System organ class preferred term, n (%) | Everolimus plus letrozole (n = 20) | FEC (n = 20) | P value (all grades) | ||
---|---|---|---|---|---|
All grades (%) | Grade 3–4 (%) | All grades (%) | Grade 3–4 (%) | ||
Mucositis oral | 15 (75.0) | 1 (5.0) | 1 (5.0) | 0 (0.0) | < 0.001 |
Anemia | 10 (50.0) | 0 (0.0) | 10 (50.0) | 0 (0.0) | 1 |
Insomnia | 6 (30.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 0.092 |
Fatigue | 4 (20.0) | 0 (0.0) | 11 (55.0) | 0 (0.0) | 0.048 |
Cough | 4 (20.0) | 0 (0.0) | 3 (15.0) | 0 (0.0) | 1 |
Aspartate/Alanine aminotransferase increased | 4 (20.0) | 0 (0.0) | 6 (30.0) | 0 (0.0) | 0.716 |
Bullous dermatitis/Rash maculo-papular | 3 (15.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0.23 |
Oropharyngeal pain | 3 (15.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0.231 |
Flu like symptoms | 2 (10.0) | 0 (0.0) | 3 (15.0) | 0 (0.0) | 1 |
Nausea | 1 (5.0) | 0 (0.0) | 13 (65.0) | 0 (0.0) | < 0.001 |
Diarrhea | 1 (5.0) | 0 (0.0) | 2 (10.0) | 0 (0.0) | 1 |
Constipation | 1 (5.0) | 0 (0.0) | 3 (15.0) | 0 (0.0) | 0.605 |
Weight loss | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 |
Tumor pain | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 |
Hyperlipidemia | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 |
Pruritus | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 |
Toxic epidermal necrolysis | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 |
Bone pain | 1 (5.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 1 |
Non-cardiac chest pain | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 |
Paresthesia | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 |
Laryngeal inflammation | 1 (5.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 |
White blood cell decreased | 1 (5.0) | 0 (0.0) | 9 (45.0) | 4 (20.0) | 0.008 |
Vomiting | 0 (0.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 1 |
Stomach pain | 0 (0.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 1 |
Anorexia | 0 (0.0) | 0 (0.0) | 6 (30.0) | 0 (0.0) | 0.02 |
Fever | 0 (0.0) | 0 (0.0) | 2 (10.0) | 0 (0.0) | 0.487 |
Alopecia | 0 (0.0) | 0 (0.0) | 9 (45.0) | 0 (0.0) | 0.001 |
Generalized edema | 0 (0.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 1 |
Bone marrow hypocellular | 0 (0.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 1 |
Palpitations | 0 (0.0) | 0 (0.0) | 1 (5.0) | 0 (0.0) | 1 |
Hot flashes | 0 (0.0) | 0 (0.0) | 2 (10.0) | 0 (0.0) | 0.487 |
Headache | 0 (0.0) | 0 (0.0) | 3 (15.0) | 0 (0.0) | 0.231 |
Neutrophil count decreased | 0 (0.0) | 0 (0.0) | 6 (30.0) | 4 (20.0) | 0.02 |