Table 3. Most Frequent Treatment-emergent Non-hematologic and Hematologic Adverse Events (≥20% Any Grade on Either Arm)a.
| Cixutumumab + M + P (n=66) | Ramucirumab + M + P (n=66) | |||||
|---|---|---|---|---|---|---|
| Non-hematologic AE | Any G, % | G3, % | G4, % | Any G, % | G3, % | G4, % |
| Fatigue | 74.2 | 16.7 | 0 | 71.2 | 7.6 | 0 |
| Weight decreased | 65.2 | 4.5 | 0 | 60.6 | 1.5 | 0 |
| Anorexia | 53.0 | 0 | 0 | 47.0 | 3.0 | 0 |
| Nausea | 53.0 | 1.5 | 0 | 47.0 | 4.5 | 0 |
| Diarrhea | 43.9 | 7.6 | 0 | 45.5 | 1.5 | 0 |
| Constipation | 40.9 | 0 | 0 | 37.9 | 1.5 | 0 |
| Hyperglycemia | 47.0 | 7.6 | 1.5 | 12.1 | 1.5 | 1.5 |
| Vomiting | 28.8 | 1.5 | 0 | 28.8 | 3.0 | 0 |
| Dehydration | 28.8 | 6.1 | 0 | 7.6 | 1.5 | 0 |
| Arthralgia | 25.8 | 6.1 | 0 | 24.2 | 4.5 | 0 |
| Back pain | 24.2 | 4.5 | 0 | 24.2 | 1.5 | 0 |
| Dyspnea | 18.2 | 3.0 | 0 | 31.8 | 7.6 | 0 |
| Peripheral edema | 15.2 | 1.5 | 0 | 21.2 | 0 | 0 |
| Ecchymosis | 15.2 | 0 | 0 | 24.2 | 0 | 0 |
| Stomatitis | 10.6 | 0 | 0 | 22.7 | 0 | 0 |
| Hypertension | 7.6 | 1.5 | 0 | 34.8 | 9.1 | 0 |
| Hematologic AE | ||||||
| Neutropenia | 42.4 | 16.7 | 15.2 | 37.9 | 22.7 | 9.1b |
| Anemia | 34.8 | 3.0 | 0 | 36.4 | 10.6 | 0 |
| Leukopenia | 31.8 | 16.7 | 6.1 | 25.8 | 15.2 | 1.5 |
| Thrombocytopenia | 18.2 | 3.0 | 1.5 | 34.8 | 7.6 | 0 |
a
Deaths assessed to be related to study treatment: ramucirumab arm, septic shock and pneumonia aspiration; cixutumumab arm, cachexia.
b
Includes 1 incidence (1.5%) of grade 5 neutropenia on ramucirumab.
Abbreviations: AE, adverse event; G, grade; M, mitoxantrone; P, prednisone.