Table 2.
Baseline characteristics of mitotane-related adverse event reports stratified by outcome seriousness.
| Characteristics | Serious outcome group (N = 398) |
Non-serious outcome group (N = 472) |
P value |
|---|---|---|---|
| Sex | |||
| Male | 129 (32.4%) | 150 (31.8%) | |
| Female | 259 (65.1%) | 290 (61.4%) | 0.012 |
| Unknown | 10 (2.5%) | 32 (6.8%) | |
| Age | |||
| 0-17 | 33 (8.3%) | 24 (5.1%) | <0.001 |
| 18-64 | 247 (62.1%) | 254 (53.8%) | |
| ≥65 | 77 (19.3%) | 93 (19.7%) | |
| Unknown | 41 (10.3%) | 101 (21.4%) | |
| Weight | |||
| Median, kg (Q1-Q3) |
66 (51-82) | 68 (43-77) | 0.872 |
| Unknown | 304 (76.4%) | 453 (96.0%) | |
| Reporting country | |||
| United States | 142 (35.7%) | 350 (74.2%) | |
| France | 81 (20.4%) | 93 (19.7%) | |
| Canada | 27 (6.8%) | 0 (0%) | |
| Germany | 21 (5.3%) | 2 (0.4%) | <0.001 |
| Colombia | 22 (5.5%) | 0 (0%) | |
| Others | 73 (18.3%) | 18 (3.8%) | |
| Unknown | 32 (8.0%) | 9 (1.9%) | |
| Reporter type | |||
| Consumer | 220 (55.3%) | 333 (70.6%) | |
| Physician | 78 (19.6%) | 49 (10.4%) | |
| Pharmacist | 16 (4.0%) | 32 (6.8%) | <0.001 |
| Health Professional | 20 (5.0%) | 5 (1.1%) | |
| Unknown | 64 (16.1%) | 53 (11.2%) | |