Table 3.
Most common AEs (≥10% in either arm) in the overall population (16).
| Adverse reactiona | Elacestrant (n =237) | SOC (n = 230) | ||
|---|---|---|---|---|
| All grades (%) | Grade ≥3 (%) | All grades (%) | Grade ≥3 (%) | |
| Musculoskeletal and connective tissue disorders | ||||
| Musculoskeletal painb | 41 | 7 | 39 | 1 |
| Gastrointestinal disorders | ||||
| Nausea | 35 | 2.5 | 19 | 0.9 |
| Vomitingb | 19 | 0.8 | 9 | 0 |
| Diarrhea | 13 | 0 | 10 | 1 |
| Constipation | 12 | 0 | 6 | 0 |
| Abdominal painb | 11 | 1 | 10 | 0.9 |
| Dyspepsia | 10 | 0 | 2.6 | 0 |
| General disorders and administration site conditions | ||||
| Fatigueb | 26 | 2 | 27 | 1 |
| Metabolism and nutritional disorders | ||||
| Decreased appetite | 15 | 0.8 | 10 | 0.4 |
| Nervous system disorders | ||||
| Headache | 12 | 2 | 12 | 0 |
| Vascular disorders | ||||
| Hot flush | 11 | 0 | 8 | 0 |
| Nausea-related AEs in the overall population, n (%) | ||||
| Dose-reduction rate due to nausea | 3 (1.3) | Not applicable | ||
| Discontinuation rate due to nausea | 3 (1.3) | 0 | ||
| Antiemetic use | 19 (8.0) | AI: 7 (10.3)Fulvestrant: 6 (3.7) | ||
a
Adverse reactions were graded using NCI Common Terminology Criteria for Adverse Events version 5.0.
b
Includes other related terms.