Table 4.
Characteristics of Patients with and without ADRa
| Patients without ADR (n = 35442) | Patients with at least one ADR (n = 32) | P‐Value (Test) | |
|---|---|---|---|
| Gender | 0.288 (χ2) | ||
| Missing | 41 | 0 | |
| Male | 16594 (46.9%) | 12 (37.5%) | |
| Female | 18807 (53.1%) | 20 (62.5%) | |
| Age (years) | 0.108 (Wilcoxon) | ||
| Missing | 142 | 0 | |
| Mean ± SD | 49.5 ± 17.9 | 45.6 ± 17.7 | |
| Median | 50.0 | 43.0 | |
| Range | 0.0 ‐ 98.0 | 2.0 ‐90.0 | |
| BMI (kg/m2) | 0.422 (Fisher exact) | ||
| Missing | 922 | 0 | |
| < 30 | 30199 (87.5%) | 30 (93.8%) | |
| ≥ 30 | 4321 (12.5%) | 2 (6.3%) | |
| Premedication | 1.000 (Fisher exact) | ||
| Missing | 571 | 0 | |
| No | 34225 (98.1%) | 32 (100.0%) | |
| Yes | 646 (1.9%) | 0 (0.0%) | |
| At least one pre‐existing risk factor | 0.017 (Fisher exact) | ||
| No | 21943 (61.9%) | 13 (40.6%) | |
| Yes | 13499 (38.1%) | 19 (59.4%) | |
| Total volume (mL) | 0.802 (Wilcoxon) | ||
| Missing | 25 | 0 | |
| Mean ± SD | 14.01 ± 4.98 | 14.38 ± 7.87 | |
| Median | 15.00 | 15.00 | |
| Range | 0.5 ‐53.0 | 3.0 ‐ 53.0 | |
| Dose (mL/kg) | 0.895 (Wilcoxon) | ||
| Missing | 167 | 0 | |
| Mean ± SD | 0.21 ± 0.07 | 0.22 ± 0.11 | |
| Median | 0.20 | 0.20 | |
| Range | 0.0 ‐ 2.1 | 0.1 ‐ 0.8 | |
| Dose in class (mL/kg) | < 0.001 (χ2) | ||
| Missing | 167 | 0 | |
| < 0.18 | 9333 (26.5%) | 6 (18.8%) | |
| 0.18 ‐ 0.66 | 25893 (73.4%) | 25 (78.1%) | |
| > 0.66 | 49 (0.1%) | 1 (3.1%) |
a
Data were extracted from the safety population (n = 35,474 patients).