Table 4.
Incidence of grades 3 and 4 adverse events in elderly patients and the total study population*
Age ≥65 yr | Age ≥70 yr | All patients | ||||
---|---|---|---|---|---|---|
Everolimus plus BSC (n = 111) |
Placebo plus BSC (n = 39) |
Everolimus plus BSC (n = 52) |
Placebo plus BSC (n = 20) |
Everolimus plus BSC (n = 274) |
Placebo plus BSC (n = 137) |
|
Adverse event, % | ||||||
Anemia | 14 | 3 | 12 | 0 | 10 | 5 |
Infection | 11 | 3 | 12 | 0 | 10 | 1 |
Lymphopenia | 9 | 0 | 10 | 0 | 4 | 0 |
Hyperglycemia | 8 | 3 | 8 | 5 | 6 | 2 |
Stomatitis | 6 | 0 | 4 | 0 | 4 | 0 |
Fatigue | 3 | 3 | 6 | 0 | 5 | 3 |
BSC = best supportive care.
Adverse events with combined grades 3 and 4 incidence of >5% in the everolimus arm of either elderly subpopulation are shown.