Trial Outcomes & Findings for Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68) (NCT NCT04363697)

Last Updated: 2026-06-16

Results Overview

Composite of cardiovascular death or worsening heart failure event (defined as worsening heart failure during index admission, rehospitalization for worsening heart failure, or urgent heart failure visit)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

2401 participants

Primary outcome timeframe

2 months

Results posted on

2026-06-16

Participant Flow

Participant milestones

Participant milestones
Measure	Dapagliflozin Dapagliflozin 10 mg administered orally once daily for 2 months	Placebo Matching placebo administered orally once daily for 2 months
Overall Study STARTED	1218	1183
Overall Study COMPLETED	1176	1119
Overall Study NOT COMPLETED	42	64

Reasons for withdrawal

Reasons for withdrawal
Measure	Dapagliflozin Dapagliflozin 10 mg administered orally once daily for 2 months	Placebo Matching placebo administered orally once daily for 2 months
Overall Study Death	36	53
Overall Study Withdrawal by Subject	6	7
Overall Study Lost to Follow-up	0	4

Baseline Characteristics

Worsening chronic heart failure patients only

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dapagliflozin n=1218 Participants Dapagliflozin 10 mg administered orally once daily for 2 months	Placebo n=1183 Participants Matching placebo administered orally once daily for 2 months	Total n=2401 Participants Total of all reporting groups
Age, Continuous	69 years n=1218 Participants	68 years n=1183 Participants	69 years n=2401 Participants
Sex: Female, Male Female	403 Participants n=1218 Participants	412 Participants n=1183 Participants	815 Participants n=2401 Participants
Sex: Female, Male Male	815 Participants n=1218 Participants	771 Participants n=1183 Participants	1586 Participants n=2401 Participants
Race/Ethnicity, Customized Asian	26 Participants n=1218 Participants	18 Participants n=1183 Participants	44 Participants n=2401 Participants
Race/Ethnicity, Customized Black or African American	224 Participants n=1218 Participants	224 Participants n=1183 Participants	448 Participants n=2401 Participants
Race/Ethnicity, Customized White	957 Participants n=1218 Participants	927 Participants n=1183 Participants	1884 Participants n=2401 Participants
Race/Ethnicity, Customized Other	11 Participants n=1218 Participants	14 Participants n=1183 Participants	25 Participants n=2401 Participants
Region North America	893 Participants n=1218 Participants	869 Participants n=1183 Participants	1762 Participants n=2401 Participants
Region Europe	325 Participants n=1218 Participants	314 Participants n=1183 Participants	639 Participants n=2401 Participants
Heart Failure chronicity Newly diagnosed heart failure	556 Participants n=1218 Participants	518 Participants n=1183 Participants	1074 Participants n=2401 Participants
Heart Failure chronicity Worsening chronic heart failure	662 Participants n=1218 Participants	665 Participants n=1183 Participants	1327 Participants n=2401 Participants
Prior heart failure hospitalization	374 Participants n=662 Participants • Worsening chronic heart failure patients only	368 Participants n=665 Participants • Worsening chronic heart failure patients only	742 Participants n=1327 Participants • Worsening chronic heart failure patients only
NYHA class 30 days prior to admission NYHA class I	33 Participants n=655 Participants • NYHA class 30 days prior to admission only measured for patients with worsening chronic heart failure.	31 Participants n=658 Participants • NYHA class 30 days prior to admission only measured for patients with worsening chronic heart failure.	64 Participants n=1313 Participants • NYHA class 30 days prior to admission only measured for patients with worsening chronic heart failure.
NYHA class 30 days prior to admission NYHA class II	199 Participants n=655 Participants • NYHA class 30 days prior to admission only measured for patients with worsening chronic heart failure.	221 Participants n=658 Participants • NYHA class 30 days prior to admission only measured for patients with worsening chronic heart failure.	420 Participants n=1313 Participants • NYHA class 30 days prior to admission only measured for patients with worsening chronic heart failure.
Prior myocardial infarction	243 Participants n=1196 Participants • Information about prior MI unknown for 38 participants	222 Participants n=1167 Participants • Information about prior MI unknown for 38 participants	465 Participants n=2363 Participants • Information about prior MI unknown for 38 participants
NYHA class 30 days prior to admission NYHA class III	369 Participants n=655 Participants • NYHA class 30 days prior to admission only measured for patients with worsening chronic heart failure.	350 Participants n=658 Participants • NYHA class 30 days prior to admission only measured for patients with worsening chronic heart failure.	719 Participants n=1313 Participants • NYHA class 30 days prior to admission only measured for patients with worsening chronic heart failure.
NYHA class 30 days prior to admission NYHA class IV	54 Participants n=655 Participants • NYHA class 30 days prior to admission only measured for patients with worsening chronic heart failure.	56 Participants n=658 Participants • NYHA class 30 days prior to admission only measured for patients with worsening chronic heart failure.	110 Participants n=1313 Participants • NYHA class 30 days prior to admission only measured for patients with worsening chronic heart failure.
Left ventricular ejection fraction	30 % of blood ejected from the heart n=1218 Participants	30 % of blood ejected from the heart n=1183 Participants	30 % of blood ejected from the heart n=2401 Participants
LVEF ≤40%	865 Participants n=1218 Participants	852 Participants n=1183 Participants	1717 Participants n=2401 Participants
Principal cause of heart failure Ischemic	323 Participants n=1218 Participants	296 Participants n=1183 Participants	619 Participants n=2401 Participants
Principal cause of heart failure Non-ischemic	727 Participants n=1218 Participants	716 Participants n=1183 Participants	1443 Participants n=2401 Participants
Principal cause of heart failure Unknown	168 Participants n=1218 Participants	171 Participants n=1183 Participants	339 Participants n=2401 Participants
Type 2 diabetes mellitus	437 Participants n=1218 Participants	415 Participants n=1183 Participants	852 Participants n=2401 Participants
History of atrial fibrillation	542 Participants n=1207 Participants • Information about history of AFib unknown for 20 participants	530 Participants n=1174 Participants • Information about history of AFib unknown for 20 participants	1072 Participants n=2381 Participants • Information about history of AFib unknown for 20 participants
History of hypertension	943 Participants n=1218 Participants	935 Participants n=1183 Participants	1878 Participants n=2401 Participants
KCCQ-12 total symptom score at randomization	33.3 points n=1215 Participants • KCCQ-12 not measured at baseline for 6 participants	33.3 points n=1180 Participants • KCCQ-12 not measured at baseline for 6 participants	33.3 points n=2395 Participants • KCCQ-12 not measured at baseline for 6 participants
Natriuretic peptides (qualifying) NT-proBNP	5016 pg/ml n=803 Participants • Participants were required to have an elevated NT-proBNP and/or BNP in order to qualify for the study. Some patients had both NT-proBNP and BNP test results reported.	4696 pg/ml n=779 Participants • Participants were required to have an elevated NT-proBNP and/or BNP in order to qualify for the study. Some patients had both NT-proBNP and BNP test results reported.	4803 pg/ml n=1582 Participants • Participants were required to have an elevated NT-proBNP and/or BNP in order to qualify for the study. Some patients had both NT-proBNP and BNP test results reported.
Natriuretic peptides (qualifying) BNP	1139 pg/ml n=421 Participants • Participants were required to have an elevated NT-proBNP and/or BNP in order to qualify for the study. Some patients had both NT-proBNP and BNP test results reported.	1092 pg/ml n=409 Participants • Participants were required to have an elevated NT-proBNP and/or BNP in order to qualify for the study. Some patients had both NT-proBNP and BNP test results reported.	1106 pg/ml n=830 Participants • Participants were required to have an elevated NT-proBNP and/or BNP in order to qualify for the study. Some patients had both NT-proBNP and BNP test results reported.
Systolic blood pressure	119 mmHg n=1218 Participants	119 mmHg n=1183 Participants	119 mmHg n=2401 Participants
Heart rate	79 bpm n=1218 Participants	77 bpm n=1183 Participants	78 bpm n=2401 Participants
Estimated GFR	63.5 ml/min/1.73m^2 n=1218 Participants	62.5 ml/min/1.73m^2 n=1183 Participants	63.1 ml/min/1.73m^2 n=2401 Participants
eGFR <60 ml/min/1.73m^2	536 Participants n=1218 Participants	551 Participants n=1183 Participants	1087 Participants n=2401 Participants
Serum potassium	4.1 mmol/L n=1218 Participants • Baseline serum potassium value was not available for 2 participants.	4.0 mmol/L n=1181 Participants • Baseline serum potassium value was not available for 2 participants.	4.0 mmol/L n=2399 Participants • Baseline serum potassium value was not available for 2 participants.
Medication use at randomization Beta-blocker	992 Participants n=1218 Participants	989 Participants n=1183 Participants	1981 Participants n=2401 Participants
Medication use at randomization Renin-angiotensin system inhibitor	859 Participants n=1218 Participants	823 Participants n=1183 Participants	1682 Participants n=2401 Participants
Medication use at randomization ACE inhibitor or ARB	539 Participants n=1218 Participants	533 Participants n=1183 Participants	1072 Participants n=2401 Participants
Medication use at randomization ARNI	339 Participants n=1218 Participants	309 Participants n=1183 Participants	648 Participants n=2401 Participants
Medication use at randomization Mineralocorticoid receptor antagonist	602 Participants n=1218 Participants	565 Participants n=1183 Participants	1167 Participants n=2401 Participants
Medication use at randomization Digoxin	68 Participants n=1218 Participants	64 Participants n=1183 Participants	132 Participants n=2401 Participants
Medication use at randomization Loop diuretic	1041 Participants n=1218 Participants	998 Participants n=1183 Participants	2039 Participants n=2401 Participants

PRIMARY outcome

Timeframe: 2 months

Outcome measures

Outcome measures
Measure	Dapagliflozin n=1218 Participants Dapagliflozin 10 mg administered orally once daily for 2 months Dapagliflozin: Dapagliflozin	Placebo n=1183 Participants Matching placebo administered orally once daily for 2 months Placebo: Matched placebo
Participants With the Composite Outcome of Cardiovascular Death or Worsening Heart Failure	133 Participants	150 Participants

SECONDARY outcome

Timeframe: 2 months

Outcome measures

Outcome measures
Measure	Dapagliflozin n=1218 Participants Dapagliflozin 10 mg administered orally once daily for 2 months Dapagliflozin: Dapagliflozin	Placebo n=1183 Participants Matching placebo administered orally once daily for 2 months Placebo: Matched placebo
Participants With the Composite Outcome of Cardiovascular Death, Rehospitalization for Heart Failure, Urgent Heart Failure Visit	127 Participants	146 Participants

SECONDARY outcome

Timeframe: 2 months

Outcome measures

Outcome measures
Measure	Dapagliflozin n=1218 Participants Dapagliflozin 10 mg administered orally once daily for 2 months Dapagliflozin: Dapagliflozin	Placebo n=1183 Participants Matching placebo administered orally once daily for 2 months Placebo: Matched placebo
Participants With the Composite Outcome of Cardiovascular Death or Rehospitalization for Heart Failure	110 Participants	133 Participants

SECONDARY outcome

Timeframe: 2 months

Outcome measures

Outcome measures
Measure	Dapagliflozin n=1218 Participants Dapagliflozin 10 mg administered orally once daily for 2 months Dapagliflozin: Dapagliflozin	Placebo n=1183 Participants Matching placebo administered orally once daily for 2 months Placebo: Matched placebo
Participants With Rehospitalization for Heart Failure or Urgent Heart Failure Visit	107 Participants	116 Participants

SECONDARY outcome

Timeframe: 2 months

Outcome measures

Outcome measures
Measure	Dapagliflozin n=1218 Participants Dapagliflozin 10 mg administered orally once daily for 2 months Dapagliflozin: Dapagliflozin	Placebo n=1183 Participants Matching placebo administered orally once daily for 2 months Placebo: Matched placebo
Number of Participants With All-cause Death	36 Participants	53 Participants

SECONDARY outcome

Timeframe: 2 months

Hierarchical Composite Endpoint combines time to all-cause mortality, number of heart failure events, time to first worsening HF events, KCCQ-12 total symptom score in a hierarchical fashion. The method compares every participant with every other participant within strata, assigning a +1 to the "better" participant and a -1 to the "worse" participant and 0 if they are "tied". 'Win' represents a participant doing better based on hierarchical comparison. The reported unit is the total number of "wins" for each treatment group from performing such a hierarchical comparison across stratification factors in the study.

Outcome measures

Outcome measures
Measure	Dapagliflozin n=1218 Participants Dapagliflozin 10 mg administered orally once daily for 2 months Dapagliflozin: Dapagliflozin	Placebo n=1183 Participants Matching placebo administered orally once daily for 2 months Placebo: Matched placebo
Hierarchical Composite of Time to Cardiovascular Death, Worsening Heart Failure Events, Time to First Worsening Heart Failure Event, and Change From Baseline in KCCQ-12 Total Symptom Score (% Wins)	172,221 number of wins	157,615 number of wins

Adverse Events

Dapagliflozin

Serious events: 24 serious events

Other events: 58 other events

Deaths: 36 deaths

Placebo

Serious events: 21 serious events

Other events: 56 other events

Deaths: 53 deaths

Serious adverse events

Other adverse events

Additional Information

Project Director

TIMI Study Group

Phone: 617-278-0145

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Dapagliflozin n=1210 participants at risk Dapagliflozin 10 mg administered orally once daily for 2 months	Placebo n=1179 participants at risk Matching placebo administered orally once daily for 2 months
Renal and urinary disorders Acute kidney injury	0.33% 4/1210 • Number of events 4 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.85% 10/1179 • Number of events 11 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Cardiac disorders Acute myocardial infarction	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
General disorders Asthenia	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Cardiac disorders Atrial fibrillation	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Cardiac disorders Cardiac failure chronic	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Infections and infestations Cystitis	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Infections and infestations Erysipelas	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
General disorders Face oedema	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Injury, poisoning and procedural complications Fall	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Vascular disorders Hypotension	0.66% 8/1210 • Number of events 8 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.25% 3/1179 • Number of events 3 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Vascular disorders Hypovolaemic shock	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Musculoskeletal and connective tissue disorders Muscular weakness	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Infections and infestations Orchitis	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Vascular disorders Orthostatic hypotension	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Renal and urinary disorders Renal impairment	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Infections and infestations Staphylococcal sepsis	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Nervous system disorders Subarachnoid haemorrhage	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Nervous system disorders Syncope	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Infections and infestations Urinary tract infection	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Infections and infestations Urosepsis	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.

Other adverse events
Measure	Dapagliflozin n=1210 participants at risk Dapagliflozin 10 mg administered orally once daily for 2 months	Placebo n=1179 participants at risk Matching placebo administered orally once daily for 2 months
Gastrointestinal disorders Abdominal discomfort	0.17% 2/1210 • Number of events 2 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Gastrointestinal disorders Abdominal pain upper	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Injury, poisoning and procedural complications Accidental overdose	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Cardiac disorders Atrial flutter	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Renal and urinary disorders Acute kidney injury	0.17% 2/1210 • Number of events 2 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.51% 6/1179 • Number of events 6 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Cardiac disorders Acute myocardial infarction	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.17% 2/1179 • Number of events 2 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Cardiac disorders Aortic valve stenosis	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Musculoskeletal and connective tissue disorders Back pain	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Investigations Blood creatinine increased	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Cardiac disorders Cardiac arrest	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Cardiac disorders Cardiac failure	0.33% 4/1210 • Number of events 4 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.25% 3/1179 • Number of events 3 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Cardiac disorders Cardiac failure chronic	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Cardiac disorders Cardiogenic shock	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Cardiac disorders Cardiomyopathy	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Infections and infestations Cellulitis	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
General disorders Chest pain	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Injury, poisoning and procedural complications Compression fracture	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Infections and infestations COVID-19	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Skin and subcutaneous tissue disorders Cutaneous vasculitis	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Psychiatric disorders Depression	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Gastrointestinal disorders Diarrhoea	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Nervous system disorders Dizziness	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Nervous system disorders Dizziness postural	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Infections and infestations Endocarditis	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.17% 2/1179 • Number of events 2 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Reproductive system and breast disorders Erectile dysfunction	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
General disorders Face oedema	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
General disorders Fatigue	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
General disorders Feeling jittery	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/1210 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.08% 1/1179 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Infections and infestations Genital infection male	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Nervous system disorders Headache	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Metabolism and nutrition disorders Hypervolaemia	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Metabolism and nutrition disorders Hypoglycaemia	0.08% 1/1210 • Number of events 1 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.00% 0/1179 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.
Vascular disorders Hypotension	0.41% 5/1210 • Number of events 5 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.	0.25% 3/1179 • Number of events 3 • Adverse events were collected during the 2 month study follow up period. (1) serious adverse events related, probably related, and possibly related to study drug, (2) any adverse events (serious or non-serious) leading to study drug discontinuation Note that safety analyses were performed in patients who had undergone randomization and received at least 1 dose of the study drug. Therefore, the number of patients included in the efficacy analyses (e.g. all cause mortality) is different from the number of patients included in the safety analyses.