Long Term Daily Use of JARDIANCE® Tablets in Japanese Patients With Type 2 Diabetes Mellitus
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02489942
Collaborator
Eli Lilly and Company (Industry)
8,145
1
65.8
123.8
Study Details
Study Description
Brief Summary
Study to investigate the safety and efficacy of long-term daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
8145 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Post Marketing Surveillance in Japan on Long Term Drug Use of JARDIANCE® Tablets in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date
:
Jun 12, 2015
Actual Primary Completion Date
:
Nov 11, 2020
Actual Study Completion Date
:
Dec 4, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Jardiance Patients with T2DM to receive Jardiance tablets 10 mg, 25 mg |
Drug: Jardiance
Empagliflozin
|
Outcome Measures
Primary Outcome Measures
- Number of Patients With Adverse Drug Reactions (ADRs) [From first drug administration until 7 days after last drug administration, up to 247 weeks.]
Number of patients with adverse drug reactions.
Secondary Outcome Measures
- Change From Baseline in Haemoglobin A1c (HbA1c) at the Last Observation During the Observation Period [At start of treatment and at last observation on treatment, up to 246 weeks.]
Change from baseline in haemoglobin A1c (HbA1c) at the last observation during the observation period.
- Change From Baseline in Fasting Plasma Glucose (FPG) at the Last- Observation During Observation Period [At start of treatment and at last observation on treatment, up to 246 weeks.]
Change from baseline in fasting plasma glucose (FPG) at the last- observation during observation period.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
Male and female Japanese patients with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment
Exclusion criteria:
None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Multiple Locations | Japan |
Sponsors and Collaborators
- Boehringer Ingelheim
- Eli Lilly and Company
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02489942
Other Study ID Numbers:
- 1245.94
First Posted:
Jul 3, 2015
Last Update Posted:
Feb 4, 2022
Last Verified:
Dec 1, 2021
Study Results
Participant Flow
| Recruitment Details | A non-interventional study to investigate the safety and efficacy of longterm daily use of JARDIANCE® Tablets in Japanese patients with type 2 diabetes mellitus. |
|---|---|
| Pre-assignment Detail | Non-randomized, post marketing surveillance, a prospective study using a continuous investigation system. No specific criteria (e.g. demographic, baseline concomitant drug in use) were defined for participant enrollment. |
| Arm/Group Title | JARDIANCE® User 10 Milligram (mg) or 25 mg |
|---|---|
| Arm/Group Description | Japanese patients with type 2 diabetes mellitus (T2DM) who never received JARDIANCE® before enrollment and who completed a 3-year JARDIANCE® observation period between June 2015 and November 2020. The usual dose was 10 milligrams (mg) of a JARDIANCE® tablet administered orally once daily. If the treatment effectiveness was insufficient, the daily dose could be increased to 25 mg once daily while the patient's condition was being carefully monitored. Duration of treatment was up to 246 weeks. |
| Period Title: Overall Study | |
| STARTED | 8145 |
| Case Report Form (CRF) Collected | 8059 |
| Treated | 8057 |
| COMPLETED | 4729 |
| NOT COMPLETED | 3416 |
Baseline Characteristics
| Arm/Group Title | JARDIANCE® User 10 Milligram (mg) or 25 mg |
|---|---|
| Arm/Group Description | Japanese patients with type 2 diabetes mellitus (T2DM) who never received JARDIANCE® before enrollment and who completed a 3-year JARDIANCE® observation period between June 2015 and November 2020. The usual dose was 10 milligrams (mg) of a JARDIANCE® tablet administered orally once daily. If the treatment effectiveness was insufficient, the daily dose could be increased to 25 mg once daily while the patient's condition was being carefully monitored. Duration of treatment was up to 246 weeks. |
| Overall Participants | 7947 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
58.8
(12.8)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
2939
37%
|
| Male |
5008
63%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
Outcome Measures
| Title | Number of Patients With Adverse Drug Reactions (ADRs) |
|---|---|
| Description | Number of patients with adverse drug reactions. |
| Time Frame | From first drug administration until 7 days after last drug administration, up to 247 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set: All patients who had received treatment of JARDIANCE® tablet at least one time except those who were found to have no observation after enrollment, invalid registration, or invalid contract with the site. |
| Arm/Group Title | JARDIANCE® User 10 Milligram (mg) or 25 mg |
|---|---|
| Arm/Group Description | Japanese patients with type 2 diabetes mellitus (T2DM) who never received JARDIANCE® before enrollment and who completed a 3-year JARDIANCE® observation period between June 2015 and November 2020. The usual dose was 10 milligrams (mg) of a JARDIANCE® tablet administered orally once daily. If the treatment effectiveness was insufficient, the daily dose could be increased to 25 mg once daily while the patient's condition was being carefully monitored. Duration of treatment was up to 246 weeks. |
| Measure Participants | 7947 |
| Count of Participants [Participants] |
1029
12.9%
|
| Title | Change From Baseline in Haemoglobin A1c (HbA1c) at the Last Observation During the Observation Period |
|---|---|
| Description | Change from baseline in haemoglobin A1c (HbA1c) at the last observation during the observation period. |
| Time Frame | At start of treatment and at last observation on treatment, up to 246 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy set: All patients in the safety set, except patients who had no available efficacy data and/or do not suffer from type 2 diabetes mellitus. |
| Arm/Group Title | JARDIANCE® User 10 Milligram (mg) or 25 mg |
|---|---|
| Arm/Group Description | Japanese patients with type 2 diabetes mellitus (T2DM) who never received JARDIANCE® before enrollment and who completed a 3-year JARDIANCE® observation period between June 2015 and November 2020. The usual dose was 10 milligrams (mg) of a JARDIANCE® tablet administered orally once daily. If the treatment effectiveness was insufficient, the daily dose could be increased to 25 mg once daily while the patient's condition was being carefully monitored. Duration of treatment was up to 246 weeks. |
| Measure Participants | 7314 |
| Mean (Standard Deviation) [Percentage change] |
-0.74
(1.34)
|
| Title | Change From Baseline in Fasting Plasma Glucose (FPG) at the Last- Observation During Observation Period |
|---|---|
| Description | Change from baseline in fasting plasma glucose (FPG) at the last- observation during observation period. |
| Time Frame | At start of treatment and at last observation on treatment, up to 246 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients included in the efficacy set and with available data for this endpoint. |
| Arm/Group Title | JARDIANCE® User 10 Milligram (mg) or 25 mg |
|---|---|
| Arm/Group Description | Japanese patients with type 2 diabetes mellitus (T2DM) who never received JARDIANCE® before enrollment and who completed a 3-year JARDIANCE® observation period between June 2015 and November 2020. The usual dose was 10 milligrams (mg) of a JARDIANCE® tablet administered orally once daily. If the treatment effectiveness was insufficient, the daily dose could be increased to 25 mg once daily while the patient's condition was being carefully monitored. Duration of treatment was up to 246 weeks. |
| Measure Participants | 2510 |
| Mean (Standard Deviation) [Milligram/deciliter (mg/dL)] |
-30.1
(55.5)
|
Adverse Events
| Time Frame | From first drug administration until 7 days after last drug administration, up to 247 weeks. | |
|---|---|---|
| Adverse Event Reporting Description | Safety Set: All patients who had received treatment of JARDIANCE Tablet at least one time except those who were found to have no observation after enrolment, invalid registration, or invalid contract with the site. | |
| Arm/Group Title | JARDIANCE® User 10 Milligram (mg) or 25 mg | |
| Arm/Group Description | Japanese patients with type 2 diabetes mellitus (T2DM) who never received JARDIANCE® before enrollment and who completed a 3-year JARDIANCE® observation period between June 2015 and November 2020. The usual dose was 10 milligrams (mg) of a JARDIANCE® tablet administered orally once daily. If the treatment effectiveness was insufficient, the daily dose could be increased to 25 mg once daily while the patient's condition was being carefully monitored. Duration of treatment was up to 246 weeks. | |
All Cause Mortality |
||
| JARDIANCE® User 10 Milligram (mg) or 25 mg | ||
| Affected / at Risk (%) | # Events | |
| Total | 42/7947 (0.5%) | |
Serious Adverse Events |
||
| JARDIANCE® User 10 Milligram (mg) or 25 mg | ||
| Affected / at Risk (%) | # Events | |
| Total | 381/7947 (4.8%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 3/7947 (0%) | |
| Pancytopenia | 2/7947 (0%) | |
| Disseminated intravascular coagulation | 1/7947 (0%) | |
| Iron deficiency anaemia | 1/7947 (0%) | |
| Lymphadenitis | 1/7947 (0%) | |
| Immune thrombocytopenia | 1/7947 (0%) | |
| Cardiac disorders | ||
| Angina pectoris | 19/7947 (0.2%) | |
| Acute myocardial infarction | 13/7947 (0.2%) | |
| Cardiac failure | 9/7947 (0.1%) | |
| Myocardial infarction | 7/7947 (0.1%) | |
| Atrial fibrillation | 3/7947 (0%) | |
| Cardiac failure congestive | 3/7947 (0%) | |
| Sinus node dysfunction | 3/7947 (0%) | |
| Coronary artery stenosis | 2/7947 (0%) | |
| Ventricular extrasystoles | 2/7947 (0%) | |
| Adams-Stokes syndrome | 1/7947 (0%) | |
| Angina unstable | 1/7947 (0%) | |
| Aortic valve stenosis | 1/7947 (0%) | |
| Arrhythmia | 1/7947 (0%) | |
| Atrial flutter | 1/7947 (0%) | |
| Bundle branch block bilateral | 1/7947 (0%) | |
| Cardiac failure chronic | 1/7947 (0%) | |
| Coronary artery occlusion | 1/7947 (0%) | |
| Myocardial ischaemia | 1/7947 (0%) | |
| Prinzmetal angina | 1/7947 (0%) | |
| Supraventricular tachycardia | 1/7947 (0%) | |
| Ventricular tachycardia | 1/7947 (0%) | |
| Intracardiac thrombus | 1/7947 (0%) | |
| Silent myocardial infarction | 1/7947 (0%) | |
| Acute coronary syndrome | 1/7947 (0%) | |
| Congestive cardiomyopathy | 1/7947 (0%) | |
| Congenital, familial and genetic disorders | ||
| Phimosis | 1/7947 (0%) | |
| Ear and labyrinth disorders | ||
| Sudden hearing loss | 3/7947 (0%) | |
| Deafness neurosensory | 2/7947 (0%) | |
| Deafness | 1/7947 (0%) | |
| Endocrine disorders | ||
| Adrenal insufficiency | 1/7947 (0%) | |
| Eye disorders | ||
| Glaucoma | 3/7947 (0%) | |
| Diabetic retinopathy | 2/7947 (0%) | |
| Cataract | 1/7947 (0%) | |
| Cataract diabetic | 1/7947 (0%) | |
| Eyelid ptosis | 1/7947 (0%) | |
| Posterior capsule opacification | 1/7947 (0%) | |
| Retinal detachment | 1/7947 (0%) | |
| Visual acuity reduced | 1/7947 (0%) | |
| Vitreous haemorrhage | 1/7947 (0%) | |
| Macular hole | 1/7947 (0%) | |
| Normal tension glaucoma | 1/7947 (0%) | |
| Gastrointestinal disorders | ||
| Pancreatitis acute | 3/7947 (0%) | |
| Melaena | 2/7947 (0%) | |
| Autoimmune pancreatitis | 2/7947 (0%) | |
| Acute abdomen | 1/7947 (0%) | |
| Colitis | 1/7947 (0%) | |
| Colitis ischaemic | 1/7947 (0%) | |
| Colitis ulcerative | 1/7947 (0%) | |
| Duodenal ulcer perforation | 1/7947 (0%) | |
| Dysphagia | 1/7947 (0%) | |
| Gastrointestinal haemorrhage | 1/7947 (0%) | |
| Hiatus hernia | 1/7947 (0%) | |
| Ileus | 1/7947 (0%) | |
| Inguinal hernia | 1/7947 (0%) | |
| Intestinal obstruction | 1/7947 (0%) | |
| Oesophageal varices haemorrhage | 1/7947 (0%) | |
| Pancreatitis | 1/7947 (0%) | |
| Salivary gland calculus | 1/7947 (0%) | |
| Haemorrhoidal haemorrhage | 1/7947 (0%) | |
| General disorders | ||
| Sudden death | 4/7947 (0.1%) | |
| Chest pain | 2/7947 (0%) | |
| Chest discomfort | 1/7947 (0%) | |
| Death | 1/7947 (0%) | |
| Fatigue | 1/7947 (0%) | |
| Inflammation | 1/7947 (0%) | |
| Vascular stent stenosis | 1/7947 (0%) | |
| Multiple organ dysfunction syndrome | 1/7947 (0%) | |
| Hepatobiliary disorders | ||
| Cholangitis | 3/7947 (0%) | |
| Cholelithiasis | 3/7947 (0%) | |
| Bile duct stone | 2/7947 (0%) | |
| Cholangitis acute | 2/7947 (0%) | |
| Cholecystitis | 2/7947 (0%) | |
| Biliary colic | 1/7947 (0%) | |
| Cholecystitis acute | 1/7947 (0%) | |
| Hepatic cirrhosis | 1/7947 (0%) | |
| Hepatic function abnormal | 1/7947 (0%) | |
| Hepatitis alcoholic | 1/7947 (0%) | |
| Jaundice cholestatic | 1/7947 (0%) | |
| Bile duct stenosis | 1/7947 (0%) | |
| Liver injury | 1/7947 (0%) | |
| Biliary obstruction | 1/7947 (0%) | |
| Immune system disorders | 1/7947 (0%) | |
| Anaphylactic shock | 1/7947 (0%) | |
| Infections and infestations | ||
| Cellulitis | 10/7947 (0.1%) | |
| Pneumonia | 4/7947 (0.1%) | |
| Pyelonephritis | 4/7947 (0.1%) | |
| Diabetic gangrene | 3/7947 (0%) | |
| Appendicitis | 2/7947 (0%) | |
| Gastroenteritis | 2/7947 (0%) | |
| Infection | 2/7947 (0%) | |
| Sepsis | 2/7947 (0%) | |
| Pneumonia bacterial | 2/7947 (0%) | |
| Brain abscess | 1/7947 (0%) | |
| Bronchitis | 1/7947 (0%) | |
| Endometritis | 1/7947 (0%) | |
| Gangrene | 1/7947 (0%) | |
| Genital herpes | 1/7947 (0%) | |
| Influenza | 1/7947 (0%) | |
| Liver abscess | 1/7947 (0%) | |
| Osteomyelitis | 1/7947 (0%) | |
| Osteomyelitis chronic | 1/7947 (0%) | |
| Pneumonia mycoplasmal | 1/7947 (0%) | |
| Septic shock | 1/7947 (0%) | |
| Urinary tract infection | 1/7947 (0%) | |
| Lymph gland infection | 1/7947 (0%) | |
| Beta haemolytic streptococcal infection | 1/7947 (0%) | |
| Arthritis bacterial | 1/7947 (0%) | |
| Staphylococcal infection | 1/7947 (0%) | |
| Acute hepatitis B | 1/7947 (0%) | |
| Abdominal abscess | 1/7947 (0%) | |
| Tonsillitis bacterial | 1/7947 (0%) | |
| Emphysematous pyelonephritis | 1/7947 (0%) | |
| Pneumocystis jirovecii pneumonia | 1/7947 (0%) | |
| Complicated appendicitis | 1/7947 (0%) | |
| Injury, poisoning and procedural complications | ||
| Fall | 13/7947 (0.2%) | |
| Road traffic accident | 6/7947 (0.1%) | |
| Subdural haematoma | 4/7947 (0.1%) | |
| Fibula fracture | 3/7947 (0%) | |
| Humerus fracture | 3/7947 (0%) | |
| Tibia fracture | 3/7947 (0%) | |
| Upper limb fracture | 3/7947 (0%) | |
| Femoral neck fracture | 2/7947 (0%) | |
| Fracture | 2/7947 (0%) | |
| Joint dislocation | 2/7947 (0%) | |
| Rib fracture | 2/7947 (0%) | |
| Spinal compression fracture | 2/7947 (0%) | |
| Heat illness | 2/7947 (0%) | |
| Adrenal gland injury | 1/7947 (0%) | |
| Clavicle fracture | 1/7947 (0%) | |
| Extradural haematoma | 1/7947 (0%) | |
| Facial bones fracture | 1/7947 (0%) | |
| Femur fracture | 1/7947 (0%) | |
| Incisional hernia | 1/7947 (0%) | |
| Tendon rupture | 1/7947 (0%) | |
| Suture rupture | 1/7947 (0%) | |
| Contusion | 1/7947 (0%) | |
| Brain contusion | 1/7947 (0%) | |
| Thermal burn | 1/7947 (0%) | |
| Post procedural complication | 1/7947 (0%) | |
| Skin laceration | 1/7947 (0%) | |
| Pelvic fracture | 1/7947 (0%) | |
| Limb injury | 1/7947 (0%) | |
| Traumatic intracranial haemorrhage | 1/7947 (0%) | |
| Toxicity to various agents | 1/7947 (0%) | |
| Meniscus injury | 1/7947 (0%) | |
| Traumatic haemothorax | 1/7947 (0%) | |
| Investigations | ||
| Blood glucose increased | 2/7947 (0%) | |
| Blood pressure decreased | 1/7947 (0%) | |
| Blood pressure increased | 1/7947 (0%) | |
| Glycosylated haemoglobin increased | 1/7947 (0%) | |
| Weight increased | 1/7947 (0%) | |
| Brain natriuretic peptide increased | 1/7947 (0%) | |
| Metabolism and nutrition disorders | 30/7947 (0.4%) | |
| Diabetes mellitus inadequate control | 12/7947 (0.2%) | |
| Hyperglycaemia | 5/7947 (0.1%) | |
| Diabetes mellitus | 4/7947 (0.1%) | |
| Hypoglycaemia | 3/7947 (0%) | |
| Dehydration | 2/7947 (0%) | |
| Diabetic ketosis | 1/7947 (0%) | |
| Ketoacidosis | 1/7947 (0%) | |
| Marasmus | 1/7947 (0%) | |
| Dyslipidaemia | 1/7947 (0%) | |
| Decreased appetite | 1/7947 (0%) | |
| Musculoskeletal and connective tissue disorders | 12/7947 (0.2%) | |
| Osteoarthritis | 5/7947 (0.1%) | |
| Arthralgia | 1/7947 (0%) | |
| Fracture malunion | 1/7947 (0%) | |
| Lumbar spinal stenosis | 1/7947 (0%) | |
| Muscle spasms | 1/7947 (0%) | |
| Polymyalgia rheumatica | 1/7947 (0%) | |
| Rhabdomyolysis | 1/7947 (0%) | |
| Rotator cuff syndrome | 1/7947 (0%) | |
| Spinal stenosis | 1/7947 (0%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Lung neoplasm malignant | 11/7947 (0.1%) | |
| Colon cancer | 10/7947 (0.1%) | |
| Pancreatic carcinoma | 7/7947 (0.1%) | |
| Gastric cancer | 4/7947 (0.1%) | |
| Rectal cancer | 3/7947 (0%) | |
| Malignant neoplasm progression | 3/7947 (0%) | |
| Hepatic cancer | 3/7947 (0%) | |
| Hepatocellular carcinoma | 3/7947 (0%) | |
| Bile duct cancer | 2/7947 (0%) | |
| Breast cancer | 2/7947 (0%) | |
| Gallbladder cancer | 2/7947 (0%) | |
| Lymphoma | 2/7947 (0%) | |
| Metastases to liver | 2/7947 (0%) | |
| Metastases to lung | 2/7947 (0%) | |
| Rectosigmoid cancer | 2/7947 (0%) | |
| Squamous cell carcinoma of lung | 2/7947 (0%) | |
| Pancreatic neoplasm | 2/7947 (0%) | |
| Renal cell carcinoma | 2/7947 (0%) | |
| Malignant neoplasm of unknown primary site | 2/7947 (0%) | |
| Bladder cancer | 1/7947 (0%) | |
| Bladder neoplasm | 1/7947 (0%) | |
| Cervix carcinoma | 1/7947 (0%) | |
| Hypopharyngeal cancer | 1/7947 (0%) | |
| Lung carcinoma cell type unspecified stage IV | 1/7947 (0%) | |
| Malignant ascites | 1/7947 (0%) | |
| Malignant pleural effusion | 1/7947 (0%) | |
| Meningioma | 1/7947 (0%) | |
| Mesothelioma malignant | 1/7947 (0%) | |
| Metastases to bone | 1/7947 (0%) | |
| Metastases to lymph nodes | 1/7947 (0%) | |
| Metastases to spine | 1/7947 (0%) | |
| Neoplasm | 1/7947 (0%) | |
| Neoplasm skin | 1/7947 (0%) | |
| Oesophageal carcinoma | 1/7947 (0%) | |
| Ovarian cancer | 1/7947 (0%) | |
| Papilloma | 1/7947 (0%) | |
| Pharyngeal cancer | 1/7947 (0%) | |
| Polycythaemia vera | 1/7947 (0%) | |
| Rectal cancer stage IV | 1/7947 (0%) | |
| Renal cancer | 1/7947 (0%) | |
| Small cell lung cancer | 1/7947 (0%) | |
| Thymoma | 1/7947 (0%) | |
| Uterine cancer | 1/7947 (0%) | |
| Hepatic cancer metastatic | 1/7947 (0%) | |
| Breast cancer metastatic | 1/7947 (0%) | |
| Breast cancer female | 1/7947 (0%) | |
| Metastases to central nervous system | 1/7947 (0%) | |
| Prostate cancer | 1/7947 (0%) | |
| Colon neoplasm | 1/7947 (0%) | |
| Testicular neoplasm | 1/7947 (0%) | |
| Lip and/or oral cavity cancer | 1/7947 (0%) | |
| Extranodal marginal zone B-cell lymphoma (MALT type) | 1/7947 (0%) | |
| Non-small cell lung cancer | 1/7947 (0%) | |
| Lung neoplasm | 1/7947 (0%) | |
| Ureteral neoplasm | 1/7947 (0%) | |
| Thyroid cancer | 1/7947 (0%) | |
| Ovarian cancer recurrent | 1/7947 (0%) | |
| Soft tissue neoplasm | 1/7947 (0%) | |
| Intraductal papillary mucinous neoplasm | 1/7947 (0%) | |
| Nervous system disorders | ||
| Cerebral infarction | 20/7947 (0.3%) | |
| Dementia | 5/7947 (0.1%) | |
| Epilepsy | 3/7947 (0%) | |
| Carotid artery stenosis | 2/7947 (0%) | |
| Cerebellar infarction | 2/7947 (0%) | |
| Cerebral haemorrhage | 2/7947 (0%) | |
| Myelopathy | 2/7947 (0%) | |
| Subarachnoid haemorrhage | 2/7947 (0%) | |
| Lacunar infarction | 2/7947 (0%) | |
| Thalamus haemorrhage | 2/7947 (0%) | |
| Thrombotic cerebral infarction | 2/7947 (0%) | |
| Altered state of consciousness | 1/7947 (0%) | |
| Brain stem haemorrhage | 1/7947 (0%) | |
| Brain stem infarction | 1/7947 (0%) | |
| Cerebellar atrophy | 1/7947 (0%) | |
| Cerebral atrophy | 1/7947 (0%) | |
| Cerebral ischaemia | 1/7947 (0%) | |
| Dizziness | 1/7947 (0%) | |
| Hypoaesthesia | 1/7947 (0%) | |
| Loss of consciousness | 1/7947 (0%) | |
| Moyamoya disease | 1/7947 (0%) | |
| Multiple sclerosis | 1/7947 (0%) | |
| Neuralgia | 1/7947 (0%) | |
| Neuralgic amyotrophy | 1/7947 (0%) | |
| Transient ischaemic attack | 1/7947 (0%) | |
| Cerebral haematoma | 1/7947 (0%) | |
| Cognitive disorder | 1/7947 (0%) | |
| Embolic cerebral infarction | 1/7947 (0%) | |
| Parkinson's disease | 1/7947 (0%) | |
| Generalised onset non-motor seizure | 1/7947 (0%) | |
| Product Issues | ||
| Device occlusion | 1/7947 (0%) | |
| Psychiatric disorders | ||
| Schizophrenia | 2/7947 (0%) | |
| Completed suicide | 1/7947 (0%) | |
| Major depression | 1/7947 (0%) | |
| Mental disorder | 1/7947 (0%) | |
| Psychiatric symptom | 1/7947 (0%) | |
| Cardiovascular somatic symptom disorder | 1/7947 (0%) | |
| Renal and urinary disorders | ||
| Nephrotic syndrome | 2/7947 (0%) | |
| Calculus urinary | 1/7947 (0%) | |
| Hydronephrosis | 1/7947 (0%) | |
| Renal artery stenosis | 1/7947 (0%) | |
| Renal failure | 1/7947 (0%) | |
| Pyelocaliectasis | 1/7947 (0%) | |
| Ureterolithiasis | 1/7947 (0%) | |
| Reproductive system and breast disorders | ||
| Benign prostatic hyperplasia | 1/7947 (0%) | |
| Cystocele | 1/7947 (0%) | |
| Haemorrhagic ovarian cyst | 1/7947 (0%) | |
| Ovarian haemorrhage | 1/7947 (0%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Pneumonia aspiration | 4/7947 (0.1%) | |
| Interstitial lung disease | 2/7947 (0%) | |
| Organising pneumonia | 2/7947 (0%) | |
| Aspiration | 1/7947 (0%) | |
| Hypoxia | 1/7947 (0%) | |
| Pleural effusion | 1/7947 (0%) | |
| Pulmonary alveolar haemorrhage | 1/7947 (0%) | |
| Skin and subcutaneous tissue disorders | ||
| Skin ulcer | 2/7947 (0%) | |
| Decubitus ulcer | 1/7947 (0%) | |
| Erythema | 1/7947 (0%) | |
| Erythema multiforme | 1/7947 (0%) | |
| Pyoderma gangrenosum | 1/7947 (0%) | |
| Diabetic foot | 1/7947 (0%) | |
| Surgical and medical procedures | ||
| Knee operation | 1/7947 (0%) | |
| Enterostomy | 1/7947 (0%) | |
| Vascular disorders | ||
| Peripheral arterial occlusive disease | 2/7947 (0%) | |
| Aneurysm | 1/7947 (0%) | |
| Aortic dissection | 1/7947 (0%) | |
| Varicose vein | 1/7947 (0%) | |
| Lymphocele | 1/7947 (0%) | |
| Hypertensive emergency | 1/7947 (0%) | |
| Infarction | 1/7947 (0%) | |
| Arterial occlusive disease | 1/7947 (0%) | |
| Peripheral venous disease | 1/7947 (0%) | |
| Subclavian vein occlusion | 1/7947 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| JARDIANCE® User 10 Milligram (mg) or 25 mg | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/7947 (0%) | |
Limitations/Caveats
Since this surveillance was an observational, non interventional study, it lacked the methodological rigour of a randomised control trial.
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Boehringer Ingelheim, Call Centre |
|---|---|
| Organization | Boehringer Ingelheim |
| Phone | 1-800-243-0217 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02489942
Other Study ID Numbers:
- 1245.94
First Posted:
Jul 3, 2015
Last Update Posted:
Feb 4, 2022
Last Verified:
Dec 1, 2021