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Table 3 Analysis endpoints and side effects during first year of protocol therapy according to treatment assignment

From: Impact of CYP19A1 and ESR1 variants on early-onset side effects during combined endocrine therapy in the TEXT trial

    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    
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)
  1. Reports of hot flashes and sweating side effects and of musculoskeletal symptoms according to common terminology criteria for adverse events (CTCAE) v3.0 at time points during the first year of protocol therapy. All data are summarized as number (%) of patients. aPatients without any adverse event data (two patients without hot flashes/sweating and one without musculoskeletal symptoms) were excluded from summary. Unk unknown, Gr grade OFS ovarian function suppression