Trial Outcomes & Findings for Post Marketing Surveillance (PMS) of JARDIANCE in Chronic Heart Failure (CHF) (NCT NCT05262764)
NCT ID: NCT05262764
Last Updated: 2026-03-24
Results Overview
Number of subjects with ADRs (focus on hypoglycaemia, the events relevant for volume depletion, influence of ketone body increased / ketoacidosis, renal impairment).
Recruitment status
COMPLETED
Target enrollment
1200 participants
Primary outcome timeframe
Up to 52 weeks
Results posted on
2026-03-24
Participant Flow
All subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This was a non-interventional, single arm study based on newly collected data Patients were observed for up to 52 weeks after start of the treatment with JARDIANCE® Tablets or until discontinuation of administration. Out of the 1200 registered subjects, 1166 had no protocol violations and were included in the safety set.
Participant milestones
| Measure |
JARDIANCE®
Patients in Japan with chronic heart failure who were prescribed JARDIANCE® (Empagliflozin) tablets and who were never treated with Empagliflozin before enrolment (including treatment for type 2 diabetes mellitus). Treatment was in accordance with the latest guidelines from The Japanese Circulation Society (JCS). Patients were observed for up to 52 weeks after start of the treatment or until discontinuation of administration.
|
|---|---|
|
Overall Study
STARTED
|
1166
|
|
Overall Study
COMPLETED
|
921
|
|
Overall Study
NOT COMPLETED
|
245
|
Reasons for withdrawal
| Measure |
JARDIANCE®
Patients in Japan with chronic heart failure who were prescribed JARDIANCE® (Empagliflozin) tablets and who were never treated with Empagliflozin before enrolment (including treatment for type 2 diabetes mellitus). Treatment was in accordance with the latest guidelines from The Japanese Circulation Society (JCS). Patients were observed for up to 52 weeks after start of the treatment or until discontinuation of administration.
|
|---|---|
|
Overall Study
Adverse Event
|
78
|
|
Overall Study
Withdrawal by Subject
|
21
|
|
Overall Study
Improvement
|
3
|
|
Overall Study
Lost to Follow-up
|
29
|
|
Overall Study
Untraceable for changing hospital
|
66
|
|
Overall Study
Other than listed
|
41
|
|
Overall Study
Other
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
JARDIANCE®
n=1166 Participants
Patients in Japan with chronic heart failure who were prescribed JARDIANCE® (Empagliflozin) tablets and who were never treated with Empagliflozin before enrolment (including treatment for type 2 diabetes mellitus). Treatment was in accordance with the latest guidelines from The Japanese Circulation Society (JCS). Patients were observed for up to 52 weeks after start of the treatment or until discontinuation of administration.
|
|---|---|
|
Age, Continuous
|
74.9 years
STANDARD_DEVIATION 12.4 • n=1166 Participants
|
|
Sex: Female, Male
Female
|
455 Participants
n=1166 Participants
|
|
Sex: Female, Male
Male
|
711 Participants
n=1166 Participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: Safety set: all patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
Number of subjects with ADRs (focus on hypoglycaemia, the events relevant for volume depletion, influence of ketone body increased / ketoacidosis, renal impairment).
Outcome measures
| Measure |
JARDIANCE®
n=1166 Participants
Patients in Japan with chronic heart failure who were prescribed JARDIANCE® (Empagliflozin) tablets and who were never treated with Empagliflozin before enrolment (including treatment for type 2 diabetes mellitus). Treatment was in accordance with the latest guidelines from The Japanese Circulation Society (JCS). Patients were observed for up to 52 weeks after start of the treatment or until discontinuation of administration.
|
|---|---|
|
Number of Subjects With Adverse Drug Reactions (ADRs)
|
61 Participants
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Safety set: all patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
Incidence of all-cause death.
Outcome measures
| Measure |
JARDIANCE®
n=1166 Participants
Patients in Japan with chronic heart failure who were prescribed JARDIANCE® (Empagliflozin) tablets and who were never treated with Empagliflozin before enrolment (including treatment for type 2 diabetes mellitus). Treatment was in accordance with the latest guidelines from The Japanese Circulation Society (JCS). Patients were observed for up to 52 weeks after start of the treatment or until discontinuation of administration.
|
|---|---|
|
Incidence of All-cause Death
|
3.01 Deaths per 100 person-years
Interval 2.03 to 4.29
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Safety set: all patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
Incidence of cardiovascular death.
Outcome measures
| Measure |
JARDIANCE®
n=1166 Participants
Patients in Japan with chronic heart failure who were prescribed JARDIANCE® (Empagliflozin) tablets and who were never treated with Empagliflozin before enrolment (including treatment for type 2 diabetes mellitus). Treatment was in accordance with the latest guidelines from The Japanese Circulation Society (JCS). Patients were observed for up to 52 weeks after start of the treatment or until discontinuation of administration.
|
|---|---|
|
Incidence of Cardiovascular Death
|
0.90 Deaths per 100 person-years
Interval 0.41 to 1.71
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: Safety set: all patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
Incidence of hospitalizations for heart failure.
Outcome measures
| Measure |
JARDIANCE®
n=1166 Participants
Patients in Japan with chronic heart failure who were prescribed JARDIANCE® (Empagliflozin) tablets and who were never treated with Empagliflozin before enrolment (including treatment for type 2 diabetes mellitus). Treatment was in accordance with the latest guidelines from The Japanese Circulation Society (JCS). Patients were observed for up to 52 weeks after start of the treatment or until discontinuation of administration.
|
|---|---|
|
Incidence of Hospitalizations for Heart Failure
|
2.53 1st Hospitalization per 100 person-years
Interval 1.64 to 3.74
|
Adverse Events
JARDIANCE®
Serious events: 148 serious events
Other events: 0 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
JARDIANCE®
n=1166 participants at risk
Patients in Japan with chronic heart failure who were prescribed JARDIANCE® (Empagliflozin) tablets and who were never treated with Empagliflozin before enrolment (including treatment for type 2 diabetes mellitus). Treatment was in accordance with the latest guidelines from The Japanese Circulation Society (JCS). Patients were observed for up to 52 weeks after start of the treatment or until discontinuation of administration.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.17%
2/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Angina pectoris
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Angina unstable
|
0.17%
2/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Arrhythmia
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Atrial fibrillation
|
0.60%
7/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Bradycardia
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Cardiac arrest
|
0.17%
2/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Cardiac failure
|
5.0%
58/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Cardiac failure acute
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.43%
5/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.26%
3/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Cardiac sarcoidosis
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.17%
2/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Cardiomyopathy
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Coronary artery disease
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Gastrointestinal disorders
Vomiting
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
General disorders
Cardiac death
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
General disorders
Death
|
0.17%
2/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
General disorders
Prosthetic cardiac valve thrombosis
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
General disorders
Sudden cardiac death
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
General disorders
Sudden death
|
0.17%
2/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.17%
2/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Hepatobiliary disorders
Cholangitis
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Abdominal wall abscess
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Abscess
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Arthritis bacterial
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Infections and infestations
COVID-19
|
0.51%
6/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Liver abscess
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Pneumonia
|
0.51%
6/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Pneumonia aspiration
|
0.34%
4/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Pneumonia bacterial
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Psoas abscess
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Pyelonephritis
|
0.17%
2/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Pyelonephritis acute
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Sepsis
|
0.26%
3/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Septic shock
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Infections and infestations
Urinary tract infection
|
0.17%
2/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Investigations
Blood pressure decreased
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Investigations
Blood urea increased
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.17%
2/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.34%
4/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.17%
2/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Metabolism and nutrition disorders
Marasmus
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Musculoskeletal and connective tissue disorders
Immobilisation syndrome
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angioimmunoblastic T-cell lymphoma
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.34%
4/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.17%
2/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.17%
2/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Nervous system disorders
Cerebral infarction
|
0.51%
6/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Nervous system disorders
Dizziness
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Nervous system disorders
Lacunar infarction
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Nervous system disorders
Loss of consciousness
|
0.17%
2/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.17%
2/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Nervous system disorders
Taste disorder
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Psychiatric disorders
Delirium
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Psychiatric disorders
Transient psychosis
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.34%
4/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Renal and urinary disorders
Azotaemia
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.17%
2/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Renal and urinary disorders
Renal disorder
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Renal and urinary disorders
Renal failure
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Vascular disorders
Aortic aneurysm
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Vascular disorders
Aortic dissection
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Vascular disorders
Deep vein thrombosis
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.09%
1/1166 • Up to 52 weeks.
Safety set: All patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place