Table 4.
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.