Trial Outcomes & Findings for Dose Range Finding Study of Bimagrumab in Sarcopenia (NCT NCT02333331)
NCT ID: NCT02333331
Last Updated: 2021-01-05
Results Overview
Change from Baseline in total Short Physical Performance Battery (SPPB) Score to week 25; SPPB is a series of six activities involving three domains of physical function - balance, usual walking speed and rising from a chair , is commonly used globally to assess and quantify (score 0-12) lower extremity function and has been shown to predict future adverse health events. A decline of one or more points in the SPPB total score is predictive of a decrease in lower extremity function and future adverse clinical outcomes in older adults, including falls, hospitalizations, institutionalization, incident disability and death
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
217 participants
Primary outcome timeframe
Baseline, week 25
Results posted on
2021-01-05
Participant Flow
A total of 220 patients were randomized to receive six doses of either BYM338 70 mg, BYM338 210 mg, BYM338 700 mg or the placebo. However, only 217 patients were enrolled and dosed with BYM338 or placebo due to the withdrawal of three patients who did not meet the inclusion/exclusion criteria prior to receiving the first dose.
Participant milestones
| Measure |
BYM338 70 mg
BYM338 70 mg intravenous infusion
|
BYM338 210 mg
BYM338 210 mg intravenous infusion
|
BYM338 700 mg
BYM338 700 mg intravenous infusion
|
Placebo
Placebo intravenous infusion
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
113
|
67
|
|
Overall Study
COMPLETED
|
17
|
12
|
95
|
64
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
18
|
3
|
Reasons for withdrawal
| Measure |
BYM338 70 mg
BYM338 70 mg intravenous infusion
|
BYM338 210 mg
BYM338 210 mg intravenous infusion
|
BYM338 700 mg
BYM338 700 mg intravenous infusion
|
Placebo
Placebo intravenous infusion
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
4
|
1
|
|
Overall Study
Death
|
0
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Deviation
|
0
|
3
|
2
|
1
|
|
Overall Study
Patient/Guardian Decision
|
1
|
2
|
9
|
1
|
Baseline Characteristics
Dose Range Finding Study of Bimagrumab in Sarcopenia
Baseline characteristics by cohort
| Measure |
BYM338 70 mg
n=19 Participants
BYM338 70 mg intravenous infusion
|
BYM338 210 mg
n=18 Participants
BYM338 210 mg intravenous infusion
|
BYM338 700 mg
n=113 Participants
BYM338 700 mg intravenous infusion
|
Placebo
n=67 Participants
Placebo intravenous infusion
|
Total
n=217 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
79.3 years
STANDARD_DEVIATION 5.89 • n=93 Participants
|
78.0 years
STANDARD_DEVIATION 6.38 • n=4 Participants
|
79.5 years
STANDARD_DEVIATION 5.46 • n=27 Participants
|
78.3 years
STANDARD_DEVIATION 5.03 • n=483 Participants
|
79.0 years
STANDARD_DEVIATION 5.45 • n=36 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
43 Participants
n=483 Participants
|
126 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
91 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
36 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
93 Participants
n=27 Participants
|
54 Participants
n=483 Participants
|
172 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 25Population: Full Analysis Set (FAS) -comprised all patients to whom study treatment had been assigned. Following the intent to treat principle, patients were analyzed according to treatment assigned at randomization.
Change from Baseline in total Short Physical Performance Battery (SPPB) Score to week 25; SPPB is a series of six activities involving three domains of physical function - balance, usual walking speed and rising from a chair , is commonly used globally to assess and quantify (score 0-12) lower extremity function and has been shown to predict future adverse health events. A decline of one or more points in the SPPB total score is predictive of a decrease in lower extremity function and future adverse clinical outcomes in older adults, including falls, hospitalizations, institutionalization, incident disability and death
Outcome measures
| Measure |
BYM338 70 mg
n=19 Participants
BYM338 70 mg intravenous infusion
|
BYM338 210 mg
n=18 Participants
BYM338 210 mg intravenous infusion
|
BYM338 700 mg
n=113 Participants
BYM338 700 mg intravenous infusion
|
Placebo
n=67 Participants
Placebo intravenous infusion
|
|---|---|---|---|---|
|
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25
Baseline
|
7.1 Score on a scale
Standard Deviation 2.12
|
7.3 Score on a scale
Standard Deviation 2.11
|
7.2 Score on a scale
Standard Deviation 1.63
|
7.3 Score on a scale
Standard Deviation 1.67
|
|
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25
Week 25
|
8.5 Score on a scale
Standard Deviation 2.48
|
8.7 Score on a scale
Standard Deviation 1.64
|
8.7 Score on a scale
Standard Deviation 2.12
|
8.4 Score on a scale
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: Baseline, week 25Population: Full Analysis Set (FAS) -comprised all patients to whom study treatment had been assigned. Following the intent to treat principle, patients were analyzed according to treatment assigned at randomization.
Change from Baseline at Week 25 in the 6 minute walk test (6MWT) distance to measure improvement in physical function
Outcome measures
| Measure |
BYM338 70 mg
n=19 Participants
BYM338 70 mg intravenous infusion
|
BYM338 210 mg
n=18 Participants
BYM338 210 mg intravenous infusion
|
BYM338 700 mg
n=113 Participants
BYM338 700 mg intravenous infusion
|
Placebo
n=67 Participants
Placebo intravenous infusion
|
|---|---|---|---|---|
|
Change From Baseline at Week 25 in the 6 Minute Walk Test (6MWT) Distance
Baseline
|
293.30 meters
Standard Deviation 91.842
|
291.81 meters
Standard Deviation 82.527
|
294.30 meters
Standard Deviation 83.602
|
312.43 meters
Standard Deviation 93.924
|
|
Change From Baseline at Week 25 in the 6 Minute Walk Test (6MWT) Distance
Week 25
|
304.98 meters
Standard Deviation 102.934
|
340.71 meters
Standard Deviation 72.911
|
315.32 meters
Standard Deviation 97.020
|
322.71 meters
Standard Deviation 103.865
|
SECONDARY outcome
Timeframe: baseline, week 25Population: Full Analysis Set (FAS) -comprised all patients to whom study treatment had been assigned. Following the intent to treat principle, patients were analyzed according to treatment assigned at randomization.
Change from Baseline to Week 25 in usual Gait speed (GS) over 4 meters Gait speed in this study was assessed as part of the SPPB, over a 4 meter distance of a 6 meter course. This test assessed a person's usual walking speed, which was defined as the speed a person normally walks from one place to another without urgency (e.g., walking down a hallway).
Outcome measures
| Measure |
BYM338 70 mg
n=19 Participants
BYM338 70 mg intravenous infusion
|
BYM338 210 mg
n=18 Participants
BYM338 210 mg intravenous infusion
|
BYM338 700 mg
n=113 Participants
BYM338 700 mg intravenous infusion
|
Placebo
n=67 Participants
Placebo intravenous infusion
|
|---|---|---|---|---|
|
Change From Baseline to Week 25 in Usual Gait Speed (GS) Over 4 Meters
Baseline
|
2.37 m/sec
Standard Deviation 0.684
|
2.72 m/sec
Standard Deviation 0.752
|
2.58 m/sec
Standard Deviation 0.624
|
2.70 m/sec
Standard Deviation 0.493
|
|
Change From Baseline to Week 25 in Usual Gait Speed (GS) Over 4 Meters
Week 25
|
3.12 m/sec
Standard Deviation 0.857
|
3.60 m/sec
Standard Deviation 0.699
|
3.30 m/sec
Standard Deviation 0.902
|
3.23 m/sec
Standard Deviation 0.838
|
SECONDARY outcome
Timeframe: baseline, week 25Population: Full Analysis Set (FAS) -comprised all patients to whom study treatment had been assigned. Following the intent to treat principle, patients were analyzed according to treatment assigned at randomization.
Change from Baseline to Week 25 on appendicular skeletal muscle index (ASMI) measured by Dual Energy X-ray Absorptiometry (DXA) Appendicular skeletal muscle index (ASMI) is a core requirement for determining the presence of sarcopenia and is calculated as the sum of the appendicular lean mass (kg) of the two upper and two lower limbs quantified by DXA, divided by height (m\^2). Therefore, an increase in ASMI indicates an increase in the quantity of an individual's lean mass.
Outcome measures
| Measure |
BYM338 70 mg
n=19 Participants
BYM338 70 mg intravenous infusion
|
BYM338 210 mg
n=18 Participants
BYM338 210 mg intravenous infusion
|
BYM338 700 mg
n=113 Participants
BYM338 700 mg intravenous infusion
|
Placebo
n=67 Participants
Placebo intravenous infusion
|
|---|---|---|---|---|
|
Percentage Change From Baseline to Week 25 on Appendicular Skeletal Muscle Index (ASMI) Measured by Dual Energy X-ray Absorptiometry (DXA)
Baseline
|
5.99 Percent Change
Standard Deviation 0.886
|
5.87 Percent Change
Standard Deviation 0.795
|
5.70 Percent Change
Standard Deviation 0.823
|
5.55 Percent Change
Standard Deviation 0.753
|
|
Percentage Change From Baseline to Week 25 on Appendicular Skeletal Muscle Index (ASMI) Measured by Dual Energy X-ray Absorptiometry (DXA)
Week 25
|
6.04 Percent Change
Standard Deviation 0.947
|
6.42 Percent Change
Standard Deviation 0.849
|
6.10 Percent Change
Standard Deviation 0.836
|
5.60 Percent Change
Standard Deviation 0.717
|
SECONDARY outcome
Timeframe: baseline, week 25Population: Full Analysis Set (FAS) -comprised all patients to whom study treatment had been assigned. Following the intent to treat principle, patients were analyzed according to treatment assigned at randomization.
Change from Baseline to Week 25 on Total lean body mass and appendicular skeletal muscle index (ASMI) measured by Dual Energy X-ray Absorptiometry (DXA) total lean body mass (LBM) is measured by dual energy x-ray absorptiometry (DXA).Percent Change = \[(LBM at Visit - LBM at Baseline) / LBM at Baseline\] \* 100.
Outcome measures
| Measure |
BYM338 70 mg
n=19 Participants
BYM338 70 mg intravenous infusion
|
BYM338 210 mg
n=18 Participants
BYM338 210 mg intravenous infusion
|
BYM338 700 mg
n=113 Participants
BYM338 700 mg intravenous infusion
|
Placebo
n=67 Participants
Placebo intravenous infusion
|
|---|---|---|---|---|
|
Percentage Change From Baseline to Week 25 on Total Lean Body Mass Measured by Dual Energy X-ray Absorptiometry (DXA)
Baseline
|
37.44 Percent Change
Standard Deviation 8.507
|
35.84 Percent Change
Standard Deviation 7.300
|
35.39 Percent Change
Standard Deviation 8.891
|
33.65 Percent Change
Standard Deviation 6.890
|
|
Percentage Change From Baseline to Week 25 on Total Lean Body Mass Measured by Dual Energy X-ray Absorptiometry (DXA)
Week 25
|
38.26 Percent Change
Standard Deviation 8.660
|
39.52 Percent Change
Standard Deviation 8.343
|
37.86 Percent Change
Standard Deviation 9.064
|
33.95 Percent Change
Standard Deviation 6.921
|
Adverse Events
BYM338 70 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
BYM338 210 mg
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
BYM338 700 mg
Serious events: 14 serious events
Other events: 94 other events
Deaths: 2 deaths
Placebo
Serious events: 5 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BYM338 70 mg
n=19 participants at risk
BYM338 70 mg intravenous infusion
|
BYM338 210 mg
n=18 participants at risk
BYM338 210 mg intravenous infusion
|
BYM338 700 mg
n=113 participants at risk
BYM338 700 mg intravenous infusion
|
Placebo
n=67 participants at risk
Placebo intravenous infusion
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.5%
1/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
General disorders
Asthenia
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.5%
1/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Infections and infestations
Influenza
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.5%
1/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Injury, poisoning and procedural complications
Aortic injury
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.5%
1/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.5%
1/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.5%
1/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.5%
1/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Nervous system disorders
Syncope
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Vascular disorders
Hypertension
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
Other adverse events
| Measure |
BYM338 70 mg
n=19 participants at risk
BYM338 70 mg intravenous infusion
|
BYM338 210 mg
n=18 participants at risk
BYM338 210 mg intravenous infusion
|
BYM338 700 mg
n=113 participants at risk
BYM338 700 mg intravenous infusion
|
Placebo
n=67 participants at risk
Placebo intravenous infusion
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
2.7%
3/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Cardiac disorders
Bradycardia
|
10.5%
2/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
2.7%
3/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.8%
2/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Ear and labyrinth disorders
Vertigo
|
10.5%
2/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
3.0%
2/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Endocrine disorders
Androgen deficiency
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Eye disorders
Trichiasis
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.3%
6/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.5%
1/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Gastrointestinal disorders
Dental necrosis
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
16.7%
3/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
19.5%
22/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
3.0%
2/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.5%
1/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
7.1%
8/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Gastrointestinal disorders
Toothache
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
3.5%
4/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
General disorders
Chest discomfort
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
General disorders
Fatigue
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
4.4%
5/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
General disorders
Infusion site swelling
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.5%
1/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
General disorders
Oedema
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
General disorders
Peripheral swelling
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.3%
6/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
3.0%
2/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Infections and infestations
Fungal skin infection
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Infections and infestations
Gingivitis
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
15.8%
3/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
4.4%
5/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Infections and infestations
Periodontitis
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
3.5%
4/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.5%
1/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
11.1%
2/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
4.4%
5/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
7.5%
5/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.3%
6/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.5%
1/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Infections and infestations
Vaginal infection
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Infections and infestations
Viral infection
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
4.4%
5/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.5%
1/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
4.4%
5/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
10.4%
7/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
10.5%
2/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
16.7%
3/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
24.8%
28/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
35.8%
24/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.8%
2/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
3.0%
2/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Injury, poisoning and procedural complications
Wound
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Investigations
Amylase increased
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
3.5%
4/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
2.7%
3/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.5%
1/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Investigations
C-reactive protein increased
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.5%
1/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Investigations
Lipase increased
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.3%
6/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Investigations
Liver function test increased
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
4.4%
5/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.8%
2/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
3.0%
2/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
11.1%
2/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
4.4%
5/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
4.5%
3/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
21.1%
4/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
27.8%
5/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
32.7%
37/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
14.9%
10/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.8%
2/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.5%
1/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
2.7%
3/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
3.0%
2/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
3.5%
4/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
3.0%
2/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.3%
6/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
4.5%
3/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.3%
6/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
3.5%
4/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Nervous system disorders
Headache
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
4.4%
5/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
4.5%
3/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Nervous system disorders
Muscle contractions involuntary
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
2.7%
3/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Nervous system disorders
Presyncope
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Product Issues
Device dislocation
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Psychiatric disorders
Insomnia
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Renal and urinary disorders
Nocturia
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
3.5%
4/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
16.7%
3/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
2.7%
3/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.8%
2/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.5%
1/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
1.8%
2/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
4.4%
5/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
5.3%
1/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.88%
1/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
0.00%
0/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
|
Vascular disorders
Hypertension
|
0.00%
0/19 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
5.6%
1/18 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
8.0%
9/113 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
6.0%
4/67 • Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER