Trial Outcomes & Findings for Study of Long-term Safety, Efficacy Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis (NCT NCT02250443)
NCT ID: NCT02250443
Last Updated: 2020-12-30
Results Overview
Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
10 participants
Primary outcome timeframe
Up to 29 month
Results posted on
2020-12-30
Participant Flow
Due to lack of efficacy in patients with sIBM, the study was terminated early.
Participant milestones
| Measure |
BYM338
BYM338 Group
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
BYM338
BYM338 Group
|
|---|---|
|
Overall Study
Administrative problems
|
7
|
|
Overall Study
Adverse Event
|
3
|
Baseline Characteristics
Study of Long-term Safety, Efficacy Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis
Baseline characteristics by cohort
| Measure |
BYM338
n=10 Participants
BYM338 Group
|
|---|---|
|
Age, Continuous
|
70.1 Years
STANDARD_DEVIATION 10.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 29 monthPopulation: safety analysis set - included all patients that received at least one dose of study drug. No statistical analysis provided for Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During this extension study
Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity
Outcome measures
| Measure |
BYM338
n=10 Participants
BYM338 Group
|
|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Serious adverse events (SAE)
|
2 Participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Death
|
0 Participants
|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Adverse Events (AE)
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1, 57, 113, 169, 365, 533, and day 729Population: Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data
To assess the effect of multiple doses of BYM338 on lean body mass as measured by DXA in terms of change from baseline.
Outcome measures
| Measure |
BYM338
n=10 Participants
BYM338 Group
|
|---|---|
|
Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA)
Day 1
|
0 Percentage Change in LBM
Standard Deviation 0
|
|
Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA)
Day 57
|
4.292 Percentage Change in LBM
Standard Deviation 2.7480
|
|
Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA)
Day 113
|
5.552 Percentage Change in LBM
Standard Deviation 3.6066
|
|
Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA)
Day 169
|
7.463 Percentage Change in LBM
Standard Deviation 4.5687
|
|
Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA)
Day 365
|
6.919 Percentage Change in LBM
Standard Deviation 2.9669
|
|
Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA)
Day 533
|
6.885 Percentage Change in LBM
Standard Deviation 3.7894
|
|
Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA)
Day 729
|
0.727 Percentage Change in LBM
Standard Deviation NA
NA- Not available, standard deviation is not evaluable when n=1
|
SECONDARY outcome
Timeframe: Day 29, 85, 169, 253, 337, 421, 505, 589, 673, 757, 1177Population: Pharmacokinetics (PK) Analysis set: Patients with available PK data and no protocol deviations with relevant impact on PK data
To obtain pharmacokinetic data from multiple i.v. dosing of BYM338 in this patient population. Pre-dose, 30 mins \& 4 hours post-dose on Day 1. Pre-dose only on each subsequent administration
Outcome measures
| Measure |
BYM338
n=10 Participants
BYM338 Group
|
|---|---|
|
Pharmacokinetics (PK) Parameter of Cmin From Multiple i.v. Dosing
Day 337 (n=10)
|
24.4 ng/mL
Standard Deviation 14.6
|
|
Pharmacokinetics (PK) Parameter of Cmin From Multiple i.v. Dosing
Day 421 (n=9)
|
24.5 ng/mL
Standard Deviation 11.5
|
|
Pharmacokinetics (PK) Parameter of Cmin From Multiple i.v. Dosing
Day 757 (n=1)
|
20.3 ng/mL
Standard Deviation NA
NA - Not available, standard deviation is not evaluable when n=1
|
|
Pharmacokinetics (PK) Parameter of Cmin From Multiple i.v. Dosing
Day 29 (n=10)
|
13.4 ng/mL
Standard Deviation 5.01
|
|
Pharmacokinetics (PK) Parameter of Cmin From Multiple i.v. Dosing
Day 85 (n=10)
|
24.1 ng/mL
Standard Deviation 13.1
|
|
Pharmacokinetics (PK) Parameter of Cmin From Multiple i.v. Dosing
Day 169 (n=10)
|
26.3 ng/mL
Standard Deviation 15.9
|
|
Pharmacokinetics (PK) Parameter of Cmin From Multiple i.v. Dosing
Day 253 (n=9)
|
28.8 ng/mL
Standard Deviation 12.1
|
|
Pharmacokinetics (PK) Parameter of Cmin From Multiple i.v. Dosing
Day 505 (n=8)
|
28.3 ng/mL
Standard Deviation 10.6
|
|
Pharmacokinetics (PK) Parameter of Cmin From Multiple i.v. Dosing
Day 589 (n=6)
|
39.8 ng/mL
Standard Deviation 30.2
|
|
Pharmacokinetics (PK) Parameter of Cmin From Multiple i.v. Dosing
Day 673 (n=2)
|
20.5 ng/mL
Standard Deviation 1.98
|
|
Pharmacokinetics (PK) Parameter of Cmin From Multiple i.v. Dosing
Day 1177 (n=1)
|
31.4 ng/mL
Standard Deviation NA
NA - Not available, standard deviation is not evaluable when n=1
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: Due to the early study termination and the small sample size in this open-label trial, this PRO analysis was cancelled.
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. Due to the no-signal this analysis was cancelled.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Day 1, 113, 169, 365, 533, 729Population: Pharmacodynamics (PD) analysis set: Patients with available PD data and no protocol deviations with relevant impact on PD data
Quadriceps muscle strength was measured, Quadriceps Quantitative Muscle Testing (QMT) by portable fixed dynamometry (PFD). A negative change from baseline indicates deterioration
Outcome measures
| Measure |
BYM338
n=10 Participants
BYM338 Group
|
|---|---|
|
Changes From Baseline in Muscle Strength.
Quadriceps score left side Day 1
|
0 Newtons
Standard Deviation 0
|
|
Changes From Baseline in Muscle Strength.
left side Day 113
|
-5.80 Newtons
Standard Deviation 28.160
|
|
Changes From Baseline in Muscle Strength.
left side Day 169
|
-5.95 Newtons
Standard Deviation 26.587
|
|
Changes From Baseline in Muscle Strength.
left side Day 365
|
-9.51 Newtons
Standard Deviation 28.149
|
|
Changes From Baseline in Muscle Strength.
left side Day 533
|
-25.77 Newtons
Standard Deviation 21.321
|
|
Changes From Baseline in Muscle Strength.
left side Day 729
|
178.26 Newtons
Standard Deviation NA
NA- Not available, standard deviation is not evaluable when n=1
|
|
Changes From Baseline in Muscle Strength.
Quadriceps score Right side Day 1
|
0 Newtons
Standard Deviation 0
|
|
Changes From Baseline in Muscle Strength.
Right side Day 113
|
-4.83 Newtons
Standard Deviation 29.904
|
|
Changes From Baseline in Muscle Strength.
Right side Day 169
|
-22.81 Newtons
Standard Deviation 18.784
|
|
Changes From Baseline in Muscle Strength.
Right side Day 365
|
-11.63 Newtons
Standard Deviation 47.141
|
|
Changes From Baseline in Muscle Strength.
Right side Day 533
|
-31.00 Newtons
Standard Deviation 29.173
|
|
Changes From Baseline in Muscle Strength.
Right side Day 729
|
-57.66 Newtons
Standard Deviation NA
NA - Not available, standard deviation is not evaluable when n=1
|
SECONDARY outcome
Timeframe: Baseline,Day 1, 113, 169, 365, 533, 729Population: Pharmacodynamics (PD) analysis set: Patients with available PD data and no protocol deviations with relevant impact on PD data
The effect of BYM338 on additional muscle function measures (hand-grip and pinch-grip dynamometry).
Outcome measures
| Measure |
BYM338
n=10 Participants
BYM338 Group
|
|---|---|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Left hand-grip day 113
|
25.58 Newtons
Standard Deviation 37.544
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Left hand-grip day 169
|
21.36 Newtons
Standard Deviation 43.815
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Left hand-grip day 365
|
-1.42 Newtons
Standard Deviation 47.973
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Left hand pinch grip day 729
|
-8.41 Newtons
Standard Deviation 46.672
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Right hand pinch grip day 1
|
0 Newtons
Standard Deviation 0
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Right hand pinch grip day 113
|
-7.55 Newtons
Standard Deviation 26.792
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Right hand pinch grip day 169
|
-9.35 Newtons
Standard Deviation 30.942
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Right hand pinch grip day 365
|
0.59 Newtons
Standard Deviation 32.094
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Right hand pinch grip day 533
|
-8.65 Newtons
Standard Deviation 21.491
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Left hand-grip day 1
|
0 Newtons
Standard Deviation 0
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Left hand-grip day 533
|
2.78 Newtons
Standard Deviation 16.934
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Left hand-grip day 729
|
8.95 Newtons
Standard Deviation 24.034
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Right hand-grip day 1
|
0 Newtons
Standard Deviation 0
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Right hand-grip day 113
|
99.59 Newtons
Standard Deviation 184.472
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Right hand-grip day 169
|
109.05 Newtons
Standard Deviation 214.248
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Right hand-grip day 365
|
77.46 Newtons
Standard Deviation 160.133
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Right hand-grip day 533
|
53.99 Newtons
Standard Deviation 127.776
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Right hand-grip day 729
|
163.66 Newtons
Standard Deviation 237.402
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Left hand pinch grip day 1
|
0 Newtons
Standard Deviation 0
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Left hand pinch grip day 113
|
7.82 Newtons
Standard Deviation 27.292
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Left hand pinch grip day 169
|
-4.74 Newtons
Standard Deviation 20.210
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Left hand pinch grip day 365
|
-7.30 Newtons
Standard Deviation 35.224
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Left hand pinch grip day 533
|
-11.40 Newtons
Standard Deviation 21.204
|
|
Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)
Right hand pinch grip day 729
|
-35.40 Newtons
Standard Deviation 44.820
|
SECONDARY outcome
Timeframe: Baseline,Day 1, 113, 169, 365, 533, 729Population: Pharmacodynamics (PD) analysis set: Patients with available PD data and no protocol deviations with relevant impact on PD data
The effect of BYM338 on additional muscle function measures (6 minute walking distance). 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
n=10 Participants
BYM338 Group
|
|---|---|
|
Changes From Baseline in Muscle Function 6 Minute Walking Distance
Day 1
|
0 Meters
Standard Deviation 0
|
|
Changes From Baseline in Muscle Function 6 Minute Walking Distance
Day 113
|
-1.56 Meters
Standard Deviation 13.685
|
|
Changes From Baseline in Muscle Function 6 Minute Walking Distance
Day 169
|
-7.41 Meters
Standard Deviation 12.463
|
|
Changes From Baseline in Muscle Function 6 Minute Walking Distance
Day 365
|
-8.97 Meters
Standard Deviation 15.763
|
|
Changes From Baseline in Muscle Function 6 Minute Walking Distance
Day 533
|
-16.99 Meters
Standard Deviation 22.382
|
|
Changes From Baseline in Muscle Function 6 Minute Walking Distance
Day 729
|
-17.86 Meters
Standard Deviation NA
NA - Not available, standard deviation is not evaluable when n=1
|
SECONDARY outcome
Timeframe: Baseline, Day 1, 57, 113Population: Pharmacodynamics (PD) analysis set: Patients with available PD data and no protocol deviations with relevant impact on PD data
Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was equal or more than 2% at Week 8 and 16 were considered responders
Outcome measures
| Measure |
BYM338
n=10 Participants
BYM338 Group
|
|---|---|
|
Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan
Day 113
|
4.51 Percentage Change
Standard Deviation 6.300
|
|
Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan
Day 1
|
0 Percentage Change
Standard Deviation 0
|
|
Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan
Day 57
|
4.14 Percentage Change
Standard Deviation 4.250
|
SECONDARY outcome
Timeframe: Day 1Population: Pharmacokinetics (PK) Analysis set: Patients with available PK data and no protocol deviations with relevant impact on PK data
To obtain pharmacokinetic data from multiple i.v. dosing of BYM338 in this patient population. Pre-dose, 30 mins \& 4 hours post-dose on Day 1.
Outcome measures
| Measure |
BYM338
n=9 Participants
BYM338 Group
|
|---|---|
|
Pharmacokinetics (PK) Parameter of Cmax
|
278 ug/mL
Standard Deviation 62.6
|
SECONDARY outcome
Timeframe: Day 1Population: Pharmacokinetics (PK) Analysis set: Patients with available PK data and no protocol deviations with relevant impact on PK data
The time to reach the maximum concentration after drug administration
Outcome measures
| Measure |
BYM338
n=9 Participants
BYM338 Group
|
|---|---|
|
Time to Reach the Maximum Concentration After Drug Administration (Tmax)
|
0.744 hr
Full Range NA • Interval 0.648 to 4.73
|
Adverse Events
BYM338 10mg/kg i.v.
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BYM338 10mg/kg i.v.
n=10 participants at risk
BYM338 10mg/kg i.v.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • period up to 104 weeks
|
|
Cardiac disorders
Myocardial infarction
|
10.0%
1/10 • period up to 104 weeks
|
|
Cardiac disorders
Tachyarrhythmia
|
10.0%
1/10 • period up to 104 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
10.0%
1/10 • period up to 104 weeks
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
10.0%
1/10 • period up to 104 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
1/10 • period up to 104 weeks
|
|
Metabolism and nutrition disorders
Iron deficiency
|
10.0%
1/10 • period up to 104 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
10.0%
1/10 • period up to 104 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
10.0%
1/10 • period up to 104 weeks
|
Other adverse events
| Measure |
BYM338 10mg/kg i.v.
n=10 participants at risk
BYM338 10mg/kg i.v.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
10.0%
1/10 • period up to 104 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
1/10 • period up to 104 weeks
|
|
Cardiac disorders
Myocardial infarction
|
10.0%
1/10 • period up to 104 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
1/10 • period up to 104 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • period up to 104 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
60.0%
6/10 • period up to 104 weeks
|
|
Gastrointestinal disorders
Frequent bowel movements
|
10.0%
1/10 • period up to 104 weeks
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
10.0%
1/10 • period up to 104 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
10.0%
1/10 • period up to 104 weeks
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • period up to 104 weeks
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • period up to 104 weeks
|
|
General disorders
Oedema peripheral
|
30.0%
3/10 • period up to 104 weeks
|
|
General disorders
Peripheral swelling
|
10.0%
1/10 • period up to 104 weeks
|
|
Infections and infestations
Cellulitis
|
10.0%
1/10 • period up to 104 weeks
|
|
Infections and infestations
Fungal skin infection
|
10.0%
1/10 • period up to 104 weeks
|
|
Infections and infestations
Influenza
|
10.0%
1/10 • period up to 104 weeks
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • period up to 104 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • period up to 104 weeks
|
|
Infections and infestations
Urinary tract infection
|
30.0%
3/10 • period up to 104 weeks
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
10.0%
1/10 • period up to 104 weeks
|
|
Injury, poisoning and procedural complications
Bone contusion
|
10.0%
1/10 • period up to 104 weeks
|
|
Injury, poisoning and procedural complications
Concussion
|
10.0%
1/10 • period up to 104 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
1/10 • period up to 104 weeks
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
10.0%
1/10 • period up to 104 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
90.0%
9/10 • period up to 104 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
10.0%
1/10 • period up to 104 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
30.0%
3/10 • period up to 104 weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
10.0%
1/10 • period up to 104 weeks
|
|
Injury, poisoning and procedural complications
Scratch
|
10.0%
1/10 • period up to 104 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
50.0%
5/10 • period up to 104 weeks
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
10.0%
1/10 • period up to 104 weeks
|
|
Investigations
Mammogram abnormal
|
10.0%
1/10 • period up to 104 weeks
|
|
Investigations
Natural killer cell count increased
|
10.0%
1/10 • period up to 104 weeks
|
|
Investigations
Vitamin D decreased
|
10.0%
1/10 • period up to 104 weeks
|
|
Investigations
Weight decreased
|
10.0%
1/10 • period up to 104 weeks
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
10.0%
1/10 • period up to 104 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
2/10 • period up to 104 weeks
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
10.0%
1/10 • period up to 104 weeks
|
|
Metabolism and nutrition disorders
Gout
|
20.0%
2/10 • period up to 104 weeks
|
|
Metabolism and nutrition disorders
Iron deficiency
|
10.0%
1/10 • period up to 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.0%
3/10 • period up to 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • period up to 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
10.0%
1/10 • period up to 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
90.0%
9/10 • period up to 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.0%
1/10 • period up to 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
20.0%
2/10 • period up to 104 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • period up to 104 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
10.0%
1/10 • period up to 104 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
10.0%
1/10 • period up to 104 weeks
|
|
Nervous system disorders
Dementia
|
10.0%
1/10 • period up to 104 weeks
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • period up to 104 weeks
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • period up to 104 weeks
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • period up to 104 weeks
|
|
Nervous system disorders
Hypogeusia
|
10.0%
1/10 • period up to 104 weeks
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • period up to 104 weeks
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • period up to 104 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
10.0%
1/10 • period up to 104 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
10.0%
1/10 • period up to 104 weeks
|
|
Renal and urinary disorders
Urinary retention
|
10.0%
1/10 • period up to 104 weeks
|
|
Reproductive system and breast disorders
Breast hyperplasia
|
10.0%
1/10 • period up to 104 weeks
|
|
Reproductive system and breast disorders
Cervical polyp
|
10.0%
1/10 • period up to 104 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • period up to 104 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
10.0%
1/10 • period up to 104 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.0%
1/10 • period up to 104 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
10.0%
1/10 • period up to 104 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
50.0%
5/10 • period up to 104 weeks
|
|
Skin and subcutaneous tissue disorders
Blister
|
10.0%
1/10 • period up to 104 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.0%
1/10 • period up to 104 weeks
|
|
Skin and subcutaneous tissue disorders
Papule
|
10.0%
1/10 • period up to 104 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • period up to 104 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.0%
3/10 • period up to 104 weeks
|
|
Skin and subcutaneous tissue disorders
Skin hypertrophy
|
10.0%
1/10 • period up to 104 weeks
|
|
Vascular disorders
Thrombophlebitis superficial
|
10.0%
1/10 • period up to 104 weeks
|
Additional Information
Study Director
Novartis Pharmaceutical
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