Trial Outcomes & Findings for Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors (NCT NCT04083781)

Last Updated: 2026-01-06

Results Overview

Rate of treated spontaneous and traumatic bleeding episodes is presented. The observation period used for reporting this endpoint is on-treatment without ancillary therapy excl. data on initial regimen for participants exposed to both regimens (OTwoATexIR). It is defined as the time period where participants are treated by either the new concizumab dosing regimen or the initial concizumab dosing regimen (only included if not exposed to the new concizumab dosing regimen) or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleed during any of the cases. The data is reported in the terms of annualised bleeding rate (ABR). Week 0 is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

134 participants

Primary outcome timeframe

On demand (arm 1): From week 0 up until start of concizumab treatment (at least 24 weeks) Concizumab (arm 2): From week 0 up until the primary analysis cut-off (at least 32 weeks)

Results posted on

2026-01-06

Participant Flow

The trial was conducted in 27 countries. There were 70 sites that randomised participants. The details are as follows: Algeria (2), Australia (2), Austria (1), Bulgaria (1), Canada (0), Croatia (1), Czech Republic (1), Denmark (1), France (4), India (4), Italy (4), Japan (6), Republic of Korea (2), Malaysia (3), Mexico (1), Poland (4), Portugal (1), Russian Federation (5), Serbia (1), South Africa (2), Spain (5), Sweden (1), Thailand (3), Turkey (4), Ukraine (2), UK (3), United States (6).

133 participants were actually randomised for the study. The data presented in the results form is till the 56 week cut off (except the data for primary outcome measure, patient reported outcome measures, maximum concizumab plasma concentration and area under the concizumab plasma concentration-time curve) as the study is still ongoing with the extension phase.

Participant milestones

Participant milestones
Measure	Arm 1: Previous on Demand: No Prophylaxis Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.
Main Part STARTED	19	33	21	60
Main Part Full Analysis Set (FAS)	19	33	21	60
Main Part Safety Analysis Set (SAS)	19	33	21	60
Main Part COMPLETED	13	27	15	53
Main Part NOT COMPLETED	6	6	6	7
Extension Part STARTED	13	27	15	53
Extension Part COMPLETED	0	0	0	0
Extension Part NOT COMPLETED	13	27	15	53

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: Previous on Demand: No Prophylaxis Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.
Main Part Physician Decision	0	1	2	0
Main Part Death	1	3	1	0
Main Part Withdrawal by Subject	5	2	3	7
Extension Part Physician Decision	0	0	0	1
Extension Part Death	0	1	0	1
Extension Part Withdrawal by Subject	0	1	0	0
Extension Part Ongoing	13	25	15	51

Baseline Characteristics

Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Previous on Demand: No Prophylaxis n=19 Participants Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) n=29 Participants Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX n=15 Participants Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX n=55 Participants Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Total n=118 Participants Total of all reporting groups
Age, Continuous	32.3 Years STANDARD_DEVIATION 17.6 • n=37 Participants	24.8 Years STANDARD_DEVIATION 14.4 • n=56 Participants	35.1 Years STANDARD_DEVIATION 10.0 • n=82 Participants	26.4 Years STANDARD_DEVIATION 11.5 • n=31 Participants	28.1 Years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants	0 Participants n=31 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=37 Participants	29 Participants n=56 Participants	15 Participants n=82 Participants	55 Participants n=31 Participants	118 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=37 Participants	3 Participants n=56 Participants	0 Participants n=82 Participants	2 Participants n=31 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=37 Participants	25 Participants n=56 Participants	15 Participants n=82 Participants	52 Participants n=31 Participants	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=37 Participants	1 Participants n=56 Participants	0 Participants n=82 Participants	1 Participants n=31 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=37 Participants	1 Participants n=56 Participants	0 Participants n=82 Participants	1 Participants n=31 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=37 Participants	13 Participants n=56 Participants	4 Participants n=82 Participants	12 Participants n=31 Participants	35 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants	0 Participants n=31 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=37 Participants	4 Participants n=56 Participants	0 Participants n=82 Participants	3 Participants n=31 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=37 Participants	9 Participants n=56 Participants	11 Participants n=82 Participants	38 Participants n=31 Participants	67 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=82 Participants	0 Participants n=31 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=37 Participants	2 Participants n=56 Participants	0 Participants n=82 Participants	1 Participants n=31 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: On demand (arm 1): From week 0 up until start of concizumab treatment (at least 24 weeks) Concizumab (arm 2): From week 0 up until the primary analysis cut-off (at least 32 weeks)

Population: Full analysis set (FAS) included all participants randomised to concizumab prophylaxis (PPX) or on-demand treatment or allocated to arms 3 or 4. This endpoint is only defined for arms 1 and 2 as per protocol.

Outcome measures

Outcome measures
Measure	Arm 1: Previous on Demand: No Prophylaxis n=19 Participants Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) n=33 Participants Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.
Rate of Treated Spontaneous and Traumatic Bleeding Episodes	9.8 Events per year Interval 6.5 to 20.2	0.0 Events per year Interval 0.0 to 3.3	—	—	—

SECONDARY outcome

Timeframe: On demand (arm 1): From week 0 up until start of concizumab treatment (at least 24 weeks) Extension concizumab (arm 1): From start of new concizumab dosing regimen (week 25) up until week 56 cut-off Concizumab (arm 2): From week 0 up until week 56 cut-off

Population: FAS included all participants randomised to concizumab prophylaxis (PPX) or on-demand treatment or allocated to arms 3 or 4. This endpoint is only defined for arms 1 and 2 as per protocol.

Rate of treated spontaneous bleeding episodes is presented. The observation period used for reporting this endpoint is OTwoATexIR. It is defined as the time period where participants are treated by either the new concizumab dosing regimen or the initial concizumab dosing regimen (only included if not exposed to the new concizumab dosing regimen) or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleed during any of the cases. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.

Outcome measures

Outcome measures
Measure	Arm 1: Previous on Demand: No Prophylaxis n=19 Participants Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) n=13 Participants Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX n=33 Participants Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.
Rate of Treated Spontaneous Bleeding Episodes	8.4 Events per year Interval 3.9 to 14.3	0.0 Events per year Interval 0.0 to 1.3	0.0 Events per year Interval 0.0 to 2.2	—	—

SECONDARY outcome

Rate of treated spontaneous and traumatic joint bleeds is presented. Observation period used for reporting this endpoint is OTwoATexIR. It is defined as time period where participants are treated by either the new concizumab dosing regimen or the initial concizumab dosing regimen (only included if not exposed to the new concizumab dosing regimen) or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleed during any of the cases. The data is reported in the terms of ABR. Week 0 is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.

Outcome measures

Outcome measures
Measure	Arm 1: Previous on Demand: No Prophylaxis n=19 Participants Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) n=13 Participants Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX n=33 Participants Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.
Rate of Treated Spontaneous and Traumatic Joint Bleeds	6.5 Events per year Interval 3.2 to 13.1	1.3 Events per year Interval 0.0 to 1.6	0.7 Events per year Interval 0.0 to 2.8	—	—

SECONDARY outcome

Rate of treated spontaneous and traumatic target joint bleeds is presented. Observation period used for reporting the endpoint is OTwoATexIR. It is defined as time period where participants are treated by either the new concizumab dosing regimen or the initial concizumab dosing regimen (only included if not exposed to new concizumab dosing regimen) or are treated by on-demand treatment and additionally have not used factor-containing products not related to treatment of a bleed during any of the cases. The data is reported in terms of ABR. Week 0 is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.

Outcome measures

Outcome measures
Measure	Arm 1: Previous on Demand: No Prophylaxis n=19 Participants Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) n=13 Participants Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX n=33 Participants Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.
Rate of Treated Spontaneous and Traumatic Target Joint Bleeds	0.0 Events per year Interval 0.0 to 2.2	0.0 Events per year Interval 0.0 to 0.0	0.0 Events per year Interval 0.0 to 0.0	—	—

SECONDARY outcome

Timeframe: Baseline (week 0), Week 24

Population: FAS included all participants randomised to concizumab prophylaxis (PPX) or on-demand treatment or allocated to arms 3 or 4. Overall number of participants analyzed = participants with available data for this outcome measure.

Change in 36-item SF-36v2 bodily pain from baseline (week 0) to week 24 is presented. SF-36 v2 Health Survey is 36-item generic patient-reported outcome (PRO) instrument measuring health-related quality of life and general health status across disease areas. SF-36 v2 scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and an SD of 10. Lowest and highest scores for bodily pain are 21.68 to 62.0. Higher values indicate better functional health and well-being. Observation period for reporting the data is on-treatment without data on initial regimen (OTexIR) which is defined as time period where participants are considered affected by on demand treatment or treatment with new concizumab dosing regimen. Week 0 is defined as time of randomisation to on-demand administration or start of new concizumab dosing regimen.

Outcome measures

Outcome measures
Measure	Arm 1: Previous on Demand: No Prophylaxis n=7 Participants Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) n=21 Participants Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX n=13 Participants Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX n=32 Participants Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.
Change in 36-item Short Form Health Survey (SF-36v2) Bodily Pain	3.2 Score on a scale Standard Deviation 10.1	9.3 Score on a scale Standard Deviation 9.2	4.3 Score on a scale Standard Deviation 10.1	6.5 Score on a scale Standard Deviation 10.0	—

SECONDARY outcome

Timeframe: Baseline (week 0), Week 24

Change in 36-item SF-36v2 physical functioning from baseline (week 0) to week 24 is presented. SF-36 v2 Health Survey is 36-item generic PRO instrument measuring health-related quality of life and general health status across disease areas. SF-36 v2 scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and an SD of 10. Lowest and highest scores for physical functioning are 19.26 to 57.54. Higher values indicate better functional health and well-being. Observation period used for reporting the data is OTexIR which is defined as time period where participants are considered affected by on demand treatment or treatment with new concizumab dosing regimen. Week 0 is defined as time of randomisation to on-demand administration or start of new concizumab dosing regimen.

Outcome measures

Outcome measures
Measure	Arm 1: Previous on Demand: No Prophylaxis n=7 Participants Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) n=21 Participants Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX n=13 Participants Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX n=32 Participants Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.
Change in SF36v2 Physical Functioning	1.6 Score on a scale Standard Deviation 10.9	3.1 Score on a scale Standard Deviation 6.2	3.8 Score on a scale Standard Deviation 8.7	4.9 Score on a scale Standard Deviation 6.7	—

SECONDARY outcome

Timeframe: On demand (arm 1 ): From week 0 until start of concizumab treatment (atleast 24 weeks) Concizumab (arms 2-4): From week 0 up until week 56 cut-off Extension Concizumab (arm 1): From start of new concizumab dosing regimen (week 25) up until week 56 cut-off

Population: Safety analysis set (SAS) included all participants exposed to concizumab PPX or randomised to on-demand treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Number of thromboembolic events is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.

Outcome measures

Outcome measures
Measure	Arm 1: Previous on Demand: No Prophylaxis n=19 Participants Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) n=13 Participants Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX n=33 Participants Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX n=21 Participants Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX n=60 Participants Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.
Number of Thromboembolic Events	0 Events	0 Events	1 Events	0 Events	0 Events

SECONDARY outcome

Timeframe: From week 0 to end of trial (week 167)

Outcome measures

Outcome data not reported

SECONDARY outcome

Number of hypersensitivity type reactions is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.

Outcome measures

Outcome measures
Measure	Arm 1: Previous on Demand: No Prophylaxis n=19 Participants Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) n=13 Participants Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX n=33 Participants Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX n=21 Participants Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX n=60 Participants Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.
Number of Hypersensitivity Type Reactions	0 Reactions	0 Reactions	1 Reactions	0 Reactions	1 Reactions

SECONDARY outcome

Timeframe: From week 0 to end of trial (week 167)

Outcome measures

Outcome data not reported

SECONDARY outcome

Number of injection site reactions is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.

Outcome measures

Outcome measures
Measure	Arm 1: Previous on Demand: No Prophylaxis n=19 Participants Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) n=13 Participants Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX n=33 Participants Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX n=21 Participants Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX n=60 Participants Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.
Number of Injection Site Reactions	0 Reactions	1 Reactions	11 Reactions	5 Reactions	43 Reactions

SECONDARY outcome

Timeframe: From week 0 to end of trial (week 167)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Concizumab (arms 2-4): From week 0 up until week 56 cut-off Extension Concizumab (arm 1): From start of new concizumab dosing regimen (week 25) up until week 56 cut-off

Population: SAS included all participants exposed to concizumab PPX or randomised to on-demand treatment. The data is presented in a combined manner across all Concizumab PPX arms (arm 2-4) and extension part of concizumab (arm 1) considering that the trial is still ongoing, and that incidence of immunogenicity can still change when the trial is completed, hence it was decided to provide now only total incidence. A more granular picture of immunogenicity per arm, will be provided once trial is finished.

Number of participants with antibodies to concizumab is presented. The observation period used for reporting the endpoint is on-treatment period which is defined as the time period where participants are considered to be affected by on-demand treatment or concizumab treatment.

Outcome measures

Outcome measures
Measure	Arm 1: Previous on Demand: No Prophylaxis n=127 Participants Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.
Number of Participants With Antibodies to Concizumab	35 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From week 0 to end of trial (week 167)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose (prior to concizumab administration at week 56)

Population: SAS included all participants exposed to concizumab PPX or randomised to on-demand treatment. Overall number of participants analyzed = participants with available data for this outcome measure. The endpoint is applicable for reported arms (extension part arm 1, arm 2, arm 3 and arm 4) only.

Pre-dose (trough) concizumab plasma concentration is presented. The observation period used for reporting the endpoint is OTexIR. It is defined as the time period where participants are considered to be affected by on demand treatment or treatment with the new concizumab dosing regimen.

Outcome measures

Outcome measures
Measure	Arm 1: Previous on Demand: No Prophylaxis n=9 Participants Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) n=24 Participants Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX n=14 Participants Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX n=49 Participants Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.
Pre-dose (Trough) Concizumab Plasma Concentration (Ctrough)	808.7 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 263.4	570.9 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 225.7	590.6 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 600.9	717.3 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 328.5	—

SECONDARY outcome

Timeframe: Pre-dose (prior to concizumab administration at week 56)

Pre-dose thrombin peak for concizumab is presented. The observation period used for reporting the endpoint is OTexIR. It is defined as the time period where participants are considered to be affected by on demand treatment or treatment with the new concizumab dosing regimen.

Outcome measures

Outcome measures
Measure	Arm 1: Previous on Demand: No Prophylaxis n=3 Participants Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) n=11 Participants Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX n=12 Participants Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX n=13 Participants Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.
Pre-dose Thrombin Peak	104.2 nanomoles per liter (nmol/L) Geometric Coefficient of Variation 39.0	67.3 nanomoles per liter (nmol/L) Geometric Coefficient of Variation 88.7	76.2 nanomoles per liter (nmol/L) Geometric Coefficient of Variation 78.6	75.3 nanomoles per liter (nmol/L) Geometric Coefficient of Variation 43.1	—

SECONDARY outcome

Timeframe: Pre-dose (prior to concizumab administration at week 56)

Pre-dose free TFPI concentration for concizumab is presented. The observation period used for reporting the endpoint is OTexIR. It is defined as the time period where participants are considered to be affected by on demand treatment or treatment with the new concizumab dosing regimen.

Outcome measures

Outcome measures
Measure	Arm 1: Previous on Demand: No Prophylaxis n=9 Participants Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) n=24 Participants Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX n=14 Participants Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX n=49 Participants Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.
Pre-dose Free Tissue Factor Pathway Inhibitor (TFPI) Concentration	13.2 ng/mL Geometric Coefficient of Variation 106.4	15.2 ng/mL Geometric Coefficient of Variation 108.7	12.1 ng/mL Geometric Coefficient of Variation 123.0	11.0 ng/mL Geometric Coefficient of Variation 95.6	—

SECONDARY outcome

Timeframe: Week 24: Predose, 3 hours (h), 6h, 9h, 24h

Maximum concizumab plasma concentration is presented. The observation period used for reporting the endpoint is on OTexIR. It is defined as the time period where participants are considered to be affected by on demand treatment or treatment with the new concizumab dosing regimen.

Outcome measures

Outcome measures
Measure	Arm 1: Previous on Demand: No Prophylaxis n=18 Participants Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) n=13 Participants Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX n=38 Participants Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.
Maximum Concizumab Plasma Concentration (Cmax)	992.2 ng/mL Geometric Coefficient of Variation 1.0	1514.1 ng/mL Geometric Coefficient of Variation 1.7	1153.0 ng/mL Geometric Coefficient of Variation 1.3	—	—

SECONDARY outcome

Timeframe: Week 24: Predose, 3 hours (h), 6h, 9h, 24h

Area under the concizumab plasma concentration-time curve is presented. The observation period used for reporting the endpoint is OTexIR. It is defined as the time period where participants are considered to be affected by on demand treatment or treatment with the new concizumab dosing regimen.

Outcome measures

Outcome measures
Measure	Arm 1: Previous on Demand: No Prophylaxis n=18 Participants Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) n=13 Participants Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX n=38 Participants Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.
Area Under the Concizumab Plasma Concentration-time Curve (AUC)	25991.5 nanogramhour per milliliter (nghr/mL) Standard Deviation 17069.7	47149.3 nanogramhour per milliliter (nghr/mL) Standard Deviation 38192.8	32903.5 nanogramhour per milliliter (nghr/mL) Standard Deviation 32741.2	—	—

Adverse Events

Arm 1: Previous on Demand: No Prophylaxis

Serious events: 3 serious events

Other events: 8 other events

Deaths: 1 deaths

Extension Arm 1: Previous on Demand: No Prophylaxis

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX)

Serious events: 9 serious events

Other events: 15 other events

Deaths: 4 deaths

Arm 3: Concizumab Non-naive: Concizumab PPX

Serious events: 2 serious events

Other events: 13 other events

Deaths: 1 deaths

Arm 4: Concizumab Naive: Concizumab PPX

Serious events: 9 serious events

Other events: 35 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1: Previous on Demand: No Prophylaxis n=19 participants at risk Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Extension Arm 1: Previous on Demand: No Prophylaxis n=13 participants at risk Participants who completed at least 24 weeks of on demand treatment started with the new concizumab dosing regimen and were planned to receive concizumab prophylaxis (PPX) in the extension part of the trial.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) n=33 participants at risk Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX n=21 participants at risk Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX n=60 participants at risk Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.
Nervous system disorders Alcoholic coma	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Infections and infestations COVID-19	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.0% 1/33 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Infections and infestations Catheter site infection	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Nervous system disorders Dizziness	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Infections and infestations Encephalitis	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.0% 1/33 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	4.8% 1/21 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.0% 1/33 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Investigations Fibrin D dimer increased	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Gastrointestinal disorders Functional gastrointestinal disorder	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Gastrointestinal disorders Haematemesis	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.0% 1/33 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Vascular disorders Haematoma	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Investigations Haemoglobin decreased	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	4.8% 1/21 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Nervous system disorders Haemorrhage intracranial	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.0% 1/33 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Injury, poisoning and procedural complications Head injury	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.0% 1/33 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Surgical and medical procedures Hip arthroplasty	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.0% 1/33 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Immune system disorders Hypersensitivity	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.0% 1/33 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Injury, poisoning and procedural complications Lower limb fracture	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Gastrointestinal disorders Melaena	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.0% 1/33 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.0% 1/33 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Nervous system disorders Presyncope	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.0% 1/33 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Investigations Prothrombin fragment 1.2 increased	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Renal and urinary disorders Renal infarct	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.0% 1/33 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Injury, poisoning and procedural complications Road traffic accident	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.0% 1/33 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.

Other adverse events

Other adverse events
Measure	Arm 1: Previous on Demand: No Prophylaxis n=19 participants at risk Participants with hemophilia A with inhibitor (HAwI) and hemophilia B with inhibitor (HAwB) received their on-demand treatment for a minimum of 24 weeks. Subsequently, following the main phase, participants transitioned to the new dosing regimen for concizumab and were scheduled to undergo concizumab prophylaxis in the trial's extension phase.	Extension Arm 1: Previous on Demand: No Prophylaxis n=13 participants at risk Participants who completed at least 24 weeks of on demand treatment started with the new concizumab dosing regimen and were planned to receive concizumab prophylaxis (PPX) in the extension part of the trial.	Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX) n=33 participants at risk Participants with HAwI and HBwI received a loading dose of 1.0 milligrams per kilograms (mg/kg) concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 3: Concizumab Non-naive: Concizumab PPX n=21 participants at risk Participants with HAwI and HBwI received a loading dose (participants entering from the phase 2 trial \[N7415-4310\] were not to receive a loading dose) of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.	Arm 4: Concizumab Naive: Concizumab PPX n=60 participants at risk Participants with HAwI and HBwI received a loading dose of 1.0 mg/kg concizumab subcutaneously followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week maintenance dose setting period on 0.20 mg/kg concizumab, the participants could be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab or stayed at 0.20mg/kg.
Infections and infestations Acarodermatitis	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	6.1% 2/33 • Number of events 2 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	23.8% 5/21 • Number of events 10 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	16.7% 10/60 • Number of events 16 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Musculoskeletal and connective tissue disorders Arthritis	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	9.5% 2/21 • Number of events 3 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Musculoskeletal and connective tissue disorders Back pain	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	4.8% 1/21 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.3% 2/60 • Number of events 2 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Investigations Blood alkaline phosphatase increased	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Investigations Blood pressure increased	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Investigations C-reactive protein increased	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Infections and infestations COVID-19	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 2 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	6.1% 2/33 • Number of events 3 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	23.8% 5/21 • Number of events 5 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	8.3% 5/60 • Number of events 5 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Eye disorders Conjunctival hyperaemia	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Gastrointestinal disorders Constipation	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	9.5% 2/21 • Number of events 2 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.3% 2/60 • Number of events 2 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	4.8% 1/21 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	9.1% 3/33 • Number of events 3 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	9.5% 2/21 • Number of events 2 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	9.5% 2/21 • Number of events 2 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	9.5% 2/21 • Number of events 3 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Skin and subcutaneous tissue disorders Erythema	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	6.7% 4/60 • Number of events 7 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Investigations Fibrin D dimer increased	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.0% 1/33 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	6.7% 4/60 • Number of events 10 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroma	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Infections and infestations Gastroenteritis	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.0% 1/33 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	9.5% 2/21 • Number of events 3 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Congenital, familial and genetic disorders Gilbert's syndrome	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Renal and urinary disorders Haematuria	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Musculoskeletal and connective tissue disorders Haemophilic arthropathy	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Nervous system disorders Headache	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.0% 1/33 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	9.5% 2/21 • Number of events 2 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	8.3% 5/60 • Number of events 9 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Immune system disorders Immunisation reaction	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	5.0% 3/60 • Number of events 4 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
General disorders Injection site erythema	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.0% 1/33 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	4.8% 1/21 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	11.7% 7/60 • Number of events 11 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
General disorders Injection site pruritus	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.3% 2/60 • Number of events 3 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
General disorders Injection site reaction	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	6.1% 2/33 • Number of events 2 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	6.7% 4/60 • Number of events 7 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	5.0% 3/60 • Number of events 3 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Infections and infestations Localised infection	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 3 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Infections and infestations Molluscum contagiosum	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Musculoskeletal and connective tissue disorders Muscle contracture	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Infections and infestations Nasopharyngitis	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	6.1% 2/33 • Number of events 2 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	14.3% 3/21 • Number of events 3 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	6.7% 4/60 • Number of events 4 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Gastrointestinal disorders Nausea	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	6.1% 2/33 • Number of events 2 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
General disorders Oedema peripheral	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	4.8% 1/21 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Infections and infestations Oral herpes	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 3 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.0% 1/33 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	9.5% 2/21 • Number of events 2 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	8.3% 5/60 • Number of events 6 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Infections and infestations Pharyngitis	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	4.8% 1/21 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	5.0% 3/60 • Number of events 3 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Investigations Prothrombin fragment 1.2 increased	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.0% 1/33 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	4.8% 1/21 • Number of events 2 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	6.7% 4/60 • Number of events 9 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Skin and subcutaneous tissue disorders Pruritus	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	3.3% 2/60 • Number of events 4 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
General disorders Pyrexia	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	9.1% 3/33 • Number of events 3 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	14.3% 3/21 • Number of events 3 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	6.7% 4/60 • Number of events 5 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Infections and infestations Respiratory tract infection viral	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 2 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Infections and infestations Rhinitis	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	9.5% 2/21 • Number of events 2 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Investigations SARS-CoV-2 test positive	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	6.1% 2/33 • Number of events 2 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Injury, poisoning and procedural complications Skin abrasion	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Infections and infestations Subcutaneous abscess	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Injury, poisoning and procedural complications Thermal burn	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Injury, poisoning and procedural complications Tibia fracture	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Infections and infestations Upper respiratory tract infection	5.3% 1/19 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	6.1% 2/33 • Number of events 2 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	19.0% 4/21 • Number of events 4 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	5.0% 3/60 • Number of events 3 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
General disorders Vaccination site pain	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/13 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	9.5% 2/21 • Number of events 2 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Infections and infestations Varicella	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	7.7% 1/13 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/60 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/19 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	15.4% 2/13 • Number of events 4 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/33 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	0.00% 0/21 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.	1.7% 1/60 • Number of events 1 • Up to week 56 cut-off Safety analysis set (SAS) included all participants exposed to concizumab prophylaxis (PPX) or randomised to no PPX. All presented AEs were treatment emergent AEs (TEAEs). TEAEs were defined as AEs which initiated or worsened during the time period where participants were considered to be affected by on demand treatment or concizumab treatment.

Additional Information

Clinical Reporting Office (2834)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER