Table 5.
Adverse Events Occurring in ≥ 10% of Patients in Either Treatment Schedule (Safety Set)
| Adverse events, N (%) | Everolimus 70 mg/week (N = 99) | Everolimus 10 mg/day (N = 100) | ||
|---|---|---|---|---|
|
| ||||
| All grades | Grade 3/4 | All grades | Grade 3/4 | |
| Fatigue | 50 (50.5) | 7 (7.1) | 37 (37.0) | 5 (5.0) |
| Nausea | 41 (41.4) | 3 (3.0) | 22 (22.0) | 0 |
| Rash | 34 (34.3) | 0 | 29 (29.0) | 0 |
| Decreased appetite | 31 (31.3) | 1 (1.0) | 25 (25.0) | 1 (1.0) |
| Diarrhea | 29 (29.3) | 2 (2.0) | 26 (26.0) | 2 (2.0) |
| Vomiting | 29 (29.3) | 4 (4.0) | 14 (14.0) | 2 (2.0) |
| Anemia | 26 (26.3) | 5 (5.1) | 19 (19.0) | 3 (3.0) |
| Constipation | 24 (24.2) | 2 (2.0) | 13 (13.0) | 0 |
| Dyspnea | 21 (21.2) | 3 (3.0) | 21 (21.0) | 4 (4.0) |
| Abdominal pain | 20 (20.2) | 3 (3.0) | 15 (15.0) | 3 (3.0) |
| Stomatitis | 18 (18.2) | 2 (2.0) | 22 (22.0) | 4 (4.0) |
| Mucosal inflammation | 17 (17.2) | 0 | 11 (11.0) | 0 |
| Edema peripheral | 16 (16.2) | 0 | 14 (14.0) | 0 |
| Thrombocytopenia | 16 (16.2) | 2 (2.0) | 18 (18.0) | 3 (3.0) |
| Asthenia | 15 (15.2) | 3 (3.0) | 23 (23.0) | 5 (5.0) |
| Pyrexia | 14 (14.1) | 0 | 16 (16.0) | 0 |
| Weight decreased | 14 (14.1) | 0 | 14 (14.0) | 0 |
| Cough | 13 (13.1) | 1 (1.0) | 16 (16.0) | 0 |
| Dehydration | 13 (13.1) | 3 (3.0) | 11 (11.0) | 3 (3.0) |
| Hypercholesterolemia | 13 (13.1) | 3 (3.0) | 10 (10.0) | 2 (2.0) |
| Hyperglycemia | 13 (13.1) | 4 (4.0) | 9 (9.0) | 4 (4.0) |
| Back pain | 10 (10.1) | 0 | 8 (8.0) | 2 (2.0) |
| Headache | 10 (10.1) | 0 | 7 (7.0) | 0 |
| Gamma-glutamyltransferase increased | 9 (9.1) | 6 (6.1) | 13 (13.0) | 7 (7.0) |
| Epistaxis | 5 (5.1) | 1 (1.0) | 10 (10.0) | 0 |