Trial Outcomes & Findings for Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy (NCT NCT04164732)
NCT ID: NCT04164732
Last Updated: 2025-05-16
Results Overview
The primary analysis assessed the effect of LCZ696 on the change from baseline in peak Volume of Oxygen (VO2) (ml/kg/min) at week 50 compared to placebo, where baseline peak VO2 came from the screening/baseline CPET. An increase in peak VO2 (mL/kg/min)/positive change is considered beneficial for the patient.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Baseline to 50 weeks
Results posted on
2025-05-16
Participant Flow
Germany (4 sites), Greece (2 sites), Korea (2 sites), Spain (4 sites), United Kingdom (1 site), United States (5 sites)
Patients who met eligibility criteria entered a single-blind treatment run-in period. Patients who were unable to tolerate either placebo or the 50 mg p.o. b.i.d. dose level,were considered treatment run-in failures and were not randomized into the double-blind, placebo-controlled study
Participant milestones
| Measure |
Run-in (All Participants)
All patients received oral (p.o.) placebo b.i.d. for 2 weeks, followed by 50 mg p.o. b.i.d. of active LCZ696 for 2 weeks
|
LCZ696 BID
Patients were treated with LCZ696. The target dose level was 200 mg p.o. b.i.d.
|
Placebo BID
Placebo to LCZ696
|
|---|---|---|---|
|
Treatment run-in Period
STARTED
|
46
|
0
|
0
|
|
Treatment run-in Period
COMPLETED
|
40
|
0
|
0
|
|
Treatment run-in Period
NOT COMPLETED
|
6
|
0
|
0
|
|
Randomized Treatment Period
STARTED
|
0
|
20
|
20
|
|
Randomized Treatment Period
Randomized Analysis Set
|
0
|
20
|
20
|
|
Randomized Treatment Period
Per Protocol Analysis Set
|
0
|
19
|
19
|
|
Randomized Treatment Period
COMPLETED
|
0
|
17
|
19
|
|
Randomized Treatment Period
NOT COMPLETED
|
0
|
3
|
1
|
Reasons for withdrawal
| Measure |
Run-in (All Participants)
All patients received oral (p.o.) placebo b.i.d. for 2 weeks, followed by 50 mg p.o. b.i.d. of active LCZ696 for 2 weeks
|
LCZ696 BID
Patients were treated with LCZ696. The target dose level was 200 mg p.o. b.i.d.
|
Placebo BID
Placebo to LCZ696
|
|---|---|---|---|
|
Treatment run-in Period
Adverse Event
|
4
|
0
|
0
|
|
Treatment run-in Period
Physician Decision
|
1
|
0
|
0
|
|
Treatment run-in Period
Screen Failure
|
1
|
0
|
0
|
|
Randomized Treatment Period
Adverse Event
|
0
|
1
|
0
|
|
Randomized Treatment Period
Protocol Deviation
|
0
|
1
|
1
|
|
Randomized Treatment Period
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy
Baseline characteristics by cohort
| Measure |
Run-in (All Participants)
n=6 Participants
All patients received oral (p.o.) placebo b.i.d. for 2 weeks, followed by 50 mg p.o. b.i.d. of active LCZ696 for 2 weeks
|
LCZ696 BID
n=20 Participants
Patients were treated with LCZ696. The target dose level was 200 mg p.o. b.i.d.
|
Placebo BID
n=20 Participants
Placebo to LCZ696
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 17.19 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 11.84 • n=7 Participants
|
57.2 years
STANDARD_DEVIATION 14.29 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 13.42 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 50 weeksPopulation: Patients in the per protocol analysis set with and available value for the outcome measure at baseline and Week 50 . Per protocol analysis set consists of all randomized patients who had no major protocol deviations with relevant impact on PD/efficacy data and who are at least 80% compliant with the overall study drug administration.
The primary analysis assessed the effect of LCZ696 on the change from baseline in peak Volume of Oxygen (VO2) (ml/kg/min) at week 50 compared to placebo, where baseline peak VO2 came from the screening/baseline CPET. An increase in peak VO2 (mL/kg/min)/positive change is considered beneficial for the patient.
Outcome measures
| Measure |
LCZ696 BID
n=18 Participants
Patients were treated with LCZ696. The target dose level was 200 mg p.o. b.i.d.
|
Placebo BID
n=19 Participants
Placebo to LCZ696
|
|---|---|---|
|
Change From Baseline in Peak VO2 as Measured by Cardiopulmonary Exercise Test (CPET)
|
1.00 mL/kg/min
Interval -0.22 to 2.23
|
0.39 mL/kg/min
Interval -0.8 to 1.58
|
Adverse Events
Run-In Period Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Run-In LCZ696 50 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Double-blind Period Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Double-blind Period LCZ696 50 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Double-blind Period LCZ696 100 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Double-blind Period LCZ696 200 mg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Double-blind Period LCZ696
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Total
Serious events: 3 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Run-In Period Placebo
n=46 participants at risk
All patients received oral (p.o.) placebo b.i.d. for 2 weeks
|
Run-In LCZ696 50 mg
n=43 participants at risk
All patients received 50 mg p.o. b.i.d. of active LCZ696 for 2 weeks
|
Double-blind Period Placebo
n=20 participants at risk
Patients in the double-blind period treated with placebo
|
Double-blind Period LCZ696 50 mg
n=1 participants at risk
Patients in the double-blind period treated with LCZ696 50mg
|
Double-blind Period LCZ696 100 mg
n=20 participants at risk
Patients in the double-blind period treated with LCZ696 100mg
|
Double-blind Period LCZ696 200 mg
n=17 participants at risk
Patients in the double-blind period treated with LCZ696 200mg
|
Double-blind Period LCZ696
n=20 participants at risk
All patients in the double-blind period treated with LCZ696
|
Total
n=46 participants at risk
Total
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
Other adverse events
| Measure |
Run-In Period Placebo
n=46 participants at risk
All patients received oral (p.o.) placebo b.i.d. for 2 weeks
|
Run-In LCZ696 50 mg
n=43 participants at risk
All patients received 50 mg p.o. b.i.d. of active LCZ696 for 2 weeks
|
Double-blind Period Placebo
n=20 participants at risk
Patients in the double-blind period treated with placebo
|
Double-blind Period LCZ696 50 mg
n=1 participants at risk
Patients in the double-blind period treated with LCZ696 50mg
|
Double-blind Period LCZ696 100 mg
n=20 participants at risk
Patients in the double-blind period treated with LCZ696 100mg
|
Double-blind Period LCZ696 200 mg
n=17 participants at risk
Patients in the double-blind period treated with LCZ696 200mg
|
Double-blind Period LCZ696
n=20 participants at risk
All patients in the double-blind period treated with LCZ696
|
Total
n=46 participants at risk
Total
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
4.3%
2/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
6.5%
3/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
4.3%
2/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
General disorders
Asthenia
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
General disorders
Chest pain
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
General disorders
Oedema
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Infections and infestations
COVID-19
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
25.0%
5/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
10.9%
5/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Infections and infestations
Cystitis
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
4.3%
2/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Nervous system disorders
Dizziness
|
4.3%
2/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
11.8%
2/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
10.0%
2/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
10.9%
5/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Nervous system disorders
Syncope
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
4.3%
2/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.9%
1/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
5.0%
1/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.2%
1/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
|
Vascular disorders
Hypotension
|
0.00%
0/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
2.3%
1/43 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
100.0%
1/1 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
0.00%
0/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
11.8%
2/17 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
15.0%
3/20 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 weeks.
|
8.7%
4/46 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 54 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.
- Publication restrictions are in place
Restriction type: OTHER