Table 3 TEAEs and TRAEs reported in ≥ 5% of study participants in one or more study arms
Preferred term, n (%) | Amcenestrant 400 mg (n = 33) | Amcenestrant 200 mg (n = 36) | Letrozole (n = 35) | |||
|---|---|---|---|---|---|---|
All | Grade ≥ 3 | All | Grade ≥ 3 | All | Grade ≥ 3 | |
TEAEs | ||||||
Any TEAE | 16 (48.5) | 0 | 16 (44.4) | 2 (5.6)a | 18 (51.4) | 0 |
Hot flush | 4 (12.1) | 0 | 1 (2.8) | 0 | 5 (14.3) | 0 |
Insomnia | 4 (12.1) | 0 | 1 (2.8) | 0 | 0 | 0 |
Headache | 3 (9.1) | 0 | 0 | 0 | 2 (5.7) | 0 |
Arthralgia | 2 (6.1) | 0 | 0 | 0 | 3 (8.6) | 0 |
Asthenia | 2 (6.1) | 0 | 2 (5.6) | 0 | 0 | 0 |
Decreased appetite | 2 (6.1) | 0 | 1 (2.8) | 0 | 0 | 0 |
Fatigue | 2 (6.1) | 0 | 1 (2.8) | 0 | 1 (2.9) | 0 |
Feeling cold | 2 (6.1) | 0 | 0 | 0 | 0 | 0 |
Procedural pain | 2 (6.1) | 0 | 1 (2.8) | 0 | 2 (5.7) | 0 |
ALT increased | 1 (3.0) | 0 | 2 (5.6) | 0 | 0 | 0 |
Anxiety | 1 (3.0) | 0 | 2 (5.6) | 0 | 0 | 0 |
Breast pain | 1 (3.0) | 0 | 0 | 0 | 3 (8.6) | 0 |
Constipation | 1 (3.0) | 0 | 2 (5.6) | 0 | 1 (2.9) | 0 |
Diarrhea | 0 | 0 | 3 (8.3) | 0 | 3 (8.6) | 0 |
TRAEs | ||||||
Any TRAE | 7 (21.2) | 0 | 8 (22.2) | 0 | 9 (25.7) | 0 |
Hot flush | 2 (6.1) | 0 | 1 (2.8) | 0 | 5 (14.3) | 0 |
Headache | 2 (6.1) | 0 | 0 (0) | 0 | 1 (2.9) | 0 |
Feeling cold | 2 (6.1) | 0 | 0 (0) | 0 | 0 (0) | 0 |
Arthralgia | 1 (3.0) | 0 | 0 (0) | 0 | 3 (8.6) | 0 |
Asthenia | 1 (3.0) | 0 | 2 (5.6) | 0 | 0 (0) | 0 |
Diarrhea | 0 (0) | 0 | 1 (2.8) | 0 | 2 (5.7) | 0 |