Table 2.
Outcomes.
| Outcome | Europe |
Effect estimates with 99% CIa | India |
Effect estimates with 99% CI | P value for test of interaction | ||
|---|---|---|---|---|---|---|---|
| 12 mg (n = 315) | 6 mg (n = 298) | 12 mg (n = 182) | 6 mg (n = 187) | ||||
| Mortality at day 28–n (%) | 57 (18.3%) | 76 (25.8%) | −8.3 (−17.7 to 1) | 76 (42.2%) | 79 (42.7%) | 0.1 (−10.0 to 10.0) | 0.12 |
| Serious adverse reactions at day 28–n (%) | 40 (12.7%) | 41 (13.8%) | −1.0 (−7.1 to 5.2) | 16 (8.8%) | 24 (12.8%) | −5.3 (−16.2 to 5) | 0.33 |
| Mortality at day 90–n (%) | 77 (24.8%) | 94 (32.1%) | −7.4 (−17.1 to 2.0) | 80 (44.4%) | 86 (46.5%) | −1.4 (−12.8 to 9.8) | 0.30 |
| No. of days alive without life support at day 90–median (IQR) | 83.0 (35.5–90.0) | 80.0 (8.0–90.0) | 6.1 (−1.3 to 13.4) | 89.5 (5.0–90.0) | 74.5 (5.0–90.0) | 1.7 (−8.4 to 11.8) | 0.37 |
| No. of days alive and out of hospital at day 90–median (IQR) | 63.0 (0.0–77.8) | 54.0 (0.0–76.0) | 4.4 (−2.3 to 11.0) | 50.5 (0.0–78.0) | 0.0 (0.0–78.0) | 3.7 (−5.4 to 12.8) | 0.88 |
| Mortality at day 180–n (%) | 82 (26.8%) | 97 (33.2%) | −6.7 (−16.4 to 2.9) | 82 (45.6%) | 87 (47.0%) | −1.0 (−12.3 to 10.3) | 0.30 |
| EQ-5D-5L index values- median (IQR)b | 0.80 (0.00–0.92) | 0.67 (0.00–0.91) | 0.08 (−0.01 to 0.16) | 0.85 (0.00–1.00) | 0.74 (0.00–1.00) | 0.02 (−0.10 to 0.14) | 0.31 |
| EQ VAS—median (IQR)b | 60.0 (0.0–80.0) | 55.0 (0.0–80.0) | 4.4 (−3.1 to 11.9) | 80.0 (0.0–100.0) | 65.0 (0.0–95.0) | 2.6 (−9.0 to 14.2) | 0.74 |
a
For continuous outcomes, adjusted mean differences (in days) and for binary outcomes, adjusted risk differences (in percentage points) are presented. Adjustment is for stratification variables.
b
These analyses are based on imputed datasets for missing values. All others are complete case analyses.