Table 3.
Summary of adverse events
| Placebo (n = 15) | Everolimus (n = 32) | |
|---|---|---|
| Total AE | 147 | 326 |
| Serious AE | 0 (0%) | 7 (2%) |
| Nonserious AE | 147 (100%) | 319 (98%) |
| AE Severity | ||
| Grade 1 | 131 (89%) | 250 (77%) |
| Grade 2 | 15 (10%) | 59 (18%) |
| Grade 3 | 1 (1%) | 15 (5%) |
| Grade 4 | 0 (0%) | 2 (1%) |
| Relationship to study drug | ||
| Suspected | 62 (42%) | 161 (49%) |
| Not Suspected | 85 (58%) | 165 (51%) |
| Action Taken | ||
| None | 97 (66%) | 162 (50%) |
| Dose Held or Adjusted | 4 (3%) | 22 (7%) |
| Discontinued Treatment | 0 (0%) | 1 (0%) |
| Concomitant Medication Given | 41 (28%) | 135 (41%) |
| Nondrug Therapy Given | 4 (3%) | 1 (0%) |
| Hospitalization | 0 (0%) | 5 (2%) |
| Not Specified | 1 (1%) | 0 (0%) |
Shown is frequency (percentage across categories), separated by treatment arm.