Trial Outcomes & Findings for Long Term Daily Use of JARDIANCE® Tablets in Japanese Patients With Type 2 Diabetes Mellitus (NCT NCT02489942)

NCT ID: NCT02489942

Last Updated: 2022-02-04

Results Overview

Number of patients with adverse drug reactions.

• Recruitment status: COMPLETED
• Target enrollment: 8145 participants
• Primary outcome timeframe: From first drug administration until 7 days after last drug administration, up to 247 weeks.
• Results posted on: 2022-02-04

Participant Flow

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.

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.

Participant milestones

Measure	JARDIANCE® User 10 Milligram (mg) or 25 mg 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 Study STARTED	8145
Overall Study Case Report Form (CRF) Collected	8059
Overall Study Treated	8057
Overall Study COMPLETED	4729
Overall Study NOT COMPLETED	3416

Reasons for withdrawal

Measure	JARDIANCE® User 10 Milligram (mg) or 25 mg 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 Study Request by patient	602
Overall Study Improvement/remission	157
Overall Study No change/Progressive disease	263
Overall Study Adverse Event	522
Overall Study Other personal reasons	1218
Overall Study Lost to Follow-up	456
Overall Study Not continuously investigated	7
Overall Study Patient started jardiance treatment out of registration period	1
Overall Study Multiple registration	1
Overall Study No patient visit after entry	100
Overall Study No treatment with Jardiance	2
Overall Study Patient received Jardiance before registration	1
Overall Study No CRF collected	86

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	JARDIANCE® User 10 Milligram (mg) or 25 mg n=7947 Participants 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.
Age, Continuous	58.8 Years STANDARD_DEVIATION 12.8 • n=7947 Participants
Sex: Female, Male Female	2939 Participants n=7947 Participants
Sex: Female, Male Male	5008 Participants n=7947 Participants

PRIMARY outcome

Timeframe: From first drug administration until 7 days after last drug administration, up to 247 weeks.

Population: 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.

Number of patients with adverse drug reactions.

Outcome measures

Measure

JARDIANCE® User 10 Milligram (mg) or 25 mg n=7947 Participants 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.

Number of Patients With Adverse Drug Reactions (ADRs)

1029 Participants

SECONDARY outcome

Timeframe: At start of treatment and at last observation on treatment, up to 246 weeks.

Population: 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.

Change from baseline in haemoglobin A1c (HbA1c) at the last observation during the observation period.

Outcome measures

Measure

JARDIANCE® User 10 Milligram (mg) or 25 mg n=7314 Participants 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.

Change From Baseline in Haemoglobin A1c (HbA1c) at the Last Observation During the Observation Period

-0.74 Percentage change Standard Deviation 1.34

SECONDARY outcome

Timeframe: At start of treatment and at last observation on treatment, up to 246 weeks.

Population: All patients included in the efficacy set and with available data for this endpoint.

Change from baseline in fasting plasma glucose (FPG) at the last- observation during observation period.

Outcome measures

Measure

JARDIANCE® User 10 Milligram (mg) or 25 mg n=2510 Participants 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.

Change From Baseline in Fasting Plasma Glucose (FPG) at the Last- Observation During Observation Period

-30.1 Milligram/deciliter (mg/dL) Standard Deviation 55.5

Adverse Events

JARDIANCE® User 10 Milligram (mg) or 25 mg

Serious events: 381 serious events

Other events: 0 other events

Deaths: 42 deaths

Serious adverse events

Measure	JARDIANCE® User 10 Milligram (mg) or 25 mg n=7947 participants at risk 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.
Blood and lymphatic system disorders Anaemia	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Blood and lymphatic system disorders Pancytopenia	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Blood and lymphatic system disorders Iron deficiency anaemia	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Blood and lymphatic system disorders Lymphadenitis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Blood and lymphatic system disorders Immune thrombocytopenia	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Angina pectoris	0.24% 19/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Acute myocardial infarction	0.16% 13/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Cardiac failure	0.11% 9/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Myocardial infarction	0.09% 7/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Atrial fibrillation	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Cardiac failure congestive	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Sinus node dysfunction	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Coronary artery stenosis	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Ventricular extrasystoles	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Adams-Stokes syndrome	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Angina unstable	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Aortic valve stenosis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Arrhythmia	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Atrial flutter	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Bundle branch block bilateral	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Cardiac failure chronic	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Coronary artery occlusion	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Myocardial ischaemia	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Prinzmetal angina	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Supraventricular tachycardia	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Ventricular tachycardia	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Intracardiac thrombus	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Silent myocardial infarction	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Acute coronary syndrome	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Cardiac disorders Congestive cardiomyopathy	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Congenital, familial and genetic disorders Phimosis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Ear and labyrinth disorders Sudden hearing loss	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Ear and labyrinth disorders Deafness neurosensory	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Ear and labyrinth disorders Deafness	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Endocrine disorders Adrenal insufficiency	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Eye disorders Glaucoma	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Eye disorders Diabetic retinopathy	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Eye disorders Cataract	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Eye disorders Cataract diabetic	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Eye disorders Eyelid ptosis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Eye disorders Posterior capsule opacification	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Eye disorders Retinal detachment	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Eye disorders Visual acuity reduced	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Eye disorders Vitreous haemorrhage	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Eye disorders Macular hole	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Eye disorders Normal tension glaucoma	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Gastrointestinal disorders Pancreatitis acute	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Gastrointestinal disorders Melaena	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Gastrointestinal disorders Autoimmune pancreatitis	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Gastrointestinal disorders Acute abdomen	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Gastrointestinal disorders Colitis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Gastrointestinal disorders Colitis ischaemic	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Gastrointestinal disorders Colitis ulcerative	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Gastrointestinal disorders Duodenal ulcer perforation	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Gastrointestinal disorders Dysphagia	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Gastrointestinal disorders Hiatus hernia	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Gastrointestinal disorders Ileus	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Gastrointestinal disorders Inguinal hernia	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Gastrointestinal disorders Intestinal obstruction	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Gastrointestinal disorders Pancreatitis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Gastrointestinal disorders Salivary gland calculus	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
General disorders Sudden death	0.05% 4/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
General disorders Chest pain	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
General disorders Chest discomfort	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
General disorders Death	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
General disorders Fatigue	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
General disorders Inflammation	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
General disorders Vascular stent stenosis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
General disorders Multiple organ dysfunction syndrome	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Hepatobiliary disorders Cholangitis	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Hepatobiliary disorders Cholelithiasis	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Hepatobiliary disorders Bile duct stone	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Hepatobiliary disorders Cholangitis acute	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Hepatobiliary disorders Cholecystitis	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Hepatobiliary disorders Biliary colic	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Hepatobiliary disorders Cholecystitis acute	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Hepatobiliary disorders Hepatic cirrhosis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Hepatobiliary disorders Hepatic function abnormal	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Hepatobiliary disorders Hepatitis alcoholic	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Hepatobiliary disorders Jaundice cholestatic	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Hepatobiliary disorders Bile duct stenosis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Hepatobiliary disorders Liver injury	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Hepatobiliary disorders Biliary obstruction	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Hepatobiliary disorders Immune system disorders	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Hepatobiliary disorders Anaphylactic shock	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Cellulitis	0.13% 10/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Pneumonia	0.05% 4/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Pyelonephritis	0.05% 4/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Diabetic gangrene	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Appendicitis	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Gastroenteritis	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Infection	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Sepsis	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Pneumonia bacterial	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Brain abscess	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Bronchitis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Endometritis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Gangrene	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Genital herpes	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Influenza	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Liver abscess	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Osteomyelitis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Osteomyelitis chronic	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Pneumonia mycoplasmal	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Septic shock	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Urinary tract infection	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Lymph gland infection	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Beta haemolytic streptococcal infection	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Arthritis bacterial	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Staphylococcal infection	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Acute hepatitis B	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Abdominal abscess	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Tonsillitis bacterial	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Emphysematous pyelonephritis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Pneumocystis jirovecii pneumonia	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Infections and infestations Complicated appendicitis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Fall	0.16% 13/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Road traffic accident	0.08% 6/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Subdural haematoma	0.05% 4/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Fibula fracture	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Humerus fracture	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Tibia fracture	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Upper limb fracture	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Femoral neck fracture	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Fracture	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Joint dislocation	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Rib fracture	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Spinal compression fracture	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Heat illness	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Adrenal gland injury	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Clavicle fracture	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Extradural haematoma	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Facial bones fracture	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Femur fracture	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Incisional hernia	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Tendon rupture	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Suture rupture	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Contusion	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Brain contusion	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Thermal burn	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Post procedural complication	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Skin laceration	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Pelvic fracture	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Limb injury	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Toxicity to various agents	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Meniscus injury	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Injury, poisoning and procedural complications Traumatic haemothorax	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Blood glucose increased	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Blood pressure decreased	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Blood pressure increased	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Glycosylated haemoglobin increased	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Weight increased	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Brain natriuretic peptide increased	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Metabolism and nutrition disorders	0.38% 30/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Diabetes mellitus inadequate control	0.15% 12/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Hyperglycaemia	0.06% 5/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Diabetes mellitus	0.05% 4/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Hypoglycaemia	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Dehydration	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Diabetic ketosis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Ketoacidosis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Marasmus	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Dyslipidaemia	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Decreased appetite	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Musculoskeletal and connective tissue disorders	0.15% 12/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Osteoarthritis	0.06% 5/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Arthralgia	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Fracture malunion	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Lumbar spinal stenosis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Muscle spasms	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Polymyalgia rheumatica	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Rhabdomyolysis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Rotator cuff syndrome	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Investigations Spinal stenosis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.14% 11/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.13% 10/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.09% 7/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.05% 4/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of unknown primary site	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal cancer	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage IV	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma malignant	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm skin	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papilloma	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pharyngeal cancer	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polycythaemia vera	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer stage IV	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testicular neoplasm	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extranodal marginal zone B-cell lymphoma (MALT type)	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteral neoplasm	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer recurrent	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Soft tissue neoplasm	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papillary mucinous neoplasm	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Cerebral infarction	0.25% 20/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Dementia	0.06% 5/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Epilepsy	0.04% 3/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Carotid artery stenosis	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Cerebellar infarction	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Cerebral haemorrhage	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Myelopathy	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Subarachnoid haemorrhage	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Lacunar infarction	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Thalamus haemorrhage	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Thrombotic cerebral infarction	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Altered state of consciousness	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Brain stem haemorrhage	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Brain stem infarction	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Cerebellar atrophy	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Cerebral atrophy	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Cerebral ischaemia	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Dizziness	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Hypoaesthesia	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Loss of consciousness	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Moyamoya disease	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Multiple sclerosis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Neuralgia	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Neuralgic amyotrophy	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Transient ischaemic attack	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Cerebral haematoma	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Cognitive disorder	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Embolic cerebral infarction	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Parkinson's disease	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Nervous system disorders Generalised onset non-motor seizure	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Psychiatric disorders Schizophrenia	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Psychiatric disorders Completed suicide	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Psychiatric disorders Major depression	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Psychiatric disorders Mental disorder	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Psychiatric disorders Psychiatric symptom	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Psychiatric disorders Cardiovascular somatic symptom disorder	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Renal and urinary disorders Nephrotic syndrome	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Renal and urinary disorders Calculus urinary	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Renal and urinary disorders Hydronephrosis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Renal and urinary disorders Renal artery stenosis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Renal and urinary disorders Renal failure	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Renal and urinary disorders Pyelocaliectasis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Renal and urinary disorders Ureterolithiasis	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Reproductive system and breast disorders Cystocele	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Reproductive system and breast disorders Haemorrhagic ovarian cyst	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Reproductive system and breast disorders Ovarian haemorrhage	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.05% 4/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Respiratory, thoracic and mediastinal disorders Aspiration	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Skin and subcutaneous tissue disorders Skin ulcer	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Skin and subcutaneous tissue disorders Erythema	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Skin and subcutaneous tissue disorders Erythema multiforme	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Skin and subcutaneous tissue disorders Pyoderma gangrenosum	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Skin and subcutaneous tissue disorders Diabetic foot	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Surgical and medical procedures Knee operation	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Surgical and medical procedures Enterostomy	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Vascular disorders Peripheral arterial occlusive disease	0.03% 2/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Vascular disorders Aneurysm	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Vascular disorders Aortic dissection	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Vascular disorders Varicose vein	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Vascular disorders Lymphocele	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Vascular disorders Hypertensive emergency	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Vascular disorders Infarction	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Vascular disorders Arterial occlusive disease	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Vascular disorders Peripheral venous disease	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Vascular disorders Subclavian vein occlusion	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.
Product Issues Device occlusion	0.01% 1/7947 • From first drug administration until 7 days after last drug administration, up to 247 weeks. 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.

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim, Call Centre

Boehringer Ingelheim

Phone: 1-800-243-0217

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place