Table 3:
Bevacizumab alone (n=72) | Bevacizumab + Everolimus (n=73) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | |
Blood/Lymphatics | ||||||||||
Neutropenia1 | 5 | 1 | 0 | 0 | 0 | 11 | 15 | 5 | 0 | 0 |
Anemia1 | 18 | 5 | 0 | 0 | 0 | 24 | 22 | 1 | 0 | 0 |
Thrombocytopenia1 | 6 | 2 | 0 | 0 | 0 | 28 | 10 | 1 | 0 | 0 |
Cardiac | 1 | 0 | 1 | 0 | 0 | 5 | 1 | 0 | 1 | 0 |
Ear/labyrinth | 2 | 0 | 0 | 0 | 0 | 2 | 20 | 0 | 0 | 0 |
Gastrointestinal | ||||||||||
Nausea1 | 19 | 3 | 4 | 0 | 0 | 13 | 12 | 6 | 0 | 0 |
Vomiting | 5 | 4 | 2 | 0 | 0 | 13 | 7 | 5 | 0 | 0 |
Other GI1,2 | 34 | 8 | 1 | 0 | 0 | 23 | 22 | 13 | 1 | 0 |
General/ | 43 | 9 | 1 | 0 | 0 | 34 | 20 | 7 | 0 | 0 |
administrative site1 | ||||||||||
Hepatobiliary | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
Immune system | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
Infections | 1 | 6 | 2 | 0 | 0 | 2 | 7 | 6 | 1 | 0 |
Metabolism/nutrition1,2 | 18 | 4 | 4 | 1 | 0 | 15 | 14 | 13 | 1 | 0 |
Musculoskeletal/ connective tissue | 24 | 6 | 1 | 0 | 0 | 12 | 8 | 4 | 0 | 0 |
Nervous system | 21 | 6 | 2 | 0 | 0 | 28 | 9 | 3 | 0 | 0 |
Peripheral neuropathy | 10 | 1 | 0 | 0 | 0 | 12 | 1 | 1 | 0 | 0 |
Other investigations | 18 | 4 | 2 | 0 | 0 | 18 | 20 | 2 | 0 | 0 |
Psychiatric | 5 | 1 | 0 | 0 | 0 | 8 | 4 | 0 | 0 | 0 |
Renal/urinary | 7 | 0 | 2 | 0 | 0 | 8 | 5 | 1 | 0 | 0 |
Respiratory/thoracic1 | 26 | 3 | 0 | 0 | 0 | 26 | 12 | 4 | 1 | 0 |
Skin/subcutaneous1 | 16 | 2 | 0 | 0 | 0 | 24 | 10 | 2 | 0 | 0 |
Vascular disorders | 7 | 11 | 10 | 2 | 1 | 4 | 7 | 12 | 1 | 1 |
Toxicities are significantly associated with treatment at the 5% level when classified as mild (Grade <=1), moderate (grade =2) and severe (Grade >=3) (highlighted as a light shadow in table)
Toxicities are significantly associated with treatment at the 5% level when classified as mild to moderate and severe (grade 3–5 non-hematologic and grade 4–5 hematologic events) (highlighted as a dark shadow in table)