Trial Outcomes & Findings for A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A (NCT NCT03528551)

Last Updated: 2022-12-22

Results Overview

An adverse event (AE) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAEs). The TEAE is defined as an event reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

160 participants

Primary outcome timeframe

Week 0 to week 108

Results posted on

2022-12-22

Participant Flow

The trial was conducted at 66 sites in 25 countries: Australia(2), Brazil(1), Canada(1), Croatia(1), Denmark(1), France(2), Germany(2), Greece(1), Hungary(2), Israel(1), Italy(2), Japan(3), Korea(1), Lithuania(1), Malaysia(1), Netherlands(2), Norway(1), Portugal(1), Spain(2), Switzerland(4), Taiwan(1), Turkey(5), Ukraine(1), United Kingdom (8), United States (USA) (19).

Out of 160 participants enrolled in this study, 102 came from trial NN7088-3859 and 58 came from trial NN7088-3885. The participants received turoctocog alfa pegol (N8-GP) injections either as once-weekly, twice weekly or three times weekly during the 104 weeks treatment period. Despite 160 participants started the trial, the total number of participants considered are 167 as 2 participants switched to twice weekly and 5 participants switched to three times weekly regimen.

Participant milestones

Participant milestones
Measure	N8-GP, Once Weekly Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.	N8-GP, Twice Weekly Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged \< 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months.	N8-GP, Three Times Weekly Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months.
Overall Study STARTED	25	133	2
Overall Study COMPLETED	23	114	2
Overall Study NOT COMPLETED	2	19	0

Reasons for withdrawal

Reasons for withdrawal
Measure	N8-GP, Once Weekly Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.	N8-GP, Twice Weekly Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged \< 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months.
Overall Study Lost to Follow-up	0	1
Overall Study Transferred to other arm/group	2	3
Overall Study Withdrawal by parent/guardian	0	5
Overall Study Protocol Violation	0	3
Overall Study Withdrawal by Subject	0	7

Baseline Characteristics

A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	N8-GP, Once Weekly n=25 Participants Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.	N8-GP, Twice Weekly n=133 Participants Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged \< 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months.	N8-GP, Three Times Weekly n=2 Participants Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months.	Total n=160 Participants Total of all reporting groups
Age, Continuous	35.1 Years STANDARD_DEVIATION 12.7 • n=5 Participants	27.3 Years STANDARD_DEVIATION 16.8 • n=7 Participants	25.3 Years STANDARD_DEVIATION 17.8 • n=5 Participants	28.4 Years STANDARD_DEVIATION 16.4 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	133 Participants n=7 Participants	2 Participants n=5 Participants	160 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	124 Participants n=7 Participants	2 Participants n=5 Participants	151 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	17 Participants n=7 Participants	1 Participants n=5 Participants	21 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	108 Participants n=7 Participants	1 Participants n=5 Participants	130 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 0 to week 108

Population: Safety analysis set (SAS) included all enrolled participants who were exposed to the trial product.

Outcome measures

Outcome measures
Measure	N8-GP, Once Weekly n=25 Participants Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.	N8-GP, Twice Weekly n=135 Participants Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged \< 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135).	N8-GP, Three Times Weekly n=7 Participants Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 5 participants switched from twice weekly to three times weekly regimen for treatment intensification. Thus, though 2 participants have started the trial with three times regimen, the data is presented for 7 participants in this arm (i.e. 2+5 = 7).
Number of Adverse Events Reported	58 Events	444 Events	8 Events

SECONDARY outcome

Timeframe: Week 0 to week 104

Population: FAS included all participants exposed to at least one dose of trial product in the current trial.

The Incidence of inhibitors against coagulation factor eight (FVIII) is defined as titre greater than or equal to (≥) 0.6 Bethesda unit. The inhibitor antibodies were measured using a heat modified Nijmegen FVIII Bethesda assay. The number of participants who developed inhibitors against FVIII are reported.

Outcome measures

Outcome measures
Measure	N8-GP, Once Weekly n=25 Participants Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.	N8-GP, Twice Weekly n=135 Participants Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged \< 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135).	N8-GP, Three Times Weekly n=7 Participants Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 5 participants switched from twice weekly to three times weekly regimen for treatment intensification. Thus, though 2 participants have started the trial with three times regimen, the data is presented for 7 participants in this arm (i.e. 2+5 = 7).
Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) ≥0.6 Bethesda Units (BU)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 0 to week 104

Population: FAS included all participants exposed to at least one dose of trial product in the current trial.

Number of bleeding episodes per participant in the prophylaxis regimen was evaluated during 104 weeks.

Outcome measures

Outcome measures
Measure	N8-GP, Once Weekly n=25 Participants Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.	N8-GP, Twice Weekly n=135 Participants Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged \< 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135).	N8-GP, Three Times Weekly n=7 Participants Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 5 participants switched from twice weekly to three times weekly regimen for treatment intensification. Thus, though 2 participants have started the trial with three times regimen, the data is presented for 7 participants in this arm (i.e. 2+5 = 7).
Number of Bleeding Episodes on Prophylaxis	123 Episodes	190 Episodes	14 Episodes

SECONDARY outcome

Timeframe: Week 0 to week 104

Population: FAS included all participants exposed to at least one dose of trial product in the current trial.

Spontaneous bleeding referred as bleeding episodes that occurred without apparent cause. The number of spontaneous bleeding episodes were evaluated during 104 weeks.

Outcome measures

Outcome measures
Measure	N8-GP, Once Weekly n=25 Participants Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.	N8-GP, Twice Weekly n=135 Participants Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged \< 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135).	N8-GP, Three Times Weekly n=7 Participants Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 5 participants switched from twice weekly to three times weekly regimen for treatment intensification. Thus, though 2 participants have started the trial with three times regimen, the data is presented for 7 participants in this arm (i.e. 2+5 = 7).
Number of Spontaneous Bleeding Episodes on Prophylaxis	98 Episodes	73 Episodes	8 Episodes

SECONDARY outcome

Timeframe: Week 0 to week 104

Population: FAS included all participants exposed to at least one dose of trial product in the current trial.

The haemostatic effect after treatment of a bleed with N8-GP was assessed using a 4-point scale: 'excellent', 'good', 'moderate' or 'none'. The evaluation was done as follows: 1. Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single injection. 2. Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection for complete resolution. 3. Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection; usually requiring more than one injection 4. None: No improvement or worsening of symptoms.

Outcome measures

Outcome measures
Measure	N8-GP, Once Weekly n=25 Participants Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.	N8-GP, Twice Weekly n=135 Participants Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged \< 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135).	N8-GP, Three Times Weekly n=7 Participants Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 5 participants switched from twice weekly to three times weekly regimen for treatment intensification. Thus, though 2 participants have started the trial with three times regimen, the data is presented for 7 participants in this arm (i.e. 2+5 = 7).
Haemostatic Effect of N8-GP When Used for Treatment of Bleeding Episodes Assessed as: Excellent, Good, Moderate, or None Moderate	0 Episodes	4 Episodes	0 Episodes
Haemostatic Effect of N8-GP When Used for Treatment of Bleeding Episodes Assessed as: Excellent, Good, Moderate, or None None	0 Episodes	0 Episodes	0 Episodes
Haemostatic Effect of N8-GP When Used for Treatment of Bleeding Episodes Assessed as: Excellent, Good, Moderate, or None Excellent	114 Episodes	94 Episodes	8 Episodes
Haemostatic Effect of N8-GP When Used for Treatment of Bleeding Episodes Assessed as: Excellent, Good, Moderate, or None Good	8 Episodes	80 Episodes	6 Episodes
Haemostatic Effect of N8-GP When Used for Treatment of Bleeding Episodes Assessed as: Excellent, Good, Moderate, or None Missing	0 Episodes	8 Episodes	0 Episodes

SECONDARY outcome

Timeframe: Week 0 to week 104

Population: FAS included all participants exposed to at least one dose of trial product in the current trial.

The mean number of N8-GP injections required per bleeding episode from start to stop of a bleed for participants was presented from week 0 to week 104.

Outcome measures

Outcome measures
Measure	N8-GP, Once Weekly n=25 Participants Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.	N8-GP, Twice Weekly n=135 Participants Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged \< 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135).	N8-GP, Three Times Weekly n=7 Participants Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 5 participants switched from twice weekly to three times weekly regimen for treatment intensification. Thus, though 2 participants have started the trial with three times regimen, the data is presented for 7 participants in this arm (i.e. 2+5 = 7).
Mean Number of N8-GP Injections Required Per Bleeding Episode	1.2 Injections per bleed Standard Deviation 0.6	1.5 Injections per bleed Standard Deviation 1.3	1.1 Injections per bleed Standard Deviation 0.4

SECONDARY outcome

Timeframe: Week 0 to week 104

Population: FAS included all participants exposed to at least one dose of trial product in the current trial.

The pre-dose FVIII activity levels were assessed in International units per millilitre (IU/mL) units from week 0 to week 104 to get an estimate of the pre-dose level for N8-GP at steady-state using mixed model.

Outcome measures

Outcome measures
Measure	N8-GP, Once Weekly n=25 Participants Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.	N8-GP, Twice Weekly n=135 Participants Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged \< 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135).	N8-GP, Three Times Weekly n=7 Participants Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 5 participants switched from twice weekly to three times weekly regimen for treatment intensification. Thus, though 2 participants have started the trial with three times regimen, the data is presented for 7 participants in this arm (i.e. 2+5 = 7).
Pre-dose FVIII Activity Levels on N8-GP Prophylaxis	0.016 IU/mL Interval 0.011 to 0.023	0.042 IU/mL Interval 0.035 to 0.049	0.049 IU/mL Interval 0.018 to 0.133

SECONDARY outcome

Timeframe: Week 0, Week 104

Population: FAS included all participants exposed to at least one dose of trial product in the current trial. 'Overall Number of Participants Analyzed' = participants with available data.

Haemophilia Joint Health Score is a validated outcome tool developed for the assessment of joint health in patients with hemophilia. It comprises an evaluation of the elbow, knee and ankle joints with regards to swelling, muscular atrophy, crepitation and range of motion, joint pain, strength, motion and axial alignment. The score range is from 0 to 24 points (a score of 0 indicates no joint damage. Higher the score higher the joint damage). Change from week 0 to end of trial (week 104) in the domain scores was presented.

Outcome measures

Outcome measures
Measure	N8-GP, Once Weekly n=21 Participants Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.	N8-GP, Twice Weekly n=112 Participants Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged \< 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135).	N8-GP, Three Times Weekly n=2 Participants Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 5 participants switched from twice weekly to three times weekly regimen for treatment intensification. Thus, though 2 participants have started the trial with three times regimen, the data is presented for 7 participants in this arm (i.e. 2+5 = 7).
Change in Joint Health Status From Start to End of Trial (Based on Haemophilia Joint Health Score)	0.238 Score on a scale Standard Deviation 7.75	-0.116 Score on a scale Standard Deviation 7.40	-10.0 Score on a scale Standard Deviation 14.1

SECONDARY outcome

Timeframe: Week 0 to week 104

Population: FAS included all participants exposed to at least one dose of trial product in the current trial.

The Haemostatic response to N8-GP during major surgical interventions was assessed using a 4-point scale: 'excellent', 'good', 'moderate' or 'none'. The evaluation was done as follows: 1. Excellent: Better than expected/predicted in this type of procedure. 2. Good: As expected in this type of procedure 3. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen 4. None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required. This endpoint was measured from week 0 to week 104.

Outcome measures

Outcome measures
Measure	N8-GP, Once Weekly n=25 Participants Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.	N8-GP, Twice Weekly n=135 Participants Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged \< 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135).	N8-GP, Three Times Weekly n=7 Participants Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 5 participants switched from twice weekly to three times weekly regimen for treatment intensification. Thus, though 2 participants have started the trial with three times regimen, the data is presented for 7 participants in this arm (i.e. 2+5 = 7).
Haemostatic Response During Major Surgical Interventions Assessed as: Excellent, Good, Moderate, or None Excellent	3 Surgeries	8 Surgeries	0 Surgeries
Haemostatic Response During Major Surgical Interventions Assessed as: Excellent, Good, Moderate, or None Good	1 Surgeries	4 Surgeries	0 Surgeries
Haemostatic Response During Major Surgical Interventions Assessed as: Excellent, Good, Moderate, or None Moderate	0 Surgeries	0 Surgeries	0 Surgeries
Haemostatic Response During Major Surgical Interventions Assessed as: Excellent, Good, Moderate, or None None	0 Surgeries	0 Surgeries	0 Surgeries
Haemostatic Response During Major Surgical Interventions Assessed as: Excellent, Good, Moderate, or None Missing	0 Surgeries	1 Surgeries	0 Surgeries

SECONDARY outcome

Timeframe: Week 0 to week 104

Population: FAS included all participants exposed to at least one dose of trial product in the current trial. 'Overall Number of Participants Analyzed' = participants with available data.

The average dose of N8-GP consumed for treatment of bleed was assessed in International units per kilogram per bleed(IU/kg/bleed). This endpoint was evaluated from week 0 to week 104.

Outcome measures

Outcome measures
Measure	N8-GP, Once Weekly n=10 Participants Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.	N8-GP, Twice Weekly n=61 Participants Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged \< 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135).	N8-GP, Three Times Weekly n=3 Participants Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 5 participants switched from twice weekly to three times weekly regimen for treatment intensification. Thus, though 2 participants have started the trial with three times regimen, the data is presented for 7 participants in this arm (i.e. 2+5 = 7).
Consumption of N8-GP Per Bleed	91.3 IU/kg/bleed Standard Deviation 85.0	81.9 IU/kg/bleed Standard Deviation 55.9	61.1 IU/kg/bleed Standard Deviation 12.0

SECONDARY outcome

Timeframe: Week 0 to week 104

Population: FAS included all participants exposed to at least one dose of trial product in the current trial.

The average dose of N8-GP consumed for prevention of bleed was assessed. This endpoint was evaluated from week 0 to week 104.

Outcome measures

Outcome measures
Measure	N8-GP, Once Weekly n=25 Participants Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.	N8-GP, Twice Weekly n=135 Participants Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged \< 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135).	N8-GP, Three Times Weekly n=7 Participants Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 5 participants switched from twice weekly to three times weekly regimen for treatment intensification. Thus, though 2 participants have started the trial with three times regimen, the data is presented for 7 participants in this arm (i.e. 2+5 = 7).
Consumption of N8-GP During Prophylaxis Treatment	3878 IU/kg Standard Deviation 296.4	5320 IU/kg Standard Deviation 565.0	7646 IU/kg Standard Deviation 877.2

SECONDARY outcome

Timeframe: Week 0, Week 104

Population: FAS included all participants exposed to at least one dose of trial product in the current trial. 'Overall Number of Participants Analyzed' = participants with available data. Number analysed = Number of participants who contributed to the analysis. In the N8-GP, once weekly arm; none of the subjects were aged \<=16 years. Hence the number analyzed is mentioned as zero.

The treatment satisfaction of a bleed with N8-GP was assessed using HEMO-SAT assessment tool which contains a questionnaire with 6 domains (Ease and convenience, efficacy, burden, specialist/nurses, centre/hospital, general satisfaction), with a scale of 0-100. The lower scores reflecting greater treatment satisfaction. In other words, decrease in the score would mean improvement. The summary of change presented was based on individual changes since week 0. Data is presented for total score.

Outcome measures

Outcome measures
Measure	N8-GP, Once Weekly n=23 Participants Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.	N8-GP, Twice Weekly n=118 Participants Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged \< 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, the data is presented for 135 participants in this arm (i.e. 133+2 = 135).	N8-GP, Three Times Weekly n=7 Participants Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 5 participants switched from twice weekly to three times weekly regimen for treatment intensification. Thus, though 2 participants have started the trial with three times regimen, the data is presented for 7 participants in this arm (i.e. 2+5 = 7).
Change From Start Till End of Trial in Treatment Satisfaction (Based on Hemo-SAT Score) Total Score (participants aged >= 17 years)	-4.65 Score on a scale Standard Deviation 8.16	-2.11 Score on a scale Standard Deviation 7.48	-12.3 Score on a scale Standard Deviation 23.78
Change From Start Till End of Trial in Treatment Satisfaction (Based on Hemo-SAT Score) Total Score (participants aged <=16 years)	—	-1.78 Score on a scale Standard Deviation 8.54	1.43 Score on a scale Standard Deviation 7.31

Adverse Events

N8-GP, Once Weekly

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

N8-GP, Twice Weekly

Serious events: 15 serious events

Other events: 46 other events

Deaths: 1 deaths

N8-GP, Three Times Weekly

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Total

Serious events: 19 serious events

Other events: 56 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	N8-GP, Once Weekly n=25 participants at risk Participants received once weekly (dosing every 7 day) prophylaxis doses of N8-GP, 75 IU/kg (International Units per kilogram) intravenous injections for 104 weeks. Participants treated with N8-GP once weekly or were on the on demand regimen in the previous trial NN7088-3859 (pathfinder2) were included in this arm. At the investigator's discretion an intensification of the dosing regimen to twice weekly was allowed if the participant experienced more than 2 bleeds within an 8 week period or experienced a severe bleed requiring hospitalization.	N8-GP, Twice Weekly n=135 participants at risk Participants received twice weekly (dosing every 3 and 4 days) prophylaxis doses of N8-GP intravenous injections for 104 weeks: N8-GP, 50 IU/kg for participants aged ≥ 12 years and N8-GP, 60 IU/kg for participants aged \< 12 years. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. At the investigator's discretion, an intensification of the dosing regimen to thrice weekly was allowed if the participant experienced spontaneous bleeding episodes. Participants in this arm were permitted to switch to three times weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 2 participants switched from once weekly to twice weekly regimen for treatment intensification. Thus, though 133 participants have started the trial with twice weekly regimen, AE data is presented for 135 participants in this arm (i.e. 133+2 = 135).	N8-GP, Three Times Weekly n=7 participants at risk Participants received three times weekly (dosing every 2, 2 and 3 days) prophylaxis doses of N8-GP, 50 IU/kg as intravenous injections for a duration of 104 weeks. Participants treated with N8-GP in the previous trials NN7088-3859 (pathfinder2) and NN7088-3885 (pathfinder5) were included in this arm. Participants in this arm were permitted to switch to twice weekly at any time if clinically justified. Otherwise any treatment regimen was preferably be kept for a minimum of 6 months. During the trial, 5 participants switched from twice weekly to three times weekly regimen for treatment intensification. Thus, though 2 participants have started the trial with three times regimen, AE data is presented for 7 participants in this arm (i.e. 2+5 = 7).	Total n=160 participants at risk Total number of participants
Musculoskeletal and connective tissue disorders Arthralgia	8.0% 2/25 • Number of events 2 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	8.1% 11/135 • Number of events 12 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	14.3% 1/7 • Number of events 1 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	8.8% 14/160 • Number of events 15 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.
Psychiatric disorders Attention deficit hyperactivity disorder	0.00% 0/25 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	0.00% 0/135 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	14.3% 1/7 • Number of events 1 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	0.62% 1/160 • Number of events 1 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.
Gastrointestinal disorders Dental caries	12.0% 3/25 • Number of events 3 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	0.00% 0/135 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	0.00% 0/7 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	1.9% 3/160 • Number of events 3 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.
Psychiatric disorders Depression	0.00% 0/25 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	0.74% 1/135 • Number of events 1 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	28.6% 2/7 • Number of events 2 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	1.9% 3/160 • Number of events 3 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.
Injury, poisoning and procedural complications Fall	0.00% 0/25 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	2.2% 3/135 • Number of events 3 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	14.3% 1/7 • Number of events 1 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	1.9% 3/160 • Number of events 4 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.
Nervous system disorders Headache	0.00% 0/25 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	7.4% 10/135 • Number of events 11 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	0.00% 0/7 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	6.2% 10/160 • Number of events 11 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.
Infections and infestations Influenza	0.00% 0/25 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	6.7% 9/135 • Number of events 9 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	0.00% 0/7 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	5.6% 9/160 • Number of events 9 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/25 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	0.00% 0/135 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	14.3% 1/7 • Number of events 1 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	0.62% 1/160 • Number of events 1 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.
Infections and infestations Nasopharyngitis	12.0% 3/25 • Number of events 3 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	15.6% 21/135 • Number of events 23 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	0.00% 0/7 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	15.0% 24/160 • Number of events 26 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.
Infections and infestations Upper respiratory tract infection	16.0% 4/25 • Number of events 13 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	8.1% 11/135 • Number of events 18 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	14.3% 1/7 • Number of events 2 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	10.0% 16/160 • Number of events 33 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.
Metabolism and nutrition disorders Vitamin B12 deficiency	8.0% 2/25 • Number of events 2 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	0.00% 0/135 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	0.00% 0/7 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.	1.2% 2/160 • Number of events 2 • Week 0 to week 108 All adverse events are treatment emergent (TEAEs). The TEAEs were defined as the events reported from date of first trial product administration until end of the treatment visit (week 104) or follow-up visit if relevant (1 month after end of the treatment). SAS included all enrolled participants as they were previously been exposed to trial product.

Additional Information

Clinical Transparency Anchor and Disclosure (1452)

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