Table 2.
Primary and secondary efficacy outcomes.
| TCZ+DEX (n = 224) | DEX (n = 226) | Treatment effect (95% CI) | |
|---|---|---|---|
| Primary outcomes | |||
| Mechanical ventilation or death up to day 14 | 27 (12%) | 32 (14%) | 0·85 (90% CrI 0·55 to 1·31)* |
| Posterior probability of any benefit | 0·728 | ||
| Posterior probability of at least a fair benefit | 0·405 | ||
| Secondary outcomes | |||
| Overall survival | |||
| Mortality at day 14 | 12 (5%) | 12 (5%) | 1·03 (0·46 to 2·29)† |
| Mortality at day 28 | 15 (7%) | 19 (8%) | 0·82 (0·41 to 1·61)† |
| Mortality at day 60 | 17 (8%) | 23 (10%) | 0·76 (0·41 to 1·42)† |
| Mortality at day 90 | 18 (8%)** | 24 (11%) | 0·77 (0·42 to 1·41)† |
| WHO—CPS score (10 pt-scale) | |||
| Day 7, median [IQR] | 5 [4–5] ¶ | 5 [4–5]†† | 0·70 (0·50 to 0·98)‡ |
| Day 14, median [IQR] | 2 [1–5]‡‡ | 2 [2–5]¶¶ | 0·68 (0·49 to 0·96)‡ |
| Time to discharge | |||
| Discharged at day 14 | 162 (72%) | 144 (64%) | 1·23 (0·98 to 1·54)† |
| Discharged at day 28 | 186 (83%) | 169 (75%) | 1·24 (1·01 to 1·53)† |
| Time to oxygen supply independency | |||
| Independent from oxygen at day 14 | 158 (71%) | 138 (62%) | 1·34 (1·07 to 1·68)† |
| Independent from oxygen at day 28 | 182 (82%) | 161 (72%) | 1·36 (1·11 to 1·67)† |
CrI: credible interval (Bayesian analysis); CI: confidence interval (frequentist analysis); NIV: non-invasive ventilation (including high-flow oxygen); MV: mechanical ventilation; WHO—CPS: World Health Organization Clinical Progression Scale.
Probability of any benefit was defined as P(HR < 1), and probability of at least a fair benefit as P(HR < 0·8).
* Median posterior hazard ratio adjusted for age and centre with 90% CrI.
** One patient died on day 94, and is not counted amongst the 18.
† Hazard ratio adjusted for age and centre with 95% CI.
‡ Odds ratio in a proportional odds model adjusted for age and centre with 95% CI.
¶ n = 220 with available data.
†† n = 225 with available data.
‡‡ n = 210 with available data.
¶¶ n = 213 with available data.