Trial Outcomes & Findings for Dapagliflozin in Respiratory Failure in Patients With COVID-19 (NCT NCT04350593)
NCT ID: NCT04350593
Last Updated: 2022-06-10
Results Overview
Time to first occurrence of new/worsened organ dysfunction during index hospitalization or death from any cause. Event rates are presented as the number of subjects with event per 100 patient month (30 days) of follow-up. Unit of Measure: Patients with events per 100 patient-months (pt-mos) at risk. New/worsened organ dysfunction is defined as at least one of the following: * Respiratory decompensation requiring initiation of mechanical ventilation (includes invasive or non-invasive ventilation, CPAP, or BiPAP), and/or initiation of extracorporeal membrane oxygenation (ECMO) * New or worsening congestive heart failure * Requirement for vasopressor therapy and/or inotropic or mechanical circulatory support * Ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest * Doubling of s-Creatinine or initiation of renal replacement therapy
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1250 participants
Primary outcome timeframe
Randomization through Day 30
Results posted on
2022-06-10
Participant Flow
Participant milestones
| Measure |
Dapagliflozin 10mg
Dapagliflozin 10 mg daily
Dapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg
|
Placebo
Dapagliflozin matching placebo 10 mg daily
Placebo: Placebo Comparator
|
|---|---|---|
|
Overall Study
STARTED
|
625
|
625
|
|
Overall Study
COMPLETED
|
617
|
620
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
N numbers might differ for some parameters based on data availability.
Baseline characteristics by cohort
| Measure |
Dapagliflozin 10mg
n=625 Participants
Dapagliflozin 10 mg daily
Dapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg
|
Placebo
n=625 Participants
Dapagliflozin matching placebo 10 mg daily
Placebo: Placebo Comparator
|
Total
n=1250 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 13.4 • n=625 Participants
|
61.8 years
STANDARD_DEVIATION 13.5 • n=625 Participants
|
61.4 years
STANDARD_DEVIATION 13.5 • n=1250 Participants
|
|
Sex: Female, Male
Female
|
260 Participants
n=625 Participants
|
273 Participants
n=625 Participants
|
533 Participants
n=1250 Participants
|
|
Sex: Female, Male
Male
|
365 Participants
n=625 Participants
|
352 Participants
n=625 Participants
|
717 Participants
n=1250 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
394 Participants
n=621 Participants • N numbers might differ for some parameters based on data availability.
|
362 Participants
n=619 Participants • N numbers might differ for some parameters based on data availability.
|
756 Participants
n=1240 Participants • N numbers might differ for some parameters based on data availability.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
166 Participants
n=621 Participants • N numbers might differ for some parameters based on data availability.
|
177 Participants
n=619 Participants • N numbers might differ for some parameters based on data availability.
|
343 Participants
n=1240 Participants • N numbers might differ for some parameters based on data availability.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
61 Participants
n=621 Participants • N numbers might differ for some parameters based on data availability.
|
80 Participants
n=619 Participants • N numbers might differ for some parameters based on data availability.
|
141 Participants
n=1240 Participants • N numbers might differ for some parameters based on data availability.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=623 Participants • N numbers might differ for some parameters based on data availability.
|
10 Participants
n=618 Participants • N numbers might differ for some parameters based on data availability.
|
17 Participants
n=1241 Participants • N numbers might differ for some parameters based on data availability.
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=623 Participants • N numbers might differ for some parameters based on data availability.
|
29 Participants
n=618 Participants • N numbers might differ for some parameters based on data availability.
|
64 Participants
n=1241 Participants • N numbers might differ for some parameters based on data availability.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=623 Participants • N numbers might differ for some parameters based on data availability.
|
0 Participants
n=618 Participants • N numbers might differ for some parameters based on data availability.
|
1 Participants
n=1241 Participants • N numbers might differ for some parameters based on data availability.
|
|
Race (NIH/OMB)
Black or African American
|
85 Participants
n=623 Participants • N numbers might differ for some parameters based on data availability.
|
84 Participants
n=618 Participants • N numbers might differ for some parameters based on data availability.
|
169 Participants
n=1241 Participants • N numbers might differ for some parameters based on data availability.
|
|
Race (NIH/OMB)
White
|
452 Participants
n=623 Participants • N numbers might differ for some parameters based on data availability.
|
459 Participants
n=618 Participants • N numbers might differ for some parameters based on data availability.
|
911 Participants
n=1241 Participants • N numbers might differ for some parameters based on data availability.
|
|
Race (NIH/OMB)
More than one race
|
43 Participants
n=623 Participants • N numbers might differ for some parameters based on data availability.
|
36 Participants
n=618 Participants • N numbers might differ for some parameters based on data availability.
|
79 Participants
n=1241 Participants • N numbers might differ for some parameters based on data availability.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=623 Participants • N numbers might differ for some parameters based on data availability.
|
0 Participants
n=618 Participants • N numbers might differ for some parameters based on data availability.
|
0 Participants
n=1241 Participants • N numbers might differ for some parameters based on data availability.
|
|
Region of Enrollment
Canada
|
2 participants
n=625 Participants
|
2 participants
n=625 Participants
|
4 participants
n=1250 Participants
|
|
Region of Enrollment
Argentina
|
13 participants
n=625 Participants
|
14 participants
n=625 Participants
|
27 participants
n=1250 Participants
|
|
Region of Enrollment
United States
|
143 participants
n=625 Participants
|
144 participants
n=625 Participants
|
287 participants
n=1250 Participants
|
|
Region of Enrollment
Brazil
|
382 participants
n=625 Participants
|
380 participants
n=625 Participants
|
762 participants
n=1250 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=625 Participants
|
2 participants
n=625 Participants
|
2 participants
n=1250 Participants
|
|
Region of Enrollment
Mexico
|
59 participants
n=625 Participants
|
59 participants
n=625 Participants
|
118 participants
n=1250 Participants
|
|
Region of Enrollment
India
|
26 participants
n=625 Participants
|
24 participants
n=625 Participants
|
50 participants
n=1250 Participants
|
|
Type 2 diabetes
|
312 Participants
n=625 Participants
|
324 Participants
n=625 Participants
|
636 Participants
n=1250 Participants
|
|
Heart failure
|
44 Participants
n=625 Participants
|
46 Participants
n=625 Participants
|
90 Participants
n=1250 Participants
|
|
Hypertension
|
526 Participants
n=625 Participants
|
534 Participants
n=625 Participants
|
1060 Participants
n=1250 Participants
|
|
Atherosclerotic cardiovascular disease
|
93 Participants
n=625 Participants
|
106 Participants
n=625 Participants
|
199 Participants
n=1250 Participants
|
|
Chronic kidney disease, estimated glomerular filtration rate (eGFR) 25-60 mL/min per 1.73 m^2
|
38 Participants
n=625 Participants
|
44 Participants
n=625 Participants
|
82 Participants
n=1250 Participants
|
|
Patients with two or more inclusion risk factors
|
292 Participants
n=625 Participants
|
319 Participants
n=625 Participants
|
611 Participants
n=1250 Participants
|
|
Age >/= 60 years
|
339 Participants
n=625 Participants
|
360 Participants
n=625 Participants
|
699 Participants
n=1250 Participants
|
|
Body Mass Index >/= 30
|
296 Participants
n=625 Participants
|
305 Participants
n=625 Participants
|
601 Participants
n=1250 Participants
|
|
Chronic obstructive pulmonary disease
|
25 Participants
n=625 Participants
|
32 Participants
n=625 Participants
|
57 Participants
n=1250 Participants
|
|
Current smoker
|
29 Participants
n=625 Participants
|
20 Participants
n=625 Participants
|
49 Participants
n=1250 Participants
|
|
Heart rate
|
79.3 beats per minute
STANDARD_DEVIATION 13.7 • n=625 Participants
|
79.7 beats per minute
STANDARD_DEVIATION 13.7 • n=625 Participants
|
79.5 beats per minute
STANDARD_DEVIATION 13.7 • n=1250 Participants
|
|
Blood pressure - systolic
|
126.6 mm Hg
STANDARD_DEVIATION 16.0 • n=625 Participants
|
127.0 mm Hg
STANDARD_DEVIATION 16.3 • n=625 Participants
|
126.8 mm Hg
STANDARD_DEVIATION 16.1 • n=1250 Participants
|
|
Blood pressure - diastolic
|
76.6 mm Hg
STANDARD_DEVIATION 10.9 • n=625 Participants
|
76.2 mm Hg
STANDARD_DEVIATION 10.6 • n=625 Participants
|
76.4 mm Hg
STANDARD_DEVIATION 10.7 • n=1250 Participants
|
|
Temperature
|
36.4 degrees Celcius
STANDARD_DEVIATION 0.6 • n=625 Participants
|
36.4 degrees Celcius
STANDARD_DEVIATION 0.7 • n=625 Participants
|
36.4 degrees Celcius
STANDARD_DEVIATION 0.6 • n=1250 Participants
|
|
Oxygen saturation
|
95.5 % (measured on supplemental oxygen)
STANDARD_DEVIATION 1.7 • n=625 Participants
|
95.2 % (measured on supplemental oxygen)
STANDARD_DEVIATION 1.8 • n=625 Participants
|
95.3 % (measured on supplemental oxygen)
STANDARD_DEVIATION 1.8 • n=1250 Participants
|
|
eGFR
|
84.1 mL/min per 1.73 m^2
STANDARD_DEVIATION 25.0 • n=625 Participants
|
83.4 mL/min per 1.73 m^2
STANDARD_DEVIATION 24.6 • n=625 Participants
|
83.8 mL/min per 1.73 m^2
STANDARD_DEVIATION 24.8 • n=1250 Participants
|
|
SARS-CoV-2 test result at baseline
Positive
|
584 Participants
n=625 Participants
|
575 Participants
n=625 Participants
|
1159 Participants
n=1250 Participants
|
|
SARS-CoV-2 test result at baseline
Negative
|
30 Participants
n=625 Participants
|
35 Participants
n=625 Participants
|
65 Participants
n=1250 Participants
|
|
SARS-CoV-2 test result at baseline
Test results not known
|
11 Participants
n=625 Participants
|
15 Participants
n=625 Participants
|
26 Participants
n=1250 Participants
|
|
Angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB)
|
225 Participants
n=625 Participants
|
219 Participants
n=625 Participants
|
444 Participants
n=1250 Participants
|
|
Beta-blocker
|
93 Participants
n=625 Participants
|
98 Participants
n=625 Participants
|
191 Participants
n=1250 Participants
|
|
Calcium blocker
|
84 Participants
n=625 Participants
|
88 Participants
n=625 Participants
|
172 Participants
n=1250 Participants
|
|
Loop-diuretic
|
49 Participants
n=625 Participants
|
63 Participants
n=625 Participants
|
112 Participants
n=1250 Participants
|
|
Statin
|
122 Participants
n=625 Participants
|
144 Participants
n=625 Participants
|
266 Participants
n=1250 Participants
|
|
Anti-coagulant
|
527 Participants
n=625 Participants
|
527 Participants
n=625 Participants
|
1054 Participants
n=1250 Participants
|
|
Biguanide
|
82 Participants
n=625 Participants
|
75 Participants
n=625 Participants
|
157 Participants
n=1250 Participants
|
|
Sulfonylurea
|
24 Participants
n=625 Participants
|
22 Participants
n=625 Participants
|
46 Participants
n=1250 Participants
|
|
Dipeptidyl peptidase 4 (DPP-4) inhibitor
|
17 Participants
n=625 Participants
|
11 Participants
n=625 Participants
|
28 Participants
n=1250 Participants
|
|
Glucagon-like peptide 1 (GLP-1) receptor agonist
|
6 Participants
n=625 Participants
|
8 Participants
n=625 Participants
|
14 Participants
n=1250 Participants
|
|
Insulin
|
223 Participants
n=625 Participants
|
221 Participants
n=625 Participants
|
444 Participants
n=1250 Participants
|
|
Remdesivir
|
114 Participants
n=625 Participants
|
111 Participants
n=625 Participants
|
225 Participants
n=1250 Participants
|
|
Systemic corticosteroids
|
176 Participants
n=625 Participants
|
179 Participants
n=625 Participants
|
355 Participants
n=1250 Participants
|
|
Dexamethasone
|
133 Participants
n=625 Participants
|
136 Participants
n=625 Participants
|
269 Participants
n=1250 Participants
|
|
Other systemic glucocorticoid
|
50 Participants
n=625 Participants
|
55 Participants
n=625 Participants
|
105 Participants
n=1250 Participants
|
PRIMARY outcome
Timeframe: Randomization through Day 30Time to first occurrence of new/worsened organ dysfunction during index hospitalization or death from any cause. Event rates are presented as the number of subjects with event per 100 patient month (30 days) of follow-up. Unit of Measure: Patients with events per 100 patient-months (pt-mos) at risk. New/worsened organ dysfunction is defined as at least one of the following: * Respiratory decompensation requiring initiation of mechanical ventilation (includes invasive or non-invasive ventilation, CPAP, or BiPAP), and/or initiation of extracorporeal membrane oxygenation (ECMO) * New or worsening congestive heart failure * Requirement for vasopressor therapy and/or inotropic or mechanical circulatory support * Ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest * Doubling of s-Creatinine or initiation of renal replacement therapy
Outcome measures
| Measure |
Dapagliflozin 10mg
n=625 Participants
Dapagliflozin 10 mg daily
Dapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg
|
Placebo
n=625 Participants
Dapagliflozin matching placebo 10 mg daily
Placebo: Placebo Comparator
|
|---|---|---|
|
Prevention of COVID-19 Complications or Death: During the 30-day Treatment Period, Time to First Occurrence of New/Worsened Organ Dysfunction During Index Hospitalization or Death From Any Cause.
|
12.4 Patients with events/100 pt-mos at risk
|
15.6 Patients with events/100 pt-mos at risk
|
PRIMARY outcome
Timeframe: Randomization through Day 30The number of patients experiencing improvement by day 30 compared with baseline (discharged from hospital without a worsening event and alive, or still in hospital without a worsening event and without oxygen support) in the hierarchical composite endpoint analysis. Hierarchical composite outcome measure includes: * Death from any cause through Day 30 * New/worsened organ dysfunction * Clinical status at Day 30 for patients still hospitalized and without any worsening organ dysfunction * Hospital discharge before Day 30 and alive at Day 30
Outcome measures
| Measure |
Dapagliflozin 10mg
n=625 Participants
Dapagliflozin 10 mg daily
Dapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg
|
Placebo
n=625 Participants
Dapagliflozin matching placebo 10 mg daily
Placebo: Placebo Comparator
|
|---|---|---|
|
Improving Clinical Recovery: Hierarchical Composite Outcome Measure Including Death From Any Cause Through Day 30, New/Worsened Organ Dysfunction, Clinical Status at Day 30 and Hospital Discharge Before Day 30 and Alive at Day 30.
|
547 participants
|
532 participants
|
SECONDARY outcome
Timeframe: Randomization through Day 30Time to hospital discharge (refers to index hospitalization only). Median time to hospital discharge is presented in days.
Outcome measures
| Measure |
Dapagliflozin 10mg
n=625 Participants
Dapagliflozin 10 mg daily
Dapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg
|
Placebo
n=625 Participants
Dapagliflozin matching placebo 10 mg daily
Placebo: Placebo Comparator
|
|---|---|---|
|
Time to Hospital Discharge
|
5 days
Interval 5.0 to 6.0
|
6 days
Interval 5.0 to 6.0
|
SECONDARY outcome
Timeframe: Randomization through Day 30Total number of days alive and free from mechanical ventilation (includes invasive or non-invasive ventilation, CPAP, or BiPAP) is calculated for each patient as total follow-up time (30 days) substracted days in hospital with mechanical ventilation and days dead.
Outcome measures
| Measure |
Dapagliflozin 10mg
n=625 Participants
Dapagliflozin 10 mg daily
Dapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg
|
Placebo
n=625 Participants
Dapagliflozin matching placebo 10 mg daily
Placebo: Placebo Comparator
|
|---|---|---|
|
Total Number of Days Alive and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP)
|
27.8 days
Standard Deviation 6.8
|
27.4 days
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Randomization through Day 30Total number of days alive, not in the ICU and free from mechanical ventilation (includes invasive or non-invasive ventilation, CPAP, or BiPAP) is calculated for each patient as total follow-up time (30 days) substracted days in ICU and days dead.
Outcome measures
| Measure |
Dapagliflozin 10mg
n=625 Participants
Dapagliflozin 10 mg daily
Dapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg
|
Placebo
n=625 Participants
Dapagliflozin matching placebo 10 mg daily
Placebo: Placebo Comparator
|
|---|---|---|
|
Total Number of Days Alive, Not in the ICU, and Free From Respiratory Decompensation Requiring Initiation of Mechanical Ventilation (Includes Invasive or Non-invasive Ventilation, CPAP, or BiPAP)
|
27.5 days
Standard Deviation 7.2
|
27.1 days
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Randomization through Day 30Acute kidney injury is defined as an episode of doubling s-creatinine compared to baseline during index hospitalization or SAE. Initiation of renal replacement therapy is defined as initiation of renal replacement therapy during index hospitalization or SAE. Event rates are presented as the number of subjects with event per 100 patient month (30 days) of follow-up. Unit of Measure: Patients with events per 100 patient-months (pt-mos) at risk.
Outcome measures
| Measure |
Dapagliflozin 10mg
n=625 Participants
Dapagliflozin 10 mg daily
Dapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg
|
Placebo
n=625 Participants
Dapagliflozin matching placebo 10 mg daily
Placebo: Placebo Comparator
|
|---|---|---|
|
Time to Composite of Acute Kidney Injury or Initiation of Renal Replacement Therapy, or Death From Any Cause
|
8.2 Patients with events/100 pt-mos at risk
|
11.2 Patients with events/100 pt-mos at risk
|
SECONDARY outcome
Timeframe: Randomization through Day 30Time to death from any cause. Event rates are presented as the number of subjects with event per 100 patient month (30 days) of follow-up. Unit of Measure: Patients with events per 100 patient-months (pt-mos) at risk.
Outcome measures
| Measure |
Dapagliflozin 10mg
n=625 Participants
Dapagliflozin 10 mg daily
Dapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg
|
Placebo
n=625 Participants
Dapagliflozin matching placebo 10 mg daily
Placebo: Placebo Comparator
|
|---|---|---|
|
Time to Death From Any Cause
|
6.8 Patients with events/100 pt-mos at risk
|
9.0 Patients with events/100 pt-mos at risk
|
Adverse Events
Dapagliflozin 10mg
Serious events: 70 serious events
Other events: 2 other events
Deaths: 41 deaths
Placebo
Serious events: 87 serious events
Other events: 2 other events
Deaths: 54 deaths
Serious adverse events
| Measure |
Dapagliflozin 10mg
n=613 participants at risk
Dapagliflozin 10 mg daily
Dapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg
|
Placebo
n=616 participants at risk
Dapagliflozin matching placebo 10 mg daily
Placebo: Placebo Comparator
|
|---|---|---|
|
Infections and infestations
Emphysematous pyelonephritis
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Infections and infestations
COVID-19
|
0.82%
5/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.49%
3/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Infections and infestations
Septic Shock
|
0.82%
5/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.97%
6/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Infections and infestations
Severe acute respiratory syndrome
|
0.49%
3/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.49%
3/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.65%
4/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Infections and infestations
Device related sepsis
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Infections and infestations
Herpes virus infection
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Infections and infestations
Infection
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Infections and infestations
Meningoencephalitis herpetic
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Infections and infestations
Sepsis
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.49%
3/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
1.3%
8/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.32%
2/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Infections and infestations
Pulmonary sepsis
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.33%
2/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Euglycemic diabetic ketoacidosis
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Psychiatric disorders
Psychotic disorder
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Nervous system disorders
Ischemic stroke
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Nervous system disorders
Myasthenia gravis
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Nervous system disorders
Cerebral disorder
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Nervous system disorders
Presnycope
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.49%
3/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.32%
2/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.32%
2/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Cardiac disorders
Cardiac failure acute
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Vascular disorders
Arterial thrombosis
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Vascular disorders
Hemorrhage
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Vascular disorders
Hypovolemic shock
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Vascular disorders
Shock
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.32%
2/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.8%
11/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
1.8%
11/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.65%
4/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.65%
4/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.49%
3/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.32%
2/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.33%
2/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.32%
2/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.32%
2/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.32%
2/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.32%
2/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract inflammation
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.4%
21/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
5.2%
32/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Renal and urinary disorders
Renal impairment
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.32%
2/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
General disorders
Asthenia
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.49%
3/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.81%
5/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
General disorders
General physical health deterioration
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Investigations
Blood electrolytes abnormal
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Cardiac disorders
Cardiac Disorder
|
0.16%
1/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.00%
0/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.16%
1/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
Other adverse events
| Measure |
Dapagliflozin 10mg
n=613 participants at risk
Dapagliflozin 10 mg daily
Dapagliflozin 10 MG: Active Comparator: Dapagliflozin 10mg
|
Placebo
n=616 participants at risk
Dapagliflozin matching placebo 10 mg daily
Placebo: Placebo Comparator
|
|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.33%
2/613 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
0.32%
2/616 • Adverse events were collected from the time of signing informed consent through the end of the 30-day treatment period.
All-cause mortality was monitored in the total started population of 1250 patients. Serious adverse events, adverse events resulting in the discontinuation of study drug, and safety events of acute kidney injury and diabetic ketoacidosis were monitored in the safety population defined as patients who received at least one dose of study medication. 613 patients in the dapagliflozin group and 616 patients in the placebo group received at least one dose of study medication.
|
Additional Information
DARE-19 Global Project Manager
Saint Luke's Hospital of Kansas City
Phone: 816-932-9858
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding results for a period that is less than or equal to 45 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication with the exception of requiring the removal of confidential information. The embargo can be extended to 90 days if there would be any patent applications to be filed by the sponsor related to the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER