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. 2021 Jul 21;9(9):586–594. doi: 10.1016/S2213-8587(21)00180-7

Table 2.

Primary and secondary outcomes

Dapagliflozin (n=625) Placebo (n=625) HR, RR, or WR (95% CI)* p value
Primary outcomes
Prevention composite outcome 70 (11·2%) 86 (13·8%) HR 0·80 (0·58–1·10) 0·17
New or worsening organ dysfunction 64 (10·2%) 80 (12·8%) HR 0·80 (0·57–1·11) NA
Respiratory decompensation 58 (9·3%) 70 (11·2%) HR 0·85 (0·60–1·20) NA
Cardiovascular decompensation 47 (7·5%) 58 (9·3%) HR 0·81 (0·55–1·19) NA
Kidney decompensation 24 (3·8%) 35 (5·6%) HR 0·65 (0·38–1·10) NA
Death from any cause 41 (6·6%) 54 (8·6%) HR 0·77 (0·52–1·16) NA
Hierarchical composite recovery outcome 547 (87·5%) 532 (85·1%) WR 1·09 (0·97–1·22) 0·14
Secondary outcomes
Composite of acute kidney injury, initiation of renal-replacement therapy, or death from any cause 48 (7·7%) 65 (10·4%) HR 0·74 (0·50–1·07) NA
Total number of days alive and free from mechanical ventilation§ 554 (88·6%) 540 (86·4%) WR 1·03 (0·92–1·15) NA
Total number of days alive, not in the ICU, and free from mechanical ventilation 539 (86·2%) 528 (84·5%) WR 1·02 (0·92–1·14) NA
Hospital discharge 567 (90·7%) 556 (89·0%) RR 1·05 (0·94–1·18) NA

HR=hazard ratio. RR=rate ratio. WR=win ratio. ICU=intensive care unit. NA=not applicable.

*

HR >1 favours placebo, RR >1 favours dapagliflozin, WR >1 favours dapagliflozin.

The outcome of death from any cause was also a separate secondary outcome.

The 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.

§

The number of patients alive and without any ventilator use during 30 days, in the total number of days analysis.

The number of patients alive and without any ventilator and ICU use during 30 days, in the total number of days analysis.