Table 2. Time-to-Event Outcomes in the Modified Intention-to-Treat Population.*.
| Outcome | No. of Patients with Event within 28 Days | Percentage of Patients with Event (95% CI)† | Median No. of Days to Event (95% CI) | Hazard Ratio (95% CI) | Log-Rank P Value‡ | |
|---|---|---|---|---|---|---|
| Day 14 | Day 28 | |||||
| Measures of worsening | ||||||
| Primary outcome: mechanical ventilation or death | ||||||
| Tocilizumab | 17 | 9.9 (6.2–15.7) | 10.6 (6.7–16.6) | NR | 0.83 (0.38–1.81) | 0.64 |
| Placebo | 10 | 10.0 (5.1–18.9) | 12.5 (6.9–22.0) | NR | ||
| Secondary outcome: clinical worsening on ordinal scale§ | ||||||
| Tocilizumab | 31 | 18.0 (12.9–24.9) | 19.3 (14.0–26.2) | NR | 1.11 (0.59–2.10) | 0.73 |
| Placebo | 14 | 14.9 (8.7–24.7) | 17.4 (10.7–27.7) | NR | ||
| Tertiary outcome: mechanical ventilation¶ | ||||||
| Tocilizumab | 11 | 6.8 (3.6–11.4) | 6.8 (3.6–11.4) | NR | 0.65 (0.26–1.62) | — |
| Placebo | 8 | 10.0 (4.6–17.7) | 10.0 (4.6–17.7) | NR | ||
| Tertiary outcome: death | ||||||
| Tocilizumab | 9 | 4.4 (2.1–8.9) | 5.6 (3.0–10.5) | NR | 1.52 (0.41–5.61) | — |
| Placebo | 3 | 1.3 (0.2–8.7) | 3.8 (1.2–11.3) | NR | ||
| Measures of improvement | ||||||
| Secondary outcome: discontinuation of supplemental oxygen among patients receiving it at baseline | ||||||
| Tocilizumab | 114 | 75.4 (67.9–82.2) | 82.6 (75.9–88.4) | 5.0 (3.8–7.6) | 0.94 (0.67–1.30) | 0.69 |
| Placebo | 56 | 78.8 (68.3–87.7) | 84.9 (75.2–92.2) | 4.9 (3.8–7.8) | ||
| Tertiary outcome: clinical improvement on ordinal scale§ | ||||||
| Tocilizumab | 147 | 86.3 (80.6–91.1) | 91.3 (86.3–95.1) | 6.0 (5.0–6.0) | 1.06 (0.80–1.41) | — |
| Placebo | 72 | 81.5 (72.4–89.0) | 88.9 (81.0–94.5) | 5.0 (4.0–7.0) | ||
| Tertiary outcome: initial discharge | ||||||
| Tocilizumab | 147 | 86.3 (80.6–91.1) | 91.3 (86.3–95.0) | 6.0 (4.0–7.0) | 1.08 (0.81–1.43) | — |
| Placebo | 72 | 81.5 (72.4–89.0) | 88.9 (81.0–94.5) | 6.0 (5.0–6.0) | ||
The modified intention-to-treat population included the 242 patients (161 in the tocilizumab group and 81 in the placebo group) who underwent randomization and received either tocilizumab or placebo before intubation or death. NR denotes not reached.
Percentages were estimated from the Kaplan–Meier curve.
P values are not reported for tertiary outcomes.
Worsening was defined as an increase in score on the ordinal clinical improvement scale by at least 1 point among patients receiving supplemental oxygen at baseline or at least 2 points among those not receiving supplemental oxygen at baseline. Improvement was defined as an increase in score by at least 2 points.
Results for the time-to-event analysis of mechanical ventilation were obtained with the use of competing-risks analyses with death treated as a competing event. The percentage of patients with an event was estimated from the cumulative incidence function for the event of interest (mechanical ventilation). The cause-specific hazard ratio is reported.