Trial Outcomes & Findings for Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction (NCT NCT02226120)
NCT ID: NCT02226120
Last Updated: 2019-02-20
Results Overview
The primary assessments for safety were the reporting of angioedema, AEs suspected to be related to LCZ696, AEs leading to study drug discontinuation and serious adverse events (SAE) including death. The assessment of safety were based primarily on the frequency of adverse events of special interest, sitting systolic and diastolic blood pressure, heart rate, and serious adverse events suspected by the investigators to be related to LCZ696 for the Safety set. Only descriptive analysis done.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1980 participants
Primary outcome timeframe
From first dose of study treatment to 30 days after last dose of study treatment, up to 30 months.
Results posted on
2019-02-20
Participant Flow
This study was conducted at 417 sites in 41 countries worldwide.
The total number in the participant flow and baseline characteristics sections reflects the number of participants treated (1980).
Participant milestones
| Measure |
LCZ696
Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
|
|---|---|
|
Overall Study
STARTED
|
1980
|
|
Overall Study
COMPLETED
|
1660
|
|
Overall Study
NOT COMPLETED
|
320
|
Reasons for withdrawal
| Measure |
LCZ696
Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
|
|---|---|
|
Overall Study
Adverse Event
|
60
|
|
Overall Study
Death
|
172
|
|
Overall Study
Study terminated by sponsor
|
1
|
|
Overall Study
Technical problems
|
4
|
|
Overall Study
Lost to Follow-up
|
13
|
|
Overall Study
Physician Decision
|
21
|
|
Overall Study
Withdrawal by parent/guardian
|
36
|
|
Overall Study
Non-compliance with study drug
|
10
|
|
Overall Study
Protocol deviation
|
1
|
|
Overall Study
missing treatment disposition pages
|
2
|
Baseline Characteristics
Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction
Baseline characteristics by cohort
| Measure |
LCZ696
n=1980 Participants
Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
|
|---|---|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 10.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
453 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1527 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
305 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1450 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
106 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study treatment to 30 days after last dose of study treatment, up to 30 months.Population: Safety Set (SAF), which consisted of all enrolled participants who received at least one dose of open-label study medication, was considered. Only descriptive analysis done.
The primary assessments for safety were the reporting of angioedema, AEs suspected to be related to LCZ696, AEs leading to study drug discontinuation and serious adverse events (SAE) including death. The assessment of safety were based primarily on the frequency of adverse events of special interest, sitting systolic and diastolic blood pressure, heart rate, and serious adverse events suspected by the investigators to be related to LCZ696 for the Safety set. Only descriptive analysis done.
Outcome measures
| Measure |
LCZ696
n=1980 Participants
Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
|
|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths as a Measure of Safety and Tolerability of LCZ696
AEs by Primary System Organ Class (SOC)
|
1289 Participants
|
|
Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths as a Measure of Safety and Tolerability of LCZ696
SAEs by Primary System Organ Class (SOC)
|
555 Participants
|
|
Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths as a Measure of Safety and Tolerability of LCZ696
Deaths by Primary System Organ Class (SOC)
|
186 Participants
|
Adverse Events
LCZ696
Serious events: 555 serious events
Other events: 352 other events
Deaths: 186 deaths
Serious adverse events
| Measure |
LCZ696
n=1980 participants at risk
Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
|
|---|---|
|
Infections and infestations
Tracheobronchitis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Urinary tract infection
|
0.51%
10/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Urosepsis
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Viral diarrhoea
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Viral infection
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Wound sepsis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Acute coronary syndrome
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Acute left ventricular failure
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.45%
9/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Adams-Stokes syndrome
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Angina pectoris
|
0.71%
14/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Angina unstable
|
0.51%
10/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Arrhythmia
|
0.20%
4/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.71%
14/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Atrioventricular block complete
|
0.25%
5/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Bradycardia
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Cardiac arrest
|
0.66%
13/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Cardiac failure
|
7.3%
144/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Cardiac failure acute
|
1.1%
21/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Cardiac failure chronic
|
1.6%
32/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Cardiac failure congestive
|
1.0%
20/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.35%
7/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Cardiogenic shock
|
0.40%
8/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Cardiovascular disorder
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.20%
4/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Cor pulmonale
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Coronary artery disease
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Left ventricular failure
|
0.20%
4/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Myocardial infarction
|
0.81%
16/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Myocardial ischaemia
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Nodal rhythm
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Palpitations
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Sinus node dysfunction
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Systolic dysfunction
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.25%
5/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Ventricular fibrillation
|
0.25%
5/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Cardiac disorders
Ventricular tachycardia
|
1.6%
31/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Endocrine disorders
Adrenal insufficiency
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Endocrine disorders
Hypothyroidism
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Eye disorders
Cataract
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Eye disorders
Open angle glaucoma
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Eye disorders
Refraction disorder
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.45%
9/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Ascites
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Constipation
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Duodenitis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Enteritis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Enterocolitis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Gastritis
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Melaena
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Gastrointestinal disorders
Vomiting
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
General disorders
Asthenia
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
General disorders
Cardiac death
|
0.20%
4/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
General disorders
Chest discomfort
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
General disorders
Chest pain
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
General disorders
Death
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
General disorders
General physical health deterioration
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
General disorders
Malaise
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.35%
7/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
General disorders
Non-cardiac chest pain
|
0.20%
4/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
General disorders
Oedema peripheral
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
General disorders
Sudden cardiac death
|
0.76%
15/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
General disorders
Sudden death
|
0.66%
13/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Hepatobiliary disorders
Cholangitis
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Hepatobiliary disorders
Hepatic congestion
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Hepatobiliary disorders
Hepatic failure
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Abdominal sepsis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Appendicitis
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Arthritis bacterial
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Bacteraemia
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Bronchitis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Bursitis infective
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Cellulitis
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Cholecystitis infective
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Cystitis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Diabetic foot infection
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Diarrhoea infectious
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Diverticulitis
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Ecthyma
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Erysipelas
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Gangrene
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Gastroenteritis
|
0.25%
5/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Hepatitis E
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Hepatitis viral
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Implant site infection
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Infection
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Infectious pleural effusion
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Influenza
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Intervertebral discitis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Localised infection
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Lower respiratory tract infection
|
0.20%
4/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Lung infection
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Orchitis
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Otitis media chronic
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Ovarian abscess
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Peritonitis
|
0.20%
4/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Pneumococcal sepsis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Pneumonia
|
2.4%
47/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Postoperative wound infection
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Pyelonephritis acute
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Respiratory tract infection
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Sepsis
|
0.61%
12/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Sepsis syndrome
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Septic shock
|
0.51%
10/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Stoma site infection
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Infections and infestations
Tooth infection
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.25%
5/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Fractured skull depressed
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Head injury
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Respiratory fume inhalation disorder
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Investigations
Arteriogram coronary
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Investigations
Blood bilirubin increased
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Investigations
Blood creatinine increased
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Investigations
Blood potassium decreased
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Investigations
Blood potassium increased
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Investigations
Ejection fraction abnormal
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Investigations
Functional residual capacity decreased
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Investigations
Hepatic enzyme increased
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Investigations
International normalised ratio increased
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Investigations
Liver function test increased
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Investigations
Weight decreased
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.20%
4/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.20%
4/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Musculoskeletal and connective tissue disorders
Rheumatic disorder
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.20%
4/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Aphasia
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Brain injury
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Brain oedema
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Cerebellar infarction
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Cerebral infarction
|
0.30%
6/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Cerebral ischaemia
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.66%
13/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Cervicogenic vertigo
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Coma
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Dementia
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Dizziness
|
0.20%
4/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Dysarthria
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Epilepsy
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Facial paralysis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Hemianaesthesia
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Hemiparesis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Ischaemic stroke
|
0.35%
7/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Loss of consciousness
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Post stroke seizure
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Presyncope
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Radiculopathy
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Seizure
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Syncope
|
0.35%
7/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.20%
4/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Product Issues
Device battery issue
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Product Issues
Device malfunction
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Product Issues
Lead dislodgement
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Psychiatric disorders
Delirium
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Psychiatric disorders
Depression
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Psychiatric disorders
Disorientation
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Psychiatric disorders
Mental disorder
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.91%
18/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Renal and urinary disorders
Haematuria
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Renal and urinary disorders
Leukocyturia
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Renal and urinary disorders
Renal failure
|
0.61%
12/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Renal and urinary disorders
Renal impairment
|
0.40%
8/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Renal and urinary disorders
Urethral stenosis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Renal and urinary disorders
Urinary retention
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Reproductive system and breast disorders
Genital ulceration
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.25%
5/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial oedema
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.51%
10/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.51%
10/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.15%
3/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.40%
8/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.40%
8/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Social circumstances
Treatment noncompliance
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Vascular disorders
Aortic aneurysm
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Vascular disorders
Aortic embolus
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Vascular disorders
Circulatory collapse
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Vascular disorders
Diabetic vascular disorder
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Vascular disorders
Haematoma
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Vascular disorders
Hypertension
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Vascular disorders
Hypotension
|
0.91%
18/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Vascular disorders
Leriche syndrome
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Vascular disorders
Orthostatic hypotension
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.10%
2/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Vascular disorders
Peripheral artery occlusion
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Vascular disorders
Peripheral artery stenosis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Vascular disorders
Shock
|
0.05%
1/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
Other adverse events
| Measure |
LCZ696
n=1980 participants at risk
Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
|
|---|---|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.0%
118/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months
|
|
Vascular disorders
Hypotension
|
12.7%
252/1980 • From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER