Table 3.
Adverse events of clinical interest
| Adverse event | R/D/E | R/E | Difference in percentage vs. R/E
|
|
|---|---|---|---|---|
| n (%) | n = 39 | n = 40 | Estimate (95% CI)a | P |
| ≥1 AE | 32 (82.1) | 39 (97.5) | −15.4 (−30.7, −2.5) | 0.024 |
| Hearing loss | 1 (2.6) | 1 (2.5) | 0.1 (−10.7, 11.1) | 0.986 |
| Grade 1 | 1 (2.6) | 1 (2.5) | ||
| Stomatitis | 30 (76.9) | 38 (95.0) | −18.1 (−34.3, −3.1) | 0.021 |
| Grade 1 | 11 (28.2) | 15 (37.5) | ||
| Grade 2 | 10 (25.6) | 13 (32.5) | ||
| Grade 3 | 9 (23.1) | 10 (25.0) | ||
| Pneumonitis | 2 (5.1) | 9 (22.5) | −17.4 (−33.4, −2.3) | 0.027 |
| Grade 1 | 1 (2.6) | 2 (5.0) | ||
| Grade 2 | 1 (2.6) | 5 (12.5) | ||
| Grade 3 | 0 | 1 (2.5) | ||
| Grade 4 | 0 | 1 (2.5) | ||
| Hyperglycemia | 11 (28.2) | 11 (27.5) | 0.7 (−19.1, 20.6) | 0.945 |
| Grade 1 | 3 (7.7) | 3 (7.5) | ||
| Grade 2 | 4 (10.3) | 5 (12.5) | ||
| Grade 3 | 4 (10.3) | 3 (7.5) | ||
R/D/E, ridaforolimus 10 mg qd × 5/week, dalotuzumab 10 mg/kg/week, and exemestane 25 mg/day; R/E, ridaforolimus 30 mg qd 5 ×/week and exemestane 25 mg/day
Only the highest reported grade of a given adverse event is counted for an individual subject
AE adverse event, CI confidence interval
a
Based on Miettinen and Nurminen method