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7.

Safety summary

Variable n (%)
Docetaxel/anthracycline combo (N=1,421) Docetaxel/anthracycline sequential (N=447) Docetaxel/other
(N=705)
Other
(N=447)
TEAE, treatment emergent adverse event; CTCAE, common terminology criteria for adverse events; *, no grade 5 TEAEs reported.
Patients with ≥1 TEAE 1,093 (76.9) 293 (65.5) 525 (74.5) 277 (62.0)
Patients with ≥1 serious TEAE 138 (9.7) 25 (5.6) 55 (7.8) 43 (9.6)
Patients with ≥1 hematological TEAE 937 (65.9) 164 (36.7) 390 (55.3) 225 (50.3)
Patients with ≥1 cardiovascular TEAE 2 (0.1) 5 (1.1) 3 (0.4) 1 (0.2)
Patients with ≥1 TEAE by CTCAE grade*
 Grade 1 860 (60.5) 250 (55.9) 386 (54.8) 217 (48.5)
 Grade 2 844 (59.4) 312 (69.8) 359 (50.9) 223 (49.9)
 Grade 3 418 (29.4) 114 (25.5) 167 (23.7) 94 (21.0)
 Grade 4 158 (11.1) 35 (7.8) 82 (11.6) 34 (7.6)
 Missing 108 (7.6) 2 (0.4) 31 (4.4) 21 (4.7)