Table 3 Analysis endpoints and side effects during first year of protocol therapy according to treatment assignment
| Â | Â | Â | Treatment | |
|---|---|---|---|---|
|  | Overall | Exemestane + OFS | Tamoxifen + OFS | |
|  | (n = 1967a) | (n = 987) | (n = 980) | |
Analysis endpoint | ||||
 Early-onset hot flashes/sweating, grade ≥2 |  | 848 (43) | 411 (42) | 437 (45) |
 Early-onset musculoskeletal symptoms, grade ≥2 |  | 516 (26) | 331 (34) | 185 (19) |
Side effect and time point | Grade | Â | Â | Â |
Hot flashes | ||||
 Baseline | Unk | 2 (0) | 2 (0) | 0 (0) |
Gr0 | 1812 (92) | 924 (94) | 888 (91) | |
Gr1 | 134 (7) | 51 (5) | 83 (8) | |
Gr2 | 19 (1) | 10 (1) | 9 (1) | |
 3 months | Unk | 8 (0) | 3 (0) | 5 (1) |
Gr0 | 637 (32) | 325 (33) | 312 (32) | |
Gr1 | 766 (39) | 386 (39) | 380 (39) | |
Gr2 | 500 (25) | 248 (25) | 252 (26) | |
Gr3 | 56 (3) | 25 (3) | 31 (3) | |
 6 months | Unk | 20 (1) | 9 (1) | 11 (1) |
Gr0 | 525 (27) | 294 (30) | 231 (24) | |
Gr1 | 797 (41) | 401 (41) | 396 (40) | |
Gr2 | 573 (29) | 260 (26) | 313 (32) | |
Gr3 | 52 (3) | 23 (2) | 29 (3) | |
Sweating | ||||
 Baseline | Unk | 3 (0) | 3 (0) | 0 (0) |
Gr0 | 1832 (93) | 920 (93) | 912 (93) | |
Gr1 | 119 (6) | 56 (6) | 63 (6) | |
Gr2 | 13 (1) | 8 (1) | 5 (1) | |
 3 months | Unk | 9 (0) | 4 (0) | 5 (1) |
Gr0 | 1332 (68) | 675 (68) | 657 (67) | |
Gr1 | 444 (23) | 219 (22) | 225 (23) | |
Gr2 | 182 (9) | 89 (9) | 93 (9) | |
 6 months | Unk | 22 (1) | 9 (1) | 13 (1) |
Gr0 | 1285 (65) | 688 (70) | 597 (61) | |
Gr1 | 447 (23) | 206 (21) | 241 (25) | |
Gr2 | 213 (11) | 84 (9) | 129 (13) | |
Musculoskeletal symptoms | ||||
 Baseline | Unk | 3 (0) | 3 (0) | 0 (0) |
Gr0 | 1669 (85) | 837 (85) | 832 (85) | |
Gr1 | 248 (13) | 125 (13) | 123 (13) | |
Gr2 | 47 (2) | 22 (2) | 25 (3) | |
Gr3 | 0 (0) | 0 (0) | 0 (0) | |
 3 months | Unk | 9 (0) | 5 (1) | 4 (0) |
Gr0 | 1360 (69) | 670 (68) | 690 (70) | |
Gr1 | 467 (24) | 231 (23) | 236 (24) | |
Gr2 | 118 (6) | 74 (7) | 44 (4) | |
Gr3 | 13 (1) | 7 (1) | 6 (1) | |
 6 months | Unk | 21 (1) | 9 (1) | 12 (1) |
Gr0 | 1070 (54) | 463 (47) | 607 (62) | |
Gr1 | 648 (33) | 366 (37) | 282 (29) | |
Gr2 | 198 (10) | 128 (13) | 70 (7) | |
Gr3 | 30 (2) | 21 (2) | 9 (1) | |
 9 months | Unk | 41 (2) | 24 (2) | 17 (2) |
Gr0 | 995 (51) | 386 (39) | 609 (62) | |
Gr1 | 670 (34) | 392 (40) | 278 (28) | |
Gr2 | 228 (12) | 159 (16) | 69 (7) | |
Gr3 | 33 (2) | 26 (3) | 7 (1) | |
 12 months | Unk | 37 (2) | 23 (2) | 14 (1) |
Gr0 | 965 (49) | 388 (39) | 577 (59) | |
Gr1 | 708 (36) | 400 (41) | 308 (31) | |
Gr2 | 235 (12) | 158 (16) | 77 (8) | |
Gr3 | 22 (1) | 18 (2) | 4 (0) | |