Trial Outcomes & Findings for Description of Tolerability of LCZ696 (Sacubitril / Valsartan) in Heart Failure With Reduced Ejection Fraction (HFrEF) Treated in Real Life Setting (NCT NCT02690974)
NCT ID: NCT02690974
Last Updated: 2019-06-07
Results Overview
The tolerability of LCZ696 was defined as the percentage of patients on LCZ696 at the dose of 97 mg sacubitril / 103 mg valsartan twice daily (bid) who did not experience down titration or treatment discontinuation because of adverse events while on this dose at month 6. Only descriptive analysis done.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
302 participants
Primary outcome timeframe
Month 6
Results posted on
2019-06-07
Participant Flow
This study was conducted in 32 study centers in Canada
Approximately 300 patients with HFrEF were planned for enrolling into the study. A total of 302 patients received at least one dose of LCZ696 and were included in the Full Analysis Set (FAS). The analysis of the primary endpoint was based on the FAS.
Participant milestones
| Measure |
LCZ696 (Sacubitril / Valsartan)
All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.
|
|---|---|
|
Overall Study
STARTED
|
302
|
|
Overall Study
COMPLETED
|
262
|
|
Overall Study
NOT COMPLETED
|
40
|
Reasons for withdrawal
| Measure |
LCZ696 (Sacubitril / Valsartan)
All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.
|
|---|---|
|
Overall Study
Adverse Event
|
16
|
|
Overall Study
Death
|
9
|
|
Overall Study
Subject/guardian decision
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal of Informed Consent
|
3
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Non-compliance with study treatment
|
1
|
|
Overall Study
Protocol-defined stopping criteria
|
1
|
|
Overall Study
Protocol Deviation
|
1
|
Baseline Characteristics
Description of Tolerability of LCZ696 (Sacubitril / Valsartan) in Heart Failure With Reduced Ejection Fraction (HFrEF) Treated in Real Life Setting
Baseline characteristics by cohort
| Measure |
LCZ696 (Sacubitril / Valsartan)
n=302 Participants
All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.
|
|---|---|
|
Age, Continuous
|
64.47 Years
STANDARD_DEVIATION 10.7659 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
240 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
271 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.
The tolerability of LCZ696 was defined as the percentage of patients on LCZ696 at the dose of 97 mg sacubitril / 103 mg valsartan twice daily (bid) who did not experience down titration or treatment discontinuation because of adverse events while on this dose at month 6. Only descriptive analysis done.
Outcome measures
| Measure |
LCZ696 (Sacubitril / Valsartan)
n=302 Participants
All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.
|
|---|---|
|
Percentage of Participants on LCZ696 200 mg Bid at Month 6
|
64.6 Percentage of Participants
Interval 59.18 to 69.96
|
SECONDARY outcome
Timeframe: Month 12Population: The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.
The tolerability of LCZ696 was defined as the percentage of patients on LCZ696 at the dose of 97 mg sacubitril / 103 mg valsartan twice daily (bid) who did not experience down titration or treatment discontinuation because of adverse events while on this dose at month 12. Only descriptive analysis done.
Outcome measures
| Measure |
LCZ696 (Sacubitril / Valsartan)
n=302 Participants
All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.
|
|---|---|
|
Percentage of Participants on LCZ696 200 mg Bid at Month 12
|
62.3 Percentage of Participants
Interval 56.78 to 67.72
|
SECONDARY outcome
Timeframe: Month 12Population: The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.
The impact of the titration scheme on the tolerability of patients maintained on LCZ696 97 mg sacubitril / 103 mg valsartan bid was defined as the percentage of patients on LCZ696 200mg requiring down-titration. Only descriptive analysis done.
Outcome measures
| Measure |
LCZ696 (Sacubitril / Valsartan)
n=302 Participants
All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.
|
|---|---|
|
Percentage of Participants Requiring Down-titration From LCZ696 200 mg
|
11.92 Percentage of Participants
Interval 8.27 to 15.58
|
SECONDARY outcome
Timeframe: Month 12Population: The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.
The impact of the titration scheme on the tolerability of patients maintained on LCZ696 97 mg sacubitril / 103 mg valsartan bid was defined as the number of down-titration during the 12 months treatment period. Dow-titration schemes considered for the analysis are 200 mg to 100 mg; 100 mg to 50 mg; and 50 mg to 0 mg (i.e. treatment discontinuation). The down-titration scheme of 50mg to 0 mg was taken in account in this analysis to ensure to reflect all actual changes in dose. Only descriptive analysis done.
Outcome measures
| Measure |
LCZ696 (Sacubitril / Valsartan)
n=302 Participants
All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.
|
|---|---|
|
Percentage of Participants With Down-titration Changes From LCZ696 200 mg During 12 Months of Treatment
200 mg dose level
|
188 Participants
|
|
Percentage of Participants With Down-titration Changes From LCZ696 200 mg During 12 Months of Treatment
100 mg dose level
|
44 Participants
|
|
Percentage of Participants With Down-titration Changes From LCZ696 200 mg During 12 Months of Treatment
50 mg dose level
|
28 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and Month 12Population: The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.
The impact of LCZ696 on functional exercise capacity was measured by the Six Minute Walk Test at 6 and 12 months. The 6MWT measures the distance an individual is able to walf over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. Only descriptive analysis done.
Outcome measures
| Measure |
LCZ696 (Sacubitril / Valsartan)
n=279 Participants
All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.
|
|---|---|
|
Change From Baseline in the Six Minute Walk Test (6MWT) at Month 6 and Month 12
Value at Baseline (Day 1)
|
392.62 Meter (m)
Standard Deviation 139.3277
|
|
Change From Baseline in the Six Minute Walk Test (6MWT) at Month 6 and Month 12
Change from Baseline at Month 6
|
11.99 Meter (m)
Standard Deviation 67.5725
|
|
Change From Baseline in the Six Minute Walk Test (6MWT) at Month 6 and Month 12
Change from Baseline at Month 12
|
8.19 Meter (m)
Standard Deviation 71.3619
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Month 3, Month 6 and Month 12Population: The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.
To describe the time of up-titration for each dose (24 mg sacubitril / 26 mg valsartan bid and 49 mg sacubitril / 51 mg valsartan bid) of LCZ696. Only descriptive analysis done.
Outcome measures
| Measure |
LCZ696 (Sacubitril / Valsartan)
n=302 Participants
All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.
|
|---|---|
|
Time to Each Up-titration to LCZ696 100 mg and LCZ696 200 mg
50- 100 mg bid level
|
21.44 Days
Standard Deviation 23.1799
|
|
Time to Each Up-titration to LCZ696 100 mg and LCZ696 200 mg
100- 200 mg bid level
|
27.37 Days
Standard Deviation 28.5601
|
|
Time to Each Up-titration to LCZ696 100 mg and LCZ696 200 mg
50- 200 mg bid level
|
46.61 Days
Standard Deviation 36.9439
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Month 3, Month 6 and Month 12Population: The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.
To describe the time of up-titration for each dose (24 mg sacubitril / 26 mg valsartan bid and 49 mg sacubitril / 51 mg valsartan bid) of LCZ696. Only descriptive analysis done.
Outcome measures
| Measure |
LCZ696 (Sacubitril / Valsartan)
n=302 Participants
All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.
|
|---|---|
|
Median Time to Reach LCZ696 200 mg
|
37.00 Days
Interval 35.0 to 42.0
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and Month 12Population: The Safety Analysis Set (FAS), which consisted of all participants with an observed value, was considered.
To describe the adherence to guideline recommended dosing of beta-blockers and MRAs at 6 and 12 months of treatment of LCZ696. Only descriptive analysis done.
Outcome measures
| Measure |
LCZ696 (Sacubitril / Valsartan)
n=302 Participants
All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.
|
|---|---|
|
Percentage of Participants on Guideline Recommended Dose of Beta-blockers and MRAs Over Time
Baseline
|
298 Participants
|
|
Percentage of Participants on Guideline Recommended Dose of Beta-blockers and MRAs Over Time
Month 6
|
272 Participants
|
|
Percentage of Participants on Guideline Recommended Dose of Beta-blockers and MRAs Over Time
Month 12
|
261 Participants
|
Adverse Events
LCZ696 (Sacubitril / Valsartan)
Serious events: 47 serious events
Other events: 98 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
LCZ696 (Sacubitril / Valsartan)
n=302 participants at risk
All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.99%
3/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Cardiac disorders
Angina pectoris
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Cardiac disorders
Atrial fibrillation
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Cardiac disorders
Atrial tachycardia
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Cardiac disorders
Cardiac arrest
|
0.99%
3/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Cardiac disorders
Cardiac failure
|
0.99%
3/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Cardiac disorders
Cardiac failure acute
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Cardiac disorders
Cardiac failure congestive
|
4.3%
13/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.99%
3/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Gastrointestinal disorders
Volvulus
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
General disorders
Death
|
0.99%
3/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
General disorders
Sudden death
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Infections and infestations
Bacteraemia
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Infections and infestations
Bronchitis
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Infections and infestations
Diverticulitis
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Infections and infestations
Gastroenteritis
|
0.66%
2/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Infections and infestations
Osteomyelitis
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Infections and infestations
Pneumonia
|
2.0%
6/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Infections and infestations
Postoperative wound infection
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Investigations
Brain natriuretic peptide increased
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Investigations
White blood cell count increased
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.66%
2/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.66%
2/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Nervous system disorders
Intracranial mass
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Nervous system disorders
Ischaemic stroke
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Nervous system disorders
Presyncope
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Product Issues
Device malfunction
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Psychiatric disorders
Adjustment disorder
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Psychiatric disorders
Delirium
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Psychiatric disorders
Suicidal ideation
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.66%
2/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Renal and urinary disorders
Renal failure
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mass
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Vascular disorders
Orthostatic hypotension
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Vascular disorders
Peripheral ischaemia
|
0.33%
1/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
Other adverse events
| Measure |
LCZ696 (Sacubitril / Valsartan)
n=302 participants at risk
All patients were initiated on either LCZ696 at 24 mg sacubitril / 26 mg valsartan or LCZ696 at 49 mg sacubitril / 51 mg valsartan bid for 2-4 weeks and were up-titrated to the next higher dose for another 2 - 4 weeks as applicable.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
18/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
General disorders
Fatigue
|
6.3%
19/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Nervous system disorders
Dizziness
|
14.9%
45/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.6%
20/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
|
Vascular disorders
Hypotension
|
10.3%
31/302 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 1 year.
|
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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER