Table 3.
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.