A Trial to Study Neladenoson Bialanate Over 20 Weeks in P... | NCT02992288 | Trialant
NCT02992288
Sponsor
Bayer
Status
Completed
Last Update Posted
Apr 23, 2019Actual
Enrollment
427Actual
Phase
Phase 2
Conditions
Heart Failure
Interventions
Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197)
Placebo
Countries
United States
Belgium
Bulgaria
Germany
Greece
Israel
Italy
Japan
Netherlands
Poland
Spain
Protocol Section
Identification Module
NCT ID
NCT02992288
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
15128
Secondary IDs
ID
Type
Description
Link
2016-003839-38
EudraCT Number
Brief Title
A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction
Official Title
A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double Blind, Dose-finding Phase II Trial to Study the Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Effects of the Oral Partial Adenosine A1 Receptor Agonist Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction
Acronym
PANTHEON
Organization
BayerINDUSTRY
Status Module
Record Verification Date
Apr 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 22, 2017Actual
Primary Completion Date
Mar 28, 2018Actual
Completion Date
May 16, 2018Actual
First Submitted Date
Dec 12, 2016
First Submission Date that Met QC Criteria
Dec 12, 2016
First Posted Date
Dec 14, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 11, 2019
Results First Submitted that Met QC Criteria
Apr 19, 2019
Results First Posted Date
Apr 23, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 19, 2019
Last Update Posted Date
Apr 23, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BayerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY 1067197) when given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).
Detailed Description
Not provided
Conditions Module
Conditions
Heart Failure
Keywords
Chronic Heart Failure
Heart Failure with Reduced Ejection Fraction
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
427Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Neladenoson bialanate (BAY1067197) (5 mg)
Experimental
Chronic heart failure with reduced ejection fraction
Drug: Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197) (10 mg)
Experimental
Chronic heart failure with reduced ejection fraction
Drug: Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197) (20 mg)
Experimental
Chronic heart failure with reduced ejection fraction
Drug: Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197) (30 mg)
Experimental
Chronic heart failure with reduced ejection fraction
Drug: Neladenoson bialanate (BAY1067197)
Neladenoson bialanate (BAY1067197) (40 mg)
Experimental
Chronic heart failure with reduced ejection fraction
Drug: Neladenoson bialanate (BAY1067197)
Placebo
Placebo Comparator
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Neladenoson bialanate (BAY1067197)
Drug
5 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197) (5 mg)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography
Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported.
Baseline, Week 20
Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20
NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported.
Baseline, Week 20
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20
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.
Baseline, Week 20
Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Men or women aged 18 years and older
Diagnosis of chronic heart failure (CHF), NYHA ( New York Heart Association ) class II-IV, LVEF ≤ 35% and elevated NT-proBNP
Exclusion Criteria:
Acute de-novo heart failure
Requirement of any intravenous (IV) treatments following 48 hours prior to randomization
Mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device)
Any cause of chronic heart failure other than ischemic cardiomyopathy and idiopathic dilated cardiomyopathy
Voors AA, Bax JJ, Hernandez AF, Wirtz AB, Pap AF, Ferreira AC, Senni M, van der Laan M, Butler J; PANTHEON Investigators. Safety and efficacy of the partial adenosine A1 receptor agonist neladenoson bialanate in patients with chronic heart failure with reduced ejection fraction: a phase IIb, randomized, double-blind, placebo-controlled trial. Eur J Heart Fail. 2019 Nov;21(11):1426-1433. doi: 10.1002/ejhf.1591. Epub 2019 Sep 16.
See Also Links
Label
URL
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
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.
Recruitment Details
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).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
FG001
Neladenoson Bialanate 5 mg
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
Chronic heart failure with reduced ejection fraction
Drug: Placebo
Neladenoson bialanate (BAY1067197)
Drug
10 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197) (10 mg)
Neladenoson bialanate (BAY1067197)
Drug
20 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197) (20 mg)
Neladenoson bialanate (BAY1067197)
Drug
30 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197) (30 mg)
Neladenoson bialanate (BAY1067197)
Drug
40 mg orally once daily for 20 weeks
Neladenoson bialanate (BAY1067197) (40 mg)
Placebo
Drug
Orally once daily for 20 weeks
Placebo
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.
Baseline, Week 20
Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20
High sensitivity troponin T (hs-TNT) was measured. Mean and standard deviation were reported.
Baseline, Week 20
Number of Participants With Composite Efficacy Outcome
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.
Baseline up to Week 26
Number of Participants With Cardiovascular (CV) Mortality
Cardiovascular (CV) mortality was assessed. Number of participants with CV mortality were reported.
Baseline up to Week 26
Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF)
Number of participants with HF hospitalization and urgent visits for HF were reported.
Baseline up to Week 26
Detroit
Michigan
48202
United States
University of Mississippi Medical Center
Jackson
Mississippi
39216
United States
St. Louis Heart & Vascular, PC
St Louis
Missouri
63136
United States
Glacier View Research Institute-Cardiology
Kalispell
Montana
59901
United States
Stony Brook University Medical Center
Stony Brook
New York
11794
United States
St. Elizabeth Youngstown Hospital
Youngstown
Ohio
44501
United States
Tennessee Center for Clinical Trials
Tullahoma
Tennessee
37388
United States
East Texas Cardiology
Houston
Texas
77002
United States
AZ St-Jan Brugge Oostende AV
Bruges
8000
Belgium
Grand Hôpital de Charleroi
Gilly
6060
Belgium
AZ Delta
Roeselare
8800
Belgium
AZ Turnhout
Turnhout
2300
Belgium
Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
Pernik
2300
Bulgaria
Specialized Hospital for Actrive Treatm of Card - Pleven
Pleven
5800
Bulgaria
NMTH Tzar Boris III
Sofia
1233
Bulgaria
UMHAT Tsaritsa Joanna-ISUL EAD Sofia
Sofia
1527
Bulgaria
Multiprofile Hospital for Active Treatment Sveta Sofia
Sofia
1618
Bulgaria
MHAT Dr Stefan Cherkezov
Veliko Tarnovo
5000
Bulgaria
Medizinische Hochschule Hannover (MHH)
Hanover
Lower Saxony
30625
Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)
Bad Oeynhausen
North Rhine-Westphalia
32545
Germany
St.-Johannes-Hospital Dortmund
Dortmund
North Rhine-Westphalia
44137
Germany
Kliniken Maria Hilf GmbH
Mönchengladbach
North Rhine-Westphalia
41063
Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen am Rhein
Rhineland-Palatinate
67063
Germany
Charité Campus Virchow-Klinikum (CVK)
Berlin
13353
Germany
KAT General Hospital of Athens
Kifisia / Athens
Attica
14561
Greece
G. Gennimatas General State Hospital of Athens
Athens
11527
Greece
Thriassio General Hospital of Elefsina
Elefsina
19018
Greece
Konstantopoulio General Hospital of Nea Ionia - Agia Olga
National Hospital Organization Takasaki General Medical C
Takasaki
Gunma
370-0829
Japan
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki
Hyōgo
660-8550
Japan
National hospital Organization Mito Medical Center
Higashiibaraki
Ibaraki
311-3193
Japan
R.I.A.C Naha City Hospital
Naha
Okinawa
902-8511
Japan
Kishiwada Tokushukai Hospital
Kishiwada
Osaka
596-8522
Japan
Takatsuki Red Cross Hospital
Takatsuki
Osaka
569-1096
Japan
Minamino Cardiovascular Hospital
Hachiōji
Tokyo
192-0918
Japan
Nihon University Itabashi Hospital
Itabashi-ku
Tokyo
173-8610
Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku
Tokyo
162-8666
Japan
Hiroshima University Hospital
Hiroshima
734-8511
Japan
Okayama Rosai Hospital
Okayama
702-8055
Japan
Osaka General Medical Center
Osaka
558-8558
Japan
Toyama Prefectural Central Hospital
Toyama
930-8550
Japan
Onze Lieve Vrouwe Gasthuis
Amsterdam
1091 AC
Netherlands
Ziekenhuis Rijnstate
Arnhem
6815 AD
Netherlands
Universitair Medisch Centrum Groningen
Groningen
9700 RB
Netherlands
Erasmus Medisch Centrum
Rotterdam
3015 CE
Netherlands
KLIMED Marek Klimkiewicz
Bialystok
15-776
Poland
CLINICAL MEDICAL RESEARCH Sp. z o. o.
Katowice
40-156
Poland
Szpital Specjalistyczny im. J. Dietla
Krakow
31-121
Poland
Nzoz Salus
Lodz
91-302
Poland
Szpital Kliniczny Przemienienia Panskiego
Poznan
61-848
Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin
71-434
Poland
IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ
Wroclaw
50-981
Poland
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela
A Coruña
15706
Spain
Hospital Universitario "Virgen de la Arrixaca"
El Palmar
Murcia
30120
Spain
Complejo Hospitalario Universitario A Coruña
A Coruña
15006
Spain
Hospital General Universitario Gregorio Marañón
Madrid
28007
Spain
Hospital Clínico Universitario San Carlos
Madrid
28040
Spain
Hospital Clínico Universitario de Valencia
Valencia
46010
Spain
Hospital Universitari i Politècnic La Fe
Valencia
46026
Spain
FG002
Neladenoson Bialanate 10 mg
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
FG003
Neladenoson Bialanate 20 mg
Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
FG004
Neladenoson Bialanate 30 mg
Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
FG005
Neladenoson Bialanate 40 mg
Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
FG000106 subjects
FG00137 subjects
FG00270 subjects
FG00373 subjects
FG00469 subjects
FG00572 subjects
Treated
FG000106 subjects
FG00137 subjects
FG00270 subjects
FG00372 subjects
FG00469 subjects
FG00572 subjects
COMPLETED
FG00089 subjects
FG00132 subjects
FG00263 subjects
FG00364 subjects
FG00461 subjects
FG00559 subjects
NOT COMPLETED
FG00017 subjects
FG0015 subjects
FG0027 subjects
FG0039 subjects
FG0048 subjects
FG00513 subjects
Type
Comment
Reasons
Adverse Event
FG0008 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0057 subjects
Non-compliance with study drug
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Physician Decision
FG0003 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Death
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0004 subjects
FG0012 subjects
FG0021 subjects
FG0035 subjects
FG004
Full analysis set (FAS) included all randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
BG001
Neladenoson Bialanate 5 mg
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
BG002
Neladenoson Bialanate 10 mg
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
BG003
Neladenoson Bialanate 20 mg
Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
BG004
Neladenoson Bialanate 30 mg
Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
BG005
Neladenoson Bialanate 40 mg
Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000106
BG00137
BG00270
BG00373
BG00469
BG00572
BG006427
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00066.9± 9.4
BG00166.6± 10.5
BG00266.4± 11.2
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00018
BG0019
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Left ventricular ejection fraction (LVEF)
Left ventricular ejection fraction (LVEF) is defined as the fraction of blood being pumped out of the left ventricle of the heart with each contraction.
Mean
Standard Deviation
Percentage of LVEF
Title
Denominators
Categories
Title
Measurements
BG00028.24± 10.67
BG001
New York Heart Association (NYHA) Class
NYHA classifies the extent of heart failure as Class I: Cardiac disease without resulting limitation of physical activity, Class II: Cardiac disease resulting in slight limitation of physical activity, Class III: Cardiac disease resulting in marked limitation of physical activity and Class IV: Cardiac disease resulting in inability to carry out any physical activity without discomfort.
Medication of interest: Angiotensin-converting enzyme inhibitor
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Angiotensin-converting enzyme inhibitor
BG00058
BG00119
BG002
Medication of interest: Angiotensin receptor blocker
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Angiotensin receptor blocker
BG00015
BG0016
BG002
Medication of interest: Angiotensin receptor-neprilysin inhibitor
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Angiotensin receptor-neprilysin inhibitor
BG00020
BG0017
BG002
Medication of interest: Mineralocorticoid receptor antagonist
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Mineralocorticoid receptor antagonist
BG00093
BG00133
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography
Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported.
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.
Posted
Mean
Standard Deviation
Percentage of LVEF
Baseline, Week 20
ID
Title
Description
OG000
Placebo
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
OG001
Neladenoson Bialanate 5 mg
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
OG002
Neladenoson Bialanate 10 mg
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
OG003
Neladenoson Bialanate 20 mg
Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
OG004
Neladenoson Bialanate 30 mg
Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
OG005
Neladenoson Bialanate 40 mg
Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
Units
Counts
Participants
OG00047
OG00119
OG00235
OG003
Title
Denominators
Categories
Title
Measurements
OG000-2.19± 8.39
OG0012.59± 8.48
OG002-3.01± 10.43
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
MCP-Mod method
Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.
0.2297
Linear dose-response shape: The multiple comparison procedures (MCP) approach was applied to calculate the adjusted one-sided one-sided p-values of the contrast test.
Superiority
Primary
Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20
NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported.
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.
Posted
Mean
Standard Deviation
log picograms per milliliter
Baseline, Week 20
ID
Title
Description
OG000
Placebo
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
OG001
Neladenoson Bialanate 5 mg
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
OG002
Neladenoson Bialanate 10 mg
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
OG003
Neladenoson Bialanate 20 mg
Secondary
Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20
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.
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.
Posted
Mean
Standard Deviation
Milliliters (mL)
Baseline, Week 20
ID
Title
Description
OG000
Placebo
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
OG001
Neladenoson Bialanate 5 mg
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
OG002
Neladenoson Bialanate 10 mg
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
OG003
Neladenoson Bialanate 20 mg
Secondary
Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20
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.
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.
Posted
Mean
Standard Deviation
Milliliters (mL)
Baseline, Week 20
ID
Title
Description
OG000
Placebo
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
OG001
Neladenoson Bialanate 5 mg
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
OG002
Neladenoson Bialanate 10 mg
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
OG003
Secondary
Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20
High sensitivity troponin T (hs-TNT) was measured. Mean and standard deviation were reported.
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.
Posted
Mean
Standard Deviation
Picograms per milliliter (pg/mL)
Baseline, Week 20
ID
Title
Description
OG000
Placebo
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
OG001
Neladenoson Bialanate 5 mg
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
OG002
Neladenoson Bialanate 10 mg
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
OG003
Neladenoson Bialanate 20 mg
Secondary
Number of Participants With Composite Efficacy Outcome
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.
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.
Posted
Count of Participants
Participants
Baseline up to Week 26
ID
Title
Description
OG000
Placebo
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
OG001
Neladenoson Bialanate 5 mg
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
OG002
Neladenoson Bialanate 10 mg
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
OG003
Neladenoson Bialanate 20 mg
Secondary
Number of Participants With Cardiovascular (CV) Mortality
Cardiovascular (CV) mortality was assessed. Number of participants with CV mortality were reported.
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.
Posted
Count of Participants
Participants
Baseline up to Week 26
ID
Title
Description
OG000
Placebo
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
OG001
Neladenoson Bialanate 5 mg
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
OG002
Neladenoson Bialanate 10 mg
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
OG003
Neladenoson Bialanate 20 mg
Secondary
Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF)
Number of participants with HF hospitalization and urgent visits for HF were reported.
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.
Posted
Count of Participants
Participants
Baseline up to Week 26
ID
Title
Description
OG000
Placebo
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
OG001
Neladenoson Bialanate 5 mg
Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.
OG002
Neladenoson Bialanate 10 mg
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
OG003
Neladenoson Bialanate 20 mg
Time Frame
From start of study drug administration up to 26 weeks
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.
8
106
31
106
24
106
EG001
Neladenoson Bialanate 5mg
Participants received 5 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
1
37
13
37
10
37
EG002
Neladenoson Bialanate 10mg
Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
5
70
28
70
15
70
EG003
Neladenoson Bialanate 20mg
Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
1
72
22
72
18
72
EG004
Neladenoson Bialanate 30mg
Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
2
69
28
69
24
69
EG005
Neladenoson Bialanate 40mg
Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.
2
72
26
72
19
72
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (21.0)
Non-systematic Assessment
EG0002 events2 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG0031 events1 affected72 at risk
EG0042 events2 affected69 at risk
EG0052 events2 affected72 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0003 events2 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0022 events2 affected70 at risk
EG003
Atrial tachycardia
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0022 events2 affected70 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG00020 events15 affected106 at risk
EG0018 events7 affected37 at risk
EG00214 events12 affected70 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Cardiac failure chronic
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0008 events5 affected106 at risk
EG0011 events1 affected37 at risk
EG0022 events2 affected70 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0003 events3 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Low cardiac output syndrome
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Right ventricular failure
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0011 events1 affected37 at risk
EG0022 events2 affected70 at risk
EG003
Cardiac ventricular thrombosis
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Acute left ventricular failure
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Large intestinal haemorrhage
Gastrointestinal disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Chest pain
General disorders
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Sudden death
General disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Oedema due to cardiac disease
General disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Infection
Infections and infestations
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Peritonitis
Infections and infestations
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (21.0)
Non-systematic Assessment
EG0002 events2 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Pneumonia legionella
Infections and infestations
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Septic shock
Infections and infestations
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Serratia sepsis
Infections and infestations
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (21.0)
Non-systematic Assessment
EG0002 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Traumatic fracture
Injury, poisoning and procedural complications
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Arteriogram coronary
Investigations
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Blood pressure decreased
Investigations
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Device function test
Investigations
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Non-systematic Assessment
EG0003 events2 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Cervix carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Chronic lymphocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Rectal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Renal cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Paraparesis
Nervous system disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Seizure
Nervous system disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Syncope
Nervous system disorders
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0011 events1 affected37 at risk
EG0022 events2 affected70 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA (21.0)
Non-systematic Assessment
EG0002 events2 affected106 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (21.0)
Non-systematic Assessment
EG0002 events2 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Pulmonary congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Atrial septal defect repair
Surgical and medical procedures
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Cardiac pacemaker insertion
Surgical and medical procedures
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Cardiac pacemaker replacement
Surgical and medical procedures
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Implantable defibrillator insertion
Surgical and medical procedures
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0022 events2 affected70 at risk
EG003
Ventricular assist device insertion
Surgical and medical procedures
MedDRA (21.0)
Non-systematic Assessment
EG0002 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Implantable defibrillator replacement
Surgical and medical procedures
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Cardiac resynchronisation therapy
Surgical and medical procedures
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Colectomy
Surgical and medical procedures
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Hypotension
Vascular disorders
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Thrombosis
Vascular disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Device failure
Product Issues
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac failure
Cardiac disorders
MedDRA (21.0)
Non-systematic Assessment
EG0009 events9 affected106 at risk
EG0012 events2 affected37 at risk
EG0022 events2 affected70 at risk
EG0031 events1 affected72 at risk
EG0043 events3 affected69 at risk
EG0056 events3 affected72 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0012 events2 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (21.0)
Non-systematic Assessment
EG0002 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Asthenia
General disorders
MedDRA (21.0)
Non-systematic Assessment
EG0002 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Fatigue
General disorders
MedDRA (21.0)
Non-systematic Assessment
EG0002 events2 affected106 at risk
EG0012 events2 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (21.0)
Non-systematic Assessment
EG0001 events1 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Non-systematic Assessment
EG0002 events2 affected106 at risk
EG0012 events2 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (21.0)
Non-systematic Assessment
EG0003 events3 affected106 at risk
EG0010 events0 affected37 at risk
EG0021 events1 affected70 at risk
EG003
Headache
Nervous system disorders
MedDRA (21.0)
Non-systematic Assessment
EG0003 events3 affected106 at risk
EG0011 events1 affected37 at risk
EG0022 events2 affected70 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA (21.0)
Non-systematic Assessment
EG0007 events6 affected106 at risk
EG0011 events1 affected37 at risk
EG0020 events0 affected70 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0010 events0 affected37 at risk
EG0023 events3 affected70 at risk
EG003
Hypotension
Vascular disorders
MedDRA (21.0)
Non-systematic Assessment
EG0000 events0 affected106 at risk
EG0011 events1 affected37 at risk
EG0026 events5 affected70 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.