Table 2.

Most common AEs (>5% of patients), irrespective of causality, occurring during the study.

Number of patients (%)a
AE, by preferred termAZD9496 250 mg BID (n = 22)Fulvestrant 500 mg single dose (n = 24)Total (n = 46)
Any AE11 (50.0)14 (58.3)25 (54.3)
Nausea4 (18.2)2 (8.3)6 (13.0)
Fatigue2 (9.1)2 (8.3)4 (8.7)
Hot flush1 (4.5)3 (12.5)4 (8.7)
Back pain1 (4.5)2 (8.3)3 (6.5)
Pain in extremity2 (9.1)1 (4.2)3 (6.5)
  • Abbreviation: BID: twice daily.

  • aSafety analysis set.