Table 4.
Treatment-Emergent Adverse Events Regardless of Causalitya
| Adverse Event | Ridaforolimus (N = 38) Number of Patients, n (%) | ||
|---|---|---|---|
| Total | Grade 3 | Grade 4 | |
| Hematologic | |||
| Anemia | 17 (44.7) | 0 (0) | 0 (0) |
| Thrombocytopenia | 8 (21.1) | 2 (5.3) | 0 (0) |
| Neutropenia | 6 (15.8) | 3 (7.9) | 0 (0) |
| Nonhematologic | |||
| Fatigue | 31 (81.6) | 2 (5.3) | 0 (0) |
| Mucosal inflammation | 22 (57.9) | 1 (2.6) | 0 (0) |
| Rash | 17 (44.7) | 0 (0) | 0 (0) |
| Peripheral edema | 17 (44.7) | 0 (0) | 0 (0) |
| Nausea | 17 (44.7) | 0 (0) | 0 (0) |
| Diarrhea | 16 (42.1) | 1 (2.6) | 0 (0) |
| Constipation | 14 (36.8) | 1 (2.6) | 0 (0) |
| Vomiting | 11 (28.9) | 1 (2.6) | 0 (0) |
| Anorexia | 11 (28.9) | 0 (0) | 0 (0) |
| Arthralgia | 11 (28.9) | 0 (0) | 0 (0) |
| Dyspnea | 10 (26.3) | 1 (2.6) | 0 (0) |
| Cough | 10 (26.3) | 0 (0) | 0 (0) |
| Back pain | 10 (26.3) | 0 (0) | 0 (0) |
| Pyrexia | 9 (23.7) | 0 (0) | 0 (0) |
| Hypertriglyceridemia | 8 (21.1) | 0 (0) | 1 (2.6) |
| Pain in extremity | 8 (21.1) | 1 (2.6) | 0 (0) |
| Nail disorder | 8 (21.1) | 0 (0) | 0 (0) |
| Hyperglycemia | 7 (18.4) | 2 (5.3) | 1 (2.6) |
| Stomatitis | 7 (18.4) | 0 (0) | 0 (0) |
| Decreased appetite | 7 (18.4) | 0 (0) | 0 (0) |
| Upper respiratory tract infection | 7 (18.4) | 0 (0) | 0 (0) |
| Epistaxis | 6 (15.8) | 0 (0) | 0 (0) |
| Hypokalemia | 4 (10.5) | 2 (5.3) | 0 (0) |
| Pruritis | 4 (10.5) | 1 (2.6) | 0 (0) |
Adverse events occurring in 15% of patients or more, and all grade 3 or 4 adverse events.