Table 3. Adverse events at any dose level.
Adverse Event of All Grades | Dose Level of Temsirolimus (mg)/Bevacizumab (mg/kg)/Cetuximab LD/MD (mg/m2) | |||||||
---|---|---|---|---|---|---|---|---|
5/5/100/75 (n = 3) |
5/10/100/75 (n = 16) |
12.5/2.5/100/75 (n = 2) |
Total (n = 21) |
|||||
G1-2 | G3-4 | G1-2 | G3-4 | G1-2 | G3-4 | G1-2 | G3-4 | |
Abdominal Pain | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
Anemia | 3 | 0 | 13 | 1 | 2 | 0 | 18 | 1 |
Anorexia | 0 | 0 | 2 | 0 | 2 | 0 | 4 | 0 |
Dermatitis | 1 | 0 | 10 | 0 | 1 | 0 | 12 | 0 |
Diarrhea | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
Dysuria | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
Epistaxis | 1 | 0 | 2 | 0 | 0 | 0 | 3 | 0 |
Fatigue | 2 | 0 | 8 | 0 | 1 | 1 | 11 | 1 |
Fever | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
Headache | 0 | 0 | 4 | 0 | 1 | 1 | 5 | 1 |
Hypercholesterolemia | 2 | 0 | 9 | 0 | 0 | 0 | 11 | 0 |
Hyperglycemia | 3 | 0 | 8 | 3 | 1 | 0 | 12 | 3 |
Hyperkalemia | 1 | 0 | 2 | 1 | 2 | 0 | 5 | 1 |
Hypertension | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 0 |
Hypertriglyceridemia | 3 | 0 | 11 | 0 | 1 | 0 | 15 | 0 |
Hypokalemia | 1 | 0 | 4 | 1 | 1 | 0 | 6 | 1 |
Hypophosphatemia | 1 | 0 | 3 | 1 | 0 | 2 | 4 | 3 |
Elevated AST | 3 | 0 | 8 | 1 | 0 | 0 | 11 | 1 |
Hyperbilirubinemia | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
Renal Insufficiency | 1 | 0 | 3 | 0 | 0 | 0 | 4 | 0 |
Elevated ALT | 2 | 0 | 6 | 0 | 1 | 0 | 9 | 0 |
Infection (ear, orbit) | 1 | 0 | 3 | 0 | 0 | 0 | 4 | 0 |
Leukopenia/Neutropenia | 0 | 1 | 5 | 0 | 1 | 0 | 6 | 1 |
Mucositis/Glossitis | 2 | 0 | 8 | 0 | 0 | 1 | 10 | 1 |
Nail Discoloration | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 0 |
Nausea | 1 | 0 | 3 | 0 | 2 | 0 | 6 | 0 |
Proteinuria | 2 | 0 | 11 | 0 | 0 | 0 | 13 | 0 |
Dyspnea with Exertion | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
Stomatitis | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 0 |
Thrombocytopenia | 0 | 0 | 3 | 0 | 2 | 0 | 5 | 0 |
Fistula | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Hypomagnesemia | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Pneumonitis | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Vomiting | 1 | 0 | 0 | 1 | 2 | 0 | 3 | 1 |
Oral thrush | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
Constipation | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
Infusion Reaction | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
Stomach leak/rupture | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
LD: loading dose; MD: maintenance dose.