Table 4 Adverse events occuring in ≥ 10% of the ITT population
Adverse event (AE), n (%) | Elacestrant dose cohort | ||
|---|---|---|---|
200/400 mg (N = 8) | 400 mg (N = 8) | Overall (N = 16) | |
At least 1 AE | 8 (100) | 8 (100) | 16 (100) |
Nausea | 5 (62.5) | 6 (75.0) | 11 (68.8) |
Fatigue | 4 (50.0) | 4 (50.0) | 8 (50.0) |
Dyspepsia | 2 (25.0) | 5 (62.5) | 7 (43.8) |
Vomiting | 5 (62.5) | 1 (12.5) | 6 (37.5) |
Decreased appetite | 4 (50.0) | 1 (12.5) | 5 (31.3) |
Dysphagia | 1 (12.5) | 4 (50.0) | 5 (31.3) |
Hot flush | 2 (25.0) | 3 (37.5) | 5 (31.3) |
Hypertension | 0 | 3 (37.5) | 3 (18.8) |
Arthralgia | 1 (12.5) | 2 (25.0) | 3 (18.8) |
Dizziness | 2 (25.0) | 1 (12.5) | 3 (18.8) |
Dyspnea | 0 | 3 (37.5) | 3 (18.8) |
Abdominal pain upper | 2 (25.0) | 1 (12.5) | 3 (18.8) |
Back pain | 0 | 2 (25.0) | 2 (12.5) |
Diarrhea | 1 (12.5) | 1 (12.5) | 2 (12.5) |
Esophageal pain | 1 (12.5) | 1 (12.5) | 2 (12.5) |
Neck pain | 1 (12.5) | 1 (12.5) | 2 (12.5) |
Pain in extremity | 1 (12.5) | 1 (12.5) | 2 (12.5) |
Cough | 1 (12.5) | 1 (12.5) | 2 (12.5) |
Nail discoloration | 1 (12.5) | 1 (12.5) | 2 (12.5) |
Anemia | 0 | 2 (25.0) | 2 (12.5) |