Table 3.
Adverse events in the safety set with incidence ≥15% in the everolimus arm of he Asian or non-Asian subset
| Adverse event, % | Asian | Non-Asian | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| EVE + TRAS + PAC | PBO + TRAS + PAC | EVE + TRAS + PAC | PBO + TRAS + PAC | |||||||||
| n = 196 | n = 104 | n = 276 | n = 134 | |||||||||
| Any grade | Grade 3 | Grade 4 | Any grade | Grade 3 | Grade 4 | Any grade | Grade 3 | Grade 4 | Any grade | Grade 3 | Grade 4 | |
| Stomatitis | 62.2 | 6.6 | 0.0 | 31.7 | 0.0 | 0.0 | 69.6 | 16.7 | 0.0 | 32.8 | 2.2 | 0.0 |
| Diarrhea | 48.0 | 6.1 | 0.0 | 40.4 | 3.8 | 0.0 | 62.7 | 11.2 | 0.0 | 51.5 | 4.5 | 0.0 |
| Rash | 43.4 | 1.0 | 0.0 | 24.0 | 1.0 | 0.0 | 38.0 | 0.4 | 0.0 | 17.9 | 0.0 | 0.0 |
| Neutropenia | 42.3 | 27.6 | 4.6 | 26.9 | 17.3 | 3.8 | 34.1 | 16.7 | 2.9 | 23.1 | 5.2 | 4.5 |
| Alopecia | 41.3 | 0.0 | 0.0 | 41.3 | 0.0 | 0.0 | 50.7 | 0.4 | 0.0 | 61.2 | 0.0 | 0.0 |
| Pyrexia | 39.8 | 0.5 | 0.0 | 26.0 | 1.0 | 0.0 | 38.4 | 2.2 | 0.0 | 26.9 | 1.5 | 0.0 |
| Cough | 38.3 | 0.5 | 0.0 | 35.6 | 0.0 | 0.0 | 41.3 | 0.4 | 0.0 | 30.6 | 1.5 | 0.0 |
| Fatigue | 33.2 | 3.1 | 0.0 | 29.8 | 1.9 | 0.0 | 36.6 | 6.2 | 0.0 | 40.3 | 3.0 | 0.0 |
| Epistaxis | 29.1 | 0.0 | 0.0 | 10.6 | 0.0 | 0.0 | 36.2 | 0.0 | 0.0 | 23.1 | 0.0 | 0.0 |
| Edema peripheral | 28.6 | 0.0 | 0.0 | 17.3 | 1.0 | 0.0 | 36.2 | 1.4 | 0.0 | 29.9 | 0.0 | 0.0 |
| ALT increased | 28.1 | 5.1 | 0.0 | 26.9 | 6.7 | 0.0 | 15.6 | 6.5 | 0.0 | 11.9 | 3.0 | 0.7 |
| Nasopharyngitis | 27.0 | 0.0 | 0.0 | 30.8 | 1.9 | 0.0 | 12.7 | 0.0 | 0.0 | 11.2 | 0.0 | 0.0 |
| Nausea | 26.0 | 0.5 | 0.0 | 25.0 | 1.9 | 0.0 | 37.3 | 1.1 | 0.0 | 41.8 | 0.0 | 0.0 |
| Hypoesthesia | 23.5 | 3.1 | 0.0 | 26.9 | 1.9 | 0.0 | 5.4 | 0.0 | 0.0 | 5.2 | 0.0 | 0.0 |
| Mouth ulceration | 23.0 | 1.0 | 0.0 | 10.6 | 0.0 | 0.0 | 5.4 | 0.7 | 0.0 | 1.5 | 0.0 | 0.0 |
| Decreased appetite | 22.4 | 1.0 | 0.0 | 16.3 | 0.0 | 0.0 | 23.9 | 1.4 | 0.0 | 13.4 | 0.0 | 0.0 |
| Myalgia | 22.4 | 0.0 | 0.0 | 25.0 | 1.0 | 0.0 | 12.0 | 0.0 | 0.0 | 14.2 | 0.0 | 0.0 |
| Neutrophil count decreased | 21.9 | 11.2 | 3.6 | 20.2 | 12.5 | 1.9 | 0.4 | 0.4 | 0.0 | 1.5 | 0.0 | 0.0 |
| Headache | 20.9 | 1.0 | 0.0 | 18.3 | 1.9 | 0.0 | 33.0 | 0.4 | 0.0 | 37.3 | 0.0 | 0.0 |
| Leukopenia | 20.4 | 8.7 | 0.5 | 14.4 | 5.8 | 1.0 | 11.6 | 4.0 | 0.4 | 6.7 | 3.0 | 0.0 |
| Neurotoxicity | 19.9 | 0.0 | 0.0 | 22.1 | 1.0 | 0.0 | 0.4 | 0.0 | 0.0 | 0.7 | 0.0 | 0.0 |
| Insomnia | 19.9 | 0.0 | 0.0 | 11.5 | 0.0 | 0.0 | 13.8 | 0.0 | 0.0 | 20.1 | 0.0 | 0.0 |
| Vomiting | 19.4 | 1.0 | 0.0 | 20.2 | 1.9 | 0.0 | 30.1 | 1.1 | 0.0 | 25.4 | 3.0 | 0.0 |
| Dizziness | 18.9 | 2.0 | 0.5 | 15.4 | 0.0 | 0.0 | 13.4 | 0.0 | 0.0 | 14.9 | 1.5 | 0.0 |
| Weight decreased | 18.9 | 0.5 | 0.0 | 4.8 | 0.0 | 0.0 | 22.5 | 2.2 | 0.0 | 5.2 | 0.0 | 0.0 |
| AST increased | 18.4 | 2.6 | 0.0 | 14.4 | 3.8 | 0.0 | 13.8 | 4.0 | 0.7 | 9.0 | 0.7 | 0.7 |
| Dyspnea | 17.3 | 2.0 | 0.0 | 1.0 | 0.0 | 0.0 | 29.3 | 4.3 | 0.7 | 17.2 | 1.5 | 0.0 |
| Constipation | 16.3 | 0.0 | 0.0 | 18.3 | 0.0 | 0.0 | 25.0 | 0.0 | 0.0 | 23.1 | 0.0 | 0.0 |
| Peripheral sensory neuropathy | 15.8 | 0.5 | 0.0 | 18.3 | 0.0 | 0.0 | 11.6 | 0.7 | 0.0 | 12.7 | 1.5 | 0.0 |
| Pruritus | 15.8 | 0.5 | 0.0 | 8.7 | 0.0 | 0.0 | 12.0 | 0.4 | 0.0 | 11.2 | 0.0 | 0.0 |
| WBC count decreased | 15.3 | 9.7 | 0.5 | 12.5 | 7.7 | 0.0 | 1.1 | 0.7 | 0.0 | 0.7 | 0.0 | 0.0 |
| Oropharyngeal pain | 15.3 | 0.0 | 0.0 | 11.5 | 0.0 | 0.0 | 15.9 | 0.0 | 0.0 | 14.2 | 0.0 | 0.0 |
| Arthralgia | 13.8 | 0.0 | 0.0 | 11.5 | 0.0 | 0.0 | 19.2 | 1.4 | 0.0 | 21.6 | 1.5 | 0.0 |
| Anemia | 13.3 | 5.6 | 1.0 | 7.7 | 1.9 | 0.0 | 43.5 | 10.5 | 1.4 | 22.4 | 3.0 | 0.0 |
| Hypercholesterolemia | 12.8 | 0.5 | 0.0 | 7.7 | 0.0 | 0.0 | 22.5 | 1.4 | 0.0 | 11.2 | 0.0 | 0.0 |
| Neuropathy peripheral | 12.8 | 0.5 | 0.0 | 15.4 | 3.8 | 0.0 | 40.2 | 6.2 | 0.0 | 31.3 | 5.2 | 0.0 |
| Pneumoniaa | 12.2 | 1.5 | 1.0 | 4.8 | 0.0 | 0.0 | 7.6 | 2.9 | 0.0 | 3.7 | 0.0 | 0.0 |
| Pneumonitisa | 12.2 | 2.0 | 0.0 | 2.9 | 0.0 | 0.0 | 19.2 | 5.4 | 1.4 | 5.2 | 0.7 | 0.0 |
| Hyperglycemiaa | 11.7 | 4.6 | 1.0 | 1.9 | 1.0 | 0.0 | 14.1 | 5.8 | 0.7 | 8.2 | 1.5 | 0.0 |
| Pain in extremity | 11.7 | 0.5 | 0.0 | 12.5 | 0.0 | 0.0 | 22.5 | 1.4 | 0.4 | 18.7 | 0.0 | 0.0 |
| Back pain | 11.2 | 1.0 | 0.0 | 11.5 | 1.0 | 0.0 | 18.1 | 1.1 | 0.0 | 21.6 | 3.0 | 0.0 |
| Hypertension | 11.2 | 2.6 | 0.0 | 11.5 | 1.0 | 0.0 | 17.8 | 2.2 | 0.0 | 10.4 | 2.2 | 0.0 |
| Hypokalemia | 10.7 | 5.1 | 0.5 | 2.9 | 2.9 | 0.0 | 17.0 | 7.2 | 2.2 | 3.7 | 0.0 | 0.0 |
| Abdominal pain | 10.7 | 1.5 | 0.0 | 9.6 | 0.0 | 0.0 | 18.1 | 0.4 | 0.0 | 14.2 | 0.0 | 0.0 |
| Asthenia | 9.2 | 2.0 | 0.0 | 8.7 | 0.0 | 0.0 | 26.8 | 1.4 | 0.0 | 23.9 | 1.5 | 0.0 |
| Urinary tract infection | 6.6 | 0.5 | 0.0 | 3.8 | 0.0 | 0.0 | 17.0 | 1.4 | 0.0 | 9.7 | 0.0 | 0.0 |
aAdverse events of special interest. EVE everolimus, PAC paclitaxel, PBO placebo, TRAS trastuzumab, ALT alanine aminotransferase, AST aspartate aminotransferase, WBC white blood cell