Table 1.

Incidence of all adverse events.

Variable	Fulvestrant–palbociclib (n = 241)	Letrozole–palbociclib (n = 242)
AEs	240 (99.6)	240 (99.2)
Grades 3-4 AEs	195 (80.9)	190 (78.5)
Treatment-related AEs	225 (93.4)	230 (95.0)
Treatment-related grades 3-4 AEs	170 (70.5)	169 (69.8)
SAEs	72 (29.9)	51 (21.1)
Treatment-related SAEs	21 (8.7)	7 (2.9)
AEs leading to treatment discontinuation	13 (5.4)	5 (2.1)

Data are presented as n (%), unless otherwise specified.

Abbreviations: AE, adverse events; SAE, serious adverse events.