Table 1 Clinical characteristics of patients with TAM -associated AEs.
From: Real-world assessment of thromboembolic risk associated with tamoxifen
Characteristics number (%) | Thromboembolism AEs reported in TAM users (n = 385) | No-thromboembolism AEs reported in TAM users (n = 4080) | All AEs reported in TAM users (n = 4465) |
|---|---|---|---|
Gender | |||
Female | 303 (78.7%) | 3448 (84.5%) | 3751 (84.0%) |
Male | 43 (11.2%) | 153 (3.8%) | 196 (4.4%) |
Missing data | 39 (10.1%) | 479 (11.7%) | 518 (11.6%) |
Age (years) | |||
< 45 | 23 (6.0%) | 462 (11.4%) | 485 (10.9%) |
45 ≤ and ≤ 64.9 | 171 (44.4%) | 1367 (33.5%) | 1538 (34.4%) |
65 ≤ and ≤ 85 | 99 (25.7%) | 731 (17.9%) | 830 (18.6%) |
> 85 | 10 (2.6%) | 39 (1.0%) | 49 (1.1%) |
Missing data | 82 (21.3%) | 1481 (36.3%) | 1563 (35.0%) |
Weight (kg) | |||
< 60 | 40 (10.39%) | 399 (9.78%) | 439 (9.83%) |
60 ≤ and ≤ 80 | 58 (15.06%) | 515 (12.62%) | 573 (12.83%) |
> 80 | 60 (15.58%) | 208 (5.10%) | 268 (6.00%) |
Missing data | 227 (58.96%) | 2958 (72.50%) | 3185 (71.33%) |
Reporters | |||
Physician (MD) | 142 (36.9%) | 1228 (30.1%) | 1370 (30.7%) |
Pharmacist (PH) | 50 (13.0%) | 295 (7.2%) | 345 (7.7%) |
Health professional (HP) | 21 (5.5%) | 306 (7.5%) | 327 (7.3%) |
Consumer (CN) | 72 (18.7%) | 1405 (34.4%) | 1477 (33.1%) |
Lawyer (LW) | 5 (1.3%) | 17 (0.4%) | 22 (0.5%) |
Missing data | 95 (24.7%) | 829(20.3%) | 924 (20.7%) |
Reporter country (top three) | |||
America (US) | 145 (37.7%) | 1485 (36.4%) | 1630 (36.5%) |
United Kingdom (UK) | 59 (15.3%) | 625 (15.3%) | 684 (15.3%) |
France (FR) | 73 (19.0%) | 471 (11.5%) | 544 (12.2%) |
Time-to-onset (days) | |||
Median (IQR) | 532 (1021) | 470 (1015) | 485 (1023) |
Min-max | 0-4960 | 0-8095 | 0-8095 |
Outcomes | |||
Death (DE) | 27 (7.0%) | 173 (4.2%) | 200 (4.5%) |
Disability (DS) | 9 (2.3%) | 200 (4.9%) | 209 (4.7%) |
Hospitalization-initial or prolonged (HO) | 157 (40.8%) | 629 (15.4%) | 786 (17.6%) |
Life-threatening (LT) | 62 (16.1%) | 118 (2.9%) | 180 (4.0%) |
Other serious outcome (OT) | 105 (27.3%) | 2077 (50.9%) | 2182 (48.9%) |
Missing data | 25 (6.5%) | 848 (20.8%) | 908 (20.3%) |
