Table 2 Severe toxicity per treatment group (as treated population)*
Group A | Group B | |||||||
|---|---|---|---|---|---|---|---|---|
(XELIRI-Bev) | (FOLFIRI-Bev) | |||||||
N = 133 | N = 132 | |||||||
Grade III | Grade IV | Grade III | Grade IV | |||||
N | % | N | % | N | % | N | % | |
Anemia | – | – | – | – | 1 | 1 | 1 | 1 |
Leucopenia | 8 | 6 | 1 | 1 | 5 | 4 | – | – |
Neutropenia | 11 | 8 | 6 | 5 | 25 | 19 | 4 | 3 |
Febrile Neutropenia | 2 | 2 | 2 | 2 | 2 | 2 | – | – |
Thrombocytopenia | – | – | 1 | 1 | – | – | – | – |
Infection | – | – | – | – | 2 | 2 | – | – |
Fever | 2 | 2 | – | – | – | – | – | – |
Fatigue | 3 | 2 | – | – | 3 | 2 | – | – |
Anorexia | – | – | – | – | 2 | 2 | – | – |
Nausea | 1 | 1 | – | – | – | – | – | – |
Vomiting1 | 7 | 5 | – | – | – | – | – | – |
Mucositis | 1 | 1 | – | – | 2 | 2 | – | – |
Diarrhea | 24 | 18 | 1 | 1 | 14 | 11 | – | – |
Other gastrointestinal | – | – | – | – | 1 | 1 | – | – |
Cholinergic syndrome | – | – | – | – | 1 | 1 | – | – |
Hiccups | 1 | 1 | – | – | – | – | – | – |
Voice changes | 1 | 1 | – | – | – | – | – | – |
Transaminasemia | 3 | 2 | – | – | 1 | 1 | – | – |
Hand–foot syndrome | 1 | 1 | – | – | 1 | 1 | – | – |
Metabolic | 3 | 2 | 1 | 1 | 4 | 3 | 2 | 2 |
Allergic reaction | 1 | 1 | – | – | – | – | – | – |
Electrolyte disturbances | 7 | 5 | – | – | 7 | 5 | 1 | 1 |
Hypertension | 6 | 5 | – | – | 5 | 4 | – | – |
Thrombosis | 4 | 3 | – | – | 5 | 4 | 2 | 2 |
Pulmonary embolism | – | – | – | – | – | – | 1 | 1 |
Syncope | 1 | 1 | – | – | 5 | 4 | – | – |
Cardiac | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 2 |
Hemorrhage | – | – | – | – | 1 | 1 | – | – |