Trial Outcomes & Findings for Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients (NCT NCT01925209)
NCT ID: NCT01925209
Last Updated: 2017-08-11
Results Overview
The 6MWD test measured the distance (in meters) that a participant walked in a 6 minute timeframe. A positive change from baseline indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
251 participants
Primary outcome timeframe
Baseline, Week 52
Results posted on
2017-08-11
Participant Flow
Participants were randomized into one of the four treatment arms in a 1:1:1:1 ratio.
The study included 4 epochs: screening (up to 28 days pre-treatment), treatment (from day 1 up to 52 weeks), treatment maintenance (from week 52 up to 104 weeks) and follow-up (28 days after last dose administration).
Participant milestones
| Measure |
BYM338/Bimagrumab 10 mg/kg
Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
|
BYM338/Bimagrumab 3 mg/kg
Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
BYM338/Bimagrumab 1 mg/kg
Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
Placebo
Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
|---|---|---|---|---|
|
Treatment Epoch
STARTED
|
63
|
63
|
63
|
62
|
|
Treatment Epoch
Full Analysis Set
|
63
|
63
|
63
|
62
|
|
Treatment Epoch
COMPLETED
|
54
|
55
|
56
|
57
|
|
Treatment Epoch
NOT COMPLETED
|
9
|
8
|
7
|
5
|
|
Maintenance Treatment Epoch
STARTED
|
49
|
46
|
52
|
50
|
|
Maintenance Treatment Epoch
COMPLETED
|
49
|
45
|
50
|
48
|
|
Maintenance Treatment Epoch
NOT COMPLETED
|
0
|
1
|
2
|
2
|
|
Follow-up
STARTED
|
57
|
61
|
56
|
58
|
|
Follow-up
COMPLETED
|
56
|
55
|
55
|
54
|
|
Follow-up
NOT COMPLETED
|
1
|
6
|
1
|
4
|
Reasons for withdrawal
| Measure |
BYM338/Bimagrumab 10 mg/kg
Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
|
BYM338/Bimagrumab 3 mg/kg
Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
BYM338/Bimagrumab 1 mg/kg
Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
Placebo
Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
|---|---|---|---|---|
|
Treatment Epoch
Physician Decision
|
1
|
0
|
0
|
0
|
|
Treatment Epoch
Non-compliance with study treatment
|
0
|
0
|
0
|
1
|
|
Treatment Epoch
Death
|
1
|
0
|
0
|
0
|
|
Treatment Epoch
Protocol deviation
|
0
|
0
|
1
|
1
|
|
Treatment Epoch
Withdrawal by Subject
|
4
|
3
|
3
|
2
|
|
Treatment Epoch
Adverse Event
|
3
|
5
|
3
|
1
|
|
Maintenance Treatment Epoch
Withdrawal by Subject
|
0
|
1
|
1
|
2
|
|
Maintenance Treatment Epoch
Adverse Event
|
0
|
0
|
1
|
0
|
|
Follow-up
Adverse Event
|
1
|
4
|
0
|
1
|
|
Follow-up
Physician Decision
|
0
|
0
|
1
|
0
|
|
Follow-up
Non-compliance with study treatment
|
0
|
0
|
0
|
1
|
|
Follow-up
Withdrawal by Subject
|
0
|
2
|
0
|
2
|
Baseline Characteristics
Efficacy and Safety of Bimagrumab/BYM338 at 52 Weeks on Physical Function, Muscle Strength, Mobility in sIBM Patients
Baseline characteristics by cohort
| Measure |
BYM338/Bimagrumab 10 mg/kg
n=63 Participants
Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
|
BYM338/Bimagrumab 3 mg/kg
n=63 Participants
Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
BYM338/Bimagrumab 1 mg/kg
n=63 Participants
Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
Placebo
n=62 Participants
Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
68.0 Years
STANDARD_DEVIATION 7.93 • n=93 Participants
|
66.5 Years
STANDARD_DEVIATION 8.72 • n=4 Participants
|
69.4 Years
STANDARD_DEVIATION 7.91 • n=27 Participants
|
68.4 Years
STANDARD_DEVIATION 8.12 • n=483 Participants
|
68.1 Years
STANDARD_DEVIATION 8.20 • n=36 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
89 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
39 Participants
n=483 Participants
|
162 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was considered for the analysis. Only those participants from the FAS who had both baseline and week 52 6MWD measurements were analyzed.
The 6MWD test measured the distance (in meters) that a participant walked in a 6 minute timeframe. A positive change from baseline indicates improvement.
Outcome measures
| Measure |
BYM338/Bimagrumab 10 mg/kg
n=61 Participants
Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
|
BYM338/Bimagrumab 3 mg/kg
n=63 Participants
Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
BYM338/Bimagrumab 1 mg/kg
n=63 Participants
Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
Placebo
n=62 Participants
Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52
|
8.63 meters
Standard Error 10.934
|
9.63 meters
Standard Error 10.770
|
-10.27 meters
Standard Error 10.718
|
-8.96 meters
Standard Error 10.765
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was considered for the analysis. Only those participants from the FAS who had both baseline and week 52 LBM measurements were analyzed.
LBM was measured via dual energy x-ray absorptiometry (DXA) and calculated as (LBM at Week 52/LBM at baseline)\*100 . A positive change from baseline indicates improvement.
Outcome measures
| Measure |
BYM338/Bimagrumab 10 mg/kg
n=62 Participants
Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
|
BYM338/Bimagrumab 3 mg/kg
n=61 Participants
Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
BYM338/Bimagrumab 1 mg/kg
n=63 Participants
Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
Placebo
n=61 Participants
Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
|---|---|---|---|---|
|
Estimated Within Treatment Group Lean Body Mass (LBM) Ratio at Week 52
|
102.8 Percentage
Interval 101.4 to 104.2
|
100.4 Percentage
Interval 99.1 to 101.8
|
98.3 Percentage
Interval 97.0 to 99.6
|
97.2 Percentage
Interval 95.9 to 98.5
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was considered for the analysis. Only those participants from the FAS who had both baseline and week 52 QMT measurements were analyzed.
Quadriceps muscle strength was measured by portable fixed dynamometry (PFD) on the right side. A negative change from baseline indicates deterioration.
Outcome measures
| Measure |
BYM338/Bimagrumab 10 mg/kg
n=60 Participants
Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
|
BYM338/Bimagrumab 3 mg/kg
n=63 Participants
Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
BYM338/Bimagrumab 1 mg/kg
n=63 Participants
Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
Placebo
n=61 Participants
Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side at Week 52
|
-12.44 newtons
Standard Error 6.021
|
-20.36 newtons
Standard Error 5.843
|
-14.89 newtons
Standard Error 5.828
|
-16.48 newtons
Standard Error 5.830
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was considered for the analysis. Only those participants from the FAS who had both baseline and week 52 sIFA measurements were analyzed.
Self-reported physical function was assessed by a newly developed patient reported outcome named sporadic inclusion body myositis (sIBM) functional assessment (sIFA). The sIFA consists of 11 items scored on an 11 point numerical rating scale from 0 (no difficulty) to 10 (unable to do) across 3 domains: upper body functioning, lower body functioning and general functioning. Participants completed the assessment where the recall period was the past week prior to completing the patient reported outcome (PRO). The total score on the sIFA scale ranges from 0 (minimum) to 110 (maximum). Higher values represent a worse outcome. A positive change from baseline indicates deterioration.
Outcome measures
| Measure |
BYM338/Bimagrumab 10 mg/kg
n=61 Participants
Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
|
BYM338/Bimagrumab 3 mg/kg
n=63 Participants
Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
BYM338/Bimagrumab 1 mg/kg
n=60 Participants
Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
Placebo
n=61 Participants
Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score at Week 52
|
1.74 score on a scale
Standard Error 1.915
|
3.56 score on a scale
Standard Error 1.876
|
6.12 score on a scale
Standard Error 1.899
|
6.85 score on a scale
Standard Error 1.895
|
SECONDARY outcome
Timeframe: Week 52Population: The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was analyzed.
Participants documented any fall occurrences in a paper diary during the study.
Outcome measures
| Measure |
BYM338/Bimagrumab 10 mg/kg
n=63 Participants
Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
|
BYM338/Bimagrumab 3 mg/kg
n=63 Participants
Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
BYM338/Bimagrumab 1 mg/kg
n=63 Participants
Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
Placebo
n=62 Participants
Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
|---|---|---|---|---|
|
Estimated Annual Number of Falls Per Patient Within Treatment Group
|
4.33 Annual number of falls per participant
|
4.02 Annual number of falls per participant
|
4.70 Annual number of falls per participant
|
5.13 Annual number of falls per participant
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was analyzed.
The SPPB evaluated lower extremities function by testing gait speed, ability to keep standing balance and time to rise from a chair five times. The sub-score for each test ranged from 0 to 4. The summary score, which was a summation of scores from the 3 tests, ranged from 0 to 12. An increase in score indicates improvement in physical performance. A negative change from baseline indicates deterioration.
Outcome measures
| Measure |
BYM338/Bimagrumab 10 mg/kg
n=62 Participants
Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
|
BYM338/Bimagrumab 3 mg/kg
n=63 Participants
Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
BYM338/Bimagrumab 1 mg/kg
n=63 Participants
Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
Placebo
n=62 Participants
Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Short Physical Performance Battery (SPPB) Score at Week 52
|
0.0 score on a scale
Standard Error 0.24
|
0.0 score on a scale
Standard Error 0.23
|
-0.5 score on a scale
Standard Error 0.23
|
-0.5 score on a scale
Standard Error 0.23
|
Adverse Events
BYM338/Bimagrumab 10 mg/kg
Serious events: 21 serious events
Other events: 63 other events
Deaths: 0 deaths
BYM338/Bimagrumab 3 mg/kg
Serious events: 11 serious events
Other events: 63 other events
Deaths: 0 deaths
BYM338/Bimagrumab 1 mg/kg
Serious events: 18 serious events
Other events: 63 other events
Deaths: 0 deaths
Placebo
Serious events: 20 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BYM338/Bimagrumab 10 mg/kg
n=63 participants at risk
Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
|
BYM338/Bimagrumab 3 mg/kg
n=63 participants at risk
Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
BYM338/Bimagrumab 1 mg/kg
n=63 participants at risk
Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
Placebo
n=62 participants at risk
Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Eye disorders
RETINAL ARTERY OCCLUSION
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Gastrointestinal disorders
DIARRHOEA
|
4.8%
3/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
3.2%
2/62 • up to 2 years
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Gastrointestinal disorders
VOLVULUS
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
General disorders
INJURY ASSOCIATED WITH DEVICE
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Infections and infestations
DIVERTICULITIS
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Infections and infestations
STREPTOCOCCAL BACTERAEMIA
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
CARBON MONOXIDE POISONING
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
CERVICAL VERTEBRAL FRACTURE
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
ENDOTRACHEAL INTUBATION COMPLICATION
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
EYE INJURY
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
FALL
|
3.2%
2/63 • up to 2 years
|
3.2%
2/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
INTENTIONAL OVERDOSE
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
PATELLA FRACTURE
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
SPINAL CORD INJURY CERVICAL
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
3.2%
2/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMATOMA
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
1.6%
1/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
VERTEBRAL FORAMINAL STENOSIS
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
4.8%
3/63 • up to 2 years
|
4.8%
3/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
4.8%
3/62 • up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
3.2%
2/63 • up to 2 years
|
3.2%
2/63 • up to 2 years
|
3.2%
2/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Nervous system disorders
SYNCOPE
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Nervous system disorders
TRANSIENT GLOBAL AMNESIA
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Renal and urinary disorders
BLADDER MASS
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Renal and urinary disorders
URINARY RETENTION
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Vascular disorders
AORTIC ANEURYSM
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
Other adverse events
| Measure |
BYM338/Bimagrumab 10 mg/kg
n=63 participants at risk
Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
|
BYM338/Bimagrumab 3 mg/kg
n=63 participants at risk
Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
BYM338/Bimagrumab 1 mg/kg
n=63 participants at risk
Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
Placebo
n=62 participants at risk
Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
7.9%
5/63 • up to 2 years
|
4.8%
3/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
4.8%
3/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
3.2%
2/63 • up to 2 years
|
9.5%
6/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Gastrointestinal disorders
CONSTIPATION
|
9.5%
6/63 • up to 2 years
|
4.8%
3/63 • up to 2 years
|
9.5%
6/63 • up to 2 years
|
4.8%
3/62 • up to 2 years
|
|
Gastrointestinal disorders
DIARRHOEA
|
50.8%
32/63 • up to 2 years
|
44.4%
28/63 • up to 2 years
|
31.7%
20/63 • up to 2 years
|
17.7%
11/62 • up to 2 years
|
|
Gastrointestinal disorders
DRY MOUTH
|
7.9%
5/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
4.8%
3/63 • up to 2 years
|
6.5%
4/62 • up to 2 years
|
|
Gastrointestinal disorders
DYSPHAGIA
|
7.9%
5/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
8.1%
5/62 • up to 2 years
|
|
Gastrointestinal disorders
NAUSEA
|
17.5%
11/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
14.3%
9/63 • up to 2 years
|
8.1%
5/62 • up to 2 years
|
|
Gastrointestinal disorders
VOMITING
|
6.3%
4/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
3.2%
2/63 • up to 2 years
|
4.8%
3/62 • up to 2 years
|
|
General disorders
ASTHENIA
|
1.6%
1/63 • up to 2 years
|
4.8%
3/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
9.7%
6/62 • up to 2 years
|
|
General disorders
FATIGUE
|
14.3%
9/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
22.2%
14/63 • up to 2 years
|
11.3%
7/62 • up to 2 years
|
|
General disorders
OEDEMA PERIPHERAL
|
7.9%
5/63 • up to 2 years
|
14.3%
9/63 • up to 2 years
|
14.3%
9/63 • up to 2 years
|
11.3%
7/62 • up to 2 years
|
|
General disorders
PYREXIA
|
4.8%
3/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
4.8%
3/63 • up to 2 years
|
8.1%
5/62 • up to 2 years
|
|
Infections and infestations
FOLLICULITIS
|
6.3%
4/63 • up to 2 years
|
3.2%
2/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Infections and infestations
INFLUENZA
|
3.2%
2/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
3.2%
2/62 • up to 2 years
|
|
Infections and infestations
NASOPHARYNGITIS
|
9.5%
6/63 • up to 2 years
|
17.5%
11/63 • up to 2 years
|
14.3%
9/63 • up to 2 years
|
9.7%
6/62 • up to 2 years
|
|
Infections and infestations
RHINITIS
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
6.5%
4/62 • up to 2 years
|
|
Infections and infestations
SINUSITIS
|
1.6%
1/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
6.5%
4/62 • up to 2 years
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
17.5%
11/63 • up to 2 years
|
17.5%
11/63 • up to 2 years
|
22.2%
14/63 • up to 2 years
|
16.1%
10/62 • up to 2 years
|
|
Infections and infestations
URINARY TRACT INFECTION
|
6.3%
4/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
3.2%
2/63 • up to 2 years
|
6.5%
4/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
CONTUSION
|
22.2%
14/63 • up to 2 years
|
36.5%
23/63 • up to 2 years
|
34.9%
22/63 • up to 2 years
|
35.5%
22/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
FALL
|
74.6%
47/63 • up to 2 years
|
87.3%
55/63 • up to 2 years
|
85.7%
54/63 • up to 2 years
|
83.9%
52/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
4.8%
3/63 • up to 2 years
|
4.8%
3/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
6.5%
4/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
6.3%
4/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
4.8%
3/63 • up to 2 years
|
4.8%
3/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
INJURY
|
6.3%
4/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
11.1%
7/63 • up to 2 years
|
4.8%
3/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
7.9%
5/63 • up to 2 years
|
4.8%
3/63 • up to 2 years
|
9.5%
6/63 • up to 2 years
|
8.1%
5/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
LACERATION
|
9.5%
6/63 • up to 2 years
|
7.9%
5/63 • up to 2 years
|
19.0%
12/63 • up to 2 years
|
14.5%
9/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
11.1%
7/63 • up to 2 years
|
15.9%
10/63 • up to 2 years
|
14.3%
9/63 • up to 2 years
|
16.1%
10/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
7.9%
5/63 • up to 2 years
|
11.1%
7/63 • up to 2 years
|
3.2%
2/63 • up to 2 years
|
12.9%
8/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
SKIN ABRASION
|
22.2%
14/63 • up to 2 years
|
22.2%
14/63 • up to 2 years
|
22.2%
14/63 • up to 2 years
|
27.4%
17/62 • up to 2 years
|
|
Injury, poisoning and procedural complications
SOFT TISSUE INJURY
|
4.8%
3/63 • up to 2 years
|
7.9%
5/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
4.8%
3/63 • up to 2 years
|
7.9%
5/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Investigations
VITAMIN D DECREASED
|
6.3%
4/63 • up to 2 years
|
3.2%
2/63 • up to 2 years
|
4.8%
3/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Investigations
WEIGHT DECREASED
|
14.3%
9/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
12.7%
8/63 • up to 2 years
|
4.8%
3/62 • up to 2 years
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
15.9%
10/63 • up to 2 years
|
4.8%
3/63 • up to 2 years
|
4.8%
3/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Metabolism and nutrition disorders
GOUT
|
4.8%
3/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
3.2%
2/62 • up to 2 years
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
3.2%
2/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
3.2%
2/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
6.3%
4/63 • up to 2 years
|
3.2%
2/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
9.5%
6/63 • up to 2 years
|
19.0%
12/63 • up to 2 years
|
4.8%
3/63 • up to 2 years
|
17.7%
11/62 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
23.8%
15/63 • up to 2 years
|
22.2%
14/63 • up to 2 years
|
30.2%
19/63 • up to 2 years
|
24.2%
15/62 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
15.9%
10/63 • up to 2 years
|
12.7%
8/63 • up to 2 years
|
22.2%
14/63 • up to 2 years
|
14.5%
9/62 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
7.9%
5/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
9.7%
6/62 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
50.8%
32/63 • up to 2 years
|
68.3%
43/63 • up to 2 years
|
39.7%
25/63 • up to 2 years
|
21.0%
13/62 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE TWITCHING
|
3.2%
2/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
3.2%
2/63 • up to 2 years
|
6.5%
4/62 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
3.2%
2/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
4.8%
3/63 • up to 2 years
|
4.8%
3/62 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
7.9%
5/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
11.1%
7/63 • up to 2 years
|
6.5%
4/62 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
6.3%
4/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
3.2%
2/62 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
7.9%
5/63 • up to 2 years
|
17.5%
11/63 • up to 2 years
|
11.1%
7/63 • up to 2 years
|
12.9%
8/62 • up to 2 years
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
7.9%
5/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
20.6%
13/63 • up to 2 years
|
11.3%
7/62 • up to 2 years
|
|
Nervous system disorders
DIZZINESS
|
9.5%
6/63 • up to 2 years
|
15.9%
10/63 • up to 2 years
|
9.5%
6/63 • up to 2 years
|
12.9%
8/62 • up to 2 years
|
|
Nervous system disorders
DYSGEUSIA
|
7.9%
5/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Nervous system disorders
HEADACHE
|
19.0%
12/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
22.2%
14/63 • up to 2 years
|
14.5%
9/62 • up to 2 years
|
|
Nervous system disorders
HYPOAESTHESIA
|
3.2%
2/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
4.8%
3/63 • up to 2 years
|
8.1%
5/62 • up to 2 years
|
|
Nervous system disorders
MUSCLE CONTRACTIONS INVOLUNTARY
|
4.8%
3/63 • up to 2 years
|
9.5%
6/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
3.2%
2/62 • up to 2 years
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/63 • up to 2 years
|
3.2%
2/63 • up to 2 years
|
3.2%
2/63 • up to 2 years
|
8.1%
5/62 • up to 2 years
|
|
Psychiatric disorders
ANXIETY
|
6.3%
4/63 • up to 2 years
|
3.2%
2/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
3.2%
2/62 • up to 2 years
|
|
Psychiatric disorders
DEPRESSED MOOD
|
6.3%
4/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Psychiatric disorders
DEPRESSION
|
6.3%
4/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
7.9%
5/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Psychiatric disorders
INSOMNIA
|
7.9%
5/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
3.2%
2/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
4.8%
3/63 • up to 2 years
|
4.8%
3/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
12.9%
8/62 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
3.2%
2/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
6.5%
4/62 • up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
6.3%
4/63 • up to 2 years
|
4.8%
3/63 • up to 2 years
|
7.9%
5/63 • up to 2 years
|
8.1%
5/62 • up to 2 years
|
|
Skin and subcutaneous tissue disorders
ACNE
|
19.0%
12/63 • up to 2 years
|
30.2%
19/63 • up to 2 years
|
12.7%
8/63 • up to 2 years
|
9.7%
6/62 • up to 2 years
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
1.6%
1/63 • up to 2 years
|
3.2%
2/63 • up to 2 years
|
1.6%
1/63 • up to 2 years
|
8.1%
5/62 • up to 2 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
9.5%
6/63 • up to 2 years
|
9.5%
6/63 • up to 2 years
|
9.5%
6/63 • up to 2 years
|
1.6%
1/62 • up to 2 years
|
|
Skin and subcutaneous tissue disorders
RASH
|
20.6%
13/63 • up to 2 years
|
12.7%
8/63 • up to 2 years
|
14.3%
9/63 • up to 2 years
|
12.9%
8/62 • up to 2 years
|
|
Skin and subcutaneous tissue disorders
ROSACEA
|
0.00%
0/63 • up to 2 years
|
6.3%
4/63 • up to 2 years
|
0.00%
0/63 • up to 2 years
|
0.00%
0/62 • up to 2 years
|
|
Vascular disorders
HAEMATOMA
|
1.6%
1/63 • up to 2 years
|
3.2%
2/63 • up to 2 years
|
11.1%
7/63 • up to 2 years
|
3.2%
2/62 • up to 2 years
|
|
Vascular disorders
HYPERTENSION
|
11.1%
7/63 • up to 2 years
|
11.1%
7/63 • up to 2 years
|
7.9%
5/63 • up to 2 years
|
14.5%
9/62 • up to 2 years
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
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