Table 1 Patient and tumor characteristics: comparison or included versus not included clinically eligible patients
Characteristic | Clinically eligible and included (n = 901) | Clinically eligible but not included (n = 1029) | p value* |
|---|---|---|---|
Arm assignment | Â | Â | Â |
 A | 475 (53 %) | 548 (53 %) | 0.81 |
 C | 426 (47 %) | 481 (47 %) | |
Age at randomization (years) | Â | Â | Â |
 18–39 | 150 (17 %) | 162 (16 %) | 0.94 |
 40–49 | 299 (33 %) | 352 (34 %) | |
 50–59 | 292 (32 %) | 344 (33 %) | |
 ≥60 | 160 (18 %) | 171 (17 %) | |
Menopausal status | Â | Â | Â |
 Premenopausal | 480 (53 %) | 551 (54 %) | 0.90 |
 Postmenopausal | 421 (47 %) | 478 (46 %) | |
Extent of surgery | Â | Â | Â |
 Breast sparing | 354 (39 %) | 396 (38 %) | 0.72 |
 Mastectomy | 547 (61 %) | 633 (62 %) | |
Extent of nodal examination | Â | Â | Â |
 Axillary node dissection | 816 (91 %) | 925 (90 %) | 0.62 |
 Sentinel biopsy | 85 (9 %) | 104 (10 %) | |
Histologically positive nodes | Â | Â | Â |
 0 | 125 (14 %) | 132 (13 %) | 0.82 |
 1–3 | 424 (47 %) | 497 (48 %) | |
 4–9 | 233 (26 %) | 262 (25 %) | |
 ≥10 | 119 (13 %) | 138 (13 %) | |
Tumor size (cm) | Â | Â | Â |
 ≤2.0 | 340 (38 %) | 429 (42 %) | 0.03 |
 2.1–4.9 | 481 (53 %) | 532 (52 %) | |
 ≥5 | 80 (9 %) | 68 (7 %) | |
Tumor grade | Â | Â | Â |
 1 | 16 (2 %) | 12 (1 %) | 1.00 |
 2 | 233 (26 %) | 274 (27 %) | |
 3 | 641 (71 %) | 730 (71 %) | |
 Unknown | 11 (1 %) | 13 (1 %) | |
Hormone receptor status | Â | Â | Â |
 ER or PR positive | 481 (53 %) | 552 (54 %) | 0.89 |
 ER and PR negative | 420 (47 %) | 476 (46 %) | |
 Unknown | - | 1 (<1 %) |