Trial Outcomes & Findings for A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction (NCT NCT02992288)
NCT ID: NCT02992288
Last Updated: 2019-04-23
Results Overview
Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
427 participants
Primary outcome timeframe
Baseline, Week 20
Results posted on
2019-04-23
Participant Flow
Study was conducted at multiple centers in 11 countries between 22 February 2017 (first participant first visit) and 16 May 2018 (last participant last visit).
Overall, 462 participants were screened. Of them, 35 participants did not complete screening due to unmet eligibility criteria, consent withdrawal, adverse events and other unspecified reasons. In total, 427 participants were randomized and 426 participants received study treatment.
Participant milestones
| Measure |
Placebo
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 5 mg
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 10 mg
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 20 mg
Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 30 mg
Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 40 mg
Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
106
|
37
|
70
|
73
|
69
|
72
|
|
Overall Study
Treated
|
106
|
37
|
70
|
72
|
69
|
72
|
|
Overall Study
COMPLETED
|
89
|
32
|
63
|
64
|
61
|
59
|
|
Overall Study
NOT COMPLETED
|
17
|
5
|
7
|
9
|
8
|
13
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 5 mg
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 10 mg
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 20 mg
Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 30 mg
Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 40 mg
Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
2
|
2
|
2
|
2
|
7
|
|
Overall Study
Non-compliance with study drug
|
0
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
3
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Death
|
2
|
0
|
2
|
1
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
1
|
5
|
3
|
4
|
Baseline Characteristics
A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction
Baseline characteristics by cohort
| Measure |
Placebo
n=106 Participants
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 5 mg
n=37 Participants
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 10 mg
n=70 Participants
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 20 mg
n=73 Participants
Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 30 mg
n=69 Participants
Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 40 mg
n=72 Participants
Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Total
n=427 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.9 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
66.6 Years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
66.4 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
68.1 Years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
67.6 Years
STANDARD_DEVIATION 9.8 • n=21 Participants
|
67.5 Years
STANDARD_DEVIATION 10.0 • n=8 Participants
|
67.2 Years
STANDARD_DEVIATION 10.0 • n=8 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
71 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
65 Participants
n=8 Participants
|
356 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
105 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
72 Participants
n=8 Participants
|
421 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
25 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
98 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
65 Participants
n=8 Participants
|
390 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Left ventricular ejection fraction (LVEF)
|
28.24 Percentage of LVEF
STANDARD_DEVIATION 10.67 • n=5 Participants
|
26.22 Percentage of LVEF
STANDARD_DEVIATION 7.99 • n=7 Participants
|
27.58 Percentage of LVEF
STANDARD_DEVIATION 8.92 • n=5 Participants
|
29.70 Percentage of LVEF
STANDARD_DEVIATION 10.87 • n=4 Participants
|
29.87 Percentage of LVEF
STANDARD_DEVIATION 11.54 • n=21 Participants
|
26.24 Percentage of LVEF
STANDARD_DEVIATION 8.92 • n=8 Participants
|
28.18 Percentage of LVEF
STANDARD_DEVIATION 10.17 • n=8 Participants
|
|
New York Heart Association (NYHA) Class
Class I
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
New York Heart Association (NYHA) Class
Class II
|
62 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
49 Participants
n=8 Participants
|
265 Participants
n=8 Participants
|
|
New York Heart Association (NYHA) Class
Class III/IV
|
44 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
161 Participants
n=8 Participants
|
|
N-terminal pro-hormone b-type natriuretic peptide (NT-proBNP)
|
2111.00 Picograms per milliliter (pg/mL)
n=5 Participants
|
2071.00 Picograms per milliliter (pg/mL)
n=7 Participants
|
2063.00 Picograms per milliliter (pg/mL)
n=5 Participants
|
1894.50 Picograms per milliliter (pg/mL)
n=4 Participants
|
2084.00 Picograms per milliliter (pg/mL)
n=21 Participants
|
2419.00 Picograms per milliliter (pg/mL)
n=8 Participants
|
2085.00 Picograms per milliliter (pg/mL)
n=8 Participants
|
|
Medical history: Chronic heart failure etiology
Ischemic
|
65 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
42 Participants
n=8 Participants
|
264 Participants
n=8 Participants
|
|
Medical history: Chronic heart failure etiology
Non-ischemic
|
41 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
162 Participants
n=8 Participants
|
|
Medical history: Chronic heart failure etiology
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Medical history: Atrial fibrillation
With Atrial fibrillation
|
44 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
171 Participants
n=8 Participants
|
|
Medical history: Atrial fibrillation
Without Atrial fibrillation
|
62 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
39 Participants
n=8 Participants
|
256 Participants
n=8 Participants
|
|
Medication of interest: Beta-blocker
Beta-blocker
|
103 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
69 Participants
n=8 Participants
|
412 Participants
n=8 Participants
|
|
Medication of interest: Beta-blocker
Not used at baseline
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Medication of interest: Angiotensin-converting enzyme inhibitor
Angiotensin-converting enzyme inhibitor
|
58 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
240 Participants
n=8 Participants
|
|
Medication of interest: Angiotensin-converting enzyme inhibitor
Not used at baseline
|
48 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
187 Participants
n=8 Participants
|
|
Medication of interest: Angiotensin receptor blocker
Angiotensin receptor blocker
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
64 Participants
n=8 Participants
|
|
Medication of interest: Angiotensin receptor blocker
Not used at baseline
|
91 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
63 Participants
n=8 Participants
|
363 Participants
n=8 Participants
|
|
Medication of interest: Angiotensin receptor-neprilysin inhibitor
Angiotensin receptor-neprilysin inhibitor
|
20 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
69 Participants
n=8 Participants
|
|
Medication of interest: Angiotensin receptor-neprilysin inhibitor
Not used at baseline
|
86 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
60 Participants
n=8 Participants
|
358 Participants
n=8 Participants
|
|
Medication of interest: Mineralocorticoid receptor antagonist
Mineralocorticoid receptor antagonist
|
93 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
57 Participants
n=8 Participants
|
355 Participants
n=8 Participants
|
|
Medication of interest: Mineralocorticoid receptor antagonist
Not used at baseline
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
72 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 20Population: Per-protocol set (PPS) included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline LVEF values not due to cardiovascular (CV) death or heart failure (HF) hospitalization or with other major protocol deviation were excluded from PPS LVEF set.
Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 5 mg
n=19 Participants
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 10 mg
n=35 Participants
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 20 mg
n=47 Participants
Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 30 mg
n=40 Participants
Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 40 mg
n=38 Participants
Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography
|
-2.19 Percentage of LVEF
Standard Deviation 8.39
|
2.59 Percentage of LVEF
Standard Deviation 8.48
|
-3.01 Percentage of LVEF
Standard Deviation 10.43
|
0.13 Percentage of LVEF
Standard Deviation 8.74
|
-2.45 Percentage of LVEF
Standard Deviation 10.54
|
1.53 Percentage of LVEF
Standard Deviation 10.01
|
PRIMARY outcome
Timeframe: Baseline, Week 20Population: PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.
NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 5 mg
n=29 Participants
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 10 mg
n=58 Participants
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 20 mg
n=59 Participants
Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 30 mg
n=53 Participants
Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 40 mg
n=56 Participants
Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20
|
-0.07 log picograms per milliliter
Standard Deviation 0.70
|
-0.24 log picograms per milliliter
Standard Deviation 0.90
|
-0.07 log picograms per milliliter
Standard Deviation 0.52
|
-0.07 log picograms per milliliter
Standard Deviation 0.56
|
0.07 log picograms per milliliter
Standard Deviation 0.55
|
-0.08 log picograms per milliliter
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Baseline, Week 20Population: PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline LVEF values not due to CV death or HF hospitalization or with other major protocol deviation were excluded from PPS LVEF set.
LVESV was defined as the volume of blood in the left ventricle at the end of contraction, or systole and the beginning of filling or diastole. Mean and standard deviation were reported.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 5 mg
n=19 Participants
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 10 mg
n=35 Participants
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 20 mg
n=47 Participants
Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 30 mg
n=40 Participants
Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 40 mg
n=38 Participants
Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20
|
-5.44 Milliliters (mL)
Standard Deviation 33.29
|
-21.41 Milliliters (mL)
Standard Deviation 48.13
|
-2.82 Milliliters (mL)
Standard Deviation 35.12
|
-4.32 Milliliters (mL)
Standard Deviation 29.73
|
-3.12 Milliliters (mL)
Standard Deviation 33.96
|
-15.16 Milliliters (mL)
Standard Deviation 39.65
|
SECONDARY outcome
Timeframe: Baseline, Week 20Population: PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline LVEF values not due to CV death or HF hospitalization or with other major protocol deviation were excluded from PPS LVEF set.
LVEDV was defined as the volume of blood in the left ventricle at end load or filling in diastole or the amount of blood in the ventricles just before systole. Mean and standard deviation were reported.
Outcome measures
| Measure |
Placebo
n=47 Participants
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 5 mg
n=19 Participants
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 10 mg
n=35 Participants
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 20 mg
n=47 Participants
Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 30 mg
n=40 Participants
Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 40 mg
n=38 Participants
Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20
|
-13.16 Milliliters (mL)
Standard Deviation 40.23
|
-21.65 Milliliters (mL)
Standard Deviation 61.96
|
-12.44 Milliliters (mL)
Standard Deviation 39.84
|
-5.92 Milliliters (mL)
Standard Deviation 30.89
|
-11.17 Milliliters (mL)
Standard Deviation 42.32
|
-19.69 Milliliters (mL)
Standard Deviation 48.38
|
SECONDARY outcome
Timeframe: Baseline, Week 20Population: PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.
High sensitivity troponin T (hs-TNT) was measured. Mean and standard deviation were reported.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 5 mg
n=29 Participants
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 10 mg
n=58 Participants
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 20 mg
n=59 Participants
Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 30 mg
n=53 Participants
Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 40 mg
n=56 Participants
Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20
|
0.13 Picograms per milliliter (pg/mL)
Standard Deviation 9.98
|
6.46 Picograms per milliliter (pg/mL)
Standard Deviation 33.04
|
3.77 Picograms per milliliter (pg/mL)
Standard Deviation 22.32
|
7.43 Picograms per milliliter (pg/mL)
Standard Deviation 37.79
|
2.59 Picograms per milliliter (pg/mL)
Standard Deviation 12.90
|
7.03 Picograms per milliliter (pg/mL)
Standard Deviation 24.81
|
SECONDARY outcome
Timeframe: Baseline up to Week 26Population: PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.
Composite efficacy outcome was the first occurrence of CV death, HF hospitalization or urgent visit for HF. Number of participants with composite efficacy outcome were reported.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 5 mg
n=29 Participants
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 10 mg
n=58 Participants
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 20 mg
n=59 Participants
Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 30 mg
n=53 Participants
Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 40 mg
n=56 Participants
Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Composite Efficacy Outcome
|
10 Participants
|
4 Participants
|
10 Participants
|
9 Participants
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 26Population: PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.
Cardiovascular (CV) mortality was assessed. Number of participants with CV mortality were reported.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 5 mg
n=29 Participants
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 10 mg
n=58 Participants
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 20 mg
n=59 Participants
Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 30 mg
n=53 Participants
Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 40 mg
n=56 Participants
Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Cardiovascular (CV) Mortality
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 26Population: PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.
Number of participants with HF hospitalization and urgent visits for HF were reported.
Outcome measures
| Measure |
Placebo
n=82 Participants
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 5 mg
n=29 Participants
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 10 mg
n=58 Participants
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 20 mg
n=59 Participants
Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 30 mg
n=53 Participants
Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 40 mg
n=56 Participants
Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF)
|
10 Participants
|
4 Participants
|
9 Participants
|
8 Participants
|
5 Participants
|
8 Participants
|
Adverse Events
Placebo
Serious events: 31 serious events
Other events: 24 other events
Deaths: 8 deaths
Neladenoson Bialanate 5mg
Serious events: 13 serious events
Other events: 10 other events
Deaths: 1 deaths
Neladenoson Bialanate 10mg
Serious events: 28 serious events
Other events: 15 other events
Deaths: 5 deaths
Neladenoson Bialanate 20mg
Serious events: 22 serious events
Other events: 18 other events
Deaths: 1 deaths
Neladenoson Bialanate 30mg
Serious events: 28 serious events
Other events: 24 other events
Deaths: 2 deaths
Neladenoson Bialanate 40mg
Serious events: 26 serious events
Other events: 19 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Placebo
n=106 participants at risk
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 5mg
n=37 participants at risk
Participants received 5 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 10mg
n=70 participants at risk
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 20mg
n=72 participants at risk
Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 30mg
n=69 participants at risk
Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 40mg
n=72 participants at risk
Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
2.7%
1/37 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
2/106 • Number of events 2 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.9%
2/69 • Number of events 2 • From start of study drug administration up to 26 weeks
|
2.8%
2/72 • Number of events 2 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
2/106 • Number of events 3 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
4.2%
3/72 • Number of events 3 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
2.9%
2/70 • Number of events 2 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Atrial tachycardia
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
2.9%
2/70 • Number of events 2 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Cardiac failure
|
14.2%
15/106 • Number of events 20 • From start of study drug administration up to 26 weeks
|
18.9%
7/37 • Number of events 8 • From start of study drug administration up to 26 weeks
|
17.1%
12/70 • Number of events 14 • From start of study drug administration up to 26 weeks
|
8.3%
6/72 • Number of events 10 • From start of study drug administration up to 26 weeks
|
14.5%
10/69 • Number of events 17 • From start of study drug administration up to 26 weeks
|
15.3%
11/72 • Number of events 16 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Cardiac failure chronic
|
4.7%
5/106 • Number of events 8 • From start of study drug administration up to 26 weeks
|
2.7%
1/37 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.9%
2/70 • Number of events 2 • From start of study drug administration up to 26 weeks
|
4.2%
3/72 • Number of events 7 • From start of study drug administration up to 26 weeks
|
2.9%
2/69 • Number of events 2 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Cardiogenic shock
|
2.8%
3/106 • Number of events 3 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Low cardiac output syndrome
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Mitral valve incompetence
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Right ventricular failure
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Ventricular tachycardia
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.7%
1/37 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.9%
2/70 • Number of events 2 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
2.7%
1/37 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
2.7%
1/37 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 2 • From start of study drug administration up to 26 weeks
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
2.7%
1/37 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 2 • From start of study drug administration up to 26 weeks
|
|
General disorders
Chest pain
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
General disorders
Sudden death
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
General disorders
Oedema due to cardiac disease
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Immune system disorders
Hypersensitivity
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Infections and infestations
Infection
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 2 • From start of study drug administration up to 26 weeks
|
|
Infections and infestations
Peritonitis
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Infections and infestations
Pneumonia
|
1.9%
2/106 • Number of events 2 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.8%
2/72 • Number of events 2 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Infections and infestations
Pneumonia legionella
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Infections and infestations
Septic shock
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Infections and infestations
Serratia sepsis
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
2.7%
1/37 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.94%
1/106 • Number of events 2 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
2.7%
1/37 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Investigations
Arteriogram coronary
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Investigations
Blood pressure decreased
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Investigations
Device function test
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
2.7%
1/37 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.9%
2/106 • Number of events 3 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
2.7%
1/37 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Nervous system disorders
Presyncope
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Nervous system disorders
Seizure
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Nervous system disorders
Syncope
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Psychiatric disorders
Confusional state
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Psychiatric disorders
Delirium
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
2.8%
2/72 • Number of events 2 • From start of study drug administration up to 26 weeks
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
2.7%
1/37 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.9%
2/70 • Number of events 2 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.9%
2/69 • Number of events 2 • From start of study drug administration up to 26 weeks
|
4.2%
3/72 • Number of events 3 • From start of study drug administration up to 26 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.9%
2/106 • Number of events 2 • From start of study drug administration up to 26 weeks
|
2.7%
1/37 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
2.8%
2/72 • Number of events 2 • From start of study drug administration up to 26 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
1.9%
2/106 • Number of events 2 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.8%
2/72 • Number of events 2 • From start of study drug administration up to 26 weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Surgical and medical procedures
Atrial septal defect repair
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
2.7%
1/37 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
2.9%
2/70 • Number of events 2 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Surgical and medical procedures
Ventricular assist device insertion
|
0.94%
1/106 • Number of events 2 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Surgical and medical procedures
Implantable defibrillator replacement
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Surgical and medical procedures
Cardiac resynchronisation therapy
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
2.7%
1/37 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Surgical and medical procedures
Colectomy
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Vascular disorders
Hypotension
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Vascular disorders
Thrombosis
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Product Issues
Device failure
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
Other adverse events
| Measure |
Placebo
n=106 participants at risk
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 5mg
n=37 participants at risk
Participants received 5 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 10mg
n=70 participants at risk
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 20mg
n=72 participants at risk
Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 30mg
n=69 participants at risk
Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
Neladenoson Bialanate 40mg
n=72 participants at risk
Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure
|
8.5%
9/106 • Number of events 9 • From start of study drug administration up to 26 weeks
|
5.4%
2/37 • Number of events 2 • From start of study drug administration up to 26 weeks
|
2.9%
2/70 • Number of events 2 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
4.3%
3/69 • Number of events 3 • From start of study drug administration up to 26 weeks
|
4.2%
3/72 • Number of events 6 • From start of study drug administration up to 26 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
5.4%
2/37 • Number of events 2 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 3 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.94%
1/106 • Number of events 2 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
2.9%
2/69 • Number of events 2 • From start of study drug administration up to 26 weeks
|
6.9%
5/72 • Number of events 5 • From start of study drug administration up to 26 weeks
|
|
General disorders
Asthenia
|
0.94%
1/106 • Number of events 2 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.8%
2/72 • Number of events 2 • From start of study drug administration up to 26 weeks
|
5.8%
4/69 • Number of events 4 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
General disorders
Fatigue
|
1.9%
2/106 • Number of events 2 • From start of study drug administration up to 26 weeks
|
5.4%
2/37 • Number of events 2 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.8%
2/72 • Number of events 2 • From start of study drug administration up to 26 weeks
|
1.4%
1/69 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.94%
1/106 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
5.6%
4/72 • Number of events 4 • From start of study drug administration up to 26 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.9%
2/106 • Number of events 2 • From start of study drug administration up to 26 weeks
|
5.4%
2/37 • Number of events 2 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/69 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
|
Nervous system disorders
Dizziness
|
2.8%
3/106 • Number of events 3 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
1.4%
1/70 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.8%
2/72 • Number of events 2 • From start of study drug administration up to 26 weeks
|
5.8%
4/69 • Number of events 4 • From start of study drug administration up to 26 weeks
|
5.6%
4/72 • Number of events 4 • From start of study drug administration up to 26 weeks
|
|
Nervous system disorders
Headache
|
2.8%
3/106 • Number of events 3 • From start of study drug administration up to 26 weeks
|
2.7%
1/37 • Number of events 1 • From start of study drug administration up to 26 weeks
|
2.9%
2/70 • Number of events 2 • From start of study drug administration up to 26 weeks
|
0.00%
0/72 • From start of study drug administration up to 26 weeks
|
8.7%
6/69 • Number of events 8 • From start of study drug administration up to 26 weeks
|
1.4%
1/72 • Number of events 1 • From start of study drug administration up to 26 weeks
|
|
Renal and urinary disorders
Renal impairment
|
5.7%
6/106 • Number of events 7 • From start of study drug administration up to 26 weeks
|
2.7%
1/37 • Number of events 1 • From start of study drug administration up to 26 weeks
|
0.00%
0/70 • From start of study drug administration up to 26 weeks
|
5.6%
4/72 • Number of events 4 • From start of study drug administration up to 26 weeks
|
8.7%
6/69 • Number of events 6 • From start of study drug administration up to 26 weeks
|
9.7%
7/72 • Number of events 7 • From start of study drug administration up to 26 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
0.00%
0/37 • From start of study drug administration up to 26 weeks
|
4.3%
3/70 • Number of events 3 • From start of study drug administration up to 26 weeks
|
5.6%
4/72 • Number of events 6 • From start of study drug administration up to 26 weeks
|
4.3%
3/69 • Number of events 3 • From start of study drug administration up to 26 weeks
|
4.2%
3/72 • Number of events 3 • From start of study drug administration up to 26 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/106 • From start of study drug administration up to 26 weeks
|
2.7%
1/37 • Number of events 1 • From start of study drug administration up to 26 weeks
|
7.1%
5/70 • Number of events 6 • From start of study drug administration up to 26 weeks
|
5.6%
4/72 • Number of events 4 • From start of study drug administration up to 26 weeks
|
4.3%
3/69 • Number of events 3 • From start of study drug administration up to 26 weeks
|
2.8%
2/72 • Number of events 2 • From start of study drug administration up to 26 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 30 days but less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER