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.