Trial Outcomes & Findings for A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight (NCT NCT04667377)
NCT ID: NCT04667377
Last Updated: 2023-11-02
Results Overview
Percentage change in body weight from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures, an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. That is, a hypothetical strategy was used for intercurrent event (ICE) "COVID-19 pandemic-related early treatment discontinuation", a treatment policy strategy for ICE "non-pandemic-related early treatment discontinuation".
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
387 participants
Primary outcome timeframe
Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.
Results posted on
2023-11-02
Participant Flow
This was a randomised, double-blinded, parallel-design, placebo-controlled, multi-national, and multi-centre study with four different BI 456906 maintenance doses (ranging from 0.6 mg/week to 4.8 mg/week) in patients with obesity or overweight (body mass index (BMI) \>=27 kg/m\^2), and without diabetes mellitus.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and 2, and 0.6 mg on Week 3 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20).
From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 0.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
2.4 mg BI 456906 - Planned Maintenance Treatment
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 to Week 14 and 2.4 mg on Week 15 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 2.4 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
3.6 mg BI 456906 - Planned Maintenance Treatment
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 and Week 12, 2.4 mg on Week 13 and Week 14, 3.0 mg on Week 15 and Week 16, and 3.6 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 3.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
4.8 mg BI 456906 - Planned Maintenance Treatment
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 and Week 8, 1.8 mg on Week 9 and Week 10, 2.4 mg on Week 11 and Week 12, 3.3 mg on Week 13 and Week 14, 4.2 mg on Week 15 and Week 16, and 4.8 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 4.8 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
Placebo
Participants with obesity or overweight were administered a solution for injection of Placebo, by a weekly subcutaneous injection of two syringes on the same injection day, for 46 weeks.
|
|---|---|---|---|---|---|
|
Dose Escalation Period
STARTED
|
78
|
78
|
77
|
77
|
77
|
|
Dose Escalation Period
Treated During Dose Escalation Period
|
77
|
78
|
77
|
77
|
77
|
|
Dose Escalation Period
COMPLETED
|
55
|
60
|
59
|
55
|
57
|
|
Dose Escalation Period
NOT COMPLETED
|
23
|
18
|
18
|
22
|
20
|
|
Maintenance Period
STARTED
|
55
|
60
|
59
|
55
|
57
|
|
Maintenance Period
COMPLETED
|
47
|
45
|
48
|
47
|
46
|
|
Maintenance Period
NOT COMPLETED
|
8
|
15
|
11
|
8
|
11
|
Reasons for withdrawal
| Measure |
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and 2, and 0.6 mg on Week 3 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20).
From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 0.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
2.4 mg BI 456906 - Planned Maintenance Treatment
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 to Week 14 and 2.4 mg on Week 15 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 2.4 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
3.6 mg BI 456906 - Planned Maintenance Treatment
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 and Week 12, 2.4 mg on Week 13 and Week 14, 3.0 mg on Week 15 and Week 16, and 3.6 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 3.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
4.8 mg BI 456906 - Planned Maintenance Treatment
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 and Week 8, 1.8 mg on Week 9 and Week 10, 2.4 mg on Week 11 and Week 12, 3.3 mg on Week 13 and Week 14, 4.2 mg on Week 15 and Week 16, and 4.8 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 4.8 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
Placebo
Participants with obesity or overweight were administered a solution for injection of Placebo, by a weekly subcutaneous injection of two syringes on the same injection day, for 46 weeks.
|
|---|---|---|---|---|---|
|
Dose Escalation Period
Other not specified below
|
3
|
3
|
2
|
1
|
3
|
|
Dose Escalation Period
Protocol Violation
|
2
|
2
|
0
|
2
|
1
|
|
Dose Escalation Period
Burden of study procedures
|
2
|
1
|
1
|
1
|
5
|
|
Dose Escalation Period
Change of residence
|
0
|
0
|
1
|
0
|
0
|
|
Dose Escalation Period
Perceived lack of efficacy
|
0
|
0
|
0
|
0
|
6
|
|
Dose Escalation Period
Adverse Event
|
9
|
10
|
12
|
17
|
3
|
|
Dose Escalation Period
Adverse event: COVID-infection
|
4
|
1
|
2
|
1
|
0
|
|
Dose Escalation Period
Not treated
|
1
|
0
|
0
|
0
|
0
|
|
Dose Escalation Period
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
2
|
|
Dose Escalation Period
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
|
Maintenance Period
Perceived lack of efficacy
|
0
|
2
|
1
|
0
|
1
|
|
Maintenance Period
Adverse Event
|
2
|
8
|
5
|
4
|
1
|
|
Maintenance Period
Adverse event: COVID infection
|
0
|
1
|
0
|
0
|
0
|
|
Maintenance Period
COVID-related
|
0
|
0
|
1
|
1
|
0
|
|
Maintenance Period
Protocol Violation
|
1
|
0
|
0
|
0
|
1
|
|
Maintenance Period
Burden of study procedures
|
1
|
2
|
0
|
1
|
0
|
|
Maintenance Period
Change of residence
|
0
|
1
|
0
|
0
|
1
|
|
Maintenance Period
Missing
|
1
|
0
|
0
|
0
|
0
|
|
Maintenance Period
Other than listed above
|
2
|
0
|
3
|
2
|
6
|
|
Maintenance Period
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
|
Maintenance Period
Lost to Follow-up
|
1
|
0
|
1
|
0
|
1
|
Baseline Characteristics
A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight
Baseline characteristics by cohort
| Measure |
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)
n=77 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and 2, and 0.6 mg on Week 3 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20).
From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 0.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
2.4 mg BI 456906 - Planned Maintenance Treatment
n=78 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 to Week 14 and 2.4 mg on Week 15 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 2.4 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
3.6 mg BI 456906 - Planned Maintenance Treatment
n=76 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 and Week 12, 2.4 mg on Week 13 and Week 14, 3.0 mg on Week 15 and Week 16, and 3.6 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 3.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
4.8 mg BI 456906 - Planned Maintenance Treatment
n=76 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 and Week 8, 1.8 mg on Week 9 and Week 10, 2.4 mg on Week 11 and Week 12, 3.3 mg on Week 13 and Week 14, 4.2 mg on Week 15 and Week 16, and 4.8 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 4.8 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
Placebo
n=77 Participants
Participants with obesity or overweight were administered a solution for injection of Placebo, by a weekly subcutaneous injection of two syringes on the same injection day, for 46 weeks.
|
Total
n=384 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.6 Years
STANDARD_DEVIATION 12.6 • n=99 Participants
|
49.0 Years
STANDARD_DEVIATION 13.1 • n=107 Participants
|
50.3 Years
STANDARD_DEVIATION 11.8 • n=206 Participants
|
47.6 Years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
50.0 Years
STANDARD_DEVIATION 13.5 • n=31 Participants
|
48.9 Years
STANDARD_DEVIATION 12.8 • n=30 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
53 Participants
n=31 Participants
|
262 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=31 Participants
|
122 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
17 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
70 Participants
n=7 Participants
|
72 Participants
n=31 Participants
|
367 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
40 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
37 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
59 Participants
n=7 Participants
|
60 Participants
n=31 Participants
|
301 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Body weight at baseline
|
106.98 Kilogram (kg)
STANDARD_DEVIATION 18.71 • n=99 Participants
|
106.57 Kilogram (kg)
STANDARD_DEVIATION 22.97 • n=107 Participants
|
104.68 Kilogram (kg)
STANDARD_DEVIATION 19.63 • n=206 Participants
|
105.86 Kilogram (kg)
STANDARD_DEVIATION 17.39 • n=7 Participants
|
104.32 Kilogram (kg)
STANDARD_DEVIATION 22.95 • n=31 Participants
|
105.68 Kilogram (kg)
STANDARD_DEVIATION 20.39 • n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.Population: Full analysis set (all randomised participants who received at least one dose of study treatment and who have analysable data for at least one efficacy endpoint) using planned maintenance treatment. Number of participants analysed = Participants with available data for the outcome measure.
Percentage change in body weight from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures, an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. That is, a hypothetical strategy was used for intercurrent event (ICE) "COVID-19 pandemic-related early treatment discontinuation", a treatment policy strategy for ICE "non-pandemic-related early treatment discontinuation".
Outcome measures
| Measure |
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)
n=76 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and 2, and 0.6 mg on Week 3 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20).
From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 0.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
2.4 mg BI 456906 - Planned Maintenance Treatment
n=78 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 to Week 14 and 2.4 mg on Week 15 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 2.4 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
3.6 mg BI 456906 - Planned Maintenance Treatment
n=76 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 and Week 12, 2.4 mg on Week 13 and Week 14, 3.0 mg on Week 15 and Week 16, and 3.6 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 3.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
4.8 mg BI 456906 - Planned Maintenance Treatment
n=76 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 and Week 8, 1.8 mg on Week 9 and Week 10, 2.4 mg on Week 11 and Week 12, 3.3 mg on Week 13 and Week 14, 4.2 mg on Week 15 and Week 16, and 4.8 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 4.8 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
Placebo
n=77 Participants
Participants with obesity or overweight were administered a solution for injection of Placebo, by a weekly subcutaneous injection of two syringes on the same injection day, for 46 weeks.
|
|---|---|---|---|---|---|
|
Percentage Change in Body Weight From Baseline to Week 46
|
-6.19 Percentage change
Standard Error 1.07
|
-12.51 Percentage change
Standard Error 1.01
|
-13.22 Percentage change
Standard Error 1.04
|
-14.94 Percentage change
Standard Error 1.01
|
-2.82 Percentage change
Standard Error 1.06
|
SECONDARY outcome
Timeframe: At baseline and at Week 46.Population: Full analysis set (all randomised participants who received at least one dose of study treatment and who have analysable data for at least one efficacy endpoint) using planned maintenance treatment. Number of participants analysed = Participants with available data for the outcome measure.
Weight loss of greater than or equal to 5 percent (≥5%) of baseline weight at Week 46 (yes/no), reported as percentage of participants who achieved a weight loss of ≥5% of baseline weight at Week 46. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. Percentages were rounded to one decimal place.
Outcome measures
| Measure |
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)
n=56 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and 2, and 0.6 mg on Week 3 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20).
From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 0.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
2.4 mg BI 456906 - Planned Maintenance Treatment
n=58 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 to Week 14 and 2.4 mg on Week 15 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 2.4 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
3.6 mg BI 456906 - Planned Maintenance Treatment
n=61 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 and Week 12, 2.4 mg on Week 13 and Week 14, 3.0 mg on Week 15 and Week 16, and 3.6 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 3.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
4.8 mg BI 456906 - Planned Maintenance Treatment
n=64 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 and Week 8, 1.8 mg on Week 9 and Week 10, 2.4 mg on Week 11 and Week 12, 3.3 mg on Week 13 and Week 14, 4.2 mg on Week 15 and Week 16, and 4.8 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 4.8 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
Placebo
n=54 Participants
Participants with obesity or overweight were administered a solution for injection of Placebo, by a weekly subcutaneous injection of two syringes on the same injection day, for 46 weeks.
|
|---|---|---|---|---|---|
|
Weight Loss of ≥ 5% of Baseline Weight at Week 46
|
60.7 Percentage of participants
|
81.0 Percentage of participants
|
82.0 Percentage of participants
|
82.8 Percentage of participants
|
25.9 Percentage of participants
|
SECONDARY outcome
Timeframe: At baseline and at Week 46.Population: Full analysis set (all randomised participants who received at least one dose of study treatment and who have analysable data for at least one efficacy endpoint) using planned maintenance treatment. Number of participants analysed = Participants with available data for the outcome measure.
Weight loss of greater than or equal to 10 percent (≥10%) of baseline weight at Week 46 (yes/no), reported as percentage of participants who achieved a weight loss of ≥10% of baseline weight at Week 46. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. Percentages were rounded to one decimal place.
Outcome measures
| Measure |
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)
n=56 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and 2, and 0.6 mg on Week 3 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20).
From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 0.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
2.4 mg BI 456906 - Planned Maintenance Treatment
n=58 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 to Week 14 and 2.4 mg on Week 15 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 2.4 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
3.6 mg BI 456906 - Planned Maintenance Treatment
n=61 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 and Week 12, 2.4 mg on Week 13 and Week 14, 3.0 mg on Week 15 and Week 16, and 3.6 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 3.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
4.8 mg BI 456906 - Planned Maintenance Treatment
n=64 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 and Week 8, 1.8 mg on Week 9 and Week 10, 2.4 mg on Week 11 and Week 12, 3.3 mg on Week 13 and Week 14, 4.2 mg on Week 15 and Week 16, and 4.8 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 4.8 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
Placebo
n=54 Participants
Participants with obesity or overweight were administered a solution for injection of Placebo, by a weekly subcutaneous injection of two syringes on the same injection day, for 46 weeks.
|
|---|---|---|---|---|---|
|
Weight Loss of ≥ 10% of Baseline Weight at Week 46
|
33.9 Percentage of participants
|
65.5 Percentage of participants
|
65.6 Percentage of participants
|
68.8 Percentage of participants
|
11.1 Percentage of participants
|
SECONDARY outcome
Timeframe: At baseline and at Week 46.Population: Full analysis set (all randomised participants who received at least one dose of study treatment and who have analysable data for at least one efficacy endpoint) using planned maintenance treatment. Number of participants analysed = Participants with available data for the outcome measure.
Weight loss of greater than or equal to 15 percent (≥15%) of baseline weight at Week 46 (yes/no), reported as percentage of participants who achieved a weight loss of ≥15% of baseline weight at Week 46. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. Percentages were rounded to one decimal place.
Outcome measures
| Measure |
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)
n=56 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and 2, and 0.6 mg on Week 3 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20).
From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 0.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
2.4 mg BI 456906 - Planned Maintenance Treatment
n=58 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 to Week 14 and 2.4 mg on Week 15 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 2.4 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
3.6 mg BI 456906 - Planned Maintenance Treatment
n=61 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 and Week 12, 2.4 mg on Week 13 and Week 14, 3.0 mg on Week 15 and Week 16, and 3.6 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 3.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
4.8 mg BI 456906 - Planned Maintenance Treatment
n=64 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 and Week 8, 1.8 mg on Week 9 and Week 10, 2.4 mg on Week 11 and Week 12, 3.3 mg on Week 13 and Week 14, 4.2 mg on Week 15 and Week 16, and 4.8 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 4.8 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
Placebo
n=54 Participants
Participants with obesity or overweight were administered a solution for injection of Placebo, by a weekly subcutaneous injection of two syringes on the same injection day, for 46 weeks.
|
|---|---|---|---|---|---|
|
Weight Loss of ≥ 15% of Baseline Weight at Week 46
|
12.5 Percentage of particpants
|
37.9 Percentage of particpants
|
45.9 Percentage of particpants
|
54.7 Percentage of particpants
|
5.6 Percentage of particpants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.Population: Full analysis set (FAS, all randomised participants who received at least one dose of study treatment and who have analysable data for at least one efficacy endpoint), using planned maintenance treatment. Number of participants analysed = Participants with available data for the outcome measure.
Absolute change in body weight from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.
Outcome measures
| Measure |
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)
n=75 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and 2, and 0.6 mg on Week 3 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20).
From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 0.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
2.4 mg BI 456906 - Planned Maintenance Treatment
n=78 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 to Week 14 and 2.4 mg on Week 15 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 2.4 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
3.6 mg BI 456906 - Planned Maintenance Treatment
n=76 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 and Week 12, 2.4 mg on Week 13 and Week 14, 3.0 mg on Week 15 and Week 16, and 3.6 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 3.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
4.8 mg BI 456906 - Planned Maintenance Treatment
n=76 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 and Week 8, 1.8 mg on Week 9 and Week 10, 2.4 mg on Week 11 and Week 12, 3.3 mg on Week 13 and Week 14, 4.2 mg on Week 15 and Week 16, and 4.8 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 4.8 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
Placebo
n=76 Participants
Participants with obesity or overweight were administered a solution for injection of Placebo, by a weekly subcutaneous injection of two syringes on the same injection day, for 46 weeks.
|
|---|---|---|---|---|---|
|
Absolute Change in Body Weight From Baseline to Week 46
|
-7.21 Kilogram (kg)
Standard Error 1.06
|
-14.75 Kilogram (kg)
Standard Error 1.03
|
-15.64 Kilogram (kg)
Standard Error 1.04
|
-18.47 Kilogram (kg)
Standard Error 1.04
|
-2.68 Kilogram (kg)
Standard Error 1.04
|
SECONDARY outcome
Timeframe: Baseline, Week 6, 12, 18, 24, 32, 40, and 46.Population: Full analysis set (FAS, all randomised participants who received at least one dose of study treatment and who have analysable data for at least one efficacy endpoint), using planned maintenance treatment. Number of participants analysed = Participants with available data for the outcome measure.
Absolute change in waist circumference from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 6, 12, 18, 24, 32, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.
Outcome measures
| Measure |
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)
n=71 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and 2, and 0.6 mg on Week 3 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20).
From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 0.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
2.4 mg BI 456906 - Planned Maintenance Treatment
n=71 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 to Week 14 and 2.4 mg on Week 15 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 2.4 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
3.6 mg BI 456906 - Planned Maintenance Treatment
n=74 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 and Week 12, 2.4 mg on Week 13 and Week 14, 3.0 mg on Week 15 and Week 16, and 3.6 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 3.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
4.8 mg BI 456906 - Planned Maintenance Treatment
n=75 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 and Week 8, 1.8 mg on Week 9 and Week 10, 2.4 mg on Week 11 and Week 12, 3.3 mg on Week 13 and Week 14, 4.2 mg on Week 15 and Week 16, and 4.8 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 4.8 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
Placebo
n=72 Participants
Participants with obesity or overweight were administered a solution for injection of Placebo, by a weekly subcutaneous injection of two syringes on the same injection day, for 46 weeks.
|
|---|---|---|---|---|---|
|
Absolute Change in Waist Circumference From Baseline to Week 46
|
-8.32 Centimeter (cm)
Standard Error 1.22
|
-14.99 Centimeter (cm)
Standard Error 1.21
|
-14.96 Centimeter (cm)
Standard Error 1.19
|
-16.01 Centimeter (cm)
Standard Error 1.19
|
-3.96 Centimeter (cm)
Standard Error 1.20
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.Population: Full analysis set (FAS, all randomised participants who received at least one dose of study treatment and who have analysable data for at least one efficacy endpoint), using planned maintenance treatment. Number of participants analysed = Participants with available data for the outcome measure.
Absolute change in systolic blood pressure from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.
Outcome measures
| Measure |
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)
n=75 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and 2, and 0.6 mg on Week 3 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20).
From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 0.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
2.4 mg BI 456906 - Planned Maintenance Treatment
n=78 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 to Week 14 and 2.4 mg on Week 15 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 2.4 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
3.6 mg BI 456906 - Planned Maintenance Treatment
n=76 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 and Week 12, 2.4 mg on Week 13 and Week 14, 3.0 mg on Week 15 and Week 16, and 3.6 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 3.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
4.8 mg BI 456906 - Planned Maintenance Treatment
n=76 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 and Week 8, 1.8 mg on Week 9 and Week 10, 2.4 mg on Week 11 and Week 12, 3.3 mg on Week 13 and Week 14, 4.2 mg on Week 15 and Week 16, and 4.8 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 4.8 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
Placebo
n=76 Participants
Participants with obesity or overweight were administered a solution for injection of Placebo, by a weekly subcutaneous injection of two syringes on the same injection day, for 46 weeks.
|
|---|---|---|---|---|---|
|
Absolute Change in Systolic Blood Pressure From Baseline to Week 46
|
-6.19 Millimeter of mercury (mmHg)
Standard Error 1.47
|
-8.08 Millimeter of mercury (mmHg)
Standard Error 1.48
|
-8.66 Millimeter of mercury (mmHg)
Standard Error 1.44
|
-8.62 Millimeter of mercury (mmHg)
Standard Error 1.46
|
-2.46 Millimeter of mercury (mmHg)
Standard Error 1.46
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.Population: Full analysis set (FAS, all randomised participants who received at least one dose of study treatment and who have analysable data for at least one efficacy endpoint), using planned maintenance treatment. Number of participants analysed = Participants with available data for the outcome measure.
Absolute change in diastolic blood pressure from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.
Outcome measures
| Measure |
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)
n=75 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and 2, and 0.6 mg on Week 3 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20).
From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 0.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
2.4 mg BI 456906 - Planned Maintenance Treatment
n=78 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 to Week 14 and 2.4 mg on Week 15 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 2.4 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
3.6 mg BI 456906 - Planned Maintenance Treatment
n=76 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 and Week 12, 2.4 mg on Week 13 and Week 14, 3.0 mg on Week 15 and Week 16, and 3.6 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 3.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
4.8 mg BI 456906 - Planned Maintenance Treatment
n=76 Participants
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 and Week 8, 1.8 mg on Week 9 and Week 10, 2.4 mg on Week 11 and Week 12, 3.3 mg on Week 13 and Week 14, 4.2 mg on Week 15 and Week 16, and 4.8 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 4.8 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
Placebo
n=76 Participants
Participants with obesity or overweight were administered a solution for injection of Placebo, by a weekly subcutaneous injection of two syringes on the same injection day, for 46 weeks.
|
|---|---|---|---|---|---|
|
Absolute Change in Diastolic Blood Pressure From Baseline to Week 46
|
-3.31 Millimeter of mercury (mmHg)
Standard Error 0.90
|
-4.36 Millimeter of mercury (mmHg)
Standard Error 0.90
|
-4.31 Millimeter of mercury (mmHg)
Standard Error 0.87
|
-4.80 Millimeter of mercury (mmHg)
Standard Error 0.89
|
-1.87 Millimeter of mercury (mmHg)
Standard Error 0.89
|
Adverse Events
0.6 mg BI 456906 - Actual Maintenance Treatment
Serious events: 2 serious events
Other events: 70 other events
Deaths: 0 deaths
2.4 mg BI 456906 - Actual Maintenance Treatment
Serious events: 3 serious events
Other events: 79 other events
Deaths: 0 deaths
3.6 mg BI 456906 - Actual Maintenance Treatment
Serious events: 4 serious events
Other events: 64 other events
Deaths: 0 deaths
4.8 mg BI 456906 - Actual Maintenance Treatment
Serious events: 4 serious events
Other events: 46 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.6 mg BI 456906 - Actual Maintenance Treatment
n=92 participants at risk
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and 2, and 0.6 mg on Week 3 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20).
From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 0.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
2.4 mg BI 456906 - Actual Maintenance Treatment
n=92 participants at risk
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 to Week 14 and 2.4 mg on Week 15 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 2.4 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
3.6 mg BI 456906 - Actual Maintenance Treatment
n=71 participants at risk
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 and Week 12, 2.4 mg on Week 13 and Week 14, 3.0 mg on Week 15 and Week 16, and 3.6 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 3.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
4.8 mg BI 456906 - Actual Maintenance Treatment
n=54 participants at risk
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 and Week 8, 1.8 mg on Week 9 and Week 10, 2.4 mg on Week 11 and Week 12, 3.3 mg on Week 13 and Week 14, 4.2 mg on Week 15 and Week 16, and 4.8 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 4.8 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
Placebo
n=77 participants at risk
Participants with obesity or overweight were administered a solution for injection of Placebo, by a weekly subcutaneous injection of two syringes on the same injection day, for 46 weeks.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.1%
1/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.9%
1/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.9%
1/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.3%
1/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.1%
1/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.9%
1/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.3%
1/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.4%
1/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.4%
1/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
1/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.3%
1/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
1.1%
1/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.9%
1/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.4%
1/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.1%
1/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal failure
|
1.1%
1/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.3%
1/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.9%
1/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.3%
1/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.4%
1/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
0.6 mg BI 456906 - Actual Maintenance Treatment
n=92 participants at risk
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and 2, and 0.6 mg on Week 3 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20).
From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 0.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
2.4 mg BI 456906 - Actual Maintenance Treatment
n=92 participants at risk
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 to Week 14 and 2.4 mg on Week 15 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 2.4 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
3.6 mg BI 456906 - Actual Maintenance Treatment
n=71 participants at risk
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 to Week 10, 1.8 mg on Week 11 and Week 12, 2.4 mg on Week 13 and Week 14, 3.0 mg on Week 15 and Week 16, and 3.6 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 3.6 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
4.8 mg BI 456906 - Actual Maintenance Treatment
n=54 participants at risk
Participants with obesity or overweight were administered a solution for injection of BI 456906, by a weekly subcutaneous injection of two syringes (0.5 mL filling volume per syringe) on the same injection day, of 0.3 mg on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5 and Week 6, 1.2 mg on Week 7 and Week 8, 1.8 mg on Week 9 and Week 10, 2.4 mg on Week 11 and Week 12, 3.3 mg on Week 13 and Week 14, 4.2 mg on Week 15 and Week 16, and 4.8 mg on Week 17 to Week 20 (dose escalation phase, with fixed dose escalation from Week 1 to Week 10 and flexible dose escalation from Week 11 to Week 20). From Week 21 to Week 46 (maintenance dosing phase) participants stayed on the dose of 4.8 mg BI 456906.
Participant not tolerating the assigned dose escalation schedule due to gastrointestinal adverse events had the option of dose adjustment during the flexible part of the dose escalation phase (Week 11 - 20) which could lead to a maintenance dose lower than the dose the participant was randomised to.
|
Placebo
n=77 participants at risk
Participants with obesity or overweight were administered a solution for injection of Placebo, by a weekly subcutaneous injection of two syringes on the same injection day, for 46 weeks.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
4.3%
4/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
4.3%
4/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
9.9%
7/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
5.6%
3/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
3.9%
3/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
4/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
10.9%
10/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
7.0%
5/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
5.6%
3/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.3%
1/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
3/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
5.4%
5/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
11.3%
8/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
3.7%
2/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.3%
1/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
12.0%
11/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
20.7%
19/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
31.0%
22/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
24.1%
13/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
5.2%
4/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.9%
22/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
22.8%
21/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
23.9%
17/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
16.7%
9/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
10.4%
8/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.6%
7/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
9.8%
9/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
11.3%
8/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
13.0%
7/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
3.9%
3/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Eructation
|
4.3%
4/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
6.5%
6/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
7.0%
5/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
3.7%
2/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.2%
2/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
7.6%
7/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
14.1%
10/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
9.3%
5/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
3.9%
3/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.4%
1/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
5.6%
3/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.3%
1/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
39.1%
36/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
65.2%
60/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
63.4%
45/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
59.3%
32/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
19.5%
15/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
14.1%
13/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
30.4%
28/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
39.4%
28/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
24.1%
13/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
5.2%
4/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
6.5%
6/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
5.4%
5/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
18.3%
13/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
9.3%
5/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
7.8%
6/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
General disorders
Injection site bruising
|
3.3%
3/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
3.3%
3/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
2.8%
2/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
5.6%
3/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
5.2%
4/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Infections and infestations
COVID-19
|
19.6%
18/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
12.0%
11/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
23.9%
17/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
13.0%
7/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
22.1%
17/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
8/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
5.4%
5/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
8.5%
6/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
5.6%
3/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
9.1%
7/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
2/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.1%
1/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
7.0%
5/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
7.4%
4/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
3.9%
3/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
4.3%
4/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
2.2%
2/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
8.5%
6/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
3.7%
2/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
2.6%
2/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.0%
11/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
10.9%
10/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
22.5%
16/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
5.6%
3/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.3%
1/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.9%
10/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
3.3%
3/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
11.3%
8/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
3.7%
2/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
6.5%
5/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.6%
7/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
2.2%
2/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
5.6%
4/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
3.7%
2/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
3.9%
3/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
1.1%
1/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
8.7%
8/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
14.1%
10/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
7.4%
4/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
2.6%
2/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
8.7%
8/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
7.6%
7/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
14.1%
10/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
9.3%
5/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
7.8%
6/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
3.3%
3/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
5.4%
5/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.4%
1/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.9%
1/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
1.3%
1/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
2/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
2.2%
2/92 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
5.6%
4/71 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
0.00%
0/54 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
2.6%
2/77 • From first drug administration until last drug administration, plus 28 days residual effect period (REP), up to 360 days.
Safety analysis was performed on the treated set (TS) according to actual maintenance treatment (defined as the actual dose participants received during the dose maintenance phase, or as the next planned maintenance dose up from the last dose taken prior to treatment discontinuation). Treated Set (TS): All randomised participants who received at least one dose of study treatment.
|
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER