Trial Outcomes & Findings for This Study Combines Data From 3 Other Studies Testing Empagliflozin in Patients With Diabetes or With Chronic Heart Failure. The Study Looks at the Numbers of Patients Who Had Lower Limb Amputations (NCT NCT04937816)
NCT ID: NCT04937816
Last Updated: 2024-02-08
Results Overview
Incidence rate of lower limb amputation (LLA). Incidence rate were provided as rate per 100 patients-years (pt-yrs) calculated as the observed number of patients with event divided by observed time-at-risk over all patients. Time at risk was derived as followed: Patient with event: time at risk in days = date of start of first event - treatment start date + 1. Patients without event: time at risk in days = last date on treatment + 7 days - treatment start date + 1. Abbreviation: pt-yrs = patient-years.
Recruitment status
COMPLETED
Target enrollment
16746 participants
Primary outcome timeframe
From first to last dose of study medication plus 7 days to account for the residual drug effect, up to 1639 days.
Results posted on
2024-02-08
Participant Flow
This meta-analysis includes three randomised, placebo-controlled, double-blind, parallel-group and event-driven studies (NCT01131676, NCT03057951, NCT03057977) to evaluate the risk of lower-limb amputation (LLA) in patients treated with empagliflozin compared to placebo in the pooled population (SAF-M1 vs. SAF-M2).
As this is a meta-analysis of three independent trials, all subjects were screened for eligibility prior to participation of the respective trial.
Participant milestones
| Measure |
Trial NCT01131676: Placebo
Oral administration of Placebo matching empagliflozin 10 or 25 milligram (mg) (1 tablet once daily) in patients with type 2 diabetes mellitus (T2DM).
|
Trial NCT01131676: Empagliflozin 10 mg
1 film-coated tablet of 10 mg empagliflozin (BI 10773) was administered orally once daily in patients with T2DM.
|
Trial NCT01131676: Empagliflozin 25 mg
1 film-coated tablet of 25 mg empagliflozin (BI 10773) was administered orally once daily in patients with T2DM.
|
Trial NCT03057951: Placebo
1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
|
Trial NCT03057951: Empagliflozin 10 mg
1 film-coated tablet of 10 milligram (mg) of empagliflozin (BI 10773) was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
|
Trial NCT03057977: Placebo
1 film-coated tablet of matching placebo was administered orally once daily in patients with heart failure with reduced ejection fraction (HFrEF).
|
Trial NCT03057977: Empagliflozin 10 mg
1 film-coated tablet of 10 milligram (mg) empagliflozin (BI 10773) was administered orally once daily in patients with heart failure with reduced ejection fraction (HFrEF).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2337
|
2347
|
2344
|
2991
|
2997
|
1867
|
1863
|
|
Overall Study
Treated
|
2333
|
2345
|
2342
|
2989
|
2996
|
1863
|
1863
|
|
Overall Study
COMPLETED
|
1650
|
1790
|
1800
|
2046
|
2051
|
1352
|
1381
|
|
Overall Study
NOT COMPLETED
|
687
|
557
|
544
|
945
|
946
|
515
|
482
|
Reasons for withdrawal
| Measure |
Trial NCT01131676: Placebo
Oral administration of Placebo matching empagliflozin 10 or 25 milligram (mg) (1 tablet once daily) in patients with type 2 diabetes mellitus (T2DM).
|
Trial NCT01131676: Empagliflozin 10 mg
1 film-coated tablet of 10 mg empagliflozin (BI 10773) was administered orally once daily in patients with T2DM.
|
Trial NCT01131676: Empagliflozin 25 mg
1 film-coated tablet of 25 mg empagliflozin (BI 10773) was administered orally once daily in patients with T2DM.
|
Trial NCT03057951: Placebo
1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
|
Trial NCT03057951: Empagliflozin 10 mg
1 film-coated tablet of 10 milligram (mg) of empagliflozin (BI 10773) was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
|
Trial NCT03057977: Placebo
1 film-coated tablet of matching placebo was administered orally once daily in patients with heart failure with reduced ejection fraction (HFrEF).
|
Trial NCT03057977: Empagliflozin 10 mg
1 film-coated tablet of 10 milligram (mg) empagliflozin (BI 10773) was administered orally once daily in patients with heart failure with reduced ejection fraction (HFrEF).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Study drug stopped, reason missing
|
5
|
3
|
4
|
6
|
1
|
0
|
0
|
|
Overall Study
Other than stated below
|
173
|
143
|
125
|
44
|
45
|
28
|
31
|
|
Overall Study
Patient refusal to continue, not due to AE
|
172
|
118
|
122
|
304
|
284
|
124
|
92
|
|
Overall Study
Lost to Follow-up
|
15
|
9
|
6
|
6
|
16
|
11
|
17
|
|
Overall Study
Protocol Violation
|
15
|
15
|
12
|
30
|
24
|
5
|
5
|
|
Overall Study
Adverse Event
|
303
|
267
|
273
|
553
|
575
|
343
|
337
|
|
Overall Study
Not treated
|
4
|
2
|
2
|
2
|
1
|
4
|
0
|
Baseline Characteristics
This Study Combines Data From 3 Other Studies Testing Empagliflozin in Patients With Diabetes or With Chronic Heart Failure. The Study Looks at the Numbers of Patients Who Had Lower Limb Amputations
Baseline characteristics by cohort
| Measure |
Trial NCT01131676: Placebo
n=2333 Participants
Oral administration of Placebo matching empagliflozin 10 or 25 milligram (mg) (1 tablet once daily) in patients with type 2 diabetes mellitus (T2DM).
|
Trial NCT01131676: Empagliflozin 10 mg
n=2345 Participants
1 film-coated tablet of 10 mg empagliflozin (BI 10773) was administered orally once daily in patients with T2DM.
|
Trial NCT01131676: Empagliflozin 25 mg
n=2342 Participants
1 film-coated tablet of 25 mg empagliflozin (BI 10773) was administered orally once daily in patients with T2DM.
|
Trial NCT03057951: Placebo
n=2989 Participants
1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
|
Trial NCT03057951: Empagliflozin 10 mg
n=2996 Participants
1 film-coated tablet of 10 milligram (mg) of empagliflozin (BI 10773) was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
|
Trial NCT03057977: Placebo
n=1863 Participants
1 film-coated tablet of matching placebo was administered orally once daily in patients with heart failure with reduced ejection fraction (HFrEF).
|
Trial NCT03057977: Empagliflozin 10 mg
n=1863 Participants
1 film-coated tablet of 10 milligram (mg) empagliflozin (BI 10773) was administered orally once daily in patients with heart failure with reduced ejection fraction (HFrEF).
|
Total
n=16731 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.2 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
63.0 Years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
63.2 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
71.9 Years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
71.8 Years
STANDARD_DEVIATION 9.3 • n=21 Participants
|
66.5 Years
STANDARD_DEVIATION 11.2 • n=10 Participants
|
67.2 Years
STANDARD_DEVIATION 10.8 • n=115 Participants
|
67.1 Years
STANDARD_DEVIATION 10.2 • n=6 Participants
|
|
Sex: Female, Male
Female
|
653 Participants
n=5 Participants
|
692 Participants
n=7 Participants
|
659 Participants
n=5 Participants
|
1336 Participants
n=4 Participants
|
1338 Participants
n=21 Participants
|
453 Participants
n=10 Participants
|
437 Participants
n=115 Participants
|
5568 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1680 Participants
n=5 Participants
|
1653 Participants
n=7 Participants
|
1683 Participants
n=5 Participants
|
1653 Participants
n=4 Participants
|
1658 Participants
n=21 Participants
|
1410 Participants
n=10 Participants
|
1426 Participants
n=115 Participants
|
11163 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
418 Participants
n=5 Participants
|
432 Participants
n=7 Participants
|
415 Participants
n=5 Participants
|
753 Participants
n=4 Participants
|
770 Participants
n=21 Participants
|
613 Participants
n=10 Participants
|
616 Participants
n=115 Participants
|
4017 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1912 Participants
n=5 Participants
|
1909 Participants
n=7 Participants
|
1926 Participants
n=5 Participants
|
2235 Participants
n=4 Participants
|
2226 Participants
n=21 Participants
|
1175 Participants
n=10 Participants
|
1164 Participants
n=115 Participants
|
12547 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
75 Participants
n=10 Participants
|
83 Participants
n=115 Participants
|
167 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
24 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
287 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
511 Participants
n=5 Participants
|
505 Participants
n=7 Participants
|
501 Participants
n=5 Participants
|
411 Participants
n=4 Participants
|
413 Participants
n=21 Participants
|
334 Participants
n=10 Participants
|
337 Participants
n=115 Participants
|
3012 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
57 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
120 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
133 Participants
n=21 Participants
|
134 Participants
n=10 Participants
|
123 Participants
n=115 Participants
|
872 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
1678 Participants
n=5 Participants
|
1707 Participants
n=7 Participants
|
1696 Participants
n=5 Participants
|
2254 Participants
n=4 Participants
|
2285 Participants
n=21 Participants
|
1301 Participants
n=10 Participants
|
1325 Participants
n=115 Participants
|
12246 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
33 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
196 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
31 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
61 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: From first to last dose of study medication plus 7 days to account for the residual drug effect, up to 1639 days.Population: Treated Set: Patients treated with at least 1 dose of study medication. Results are reported by the pooled population (SAF-M1 and SAF-M2) and for each study separately. For trial NCT01131676, 10 mg and 25 mg were combined, as the overall safety profile is similar for empagliflozin 10 mg and 25 mg. This approach was agreed with the European Medicines Agency (EMA).
Incidence rate of lower limb amputation (LLA). Incidence rate were provided as rate per 100 patients-years (pt-yrs) calculated as the observed number of patients with event divided by observed time-at-risk over all patients. Time at risk was derived as followed: Patient with event: time at risk in days = date of start of first event - treatment start date + 1. Patients without event: time at risk in days = last date on treatment + 7 days - treatment start date + 1. Abbreviation: pt-yrs = patient-years.
Outcome measures
| Measure |
SAF-M1 Placebo
n=7185 Participants
Safety analysis grouping (SAF)-M1 - Placebo included the pooled population of all three studies. Patients with type 2 diabetes mellitus (T2DM) (NCT01131676), patients with heart failure with preserved ejection fraction (HFpEF) (NCT03057951) and patients with heart failure with reduced ejection fraction (HFrEF) (NCT03057977) treated with placebo. In all three trials, 1 film-coated tablet of placebo matching empagliflozin was administered orally once daily.
|
SAF-M1 Empagliflozin
n=9546 Participants
Safety analysis grouping (SAF)-M1 included the pooled population of all three studies. Patients with T2DM (NCT01131676), patients with HFpEF (NCT03057951) and patients with HFrEF (NCT03057977) treated with 10 milligram (mg) or 25 mg empagliflozin.
|
SAF-M2 Placebo
n=4852 Participants
SAF-M2 included the pooled population of the 2 chronic heart failure studies (NCT03057951, NCT03057977). Patients with HFpEF and patients with HFrEF treated with placebo. In both trials, 1 film-coated tablet of placebo matching empagliflozin was administered orally once daily.
|
SAF-M2 Empagliflozin 10 mg
n=4859 Participants
SAF-M2 included the pooled population of the 2 chronic heart failure studies (NCT03057951, NCT03057977). Patients with HFpEF and patients with HFrEF treated with 10 mg empagliflozin, administered as film-coated tablet orally once daily.
|
Trial NCT01131676: Placebo
n=2333 Participants
Oral administration of Placebo matching empagliflozin 10 or 25 milligram (mg) (1 tablet once daily) in patients with type 2 diabetes mellitus (T2DM).
|
Trial NCT01131676: Empagliflozin 10 mg or 25 mg
n=4687 Participants
1 film-coated tablet of 10 mg or 25 mg empagliflozin (BI 10773) was administered orally once daily in patients with T2DM.
|
Trial NCT03057951: Placebo
n=2989 Participants
1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
|
Trial NCT03057951: Empagliflozin 10 mg
n=2996 Participants
1 film-coated tablet of 10 milligram (mg) of empagliflozin (BI 10773) was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
|
Trial NCT03057977: Placebo
n=1863 Participants
1 film-coated tablet of matching placebo was administered orally once daily in patients with heart failure with reduced ejection fraction (HFrEF).
|
Trial NCT03057977: Empagliflozin 10 mg
n=1863 Participants
1 film-coated tablet of 10 milligram (mg) empagliflozin (BI 10773) was administered orally once daily in patients with heart failure with reduced ejection fraction (HFrEF).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence Rate of Lower Limb Amputation (LLA)
|
0.40 Patients with events per 100pt-yrs
Interval 0.3 to 0.52
|
0.48 Patients with events per 100pt-yrs
Interval 0.39 to 0.58
|
0.27 Patients with events per 100pt-yrs
Interval 0.17 to 0.39
|
0.23 Patients with events per 100pt-yrs
Interval 0.13 to 0.34
|
0.59 Patients with events per 100pt-yrs
Interval 0.41 to 0.81
|
0.64 Patients with events per 100pt-yrs
Interval 0.51 to 0.79
|
0.27 Patients with events per 100pt-yrs
Interval 0.15 to 0.42
|
0.20 Patients with events per 100pt-yrs
Interval 0.1 to 0.33
|
0.27 Patients with events per 100pt-yrs
Interval 0.1 to 0.52
|
0.31 Patients with events per 100pt-yrs
Interval 0.12 to 0.58
|
SECONDARY outcome
Timeframe: From first to last dose of study medication plus 7 days to account for the residual drug effect, up to 1639 days.Population: Treated Set: Patients treated with at least 1 dose of study medication. Results are reported by the pooled population (SAF-M1 and SAF-M2) and for each study separately. For trial NCT01131676, 10 mg and 25 mg were combined, as the overall safety profile is similar for empagliflozin 10 mg and 25 mg. This approach was agreed with the European Medicines Agency (EMA).
Incidence rate of adverse events (AEs) related to amputation. Incidence rate were provided as rate per 100 patients-years (pt-yrs) calculated as the observed number of patients with event divided by observed time-at-risk over all patients. Time at risk was derived as followed: Patient with event: time at risk in days = date of start of first event - treatment start date + 1. Patients without event: time at risk in days = last date on treatment + 7 days - treatment start date + 1. A search with a pre-defined list of MedDRA preferred terms was performed to identify all AEs related to amputation. These AE included vascular disorders, diabetic-foot-related events, wound/infections, nervous system disorders and volume depletion events. Abbreviation: pt-yrs = patient-years.
Outcome measures
| Measure |
SAF-M1 Placebo
n=7185 Participants
Safety analysis grouping (SAF)-M1 - Placebo included the pooled population of all three studies. Patients with type 2 diabetes mellitus (T2DM) (NCT01131676), patients with heart failure with preserved ejection fraction (HFpEF) (NCT03057951) and patients with heart failure with reduced ejection fraction (HFrEF) (NCT03057977) treated with placebo. In all three trials, 1 film-coated tablet of placebo matching empagliflozin was administered orally once daily.
|
SAF-M1 Empagliflozin
n=9546 Participants
Safety analysis grouping (SAF)-M1 included the pooled population of all three studies. Patients with T2DM (NCT01131676), patients with HFpEF (NCT03057951) and patients with HFrEF (NCT03057977) treated with 10 milligram (mg) or 25 mg empagliflozin.
|
SAF-M2 Placebo
n=4852 Participants
SAF-M2 included the pooled population of the 2 chronic heart failure studies (NCT03057951, NCT03057977). Patients with HFpEF and patients with HFrEF treated with placebo. In both trials, 1 film-coated tablet of placebo matching empagliflozin was administered orally once daily.
|
SAF-M2 Empagliflozin 10 mg
n=4859 Participants
SAF-M2 included the pooled population of the 2 chronic heart failure studies (NCT03057951, NCT03057977). Patients with HFpEF and patients with HFrEF treated with 10 mg empagliflozin, administered as film-coated tablet orally once daily.
|
Trial NCT01131676: Placebo
n=2333 Participants
Oral administration of Placebo matching empagliflozin 10 or 25 milligram (mg) (1 tablet once daily) in patients with type 2 diabetes mellitus (T2DM).
|
Trial NCT01131676: Empagliflozin 10 mg or 25 mg
n=4687 Participants
1 film-coated tablet of 10 mg or 25 mg empagliflozin (BI 10773) was administered orally once daily in patients with T2DM.
|
Trial NCT03057951: Placebo
n=2989 Participants
1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
|
Trial NCT03057951: Empagliflozin 10 mg
n=2996 Participants
1 film-coated tablet of 10 milligram (mg) of empagliflozin (BI 10773) was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).
|
Trial NCT03057977: Placebo
n=1863 Participants
1 film-coated tablet of matching placebo was administered orally once daily in patients with heart failure with reduced ejection fraction (HFrEF).
|
Trial NCT03057977: Empagliflozin 10 mg
n=1863 Participants
1 film-coated tablet of 10 milligram (mg) empagliflozin (BI 10773) was administered orally once daily in patients with heart failure with reduced ejection fraction (HFrEF).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence Rate of Adverse Events Related to Amputation
Diabetic foot related AE
|
0.50 Patients with events per 100 pt-yrs
Interval 0.39 to 0.63
|
0.64 Patients with events per 100 pt-yrs
Interval 0.53 to 0.76
|
0.32 Patients with events per 100 pt-yrs
Interval 0.21 to 0.46
|
0.46 Patients with events per 100 pt-yrs
Interval 0.32 to 0.62
|
0.75 Patients with events per 100 pt-yrs
Interval 0.54 to 0.99
|
0.76 Patients with events per 100 pt-yrs
Interval 0.62 to 0.93
|
0.38 Patients with events per 100 pt-yrs
Interval 0.23 to 0.55
|
0.30 Patients with events per 100 pt-yrs
Interval 0.18 to 0.46
|
0.18 Patients with events per 100 pt-yrs
Interval 0.05 to 0.39
|
0.84 Patients with events per 100 pt-yrs
Interval 0.51 to 1.26
|
|
Incidence Rate of Adverse Events Related to Amputation
Vascular adverse event
|
1.48 Patients with events per 100 pt-yrs
Interval 1.28 to 1.69
|
1.57 Patients with events per 100 pt-yrs
Interval 1.4 to 1.75
|
1.27 Patients with events per 100 pt-yrs
Interval 1.03 to 1.54
|
1.21 Patients with events per 100 pt-yrs
Interval 0.98 to 1.47
|
1.77 Patients with events per 100 pt-yrs
Interval 1.44 to 2.13
|
1.81 Patients with events per 100 pt-yrs
Interval 1.57 to 2.06
|
1.21 Patients with events per 100 pt-yrs
Interval 0.94 to 1.51
|
1.17 Patients with events per 100 pt-yrs
Interval 0.9 to 1.47
|
1.44 Patients with events per 100 pt-yrs
Interval 0.98 to 1.97
|
1.33 Patients with events per 100 pt-yrs
Interval 0.9 to 1.85
|
|
Incidence Rate of Adverse Events Related to Amputation
Infections potentially related to LLA
|
2.19 Patients with events per 100 pt-yrs
Interval 1.94 to 2.44
|
2.04 Patients with events per 100 pt-yrs
Interval 1.85 to 2.25
|
1.85 Patients with events per 100 pt-yrs
Interval 1.56 to 2.17
|
1.78 Patients with events per 100 pt-yrs
Interval 1.5 to 2.09
|
2.64 Patients with events per 100 pt-yrs
Interval 2.23 to 3.09
|
2.22 Patients with events per 100 pt-yrs
Interval 1.96 to 2.5
|
1.97 Patients with events per 100 pt-yrs
Interval 1.62 to 2.36
|
1.75 Patients with events per 100 pt-yrs
Interval 1.42 to 2.11
|
1.57 Patients with events per 100 pt-yrs
Interval 1.09 to 2.13
|
1.88 Patients with events per 100 pt-yrs
Interval 1.35 to 2.49
|
|
Incidence Rate of Adverse Events Related to Amputation
Wound/infection
|
0.86 Patients with events per 100 pt-yrs
Interval 0.71 to 1.02
|
0.86 Patients with events per 100 pt-yrs
Interval 0.73 to 0.99
|
0.65 Patients with events per 100 pt-yrs
Interval 0.49 to 0.84
|
0.46 Patients with events per 100 pt-yrs
Interval 0.32 to 0.62
|
1.14 Patients with events per 100 pt-yrs
Interval 0.87 to 1.43
|
1.12 Patients with events per 100 pt-yrs
Interval 0.94 to 1.32
|
0.61 Patients with events per 100 pt-yrs
Interval 0.42 to 0.83
|
0.48 Patients with events per 100 pt-yrs
Interval 0.32 to 0.68
|
0.76 Patients with events per 100 pt-yrs
Interval 0.44 to 1.16
|
0.40 Patients with events per 100 pt-yrs
Interval 0.18 to 0.7
|
|
Incidence Rate of Adverse Events Related to Amputation
Nervous system disorder
|
1.54 Patients with events per 100 pt-yrs
Interval 1.34 to 1.76
|
1.81 Patients with events per 100 pt-yrs
Interval 1.62 to 2.0
|
0.85 Patients with events per 100 pt-yrs
Interval 0.66 to 1.07
|
0.92 Patients with events per 100 pt-yrs
Interval 0.72 to 1.14
|
2.53 Patients with events per 100 pt-yrs
Interval 2.12 to 2.96
|
2.41 Patients with events per 100 pt-yrs
Interval 2.14 to 2.7
|
0.92 Patients with events per 100 pt-yrs
Interval 0.69 to 1.19
|
0.99 Patients with events per 100 pt-yrs
Interval 0.74 to 1.27
|
0.67 Patients with events per 100 pt-yrs
Interval 0.37 to 1.05
|
0.75 Patients with events per 100 pt-yrs
Interval 0.44 to 1.15
|
|
Incidence Rate of Adverse Events Related to Amputation
Volume depletion
|
0.67 Patients with events per 100 pt-yrs
Interval 0.54 to 0.81
|
0.65 Patients with events per 100 pt-yrs
Interval 0.54 to 0.77
|
0.95 Patients with events per 100 pt-yrs
Interval 0.75 to 1.18
|
1.16 Patients with events per 100 pt-yrs
Interval 0.94 to 1.41
|
0.28 Patients with events per 100 pt-yrs
Interval 0.16 to 0.43
|
0.32 Patients with events per 100 pt-yrs
Interval 0.23 to 0.43
|
0.90 Patients with events per 100 pt-yrs
Interval 0.67 to 1.17
|
1.16 Patients with events per 100 pt-yrs
Interval 0.9 to 1.46
|
1.08 Patients with events per 100 pt-yrs
Interval 0.69 to 1.55
|
1.16 Patients with events per 100 pt-yrs
Interval 0.76 to 1.64
|
Adverse Events
SAF-M1 Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SAF-M1 Empagliflozin 10 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SAF-M1 Empagliflozin 25 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SAF-M2 Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SAF-M2 Empagliflozin 10 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Trial NCT01131676: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Trial NCT01131676: Empagliflozin 10 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Trial NCT01131676: Empagliflozin 25 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Trial NCT03057977: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Trial NCT03057977: Empagliflozin 10 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Trial NCT03057951: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Trial NCT03057951: Empagliflozin 10 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place