Table 5 Adverse events.
FTD/TPI (N = 70) | FTD/TPI plus ramucirumab (N = 36) | P value | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
Any grade | % | Grade ≥ 3 | % | Any grade | % | Grade ≥ 3 | % | Any grade | Grade ≥ 3 | |
Any adverse events | 70 | 100.0 | 45 | 64.3 | 36 | 100.0 | 26 | 72.2 | 1.000 | 0.514 |
Leucopenia | 50 | 71.4 | 25 | 35.7 | 27 | 75.0 | 12 | 33.3 | 0.819 | 0.833 |
Neutropenia | 51 | 72.9 | 33 | 47.1 | 30 | 83.3 | 22 | 61.1 | 0.334 | 0.219 |
Anemia | 69 | 98.6 | 16 | 22.9 | 31 | 86.1 | 5 | 13.9 | 0.095 | 0.315 |
Thrombocytopenia | 46 | 65.7 | 7 | 10.0 | 24 | 66.7 | 5 | 13.9 | 1.000 | 0.536 |
Fatigue | 46 | 65.7 | 2 | 2.9 | 30 | 83.3 | 4 | 11.1 | 0.070 | 0.177 |
Decreased appetite | 39 | 55.7 | 6 | 8.6 | 29 | 80.6 | 8 | 22.2 | 0.018 | 0.069 |
Nausea | 34 | 48.6 | 2 | 2.9 | 25 | 69.4 | 1 | 2.8 | 0.063 | 1.000 |
Vomiting | 16 | 22.9 | 1 | 1.4 | 9 | 25.0 | 0 | 0.0 | 0.813 | 1.000 |
Diarrhea | 18 | 25.7 | 0 | 0.0 | 10 | 27.8 | 0 | 0.0 | 0.820 | 1.000 |
Stomatitis | 7 | 10.0 | 0 | 0.0 | 7 | 19.4 | 0 | 0.0 | 0.227 | 1.000 |
Rash | 5 | 7.1 | 1 | 1.4 | 6 | 16.7 | 0 | 0.0 | 0.178 | 1.000 |
Proteinuriaa | – | – | – | – | 7 | 19.4 | 2 | 5.6 | – | – |
Febrile neutropenia | – | – | 2 | 2.9 | – | – | 5 | 13.8 | – | 0.043 |