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 |
EOW, every other week; PY, person-years
aDose categories: 'Very low dose': > 0 to < 14 mg/kg EOW or weekly, 'Label dose': About the label dose of 20 mg/kg EOW, range of 14 to 27 mg/kg EOW, '40 mg/kg EOW': > 27 to 52 mg/kg EOW,' 20 mg/kg/week': 14 to 27 mg/kg/week, '40 mg/kg weekly': > 27 to 52 mg/kg/week. Patients receiving > 52 mg/kg EOW or weekly are censored at the date of their first such dose report
bAverage dose received from first treatment to the end of follow-up, in multiples of the label dose, ranging from > 0 to 4 times label dose. Average dose categories: 'Below label dose' is average dose < 0.95;'Label dose' is from 0.95 to < 1.05; 'Between label and double dose' is from 1.05 to < 1.75; 'Double dose' is 1.75 to < 2.25; 'Above double to quadruple dose' is 2.25 to 4.0