Table 2 Crude incidence rates of death or invasive ventilation by current and average relative dose categories
Deaths | Composite outcome: invasive ventilation or death | |||||
|---|---|---|---|---|---|---|
N (%) events | Total PY, N (%) | Crude incidence rate/100 PY | N (%) events | Total PY, N (%) | Crude incidence rate/100 PY | |
Total events/person-time | 88 (of 332 patients) | 1609.4 | 5.47 | 97 (of 270 patients) | 1236.8 | 7.84 |
Current dose category at the time of eventa | ||||||
None (not currently treated) | 7 (8.0) | 5.7 (0.4) | 121.87 | 4 (4.1) | 4.4 (0.4) | 91.71 |
Very low dose | 0 | 7.9 (0.5) | 0.00 | 1 (1.0) | 7.5 (0.6) | 13.30 |
Label dose | 65 (73.9) | 948.6 (58.9) | 6.85 | 71 (73.2) | 707.5 (57.2) | 10.03 |
40 mg/kg EOW | 3 (3.4) | 224.6 (14.0) | 1.34 | 7 (7.2) | 184.0 (14.9) | 3.80 |
20 mg/kg/week | 13 (14.8) | 262.6 (16.3) | 4.95 | 13 (13.4) | 198.7 (16.1) | 6.54 |
40 mg/kg/week | 0 | 160.1 (9.9) | 0.00 | 1 (1.0) | 134.7 (10.9) | 0.74 |
Category of average relative dose over time at the time of eventb | ||||||
Below label dose | 8 (9.1) | 22.8 (1.4) | 35.07 | 5 (5.2) | 21.1 (1.7) | 23.71 |
Label dose | 52 (59.1) | 854.0 (53.1) | 6.09 | 60 (61.9) | 633.1 (51.2) | 9.48 |
Between label and double dose | 14 (15.9) | 339.2 (21.1) | 4.13 | 16 (16.5) | 283.9 (23.0) | 5.63 |
Double dose | 12 (13.6) | 249.3 (15.5) | 4.81 | 16 (16.5) | 189.1 (15.3) | 8.46 |
Above double to quadruple dose | 2 (2.3) | 144.1 (9.0) | 1.39 | 0 | 109.6 (8.9) | 0.00 |