Table 2.
Analysis of the hierarchical composite endpoint (FAS)
| Variable | Dapa 10 mg (N = 625) n (%) |
Placebo (N = 625) n (%) |
Difference between treatment groups | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Win odds | 95% CI | p-value | |||||||||
| The hierarchical composite endpoint of all-cause mortality, new/worsened organ dysfunctiona, in hospital clinical status at day 30 and discharge from hospitalb | 619 (99.0) | 622 (99.5) | |||||||||
| Primary | 1.09 | (0.97, 1.22) | 0.136 | ||||||||
| Direct | 1.07 | (0.94, 1.21) | 0.326 | ||||||||
| Discharge from hospitalc | 544 (87.0) | 532 (85.1) | |||||||||
| Days to discharge | |||||||||||
| (0, 3] | 158 (25.3) | 146 (23.4) | |||||||||
| (3, 6] | 198 (31.7) | 212 (33.9) | |||||||||
| (6, 9] | 109 (17.4) | 104 (16.6) | |||||||||
| (9, 12] | 40 (6.4) | 36 (5.8) | |||||||||
| (12, 15] | 23 (3.7) | 19 (3.0) | |||||||||
| (15, 30] | 16 (2.6) | 15 (2.4) | |||||||||
| In hospital clinical status at day 30 | 5 (0.8) | 3 (0.5) | |||||||||
| Hospitalized, not requiring supplemental oxygen | 3 (0.5) | 0 | |||||||||
| Hospitalized, requiring supplemental oxygen | 1 (0.2) | 3 (0.5) | |||||||||
| Hospitalized, on high flow oxygen devices | 1 (0.2) | 0 | |||||||||
| New/worsened organ dysfunctiond | 29 (4.6) | 33 (5.3) | |||||||||
| 1 evente | 16 (2.6) | 19 (3.0) | |||||||||
| Multi-organ dysfunction (≥ 2 events) | 13 (2.1) | 14 (2.2) | |||||||||
| 2 events | 7 (1.1) | 2 (0.3) | |||||||||
| 3 events | 3 (0.5) | 6 (1.0) | |||||||||
| 4 events | 2 (0.3) | 4 (0.6) | |||||||||
| 5 events | 0 | 2 (0.3) | |||||||||
| 6 events | 1 (0.2) | 0 | |||||||||
| 7 events | 0 | 0 | |||||||||
| 8 events | 0 | 0 | |||||||||
| All-cause mortalitye | 41 (6.6) | 54 (8.6) | |||||||||
| Subject censored | 6 (1.0) | 3 (0.5) | |||||||||
| Withdrawal of consentf | 6 (1.0) | 3 (0.5) | |||||||||
| Unknown vital status | 0 | 0 | |||||||||
The percentages are calculated using the total number of subjects in each treatment group. Components of the composite are listed in decreasing order of ranks, where a higher rank corresponds to a better outcome
Win odds (primary) for Dapa 10 mg vs placebo and confidence interval are calculated from Cox regression model stratified by country, with a factor for treatment group. The 2-sided p-value is calculated from the log-rank test stratified by country
Win odds (direct) for Dapa 10 mg vs placebo, confidence intervals and 2-sided p-value are calculated using the theory of U-statistics, which does not require distributional assumptions
CI confidence interval, Dapa dapagliflozin, FAS full analysis set, N number of subjects in treatment group
aIn-hospital events, as defined in the prevention composite endpoint
bTotal number of subjects with non-missing vital status on Day 30
cSubjects inside this category are ranked using the timing of the event, a later event corresponding to a worse outcome
dSubjects with multiple events from the components of the prevention composite endpoint. Repeated events of the same component of a subject are not counted
eSubjects inside this category are ranked using the timing of the event, later corresponding to a better outcome
fIn-hospital withdrawal of consent and alive on Day 30