47.97 (8.00)	40.33 (7.05)	36.20 (7.15)	38.13 (7.51)

15. Secondary Outcome

Title	Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Month (6 Months)
Description	Preventive dose of turoctocog alfa (IU/kg body weight (BW) per month) per participant in the prophylaxis regimen was evaluated during month 0-6.
Time Frame	Month 0-6

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from the prophylaxis regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	8	26	10	7
Mean (Standard Deviation) [IU/kg BW/month/participant]	600.3 (112.6)	522.5 (87.59)	454.5 (92.79)	500.7 (84.39)

16. Secondary Outcome

Title	Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Month (24 Months)
Description	Preventive dose of turoctocog alfa (IU/kg body weight (BW) per month) per participant in the prophylaxis regimen was evaluated during month 0-24.
Time Frame	Month 0-24

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from the prophylaxis regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	9	31	11	12
Mean (Standard Deviation) [IU/kg BW/month/participant]	606.3 (118.5)	533.0 (82.90)	467.6 (91.40)	490.8 (115.7)

17. Secondary Outcome

Title	Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Year (6 Months)
Description	Preventive dose of turoctocog alfa (IU/kg body weight per year) per participant in the prophylaxis regimen was evaluated during month 0-6.
Time Frame	Month 0-6

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from the prophylaxis regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	8	26	10	7
Mean (Standard Deviation) [IU/kg BW/year/participant]	7204 (1351)	6270 (1051)	5454 (1113)	6009 (1013)

18. Secondary Outcome

Title	Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Year (24 Months)
Description	Preventive dose of turoctocog alfa (IU/kg body weight (BW) per year) per participant in the prophylaxis regimen was evaluated during month 0-24.
Time Frame	Month 0-24

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from the prophylaxis regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	9	31	11	12
Mean (Standard Deviation) [IU/kg BW/year/participant]	7276 (1422)	6396 (994.7)	5611 (1097)	5890 (1388)

19. Secondary Outcome

Title	Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Month (6 Months)
Description	Total consumption of turoctocog alfa (IU/kg body weight per month) per participant in both prophylaxis and on-demand regimen was evaluated during month 0-6.
Time Frame	Month 0-6

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	9	33	11	15
Mean (Standard Deviation) [IU/kg BW/month/participant]	603.5 (141.2)	496.0 (146.7)	479.6 (103.9)	377.2 (218.9)

20. Secondary Outcome

Title	Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Month (24 Months)
Description	Total consumption of turoctocog alfa (IU/kg body weight per month) per participant in both prophylaxis and on-demand regimen was evaluated during month 0-24.
Time Frame	Month 0-24

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	9	33	11	15
Mean (Standard Deviation) [IU/kg BW/month/participant]	615.3 (123.8)	516.7 (121.1)	477.0 (94.37)	429.1 (192.7)

21. Secondary Outcome

Title	Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Year (6 Months)
Description	Total consumption of turoctocog alfa (IU/kg body weight per year) per participant in both prophylaxis and on-demand regimen was evaluated during month 0-6.
Time Frame	Month 0-6

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	9	33	11	15
Mean (Standard Deviation) [IU/kg BW/year/participant]	7242 (1695)	5951 (1760)	5756 (1247)	4527 (2627)

22. Secondary Outcome

Title	Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Year (24 Months)
Description	Total consumption of turoctocog alfa (IU/kg body weight per year) per participant in both prophylaxis and on-demand regimen was evaluated during month 0-24.
Time Frame	Month 0-24

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	9	33	11	15
Mean (Standard Deviation) [IU/kg BW/year/participant]	7384 (1486)	6201 (1453)	5724 (1132)	5149 (2312)

23. Secondary Outcome

Title	Frequency of Adverse Events (6 Months)
Description	Frequency of adverse events (AEs) are presented as rate of events, which was calculated as the number of AEs per patient years. All presented AEs are treatment emergent (TEAEs), which were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.
Time Frame	Month 0-6

Outcome Measure Data

Analysis Population Description

The safety analysis set included participants who received at least one dose of the trial product. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	9	33	11	15
Number [Events per person-year]	4.908	2.093	2.325	1.922

24. Secondary Outcome

Title	Frequency of Adverse Events (24 Months)
Description	Frequency of adverse events (AEs) are presented as rate of events, which was calculated as the number of AEs per patient years. All presented AEs are treatment emergent (TEAEs), which were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.
Time Frame	Month 0-24

Outcome Measure Data

Analysis Population Description

The safety analysis set included participants who received at least one dose of the trial product. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	9	33	11	15
Number [Events per person-year]	2.941	1.210	1.074	1.123

25. Secondary Outcome

Title	Frequency of Serious Adverse Events (6 Months)
Description	Frequency of serious adverse events (SAEs) are presented as rate of events, which was calculated as the number of SAEs per patient years. All presented SAEs are treatment emergent, which were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.
Time Frame	Month 0-6

Outcome Measure Data

Analysis Population Description

The safety analysis set included participants who received at least one dose of the trial product. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	9	33	11	15
Number [Events per person-year]	0	0	0.634	0

26. Secondary Outcome

Title	Frequency of Serious Adverse Events (24 Months)
Description	Frequency of serious adverse events (SAEs) are presented as rate of events, which was calculated as the number of SAEs per patient years. All presented SAEs are treatment emergent, which were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.
Time Frame	Month 0-24

Outcome Measure Data

Analysis Population Description

The safety analysis set included participants who received at least one dose of the trial product. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	9	33	11	15
Number [Events per person-year]	0.065	0	0.161	0

27. Secondary Outcome

Title	Haemostatic Effect of Turoctocog Alfa (Surgery): 6 Months
Description	The haemostatic effect of turoctocog alfa when used for surgery was evaluated during month 0-6. The effect was assessed on a four-point scale for haemostatic response (excellent, good, moderate and none) and assessed by the investigator/surgeon on the day of surgery (day 1) and on the last day in the post-operative period the participant was at the trial/surgery site.
Time Frame	Month 0-6

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen.

Arm/Group Title	Minor Surgery	Major Surgery
Arm/Group Description	Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire.	Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered.
Measure Participants	3	3
Measure surgeries	3	3
During surgery: Excellent	2	1
During surgery: Good	1	2
During surgery: Moderate	0	0
During surgery: None	0	0
After surgery: Excellent	3	2
After surgery: Good	0	1
After surgery: Moderate	0	0
After surgery: None	0	0

28. Secondary Outcome

Title	Haemostatic Effect of Turoctocog Alfa (Surgery): 24 Months
Description	The haemostatic effect of turoctocog alfa when used for surgery was evaluated during month 0-24. The effect was assessed on a four-point scale for haemostatic response (excellent, good, moderate and none) and assessed by the investigator/surgeon on the day of surgery (day 1) and on the last day in the post-operative period the participant was at the trial/surgery site. Haemostatic response of 'not applicable' indicated that turoctocog alfa was not used.
Time Frame	Month 0-24

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen.

Arm/Group Title	Minor Surgery	Major Surgery
Arm/Group Description	Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire.	Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered.
Measure Participants	5	3
Measure surgeries	6	4
During surgery: Excellent	3	1
During surgery: Good	1	3
During surgery: Moderate	0	0
During surgery: None	0	0
During surgery: Not applicable	2	0
After surgery: Excellent	5	2
After surgery: Good	0	2
After surgery: Moderate	0	0
After surgery: None	0	0
After surgery: Not applicable	1	0

29. Secondary Outcome

Title	Loss of Blood (Surgery): 6 Months
Description	Loss of blood was evaluated during month 0-6: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first.
Time Frame	Month 0-6

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen. "Overall Number of Units Analyzed" = number of surgeries where blood loss happened.

Arm/Group Title	Minor Surgery	Major Surgery
Arm/Group Description	Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire.	Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered.
Measure Participants	3	3
Measure surgeries with blood loss	2	3
Mean (Standard Deviation) [mL]	2.0 (1.4)	106.7 (90.2)

30. Secondary Outcome

Title	Loss of Blood (Surgery): 24 Months
Description	Loss of blood was evaluated during month 0-24: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first.
Time Frame	Month 0-24

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen. "Overall Number of Units Analyzed" = number of surgeries where blood loss happened.

Arm/Group Title	Minor Surgery	Major Surgery
Arm/Group Description	Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire.	Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered.
Measure Participants	5	3
Measure surgeries with blood loss	2	4
Mean (Standard Deviation) [mL]	2.0 (1.4)	81.3 (89.5)

31. Secondary Outcome

Title	Requirements for Transfusion (Surgery): 6 Months
Description	Surgeries required transfusion was evaluated during month 0-6: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first.
Time Frame	Month 0-6

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen.

Arm/Group Title	Minor Surgery	Major Surgery
Arm/Group Description	Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire.	Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered.
Measure Participants	3	3
Measure surgeries	3	3
Number [Surgeries]	0	0

32. Secondary Outcome

Title	Requirements for Transfusion (Surgery): 24 Months
Description	Surgeries required transfusion was evaluated during month 0-24: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first.
Time Frame	Month 0-24

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen.

Arm/Group Title	Minor Surgery	Major Surgery
Arm/Group Description	Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire.	Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered.
Measure Participants	5	3
Measure surgeries	6	4
Number [Surgeries]	0	0

33. Secondary Outcome

Title	Adverse Events (Surgery): 6 Months
Description	TEAEs during surgery were recorded during month 0-6: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first. TEAEs were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.
Time Frame	Month 0-6

Outcome Measure Data

Analysis Population Description

The safety analysis set included participants who received at least one dose of the trial product. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen.

Arm/Group Title	Minor Surgery	Major Surgery
Arm/Group Description	Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire.	Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered.
Measure Participants	3	3
Number [Events]	1	1

34. Secondary Outcome

Title	Adverse Events (Surgery): 24 Months
Description	TEAEs during surgery were recorded during month 0-24: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first. TEAEs were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.
Time Frame	Month 0-24

Outcome Measure Data

Analysis Population Description

The safety analysis set included participants who received at least one dose of the trial product. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen.

Arm/Group Title	Minor Surgery	Major Surgery
Arm/Group Description	Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire.	Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered.
Measure Participants	5	3
Number [Events]	4	1

35. Secondary Outcome

Title	Serious Adverse Events (Surgery): 6 Months
Description	Treatment emergent serious adverse events occurred during surgery were recorded from month 0 to month 6: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant is at the trial/surgery site whatever comes first. Treatment emergent events were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.
Time Frame	Month 0-6

Outcome Measure Data

Analysis Population Description

The safety analysis set included participants who received at least one dose of the trial product. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen.

Arm/Group Title	Minor Surgery	Major Surgery
Arm/Group Description	Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire.	Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered.
Measure Participants	3	3
Number [Events]	0	0

36. Secondary Outcome

Title	Serious Adverse Events (Surgery): 24 Months
Description	Treatment emergent serious adverse events occurred during surgery were recorded from month 0 to month 24: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant is at the trial/surgery site whatever comes first. Treatment emergent events were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.
Time Frame	Month 0-24

Outcome Measure Data

Analysis Population Description

The safety analysis set included participants who received at least one dose of the trial product. "Overall Number of Participants Analyzed" = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen.

Arm/Group Title	Minor Surgery	Major Surgery
Arm/Group Description	Participants who underwent minor surgery (including tooth extraction) during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 30-60 IU/dL. Minor surgery: Any invasive operative procedure in which only skin, mucous membranes, or superficial connective tissue was manipulated. Examples of minor surgery: vascular cutdown for catheter/fistula placement, implanting pumps or central venous access device (CVAD) in subcutaneous tissue, biopsies or placement of probes, leads, or catheters requiring the entry into a body cavity only through a needle/guidewire.	Participants who underwent major surgery during month 0-6 (main phase), were treated with turoctocog alfa according to WFH recommendations and were to maintain FVIII activity levels at 80-100 IU/dL pre- and postoperatively. Major surgery: Any invasive operative procedure where any one or more of the following occurred: 1) A body cavity was entered. 2) A mesenchymal barrier (e.g. pleura, peritoneum or dura) was crossed. 3) A fascial plane was opened. 4) An organ was removed. 5) Normal anatomy was operatively altered.
Measure Participants	5	3
Number [Events]	0	0

37. Secondary Outcome

Title	Change in Total Scores for Reported Health-related Quality of Life (for Participants): Month 6
Description	Reported results are baseline (month 0) and change from baseline (at month 6) of end of disease and age specific HRQOL. HRQOL was collected through use of the patient reported outcome (PRO) instruments, HAEMO-QOL (for children (8-12 years)/adolescents (13-16 years)) and HAEM-A-QOL (for adults (>=17 years)). HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. HAEM-A-QOL assessment included questions on physical health, feeling, view of yourself, sports and leisure, work and school, dealing with haemophilia, treatment, future, family planning, and partnership and sexuality. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Observed mean of the means of all the questions for HAEMO-QOL and HAEM-A-QOL, respectively are presented.
Time Frame	Month 0, Month 6

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Older Children (8 to 12 Years)	Adolescents (12 to <18 Years)	Adults (17 and Older)
Arm/Group Description	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg (for <12 years participants) and 25 IU/kg (for 12 years participants). Prophylaxis doses ranged from 25-50 IU/kg (for <12 years participants) and 20-40 IU/kg (for 12 years participants) with every-second-day treatment, or 25-60 IU/kg (for <12 years participants) and 20-50 IU/kg (for 12 years participants) with 3-times-weekly treatment. Bleeds and surgeries were treated in the same way as for the other two treatment groups (adolescents (13 to 16 years) and adults (17 and older)).	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	22	6	18
Baseline	41.3 (16.4)	42.2 (12.8)	47.2 (13.8)
Change from baseline	-6.8 (14.5)	-3.5 (3.6)	-3.4 (12.8)

38. Secondary Outcome

Title	Change in Total Scores for Reported Health-related Quality of Life (for Participants): Month 24
Description	Reported results are baseline (month 0) and change from baseline (at month 24) of end of disease and age specific HRQOL. HRQOL was collected through use of the patient reported outcome (PRO) instruments, HAEM-A-QOL (for adults (>=17 years)) and HAEMO-QOL (for children (8-12 years)/adolescents (13-16 years)). HAEM-A-QOL assessment included questions on physical health, feeling, view of yourself, sports and leisure, work and school, dealing with haemophilia, treatment, future, family planning, and partnership and sexuality. HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Observed mean of the means of all the questions for HAEM-A-QOL and HAEMO-QOL, respectively are presented.
Time Frame	Month 0, Month 24

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Older Children (8 to 12 Years)	Adolescents (13 to 16 Years)	Adults (17 and Older)
Arm/Group Description	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 30 IU/kg (for <12 years participants) and 25 IU/kg (for 12 years participants). Prophylaxis doses ranged from 25-50 IU/kg (for <12 years participants) and 20-40 IU/kg (for 12 years participants) with every-second-day treatment, or 25-60 IU/kg (for <12 years participants) and 20-50 IU/kg (for 12 years participants) with 3-times-weekly treatment. Bleeds and surgeries were treated in the same way as for the other two treatment groups (adolescents (13 to 16 years) and adults (17 and older)).	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	22	6	18
Baseline	41.3 (16.4)	42.2 (12.8)	47.2 (13.8)
Change from baseline	-10.1 (15.0)	-4.9 (8.8)	-6.3 (9.7)

39. Secondary Outcome

Title	Change in Total Scores for Reported Health-related Quality of Life (for Parents): Month 6
Description	Reported results are baseline (month 0) and change from baseline (at month 6) of end of disease and age specific health related quality of life (HRQOL). HRQOL was collected through use of the PRO instrument, HAEMO-QOL (for parents of the children (4-7 years and 8-12 years)/adolescents (13-16 years)). HAEMO-QOL assessment included questions on physical health, feeling, view of himself, family, friends, perceived support, other persons, nursery School or Kindergarten, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Observed mean of the means of all the questions for HAEMO-QOL are presented.
Time Frame	Month 0, Month 6

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Small Children (4 to 7 Years)	Older Children (8 to 12 Years)	Adolescents (12 to <18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg (for <12 years participants) and 25 IU/kg (for 12 years participants). Prophylaxis doses ranged from 25-50 IU/kg (for <12 years participants) and 20-40 IU/kg (for 12 years participants) with every-second-day treatment, or 25-60 IU/kg (for <12 years participants) and 20-50 IU/kg (for 12 years participants) with 3-times-weekly treatment. Bleeds and surgeries were treated in the same way as for the other two treatment groups (small children (4 to 7 years) and adolescents (13 to 16 years)).	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	19	22	6
Baseline	45.7 (15.2)	48.3 (14.1)	40.8 (11.7)
Change from baseline	-6.2 (7.7)	-9.9 (8.7)	-1.5 (7.2)

40. Secondary Outcome

Title	Change in Total Scores for Reported Health-related Quality of Life (for Parents): Month 24
Description	Reported results are baseline (month 0) and change from baseline (at month 24) of end of disease and age specific health related quality of life (HRQOL). HRQOL was collected through use of the PRO instrument, HAEMO-QOL (for parents of the children (4-7 years and 8-12 years)/adolescents (13-16 years)). HAEMO-QOL assessment included questions on physical health, feeling, view of himself, family, friends, perceived support, other persons, nursery School or Kindergarten, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Observed mean of the means of all the questions for HAEMO-QOL are presented.
Time Frame	Month 0, Month 24

Outcome Measure Data

Analysis Population Description

The full analysis set included all dosed participants with data after dosing. "Overall Number of Participants Analyzed" = number of participants from both prophylaxis and on-demand regimen. "Number Analyzed" = number of participants with available data.

Arm/Group Title	Small Children (4 to 7 Years)	Older Children (8 to 12 Years)	Adolescents (13 to 16 Years)
Arm/Group Description	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 30 IU/kg (for <12 years participants) and 25 IU/kg (for 12 years participants). Prophylaxis doses ranged from 25-50 IU/kg (for <12 years participants) and 20-40 IU/kg (for 12 years participants) with every-second-day treatment, or 25-60 IU/kg (for <12 years participants) and 20-50 IU/kg (for 12 years participants) with 3-times-weekly treatment. Bleeds and surgeries were treated in the same way as for the other two treatment groups (small children (4 to 7 years) and adolescents (13 to 16 years)).	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	19	22	6
Baseline	45.7 (15.2)	48.3 (14.1)	40.8 (11.7)
Change from baseline	-6.7 (11.5)	-11.3 (10.7)	-3.1 (3.9)

41. Secondary Outcome

Title	Incremental Recovery of FVIII
Description	Blood samples for the evaluation of incremental recovery of FVIII were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. The incremental recovery was calculated as (FVIII: coagulant (C) activity measured in plasma 30 minutes after dosing - FVIII:C activity measured in plasma immediately before dosing)/(dose injected at time 0 minute), where the dose was expressed as IU FVIII product per kg body weight. The results are based on the chromogenic assay.
Time Frame	Days 1-2

Outcome Measure Data

Analysis Population Description

Full analysis set excluding outliers. The full analysis set included all dosed participants with data after dosing. Exceptional outlier pharmacokinetic (PK) profiles and/or individual plasma concentrations were excluded from the analysis.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	4	6	3	4
Mean (Standard Deviation) [(IU/mL)/(IU/kg BW)]	0.022 (0.003)	0.026 (0.005)	0.014 (0.007)	0.026 (0.004)

42. Secondary Outcome

Title	Area Under the Curve (AUC0-inf)
Description	Blood samples for the evaluation of AUC0-inf were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. AUC0-inf was defined as the area under the concentration versus time from time curve zero to infinity. The results are based on the chromogenic assay.
Time Frame	Days 1-2

Outcome Measure Data

Analysis Population Description

Full analysis set excluding outliers. The full analysis set included all dosed participants with data after dosing. Exceptional outlier PK profiles and/or individual plasma concentrations were excluded from the analysis.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	3	6	3	4
Mean (Standard Deviation) [IU*h/mL]	16.4 (3.5)	17.7 (7.3)	11.2 (4.7)	16.9 (1.5)

43. Secondary Outcome

Title	Half-life (t½)
Description	Blood samples for the evaluation of t½ were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. The results are based on the chromogenic assay.
Time Frame	Days 1-2

Outcome Measure Data

Analysis Population Description

Full analysis set excluding outliers. The full analysis set included all dosed participants with data after dosing. Exceptional outlier PK profiles and/or individual plasma concentrations were excluded from the analysis.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	3	6	3	4
Mean (Standard Deviation) [Hour (h)]	8.5 (1.4)	8.3 (3.1)	11.6 (0.6)	8.4 (1.9)

44. Secondary Outcome

Title	Clearance (CL)
Description	Blood samples for the evaluation of CL were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. The results are based on the chromogenic assay.
Time Frame	Days 1-2

Outcome Measure Data

Analysis Population Description

Full analysis set excluding outliers. The full analysis set included all dosed participants with data after dosing. Exceptional outlier PK profiles and/or individual plasma concentrations were excluded from the analysis.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	3	6	3	4
Mean (Standard Deviation) [mL/h/kg]	3.7 (0.9)	3.5 (1.2)	5.5 (2.2)	3.5 (0.3)

45. Secondary Outcome

Title	Highest Measured FVIII Activity in the Profile (Cmax)
Description	Blood samples for the evaluation of Cmax were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. The results are based on the chromogenic assay.
Time Frame	Days 1-2

Outcome Measure Data

Analysis Population Description

Full analysis set excluding outliers. The full analysis set included all dosed participants with data after dosing. Exceptional outlier PK profiles and/or individual plasma concentrations were excluded from the analysis.

Arm/Group Title	Small Children (0 to <6 Years)	Older Children (6 to <12 Years)	Adolescents (12 to <18 Years)	Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.	Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
Measure Participants	4	6	3	4
Mean (Standard Deviation) [IU/mL]	1.2 (0.2)	1.4 (0.3)	0.9 (0.5)	1.6 (0.2)

Adverse Events

Time Frame	All presented AEs are treatment emergent (TEAEs), which was defined as the events reported after trial product administration (day 1) until the end of the post-treatment follow-up period (i.e. month 24 + 14 days).
Adverse Event Reporting Description	The safety analysis set included participants who received at least one dose of the trial product.
Arm/Group Title	Small Children (0 to <6 Years)		Older Children (6 to <12 Years)		Adolescents (12 to <18 Years)		Adults (>=18 Years)
Arm/Group Description	Participants were to receive turoctocog alfa intravenous (i.v.) injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the World Federation of Haemophilia (WFH) guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their coagulation factor VIII (FVIII) activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.		Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 30 IU/kg. Prophylaxis doses ranged from 25-50 IU/kg (once every-second-day), or 25-60 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance, and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.		Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.		Participants were to receive turoctocog alfa i.v. injections for at least 6 months (main phase) as either prophylaxis or on-demand treatment at investigator's discretion. Participants who completed 6 months of treatment (prophylaxis or on-demand) in the main phase, were to continue the same treatment for up to approximately 18 months (extension phase). Participants were allowed to switch between treatments in the 'extension phase'. The recommended prophylaxis starting dose was 25 IU/kg. Prophylaxis doses ranged from 20-40 IU/kg (once every-second-day), or 20-50 IU/kg (3-times-weekly). Bleeds were treated with one or more turoctocog alfa i.v. bolus injections as determined by the investigator and based on the WFH guidance. Participants who underwent surgery were treated with turoctocog alfa according to WFH guidance and their FVIII activity levels were to be maintained as per the following guidance: Minor surgery: 30-60 IU/dL. Major surgery: 80-100 IU/dL pre- and postoperatively.
All Cause Mortality
	Small Children (0 to <6 Years)		Older Children (6 to <12 Years)		Adolescents (12 to <18 Years)		Adults (>=18 Years)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/33 (0%)		0/11 (0%)		0/15 (0%)
Serious Adverse Events
	Small Children (0 to <6 Years)		Older Children (6 to <12 Years)		Adolescents (12 to <18 Years)		Adults (>=18 Years)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/9 (11.1%)		0/33 (0%)		2/11 (18.2%)		0/15 (0%)
Infections and infestations
Hand-foot-and-mouth disease	1/9 (11.1%)	1	0/33 (0%)	0	0/11 (0%)	0	0/15 (0%)	0
Lung infection	0/9 (0%)	0	0/33 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0
Injury, poisoning and procedural complications
Femur fracture	0/9 (0%)	0	0/33 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma	0/9 (0%)	0	0/33 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0
Other (Not Including Serious) Adverse Events
	Small Children (0 to <6 Years)		Older Children (6 to <12 Years)		Adolescents (12 to <18 Years)		Adults (>=18 Years)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/9 (88.9%)		18/33 (54.5%)		7/11 (63.6%)		10/15 (66.7%)
Eye disorders
Xerophthalmia	0/9 (0%)	0	0/33 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1
Gastrointestinal disorders
Abdominal pain upper	0/9 (0%)	0	1/33 (3%)	1	0/11 (0%)	0	1/15 (6.7%)	1
Constipation	1/9 (11.1%)	1	0/33 (0%)	0	0/11 (0%)	0	0/15 (0%)	0
Dental caries	1/9 (11.1%)	1	0/33 (0%)	0	0/11 (0%)	0	0/15 (0%)	0
Diarrhoea	1/9 (11.1%)	1	2/33 (6.1%)	2	1/11 (9.1%)	1	1/15 (6.7%)	1
Gastritis	1/9 (11.1%)	1	1/33 (3%)	1	0/11 (0%)	0	0/15 (0%)	0
Loose tooth	0/9 (0%)	0	0/33 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1
Tooth development disorder	1/9 (11.1%)	1	0/33 (0%)	0	0/11 (0%)	0	0/15 (0%)	0
Gastrointestinal disorder	1/9 (11.1%)	1	0/33 (0%)	0	0/11 (0%)	0	0/15 (0%)	0
Nausea	0/9 (0%)	0	0/33 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0
Toothache	0/9 (0%)	0	0/33 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1
Vomiting	1/9 (11.1%)	1	0/33 (0%)	0	0/11 (0%)	0	0/15 (0%)	0
General disorders
Chest pain	0/9 (0%)	0	0/33 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1
Puncture site reaction	0/9 (0%)	0	0/33 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0
Pyrexia	4/9 (44.4%)	7	2/33 (6.1%)	2	0/11 (0%)	0	0/15 (0%)	0
Hepatobiliary disorders
Hepatic function abnormal	0/9 (0%)	0	0/33 (0%)	0	0/11 (0%)	0	2/15 (13.3%)	2
Immune system disorders
Drug hypersensitivity	0/9 (0%)	0	0/33 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1
Infections and infestations
Conjunctivitis	1/9 (11.1%)	1	0/33 (0%)	0	0/11 (0%)	0	0/15 (0%)	0
Fungal skin infection	0/9 (0%)	0	0/33 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1
Gastroenteritis	1/9 (11.1%)	1	1/33 (3%)	1	0/11 (0%)	0	0/15 (0%)	0
Gastrointestinal fungal infection	0/9 (0%)	0	0/33 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0
Nasopharyngitis	1/9 (11.1%)	1	6/33 (18.2%)	7	2/11 (18.2%)	2	1/15 (6.7%)	1
Oral herpes	1/9 (11.1%)	1	0/33 (0%)	0	0/11 (0%)	0	0/15 (0%)	0
Otitis externa	0/9 (0%)	0	0/33 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1
Pharyngitis	1/9 (11.1%)	1	1/33 (3%)	1	0/11 (0%)	0	0/15 (0%)	0
Pneumonia	1/9 (11.1%)	1	0/33 (0%)	0	0/11 (0%)	0	0/15 (0%)	0
Respiratory tract infection	0/9 (0%)	0	2/33 (6.1%)	3	0/11 (0%)	0	0/15 (0%)	0
Tonsillitis	1/9 (11.1%)	2	2/33 (6.1%)	6	0/11 (0%)	0	0/15 (0%)	0
Upper respiratory tract infection	7/9 (77.8%)	12	7/33 (21.2%)	9	2/11 (18.2%)	3	3/15 (20%)	3
Viral rash	0/9 (0%)	0	0/33 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0
Bronchitis	1/9 (11.1%)	1	0/33 (0%)	0	0/11 (0%)	0	0/15 (0%)	0
Gastrointestinal infection	1/9 (11.1%)	1	0/33 (0%)	0	0/11 (0%)	0	0/15 (0%)	0
Laryngitis	0/9 (0%)	0	0/33 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1
Mumps	1/9 (11.1%)	1	0/33 (0%)	0	0/11 (0%)	0	0/15 (0%)	0
Rhinitis	0/9 (0%)	0	2/33 (6.1%)	3	0/11 (0%)	0	0/15 (0%)	0
Tinea manuum	1/9 (11.1%)	1	0/33 (0%)	0	0/11 (0%)	0	0/15 (0%)	0
Injury, poisoning and procedural complications
Wound	0/9 (0%)	0	0/33 (0%)	0	0/11 (0%)	0	2/15 (13.3%)	2
Investigations
Antiphospholipid antibodies positive	0/9 (0%)	0	0/33 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0
Platelet count increased	0/9 (0%)	0	0/33 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0
Alanine aminotransferase increased	0/9 (0%)	0	0/33 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0
Aspartate aminotransferase increased	0/9 (0%)	0	0/33 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0
Metabolism and nutrition disorders
Malnutrition	0/9 (0%)	0	1/33 (3%)	1	1/11 (9.1%)	1	0/15 (0%)	0
Musculoskeletal and connective tissue disorders
Muscle spasms	0/9 (0%)	0	0/33 (0%)	0	1/11 (9.1%)	1	0/15 (0%)	0
Nervous system disorders
Neuralgia	0/9 (0%)	0	0/33 (0%)	0	0/11 (0%)	0	1/15 (6.7%)	1
Renal and urinary disorders
Urethral disorder	1/9 (11.1%)	1	0/33 (0%)	0	0/11 (0%)	0	0/15 (0%)	0
Reproductive system and breast disorders
Balanoposthitis	1/9 (11.1%)	1	0/33 (0%)	0	0/11 (0%)	0	0/15 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	1/9 (11.1%)	2	1/33 (3%)	1	1/11 (9.1%)	1	0/15 (0%)	0
Oropharyngeal pain	0/9 (0%)	0	2/33 (6.1%)	2	0/11 (0%)	0	1/15 (6.7%)	1
Rhinorrhoea	0/9 (0%)	0	3/33 (9.1%)	3	0/11 (0%)	0	0/15 (0%)	0
Skin and subcutaneous tissue disorders
Dermatitis allergic	1/9 (11.1%)	1	1/33 (3%)	1	0/11 (0%)	0	0/15 (0%)	0
Urticaria papular	1/9 (11.1%)	1	1/33 (3%)	1	0/11 (0%)	0	0/15 (0%)	0
Urticaria	0/9 (0%)	0	2/33 (6.1%)	2	0/11 (0%)	0	0/15 (0%)	0

Limitations/Caveats

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Principal Investigators are NOT employed by the organization sponsoring the study.

At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.