Trial Outcomes & Findings for Regulatory Request NIS in Korea (NCT NCT03642717)
NCT ID: NCT03642717
Last Updated: 2021-05-21
Results Overview
Percentage of participants with any adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse event was calculated by Exact Method.
COMPLETED
658 participants
From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
2021-05-21
Participant Flow
This post-marketing surveillance study re-examined case report forms retrieving at 20 sites from 21 January 2016 till 11 August 2020 for subjects who had Type 2 Diabetes Mellitus, and were initially administered Jardiance Duo® following the study start date investigating factors affecting the safety and effectiveness of study drug.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
JARDIANCE DUO® (Empagliflozin/Metformin)
All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
|
|---|---|
|
Overall Study
STARTED
|
658
|
|
Overall Study
COMPLETED
|
620
|
|
Overall Study
NOT COMPLETED
|
38
|
Reasons for withdrawal
| Measure |
JARDIANCE DUO® (Empagliflozin/Metformin)
All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
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|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Inclusion/exclusion criteria violation
|
33
|
|
Overall Study
Taken study drug prior to contract date
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
JARDIANCE DUO® (Empagliflozin/Metformin)
n=620 Participants
All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
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|---|---|
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Age, Continuous
|
56.39 Years
STANDARD_DEVIATION 12.78 • n=620 Participants
|
|
Sex: Female, Male
Female
|
221 Participants
n=620 Participants
|
|
Sex: Female, Male
Male
|
399 Participants
n=620 Participants
|
PRIMARY outcome
Timeframe: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.Population: Safety analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo® 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 event was calculated by Exact Method.
Outcome measures
| Measure |
JARDIANCE DUO® (Empagliflozin/Metformin)
n=620 Participants
All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
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|---|---|
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Percentage of Participants With Any Adverse Events
|
11.94 Percentage of participants
Interval 9.49 to 14.75
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PRIMARY outcome
Timeframe: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.Population: Safety analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo® 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 event was calculated by Exact Method.
Outcome measures
| Measure |
JARDIANCE DUO® (Empagliflozin/Metformin)
n=620 Participants
All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
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|---|---|
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Percentage of Participants With Adverse Events Relating to Study Drug
|
5.48 Percentage of participants
Interval 3.83 to 7.58
|
PRIMARY outcome
Timeframe: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.Population: Safety analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo® 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 event was calculated by Exact Method.
Outcome measures
| Measure |
JARDIANCE DUO® (Empagliflozin/Metformin)
n=620 Participants
All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
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|---|---|
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Percentage of Participants With Unexpected Adverse Events
|
9.03 Percentage of participants
Interval 6.89 to 11.57
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PRIMARY outcome
Timeframe: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.Population: Safety analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo® once at least, and were followed up by the physician once or more.
Percentage of participants with adverse events of special interest was reported. The 95% Confidence Interval for the percentage of participants with adverse event was calculated by Exact Method.
Outcome measures
| Measure |
JARDIANCE DUO® (Empagliflozin/Metformin)
n=620 Participants
All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
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|---|---|
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Percentage of Participants With Adverse Events of Special Interest
|
0.65 Percentage of participants
Interval 0.18 to 1.64
|
PRIMARY outcome
Timeframe: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.Population: Safety analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo® 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 event was calculated by Exact Method.
Outcome measures
| Measure |
JARDIANCE DUO® (Empagliflozin/Metformin)
n=620 Participants
All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
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|---|---|
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Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug
|
2.90 Percentage of participants
Interval 1.73 to 4.55
|
SECONDARY outcome
Timeframe: At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).Population: Effective analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo®, and were evaluated for the effectiveness.
Change in the glycosylated hemoglobin (HbA1c) at Last Visit from baseline was reported.
Outcome measures
| Measure |
JARDIANCE DUO® (Empagliflozin/Metformin)
n=497 Participants
All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
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|---|---|
|
Change in the Glycosylated Hemoglobin (HbA1c) at Last Visit From Baseline
|
-0.72 Percentage of glycosylated hemoglobin
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: At last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).Population: Effective analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo®, and were evaluated for the effectiveness.
Number of participants reached target effectiveness response in the glycosylated hemoglobin (HbA1c) (HbA1c \< 7%) at Last Visit was reported. Target effectiveness response in the glycosylated hemoglobin (HbA1c) was defined as HbA1c less than 7%.
Outcome measures
| Measure |
JARDIANCE DUO® (Empagliflozin/Metformin)
n=497 Participants
All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
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|---|---|
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Number of Participants Reached Target Effectiveness Response in the Glycosylated Hemoglobin (HbA1c) (HbA1c < 7%) at Last Visit
less than 7%
|
239 Participants
|
|
Number of Participants Reached Target Effectiveness Response in the Glycosylated Hemoglobin (HbA1c) (HbA1c < 7%) at Last Visit
greater than or equal to 7%
|
258 Participants
|
SECONDARY outcome
Timeframe: At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).Population: Effective analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo®, and were evaluated for the effectiveness.
Number of participants with relative effectiveness response in the glycosylated hemoglobin (HbA1c) at Last Visit was reported. Relative effectiveness response in the glycosylated hemoglobin (HbA1c) at last visit was defined as HbA1c decrease of 0.5% or more at the last visit comparing to baseline.
Outcome measures
| Measure |
JARDIANCE DUO® (Empagliflozin/Metformin)
n=497 Participants
All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
|
|---|---|
|
Number of Participants With Relative Effectiveness Response in the Glycosylated Hemoglobin (HbA1c) (HbA1c Decrease of 0.5% Comparing to Baseline) at Last Visit
greater than or equal to 0.5%
|
242 Participants
|
|
Number of Participants With Relative Effectiveness Response in the Glycosylated Hemoglobin (HbA1c) (HbA1c Decrease of 0.5% Comparing to Baseline) at Last Visit
less than 0.5%
|
255 Participants
|
SECONDARY outcome
Timeframe: At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).Population: Effective analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo®, and were evaluated for the effectiveness. Only those subjects with non-missing outcome measures were included in this analysis.
Change in the Fasting Plasma Glucose (FPG) at Last Visit from baseline was reported.
Outcome measures
| Measure |
JARDIANCE DUO® (Empagliflozin/Metformin)
n=417 Participants
All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
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|---|---|
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Change in the Fasting Plasma Glucose (FPG) at Last Visit From Baseline
|
-26.86 milligrams per deciliter (mg/dl)
Standard Deviation 50.91
|
SECONDARY outcome
Timeframe: At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).Population: Effective analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo®, and were evaluated for the effectiveness. Only those subjects with non-missing outcome measures were included in this analysis.
Change in the body weight at Last Visit from baseline was reported.
Outcome measures
| Measure |
JARDIANCE DUO® (Empagliflozin/Metformin)
n=372 Participants
All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
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|---|---|
|
Change in the Body Weight at Last Visit From Baseline
|
-2.18 kilogram (kg)
Standard Deviation 3.53
|
SECONDARY outcome
Timeframe: At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).Population: Effective analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo®, and were evaluated for the effectiveness. Only those subjects with non-missing outcome measures were included in this analysis.
Change in the systolic blood pressure (SBP) at Last Visit from baseline was reported.
Outcome measures
| Measure |
JARDIANCE DUO® (Empagliflozin/Metformin)
n=448 Participants
All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
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|---|---|
|
Change in the Systolic Blood Pressure (SBP) at Last Visit From Baseline
|
-1.96 millimetre of mercury (mmHg)
Standard Deviation 15.45
|
SECONDARY outcome
Timeframe: At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).Population: Effective analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo®, and were evaluated for the effectiveness. Only those subjects with non-missing outcome measures were included in this analysis.
Change in the diastolic blood pressure (DBP) at Last Visit from baseline was reported.
Outcome measures
| Measure |
JARDIANCE DUO® (Empagliflozin/Metformin)
n=448 Participants
All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
|
|---|---|
|
Change in the Diastolic Blood Pressure (DBP) at Last Visit From Baseline
|
-2.04 millimetre of mercury (mmHg)
Standard Deviation 10.80
|
SECONDARY outcome
Timeframe: At last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).Population: Effective analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo®, and were evaluated for the effectiveness.
Number of participants per final effectiveness assessment category at Last Visit was reported. The final effectiveness 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 DUO® (Empagliflozin/Metformin)
n=497 Participants
All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
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|---|---|
|
Number of Participants Per Final Effectiveness Assessment Category at Last Visit
Aggravated
|
45 Participants
|
|
Number of Participants Per Final Effectiveness Assessment Category at Last Visit
Improved
|
330 Participants
|
|
Number of Participants Per Final Effectiveness Assessment Category at Last Visit
Unchanged
|
103 Participants
|
|
Number of Participants Per Final Effectiveness Assessment Category at Last Visit
Unassessable
|
19 Participants
|
Adverse Events
JARDIANCE DUO® (Empagliflozin/Metformin)
Serious adverse events
| Measure |
JARDIANCE DUO® (Empagliflozin/Metformin)
n=620 participants at risk
All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).
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|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.16%
1/620 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
Safety analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo® once at least, and were followed up by the physician once or more.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.16%
1/620 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
Safety analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo® once at least, and were followed up by the physician once or more.
|
|
Infections and infestations
Cellulitis
|
0.16%
1/620 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
Safety analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo® once at least, and were followed up by the physician once or more.
|
|
Infections and infestations
Pneumonia
|
0.16%
1/620 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
Safety analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo® once at least, and were followed up by the physician once or more.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.16%
1/620 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
Safety analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo® once at least, and were followed up by the physician once or more.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.16%
1/620 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
Safety analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo® once at least, and were followed up by the physician once or more.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.16%
1/620 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
Safety analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo® once at least, and were followed up by the physician once or more.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.16%
1/620 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
Safety analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo® once at least, and were followed up by the physician once or more.
|
|
Nervous system disorders
Cerebral infarction
|
0.32%
2/620 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
Safety analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo® once at least, and were followed up by the physician once or more.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.16%
1/620 • From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
Safety analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo® 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
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER