Trial Outcomes & Findings for A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors (NCT NCT03196284)
NCT ID: NCT03196284
Last Updated: 2021-10-22
Results Overview
The number of bleeding episodes that were treated during at least 24 weeks from treatment onset (week 0) are presented.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
During at least 24 weeks from treatment onset (week 0)
Results posted on
2021-10-22
Participant Flow
The trial was conducted at 17 sites in 12 countries as follows: Austria (1), Croatia (1), Denmark (1), Italy (2), Spain (2), Sweden (1), the United Kingdom (1), Israel (1), Malaysia (2), Ukraine (1), Japan (2) and the United States (2). In addition to these sites, 4 sites were approved by the IRB/IEC and/or local health authority but did not screen or assign any participants to treatment.
The trial consisted of two treatment periods: main part which lasted 24 weeks for participants randomised to eptacog alfa and at least 24 weeks for participants randomised to concizumab, and an extension part which lasted up to 94 weeks.
Participant milestones
| Measure |
Concizumab- Main Part
Participants were to receive subcutaneous (s.c.) injection of concizumab once daily for 24 weeks. The initial dose was 0.15 milligrams per kilogram (mg/kg) and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Concizumab- Extension Part
Participants who completed main part treatment were to receive s.c. injection of concizumab once daily for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with 0.15 mg/kg of concizumab. The dose was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated.
|
|---|---|---|---|
|
Main Part
STARTED
|
17
|
9
|
0
|
|
Main Part
Concizumab 0.15 mg/kg
|
15
|
0
|
0
|
|
Main Part
Concizumab 0.20 mg/kg
|
2
|
0
|
0
|
|
Main Part
Concizumab 0.25 mg/kg
|
0
|
0
|
0
|
|
Main Part
COMPLETED
|
17
|
8
|
0
|
|
Main Part
NOT COMPLETED
|
0
|
1
|
0
|
|
Extension Part
STARTED
|
0
|
0
|
25
|
|
Extension Part
Concizumab 0.15 mg/kg
|
0
|
0
|
12
|
|
Extension Part
Concizumab 0.20 mg/kg
|
0
|
0
|
9
|
|
Extension Part
Concizumab 0.25 mg/kg
|
0
|
0
|
4
|
|
Extension Part
COMPLETED
|
0
|
0
|
22
|
|
Extension Part
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Concizumab- Main Part
Participants were to receive subcutaneous (s.c.) injection of concizumab once daily for 24 weeks. The initial dose was 0.15 milligrams per kilogram (mg/kg) and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Concizumab- Extension Part
Participants who completed main part treatment were to receive s.c. injection of concizumab once daily for 52-94 weeks. Participants who received concizumab during the main part were to continue with their treatment at last dose by the end of main part and those received eptacog alfa during the main part were to start their treatment with 0.15 mg/kg of concizumab. The dose was then escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated.
|
|---|---|---|---|
|
Main Part
Withdrawal by Subject
|
0
|
1
|
0
|
|
Extension Part
Lack of Efficacy
|
0
|
0
|
1
|
|
Extension Part
Withdrawal by Subject
|
0
|
0
|
1
|
|
Extension Part
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors
Baseline characteristics by cohort
| Measure |
Concizumab
n=17 Participants
Participants were to receive subcutaneous (s.c.) injection of concizumab once daily. In main part, the initial dose was 0.15 milligrams per kilogram (mg/kg) and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. Participants who completed the main part of the study continued their treatment in the extension part for 52-94 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after dosing with concizumab had initiated.
|
Eptacog Alfa
n=9 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks in main part. All participants were then switched to concizumab treatment in the extension part.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.1 Years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
41.1 Years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
36.5 Years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During at least 24 weeks from treatment onset (week 0)Population: The FAS included all randomised participants.
The number of bleeding episodes that were treated during at least 24 weeks from treatment onset (week 0) are presented.
Outcome measures
| Measure |
Concizumab- Main Part
n=17 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=9 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
The Number of Bleeding Episodes
|
47 episodes
|
77 episodes
|
—
|
SECONDARY outcome
Timeframe: During at least 76 weeks from treatment onset (week 0)Population: The FAS included all randomised participants.
The number of bleeding episodes that were treated during at least 76 weeks from treatment onset (week 0) are presented. This outcome measure is applicable for only 'Concizumab' treatment arm.
Outcome measures
| Measure |
Concizumab- Main Part
n=25 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
The Number of Bleeding Episodes
|
256 episodes
|
—
|
—
|
SECONDARY outcome
Timeframe: During at least 24 weeks from treatment onset (week 0)Population: The FAS included all randomised participants.
Bleeds that were not linked to a specific, known action or event are called spontaneous bleeding episodes. The number of spontaneous bleeding episodes that were treated during at least 24 weeks from treatment onset (week 0) are presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=15 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=2 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=9 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
The Number of Spontaneous Bleeding Episodes
|
19 episodes
|
5 episodes
|
69 episodes
|
SECONDARY outcome
Timeframe: During at least 76 weeks from treatment onset (week 0)Population: The FAS included all randomised participants.
Bleeds that were not linked to a specific, known action or event are called spontaneous bleeding episodes. The number of spontaneous bleeding episodes that were treated during at least 76 weeks from treatment onset (week 0) are presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=12 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=9 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=4 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
The Number of Spontaneous Bleeding Episodes
|
36 episodes
|
9 episodes
|
7 episodes
|
SECONDARY outcome
Timeframe: During at least 24 weeks from treatment onset (week 0)Population: The safety analysis set (SAS) included all randomised participants.
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily had a causal relationship with this treatment. A TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. Number of TEAEs that occurred during at least 24 weeks from treatment onset (week 0) are presented. The data is presented per the dose level which the participants have reached at the time of event.
Outcome measures
| Measure |
Concizumab- Main Part
n=17 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=2 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=9 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Number of Treatment-emergent Adverse Events (TEAEs) During at Least 24 Weeks From Treatment Onset
|
39 events
|
4 events
|
18 events
|
SECONDARY outcome
Timeframe: During at least 76 weeks from treatment onset (week 0)Population: The SAS included all randomised participants. Overall number of participants analysed = number of participants contributed to the analysis at the particular dose level.
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily had a causal relationship with this treatment. A TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. Number of TEAEs that occurred during at least 76 weeks from treatment onset (week 0) are presented. The data is presented per the dose level which the participants have reached at the time of event.
Outcome measures
| Measure |
Concizumab- Main Part
n=25 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=13 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=4 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Number of Treatment-emergent Adverse Events (TEAEs) During at Least 76 Weeks From Treatment Onset
|
104 events
|
24 events
|
3 events
|
SECONDARY outcome
Timeframe: Within 24 hours after eptacog alfa administrationPopulation: The SAS included all randomised participants.
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily had a causal relationship with this treatment. A TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. Number of TEAEs that occurred within 24 hours after eptacog alfa administration are presented. This outcome measure is applicable only for 'Eptacog alfa' treatment arm.
Outcome measures
| Measure |
Concizumab- Main Part
n=9 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Number of Treatment-emergent Adverse Events (TEAEs) Within 24 Hours After Eptacog Alfa Administration
|
0 events
|
—
|
—
|
SECONDARY outcome
Timeframe: During at least 24 weeks from treatment onset (week 0)Population: The FAS included all participants who received concizumab.
Occurrence of anti-concizumab antibodies during at least 24 weeks from treatment onset (week 0) is presented. This outcome measure is applicable for only 'Concizumab' treatment arm.
Outcome measures
| Measure |
Concizumab- Main Part
n=17 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Occurrence of Anti-concizumab Antibodies During at Least 24 Weeks From Treatment Onset
Yes
|
3 Participants
|
—
|
—
|
|
Occurrence of Anti-concizumab Antibodies During at Least 24 Weeks From Treatment Onset
No
|
14 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During at least 76 weeks from treatment onset (week 0)Population: The FAS included all participants who received concizumab.
Occurrence of anti-concizumab antibodies during at least 76 weeks from treatment onset (week 0) is presented. This outcome measure is applicable for only 'Concizumab' treatment arm.
Outcome measures
| Measure |
Concizumab- Main Part
n=25 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Occurrence of Anti-concizumab Antibodies During at Least 76 Weeks From Treatment Onset
Yes
|
6 Participants
|
—
|
—
|
|
Occurrence of Anti-concizumab Antibodies During at Least 76 Weeks From Treatment Onset
No
|
19 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During at least 24 weeks from treatment onset (week 0)Population: The SAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis.
Change in fibrinogen during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=14 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=2 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=8 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Change in Fibrinogen
|
-0.24 Grams per liter (g/L)
Standard Deviation 0.45
|
-1.24 Grams per liter (g/L)
Standard Deviation 1.61
|
0.13 Grams per liter (g/L)
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: During at least 76 weeks from treatment onset (week 0)Population: The SAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis.
Change in fibrinogen during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=11 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=9 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=3 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Change in Fibrinogen
|
-0.14 g/L
Standard Deviation 0.51
|
-0.56 g/L
Standard Deviation 0.72
|
-1.51 g/L
Standard Deviation 1.44
|
SECONDARY outcome
Timeframe: During at least 24 weeks from treatment onset (week 0)Population: The SAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis.
Change in D-dimer during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=15 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=2 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=8 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Change in D-dimer
|
227 Nanograms per milliliter (ng/mL)
Standard Deviation 239
|
550 Nanograms per milliliter (ng/mL)
Standard Deviation 608
|
-48 Nanograms per milliliter (ng/mL)
Standard Deviation 614
|
SECONDARY outcome
Timeframe: During at least 76 weeks from treatment onset (week 0)Population: The SAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis.
Change in D-dimer during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=11 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=9 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=3 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Change in D-dimer
|
308 ng/mL
Standard Deviation 601
|
193 ng/mL
Standard Deviation 912
|
340 ng/mL
Standard Deviation 887
|
SECONDARY outcome
Timeframe: During at least 24 weeks from treatment onset (week 0)Population: The SAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis.
Change in F1 + 2 during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=15 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=2 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=8 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Change in Prothrombin Fragment 1 + 2 (F1 + 2)
|
154 Picomoles per liter (pmol/L)
Standard Deviation 256
|
164 Picomoles per liter (pmol/L)
Standard Deviation 1
|
0 Picomoles per liter (pmol/L)
Standard Deviation 33
|
SECONDARY outcome
Timeframe: During at least 76 weeks from treatment onset (week 0)Population: The SAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis.
Change in F1 + 2 during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=11 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=9 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=3 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Change in Prothrombin Fragment 1 + 2 (F1 + 2)
|
159 pmol/L
Standard Deviation 202
|
457 pmol/L
Standard Deviation 458
|
349 pmol/L
Standard Deviation 452
|
SECONDARY outcome
Timeframe: During at least 24 weeks from treatment onset (week 0)Population: The SAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis.
Change in PT during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=15 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=2 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=7 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Change in Prothrombin Time (PT)
|
0.2 Seconds (sec)
Standard Deviation 0.4
|
-1.0 Seconds (sec)
Standard Deviation 1.0
|
0.0 Seconds (sec)
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: During at least 76 weeks from treatment onset (week 0)Population: The SAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis.
Change in PT during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=11 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=9 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=3 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Change in Prothrombin Time (PT)
|
-0.4 sec
Standard Deviation 0.6
|
0.4 sec
Standard Deviation 0.6
|
0.3 sec
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: During at least 24 weeks from treatment onset (week 0)Population: The SAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis.
Change in APTT during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=15 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=2 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=7 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Change in Activated Partial Thromboplastin Time (APTT)
|
-2.6 sec
Standard Deviation 12.1
|
0.9 sec
Standard Deviation 2.3
|
5.9 sec
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: During at least 76 weeks from treatment onset (week 0)Population: The SAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis.
Change in APTT during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=11 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=9 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=3 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Change in Activated Partial Thromboplastin Time (APTT)
|
-6.6 sec
Standard Deviation 9.0
|
3.7 sec
Standard Deviation 6.9
|
20.9 sec
Standard Deviation 17.3
|
SECONDARY outcome
Timeframe: During at least 24 weeks from treatment onset (week 0)Population: The SAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis.
Change in AT during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=15 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=2 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=8 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Change in Anti-thrombin (AT)
|
-1 Percentage point of AT
Standard Deviation 11
|
8 Percentage point of AT
Standard Deviation 4
|
1 Percentage point of AT
Standard Deviation 10
|
SECONDARY outcome
Timeframe: After at least 76 weeks from treatment onset (week 0)Population: The SAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis.
Change in AT after at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=11 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=9 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=3 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Change in Anti-thrombin (AT)
|
-3 Percentage point of AT
Standard Deviation 15
|
-5 Percentage point of AT
Standard Deviation 11
|
-1 Percentage point of AT
Standard Deviation 14
|
SECONDARY outcome
Timeframe: Prior to the last dose administration at 24 weeksPopulation: The FAS included all randomised participants.
Concentration of concizumab prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=15 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=2 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Concentration of Concizumab
|
350.6 ng/mL
Standard Deviation 316.8
|
517.5 ng/mL
Standard Deviation 309.0
|
—
|
SECONDARY outcome
Timeframe: Prior to the last dose administration after atleast 76 weeksPopulation: The FAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis.
Concentration of concizumab prior to the last dose administration after atleast 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=11 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=9 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=3 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Concentration of Concizumab
|
205.5 ng/mL
Standard Deviation 254.5
|
1354.7 ng/mL
Standard Deviation 1004.3
|
941.7 ng/mL
Standard Deviation 943.1
|
SECONDARY outcome
Timeframe: Prior to the last dose administration at 24 weeksPopulation: The FAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis.
Free TFPI (TFPI not bound to concizumab) concentration value prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=15 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=2 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=8 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value
|
29.9 ng/mL
Standard Deviation 9.6
|
4.8 ng/mL
Standard Deviation 0.0
|
94.3 ng/mL
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: Prior to the last dose administration after atleast 76 weeksPopulation: The FAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis.
Free TFPI concentration value prior to the last dose administration after atleast 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=11 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=9 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=3 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value
|
30.3 ng/mL
Standard Deviation 28.2
|
8.3 ng/mL
Standard Deviation 4.9
|
12.2 ng/mL
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: Prior to the last dose administration at 24 weeksPopulation: The FAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis.
Peak thrombin generation is the maximal concentration of thrombin formed at a given point in time. Peak thrombin generation prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=15 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=2 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=1 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Peak Thrombin Generation
|
57.8 Nanomoles per liter (nmol/L)
Standard Deviation 28.9
|
119.0 Nanomoles per liter (nmol/L)
Standard Deviation 12.7
|
12.0 Nanomoles per liter (nmol/L)
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was available for analysis.
|
SECONDARY outcome
Timeframe: Prior to the last dose administration after atleast 76 weeksPopulation: The FAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis.
Peak thrombin generation is the maximal concentration of thrombin formed at a given point in time. Peak thrombin generation prior to the last dose administration after atleast 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=11 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=9 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=3 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Peak Thrombin Generation
|
79.5 nmol/L
Standard Deviation 55.3
|
98.7 nmol/L
Standard Deviation 20.4
|
75.7 nmol/L
Standard Deviation 30.6
|
SECONDARY outcome
Timeframe: Prior to the last dose administration at 24 weeksPopulation: The FAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis.
Endogenous thrombin potential prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=15 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=2 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=1 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Endogenous Thrombin Potential
|
901.5 Nanomolar*minute (nM*min)
Standard Deviation 347.6
|
1589.5 Nanomolar*minute (nM*min)
Standard Deviation 133.6
|
228.0 Nanomolar*minute (nM*min)
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was available for analysis.
|
SECONDARY outcome
Timeframe: Prior to the last dose administration after atleast 76 weeksPopulation: The FAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis.
Endogenous thrombin potential prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=11 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=9 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=3 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Endogenous Thrombin Potential
|
1056.5 nM*min
Standard Deviation 438.5
|
1356.9 nM*min
Standard Deviation 223.9
|
1178.0 nM*min
Standard Deviation 184.3
|
SECONDARY outcome
Timeframe: Prior to the last dose administration at 24 weeksPopulation: The FAS included all randomised participants. Overall number of participants analysed = number of participants available for analysis.
Thrombin generation velocity index prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=15 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=2 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=1 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Thrombin Generation Velocity Index
|
5.3 nM/min
Standard Deviation 3.3
|
14.5 nM/min
Standard Deviation 3.5
|
1.0 nM/min
Standard Deviation NA
Standard deviation could not be calculated as only 1 participant was available for analysis.
|
SECONDARY outcome
Timeframe: Prior to the last dose administration after atleast 76 weeksPopulation: The FAS included all randomised participants. Overall number of participants analysed = number of participants available for the analysis.
Thrombin generation velocity index prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Outcome measures
| Measure |
Concizumab- Main Part
n=11 Participants
Participants were to receive s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg and then the dose was escalated to 0.20 and 0.25 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose. A single injection of 90 micrograms per kilogram (μg/kg) eptacog alfa (rFVIIa) was administered in a non-bleeding state one week after the dosing with concizumab had initiated.
|
Eptacog Alfa- Main Part
n=9 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Eptacog Alfa- Main Part
n=3 Participants
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
|---|---|---|---|
|
Thrombin Generation Velocity Index
|
10.0 nM/min
Standard Deviation 12.0
|
9.7 nM/min
Standard Deviation 3.5
|
6.7 nM/min
Standard Deviation 3.2
|
Adverse Events
Eptacog Alfa- Main Part
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Concizumab 0.15 mg/kg- Main Part
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Concizumab 0.20 mg/kg- Main Part
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Concizumab 0.15 mg/kg- Extension Part
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Concizumab 0.20 mg/kg- Extension Part
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Concizumab 0.25 mg/kg- Extension Part
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eptacog Alfa- Main Part
n=9 participants at risk
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Concizumab 0.15 mg/kg- Main Part
n=17 participants at risk
Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose.
|
Concizumab 0.20 mg/kg- Main Part
n=2 participants at risk
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose.
|
Concizumab 0.15 mg/kg- Extension Part
n=23 participants at risk
Participants who were on treatment with concizumab once daily at the end of main part of the study continued their treatment in the extension part. Participants who received eptacog alfa in the main part switched to treatment with concizumab in the extension part (a loading dose of 0.5 mg/kg was given as the first concizumab dose). The dose of concizumab was 0.15 mg/kg.
|
Concizumab 0.20 mg/kg- Extension Part
n=13 participants at risk
Participants who were on treatment with concizumab once daily at the end of main part of the study continued their treatment in the extension part. Participants who received eptacog alfa in the main part switched to treatment with concizumab in the extension part (a loading dose of 0.5 mg/kg was given as the first concizumab dose). The initial dose of concizumab was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes.
|
Concizumab 0.25 mg/kg- Extension Part
n=4 participants at risk
Participants who were on treatment with concizumab once daily at the end of main part of the study continued their treatment in the extension part. Participants who received eptacog alfa in the main part switched to treatment with concizumab in the extension part (a loading dose of 0.5 mg/kg was given as the first concizumab dose). The initial dose of concizumab was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
4.3%
1/23 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Surgical and medical procedures
Central venous catheter removal
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
11.1%
1/9 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
4.3%
1/23 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Infections and infestations
Hordeolum
|
11.1%
1/9 • Number of events 2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
4.3%
1/23 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
4.3%
1/23 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
4.3%
1/23 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
4.3%
1/23 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
7.7%
1/13 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
4.3%
1/23 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
Other adverse events
| Measure |
Eptacog Alfa- Main Part
n=9 participants at risk
Participants were to receive eptacog alfa on-demand treatment for 24 weeks.
|
Concizumab 0.15 mg/kg- Main Part
n=17 participants at risk
Participants received s.c. injection of 0.15 mg/kg concizumab once daily for 24 weeks. A loading dose of 0.5 mg/kg was given as the first concizumab dose.
|
Concizumab 0.20 mg/kg- Main Part
n=2 participants at risk
Participants received s.c. injection of concizumab once daily for 24 weeks. The initial dose was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes. A loading dose of 0.5 mg/kg was given as the first concizumab dose.
|
Concizumab 0.15 mg/kg- Extension Part
n=23 participants at risk
Participants who were on treatment with concizumab once daily at the end of main part of the study continued their treatment in the extension part. Participants who received eptacog alfa in the main part switched to treatment with concizumab in the extension part (a loading dose of 0.5 mg/kg was given as the first concizumab dose). The dose of concizumab was 0.15 mg/kg.
|
Concizumab 0.20 mg/kg- Extension Part
n=13 participants at risk
Participants who were on treatment with concizumab once daily at the end of main part of the study continued their treatment in the extension part. Participants who received eptacog alfa in the main part switched to treatment with concizumab in the extension part (a loading dose of 0.5 mg/kg was given as the first concizumab dose). The initial dose of concizumab was 0.15 mg/kg which was then escalated to 0.20 mg/kg based on the number of spontaneous bleeding episodes.
|
Concizumab 0.25 mg/kg- Extension Part
n=4 participants at risk
Participants who were on treatment with concizumab once daily at the end of main part of the study continued their treatment in the extension part. Participants who received eptacog alfa in the main part switched to treatment with concizumab in the extension part (a loading dose of 0.5 mg/kg was given as the first concizumab dose). The initial dose of concizumab was 0.15 mg/kg which was then escalated to 0.25 mg/kg based on the number of spontaneous bleeding episodes.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
11.1%
1/9 • Number of events 2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
50.0%
1/2 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
8.7%
2/23 • Number of events 2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Infections and infestations
Cellulitis
|
11.1%
1/9 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
4.3%
1/23 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
7.7%
1/13 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
4.3%
1/23 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Injury, poisoning and procedural complications
Contusion
|
22.2%
2/9 • Number of events 3 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
7.7%
1/13 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
25.0%
1/4 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
8.7%
2/23 • Number of events 3 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
7.7%
1/13 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
7.7%
1/13 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
7.7%
1/13 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Gastrointestinal disorders
Flatulence
|
11.1%
1/9 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
4.3%
1/23 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
7.7%
1/13 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
4.3%
1/23 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
7.7%
1/13 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Infections and infestations
Gastroenteritis
|
11.1%
1/9 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
50.0%
1/2 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
4.3%
1/23 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Musculoskeletal and connective tissue disorders
Haemophilic arthropathy
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
11.8%
2/17 • Number of events 2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Hepatobiliary disorders
Hepatic cyst
|
11.1%
1/9 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Infections and infestations
Influenza
|
11.1%
1/9 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
7.7%
1/13 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
General disorders
Injection site bruising
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
8.7%
2/23 • Number of events 3 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
General disorders
Injection site erythema
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
General disorders
Injection site haematoma
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
17.6%
3/17 • Number of events 6 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
4.3%
1/23 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
7.7%
1/13 • Number of events 3 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 5 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
4.3%
1/23 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
7.7%
1/13 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
17.6%
3/17 • Number of events 3 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
4.3%
1/23 • Number of events 3 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
25.0%
1/4 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
50.0%
1/2 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Investigations
Prothrombin fragment 1.2 increased
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
7.7%
1/13 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Investigations
Prothrombin level increased
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
11.8%
2/17 • Number of events 2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
4.3%
1/23 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
25.0%
1/4 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Infections and infestations
Respiratory tract infection
|
11.1%
1/9 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
7.7%
1/13 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
4.3%
1/23 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
7.7%
1/13 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Infections and infestations
Skin infection
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
4.3%
1/23 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Nervous system disorders
Ulnar nerve palsy
|
11.1%
1/9 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
1/9 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
13.0%
3/23 • Number of events 5 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
7.7%
1/13 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
5.9%
1/17 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/2 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/23 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/17 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
50.0%
1/2 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
4.3%
1/23 • Number of events 1 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/13 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
0.00%
0/4 • From start of study drug administration (week 0) up to 126 weeks
Results are based on the safety analysis set which included all randomized participants. All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset from the first exposure to treatment (randomisation date, in case of on-demand arm) until the last visit in the trial.
|
Additional Information
Clinical Reporting 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