Trial Outcomes & Findings for Effective Study of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D (RHYTHM) (NCT NCT04491136)
NCT ID: NCT04491136
Last Updated: 2025-05-16
Results Overview
VA events were measured through devices to determine sustained ventricular tachycardia (SVT), non-sustained ventricular tachycardia (NSVT) and premature ventricular contraction (PVC). SVT was defined as tachycardia lasting for ≥30 seconds or with hemodynamic disorder as determined by Holter and/or device. NSVT was defined as recorded by Holter and/or device. PVC was defined as an early ventricular depolarization as determined by the device, and/or detected by Holter. PVC data were not available for patients with single -lumen implantation type
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
201 participants
Primary outcome timeframe
Up to 12 months (6 months of ACEI/ARB treatment and 6 months of ARNI treatment)
Results posted on
2025-05-16
Participant Flow
Participants took part in 23 investigative sites in China
All patients provided written informed consent prior to the start of any study-related activities.
Participant milestones
| Measure |
ACEI/ARB Followed by ARNI
Patients received angiotensin-converting enzyme inhibitor/angiotensin receptor blockers treatment the first 6 months. The following 6 months patients received angiotensin receptor neprilysin inhibitor treatment.
|
|---|---|
|
Overall Study
STARTED
|
201
|
|
Overall Study
Safety Set (SS)
|
201
|
|
Overall Study
Efficacy Analysis Set (EAS)
|
140
|
|
Overall Study
COMPLETED
|
122
|
|
Overall Study
NOT COMPLETED
|
79
|
Reasons for withdrawal
| Measure |
ACEI/ARB Followed by ARNI
Patients received angiotensin-converting enzyme inhibitor/angiotensin receptor blockers treatment the first 6 months. The following 6 months patients received angiotensin receptor neprilysin inhibitor treatment.
|
|---|---|
|
Overall Study
Patient withdraw informed consent
|
9
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Physician Decision
|
45
|
|
Overall Study
sponsor terminated the study early
|
16
|
|
Overall Study
Patient/guardian's decision
|
1
|
Baseline Characteristics
Effective Study of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D (RHYTHM)
Baseline characteristics by cohort
| Measure |
ACEI/ARB Followed by ARNI
n=201 Participants
Patients received angiotensin-converting enzyme inhibitor/angiotensin receptor blockers treatment the first 6 months. The following 6 months patients received angiotensin receptor neprilysin inhibitor treatment.
|
|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 10.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
160 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
201 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months (6 months of ACEI/ARB treatment and 6 months of ARNI treatment)Population: Efficacy analysis set (EAS): Patients in the safety set who received at least one dose of ARNI and completed 12 months of complete treatment and follow-up or withdrew early after receiving at least one dose of ARNI. Only subjects who had this measurement index successfully paired (ACEI/ARB treatment and ARNI treatment) were included in the analysis.
VA events were measured through devices to determine sustained ventricular tachycardia (SVT), non-sustained ventricular tachycardia (NSVT) and premature ventricular contraction (PVC). SVT was defined as tachycardia lasting for ≥30 seconds or with hemodynamic disorder as determined by Holter and/or device. NSVT was defined as recorded by Holter and/or device. PVC was defined as an early ventricular depolarization as determined by the device, and/or detected by Holter. PVC data were not available for patients with single -lumen implantation type
Outcome measures
| Measure |
ACEI/ARB
n=76 Participants
Patients received angiotensin-converting enzyme inhibitor/angiotensin receptor blockers treatment the first 6 months.
|
ARNI
n=76 Participants
The following 6 months patients received angiotensin receptor neprilysin inhibitor treatment (sacubitril/valsartan).
|
|---|---|---|
|
Proportion of Paired Patients With Ventricular Arrhythmia (VA) Events
At least one SVT occurred
|
13 Participants
|
12 Participants
|
|
Proportion of Paired Patients With Ventricular Arrhythmia (VA) Events
At least one NSVT occurred
|
23 Participants
|
21 Participants
|
|
Proportion of Paired Patients With Ventricular Arrhythmia (VA) Events
At least one PVC occurred
|
40 Participants
|
38 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months (6 months of ACEI/ARB treatment and 6 months of ARNI treatment)Population: Efficacy analysis set (EAS): Patients in the safety set who received at least one dose of ARNI and completed 12 months of complete treatment and follow-up or withdrew early after receiving at least one dose of ARNI. Only subjects who had this measurement index successfully paired (ACEI/ARB treatment and ARNI treatment) were included in the analysis.
Once VA events were detected, implantable cardioverter defibrillator (ICD) could treat with high-energy shocks or Anti-tachycardia pacing (ATP). ATP consists of one or more trains of pacing stimuli, expressed as a percentage of the tachycardia cycle length for a given RR interval, from the onset of the preceding R wave. Patients with sustained VA events would receive ICD or cardiac resynchronization therapy-defibrillator (CRT-D) shock therapy.
Outcome measures
| Measure |
ACEI/ARB
n=87 Participants
Patients received angiotensin-converting enzyme inhibitor/angiotensin receptor blockers treatment the first 6 months.
|
ARNI
n=87 Participants
The following 6 months patients received angiotensin receptor neprilysin inhibitor treatment (sacubitril/valsartan).
|
|---|---|---|
|
Proportion of Paired Patients Who Experienced at Least One ICD or CRT-D Shock and ATP Event
Occurrence of at least one ICD or CRT-D shock
|
3 Participants
|
2 Participants
|
|
Proportion of Paired Patients Who Experienced at Least One ICD or CRT-D Shock and ATP Event
Occurrence of at least one ATP event
|
15 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months (6 months of ACEI/ARB treatment and 6 months of ARNI treatment)Population: Efficacy analysis set (EAS): Patients in the safety set who received at least one dose of ARNI and completed 12 months of complete treatment and follow-up or withdrew early after receiving at least one dose of ARNI. Only subjects who had this measurement index successfully paired (ACEI/ARB treatment and ARNI treatment) were included in the analysis.
To assess the number of occurrences of Ventricular arrhythmia (VA) events and Implantable cardioverter defibrillator (ICD) or Cardiac resynchronization therapy-defibrillator (CRT-D) shocks over 6 months of ACEI/ARB and 6 months of ARNI treatment. PVC data were not available for patients with single-lumen implantation type
Outcome measures
| Measure |
ACEI/ARB
n=87 Participants
Patients received angiotensin-converting enzyme inhibitor/angiotensin receptor blockers treatment the first 6 months.
|
ARNI
n=87 Participants
The following 6 months patients received angiotensin receptor neprilysin inhibitor treatment (sacubitril/valsartan).
|
|---|---|---|
|
Pairwise Number of SVT, NSVT, PVC, ICD or CRT-D Shocks and ATP Events Experienced by Patients
SVT
|
170 number of events
|
117 number of events
|
|
Pairwise Number of SVT, NSVT, PVC, ICD or CRT-D Shocks and ATP Events Experienced by Patients
NSVT
|
5353 number of events
|
1648 number of events
|
|
Pairwise Number of SVT, NSVT, PVC, ICD or CRT-D Shocks and ATP Events Experienced by Patients
PVC
|
9676979 number of events
|
17482398 number of events
|
|
Pairwise Number of SVT, NSVT, PVC, ICD or CRT-D Shocks and ATP Events Experienced by Patients
ICD or CRT-D shock
|
6 number of events
|
5 number of events
|
|
Pairwise Number of SVT, NSVT, PVC, ICD or CRT-D Shocks and ATP Events Experienced by Patients
ATP
|
217 number of events
|
156 number of events
|
SECONDARY outcome
Timeframe: Up to 12 months (6 months of ACEI/ARB treatment and 6 months of ARNI treatment)Population: Efficacy analysis set (EAS): Patients in the safety set who received at least one dose of ARNI and completed 12 months of complete treatment and follow-up or withdrew early after receiving at least one dose of ARNI. Only participants with assessment of LVEF at 6 months of ACEI/ARB treatment and 6 months of ARNI treatment are included in the analysis.
To compare the changes in Left Ventricular Ejection Fraction (LVEF) between ACEI/ARB and ARNI treatments. LVEF is a measurement expressed as a percentage of how much blood in the left ventricle is pumped out with each contraction of the heart.
Outcome measures
| Measure |
ACEI/ARB
n=108 Participants
Patients received angiotensin-converting enzyme inhibitor/angiotensin receptor blockers treatment the first 6 months.
|
ARNI
n=108 Participants
The following 6 months patients received angiotensin receptor neprilysin inhibitor treatment (sacubitril/valsartan).
|
|---|---|---|
|
Left Ventricular Ejection Fraction
|
38.84 percentage of ejected blood
Standard Deviation 9.923
|
41.24 percentage of ejected blood
Standard Deviation 10.021
|
SECONDARY outcome
Timeframe: Up to 12 months (6 months of ACEI/ARB treatment and 6 months of ARNI treatment)Population: Efficacy analysis set (EAS): Patients in the safety set who received at least one dose of ARNI and completed 12 months of complete treatment and follow-up or withdrew early after receiving at least one dose of ARNI. Only participants with assessment of NYHA at 6 months of ACEI/ARB treatment and 6 months of ARNI treatment are included in the analysis.
To compare the changes in New York Heart Association (NYHA) level between ACEI/ARB and ARNI treatments. NYHA classification is a subjective physician's assessment of heart failure patient's functional capacity and symptomatic status. Class I - No limitation of physical activity. Class II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV - Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Outcome measures
| Measure |
ACEI/ARB
n=109 Participants
Patients received angiotensin-converting enzyme inhibitor/angiotensin receptor blockers treatment the first 6 months.
|
ARNI
n=109 Participants
The following 6 months patients received angiotensin receptor neprilysin inhibitor treatment (sacubitril/valsartan).
|
|---|---|---|
|
New York Heart Association Classification
|
2.03 score on a scale
Standard Deviation 0.499
|
2.00 score on a scale
Standard Deviation 0.509
|
SECONDARY outcome
Timeframe: Up to 12 months (6 months of ACEI/ARB treatment and 6 months of ARNI treatment)Population: Efficacy analysis set (EAS): Patients in the safety set who received at least one dose of ARNI and completed 12 months of complete treatment and follow-up or withdrew early after receiving at least one dose of ARNI. Only participants with assessment of NT-proBNP at 6 months of ACEI/ARB treatment and 6 months of ARNI treatment are included in the analysis.
To compare the changes in the N-Terminal prohormone of Brain Natriuretic Peptide(NT-proBNP) level between ACEI/ARB and ARNI treatments. NT-proBNP are small proteins produced in large amounts when the heart senses it needs to work harder, such as in heart failure.
Outcome measures
| Measure |
ACEI/ARB
n=107 Participants
Patients received angiotensin-converting enzyme inhibitor/angiotensin receptor blockers treatment the first 6 months.
|
ARNI
n=107 Participants
The following 6 months patients received angiotensin receptor neprilysin inhibitor treatment (sacubitril/valsartan).
|
|---|---|---|
|
N-Terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) Level
|
1233.79 pg/mL
Standard Deviation 1974.401
|
1002.33 pg/mL
Standard Deviation 1738.400
|
SECONDARY outcome
Timeframe: Up to 12 months (6 months of ACEI/ARB treatment and 6 months of ARNI treatment)Population: Efficacy analysis set (EAS): Patients in the safety set who received at least one dose of ARNI and completed 12 months of complete treatment and follow-up or withdrew early after receiving at least one dose of ARNI.
To compare the healthcare resource utilization of Heart Failure (HF) patients during ACEI/ARB and ARNI treatments
Outcome measures
| Measure |
ACEI/ARB
n=140 Participants
Patients received angiotensin-converting enzyme inhibitor/angiotensin receptor blockers treatment the first 6 months.
|
ARNI
n=140 Participants
The following 6 months patients received angiotensin receptor neprilysin inhibitor treatment (sacubitril/valsartan).
|
|---|---|---|
|
Number of Hospitalizations for Arrhythmia or HF Related Hospitalizations
Number of hospitalizations
|
25 number of hospitalizations
|
16 number of hospitalizations
|
|
Number of Hospitalizations for Arrhythmia or HF Related Hospitalizations
Number of hospitalizations for heart failure
|
13 number of hospitalizations
|
3 number of hospitalizations
|
Adverse Events
ACEI/ARB
Serious events: 38 serious events
Other events: 99 other events
Deaths: 3 deaths
ARNI
Serious events: 19 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ACEI/ARB
n=201 participants at risk
Patients received angiotensin-converting enzyme inhibitor/angiotensin receptor blockers treatment the first 6 months.
|
ARNI
n=140 participants at risk
The following 6 months patients received angiotensin receptor neprilysin inhibitor treatment
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Arrhythmia
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Arrhythmic storm
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
1.4%
2/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Atrial flutter
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Cardiac failure
|
7.5%
15/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
2.9%
4/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Cardiac failure acute
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Cardiac failure chronic
|
2.0%
4/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
1.4%
2/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
1.4%
2/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
General disorders
Chest pain
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
General disorders
Complication associated with device
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
Erysipelas
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
Gastroenteritis
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
Pneumonia
|
2.0%
4/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
Pyelonephritis acute
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Gout
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal neoplasm
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Product Issues
Lead dislodgement
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Psychiatric disorders
Depression
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Vascular disorders
Hypotension
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
Other adverse events
| Measure |
ACEI/ARB
n=201 participants at risk
Patients received angiotensin-converting enzyme inhibitor/angiotensin receptor blockers treatment the first 6 months.
|
ARNI
n=140 participants at risk
The following 6 months patients received angiotensin receptor neprilysin inhibitor treatment
|
|---|---|---|
|
Investigations
Platelet count decreased
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Urinary occult blood positive
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
White blood cell count decreased
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
White blood cell count increased
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Acidosis
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
2.1%
3/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Blood and lymphatic system disorders
Red blood cell abnormality
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
3/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Cardiac dysfunction
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Cardiac failure
|
1.5%
3/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Cardiac failure chronic
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
1.4%
2/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Palpitations
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Sinus bradycardia
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Ventricular fibrillation
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Ventricular pre-excitation
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
1.4%
2/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Endocrine disorders
Hypothyroidism
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Eye disorders
Cataract
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Eye disorders
Photophobia
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
3/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Gastrointestinal disorders
Constipation
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
4/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
2.9%
4/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Gastrointestinal disorders
Gingival bleeding
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Gastrointestinal disorders
Nausea
|
1.5%
3/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Gastrointestinal disorders
Toothache
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
3/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
General disorders
Adverse drug reaction
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
General disorders
Asthenia
|
2.0%
4/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
General disorders
Chest discomfort
|
2.5%
5/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
2.9%
4/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
General disorders
Chest pain
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
General disorders
Oedema
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
General disorders
Oedema peripheral
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
General disorders
Pain
|
1.5%
3/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
General disorders
Peripheral swelling
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
General disorders
Pyrexia
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
2.1%
3/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Hepatobiliary disorders
Hepatic failure
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
1.4%
2/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Immune system disorders
Hypersensitivity
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Immune system disorders
Immunodeficiency
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
Appendicitis
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
COVID-19
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
COVID-19 pneumonia
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
Cystitis
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
Eye infection
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
Laryngopharyngitis
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
Liver abscess
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
Nasopharyngitis
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
2.1%
3/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
Sepsis
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
8/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
2.1%
3/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Infections and infestations
Urinary tract infection
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Injury, poisoning and procedural complications
Eyelid injury
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
1.4%
2/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Injury, poisoning and procedural complications
Foreign body in throat
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Alanine aminotransferase increased
|
1.5%
3/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Blood bilirubin unconjugated increased
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Blood creatinine increased
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Blood glucose abnormal
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
2.9%
4/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Blood glucose decreased
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Blood potassium decreased
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Blood pressure decreased
|
1.5%
3/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Blood urea increased
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Brain natriuretic peptide increased
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Coagulation test abnormal
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Fibrin D dimer increased
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Glomerular filtration rate decreased
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Glucose urine present
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Lipids increased
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
2.1%
3/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Lipoprotein (a) increased
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Investigations
Neutrophil count increased
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
1.5%
3/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
1.5%
3/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Hyperhomocysteinaemia
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.0%
4/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
5.7%
8/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.5%
5/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
2.1%
3/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.5%
3/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Sodium retention
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Nervous system disorders
Cerebral atrophy
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Nervous system disorders
Cerebral ischaemia
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Nervous system disorders
Dizziness
|
5.5%
11/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
1.4%
2/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Nervous system disorders
Headache
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Nervous system disorders
Muscle spasticity
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Psychiatric disorders
Insomnia
|
2.0%
4/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Psychiatric disorders
Poor quality sleep
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Psychiatric disorders
Sleep disorder
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Renal and urinary disorders
Dysuria
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Renal and urinary disorders
Oliguria
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Renal and urinary disorders
Renal failure
|
1.5%
3/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Renal and urinary disorders
Renal impairment
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.5%
3/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Reproductive system and breast disorders
Breast pain
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.5%
11/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
3/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
1.00%
2/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Skin and subcutaneous tissue disorders
Solar dermatitis
|
0.50%
1/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.00%
0/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Vascular disorders
Diabetic vascular disorder
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Vascular disorders
Hypertension
|
2.0%
4/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
0.71%
1/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
|
Vascular disorders
Hypotension
|
7.5%
15/201 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
5.0%
7/140 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment. Patients were followed up for 6 months for each treatment, up to a maximum duration of 13 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER