Trial Outcomes & Findings for JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus (NCT NCT02848833)
NCT ID: NCT02848833
Last Updated: 2021-05-11
Results Overview
Percentage of participants with any adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Recruitment status
COMPLETED
Target enrollment
3368 participants
Primary outcome timeframe
From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Results posted on
2021-05-11
Participant Flow
This was and observational prospective, non-interventional, open-label, multi-centre study to monitor the safety profile and efficacy of JARDIANCE® (empagliflozin, 10 milligram (mg), 25mg) in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting.
All subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
JARDIANCE®
JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
|
|---|---|
|
Overall Study
STARTED
|
3368
|
|
Overall Study
COMPLETED
|
3231
|
|
Overall Study
NOT COMPLETED
|
137
|
Reasons for withdrawal
| Measure |
JARDIANCE®
JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
|
|---|---|
|
Overall Study
subject who are duplicated
|
1
|
|
Overall Study
have not taken the study drug
|
11
|
|
Overall Study
follow-up failure
|
6
|
|
Overall Study
Protocol Violation
|
119
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
JARDIANCE®
n=3231 Participants
JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
|
|---|---|
|
Age, Continuous
|
56.66 years
STANDARD_DEVIATION 11.60 • n=3231 Participants
|
|
Sex: Female, Male
Female
|
1380 Participants
n=3231 Participants
|
|
Sex: Female, Male
Male
|
1851 Participants
n=3231 Participants
|
PRIMARY outcome
Timeframe: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.Population: Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
Percentage of participants with any adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Outcome measures
| Measure |
JARDIANCE®
n=3231 Participants
JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
|
|---|---|
|
Percentage of Participants With Any Adverse Events
|
13.93 Percentage of participants
Interval 12.75 to 15.17
|
PRIMARY outcome
Timeframe: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.Population: Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
Percentage of participants with adverse events relating to study drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Outcome measures
| Measure |
JARDIANCE®
n=3231 Participants
JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
|
|---|---|
|
Percentage of Participants With Adverse Events Relating to Study Drug
|
5.14 Percentage of participants
Interval 4.4 to 5.96
|
PRIMARY outcome
Timeframe: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.Population: Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
Percentage of participants with unexpected adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Outcome measures
| Measure |
JARDIANCE®
n=3231 Participants
JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
|
|---|---|
|
Percentage of Participants With Unexpected Adverse Events
|
11.54 Percentage of participants
Interval 10.46 to 12.7
|
PRIMARY outcome
Timeframe: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.Population: Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
Percentage of participants with adverse events of special interest (AESI) was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method. The following are considered as AESIs: * Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection * Increased urination * Urinary tract infection (UTI) * Volume depletion * Diabetic Ketoacidosis (DKA) * Decreased renal function: * Hepatic injury * Lower limb amputation
Outcome measures
| Measure |
JARDIANCE®
n=3231 Participants
JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
|
|---|---|
|
Percentage of Participants With Adverse Events of Special Interest
|
1.45 Percentage of participants
Interval 1.07 to 1.93
|
PRIMARY outcome
Timeframe: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.Population: Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
Percentage of participants with adverse events leading to discontinuation of the drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Outcome measures
| Measure |
JARDIANCE®
n=3231 Participants
JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
|
|---|---|
|
Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug
|
3.25 Percentage of participants
Interval 2.67 to 3.92
|
SECONDARY outcome
Timeframe: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).Population: Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.
Change from baseline in glycosylated hemoglobin (HbA1c) at last visit.
Outcome measures
| Measure |
JARDIANCE®
n=2567 Participants
JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
|
|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Last Visit
|
-0.68 Percentage of glycosylated hemoglobin
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).Population: Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.
Number of patients who had glycosylated hemoglobin (HbA1c) reaching less than 7% (target efficacy response rate) at the last visit.
Outcome measures
| Measure |
JARDIANCE®
n=2567 Participants
JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
|
|---|---|
|
Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit
greater than or equal to 7%
|
1435 Participants
|
|
Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit
lower than 7%
|
1132 Participants
|
SECONDARY outcome
Timeframe: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).Population: Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.
Number of patients with relative effectiveness response in glycosylated hemoglobin (HbA1c) (decrease by at least 0.5% comparing to baseline) at the last visit
Outcome measures
| Measure |
JARDIANCE®
n=2567 Participants
JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
|
|---|---|
|
Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit
greater than or equal to 0.5%
|
1315 Participants
|
|
Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit
lower than 0.5%
|
1252 Participants
|
SECONDARY outcome
Timeframe: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).Population: Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.
Change from baseline in fasting plasma glucose (FPG) at last visit.
Outcome measures
| Measure |
JARDIANCE®
n=2160 Participants
JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
|
|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Last Visit
|
-25.59 milligram per deciliter (mg/dl)
Standard Deviation 59.84
|
SECONDARY outcome
Timeframe: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).Population: Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.
Change from baseline in body weight at last visit.
Outcome measures
| Measure |
JARDIANCE®
n=2097 Participants
JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
|
|---|---|
|
Change From Baseline in Body Weight at Last Visit
|
-1.91 kilogram
Standard Deviation 3.37
|
SECONDARY outcome
Timeframe: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).Population: Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.
Change from baseline in systolic blood pressure (SBP) at last visit.
Outcome measures
| Measure |
JARDIANCE®
n=2355 Participants
JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
|
|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) at Last Visit
|
-3.95 millimeters of mercury (mmHg)
Standard Deviation 15.44
|
SECONDARY outcome
Timeframe: At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).Population: Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.
Change from baseline in diastolic blood pressure (DBP) at last visit.
Outcome measures
| Measure |
JARDIANCE®
n=2354 Participants
JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
|
|---|---|
|
Change From Baseline in Diastolic Blood Pressure (DBP) at Last Visit
|
-1.80 millimeters of mercury (mmHg)
Standard Deviation 10.82
|
SECONDARY outcome
Timeframe: At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).Population: Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.
Number of participants per final effectiveness assessment category at last visit was reported. The final effeciveness consisted of 4 categories: Improved (If determined as there was any effect of maintaining or improving disease related factors.), Unchanged (If disease related factors had not been changed compared with before administration, and not determined as there was any effect of maintaining symptoms.), Aggravated (If disease related factors were worse than before administration.), and Unassessable (If it cannot be determined due to insufficient information collected.).
Outcome measures
| Measure |
JARDIANCE®
n=2567 Participants
JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
|
|---|---|
|
Number of Participants Per Final Effectiveness Assessment Category at Last Visit
Improved
|
1749 Participants
|
|
Number of Participants Per Final Effectiveness Assessment Category at Last Visit
Unchanged
|
546 Participants
|
|
Number of Participants Per Final Effectiveness Assessment Category at Last Visit
Aggravated
|
195 Participants
|
|
Number of Participants Per Final Effectiveness Assessment Category at Last Visit
Unassessable
|
77 Participants
|
Adverse Events
JARDIANCE®
Serious events: 55 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
JARDIANCE®
n=3231 participants at risk
JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Cardiac disorders
Angina unstable
|
0.12%
4/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Cardiac disorders
Coronary artery disease
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Cardiac disorders
Prinzmetal angina
|
0.06%
2/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Eye disorders
Glaucoma
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Eye disorders
Pathologic myopia
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Eye disorders
Retinal detachment
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Eye disorders
Retinal vein occlusion
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Gastrointestinal disorders
Colitis
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Gastrointestinal disorders
Nausea
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Gastrointestinal disorders
Vomiting
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
General disorders
Pyrexia
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
General disorders
Vascular stent stenosis
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
General disorders
Vascular stent thrombosis
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Infections and infestations
Appendiceal abscess
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Infections and infestations
Appendicitis
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Infections and infestations
Cellulitis
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Infections and infestations
Meningitis
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Infections and infestations
Otitis media chronic
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Infections and infestations
Peritonsillar abscess
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Infections and infestations
Pneumonia
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Infections and infestations
Pyelonephritis acute
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Infections and infestations
Sepsis
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Infections and infestations
Subcutaneous abscess
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Infections and infestations
Vestibular neuronitis
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Investigations
Alanine aminotransferase increased
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Investigations
Aspartate aminotransferase increased
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.09%
3/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Nervous system disorders
Cerebral infarction
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Nervous system disorders
Headache
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Reproductive system and breast disorders
Cervix inflammation
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Vascular disorders
Deep vein thrombosis
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of ampulla of Vater
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.03%
1/3231 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place