Table 2. Incidences of severea toxicity suffered by cycle and by patient.
ECMF
|
CMF
|
Total
|
||||
---|---|---|---|---|---|---|
N | % | N | % | N | % | |
Number of cycles | (n=7144) | (n=5298) | (n=12442) | |||
Nausea | 204 | 2.9 | 89 | 1.7 | 293 | 2 |
Vomiting | 172 | 2.4 | 45 | 0.9 | 217 | 2 |
Stomatitis | 86 | 1.2 | 34 | 0.6 | 120 | 1 |
Alopecia | 3850 | 53.9 | 769 | 14.5 | 4619 | 37 |
Constipation | 100 | 1.4 | 37 | 0.7 | 137 | 1 |
Infection | 76 | 1.1 | 62 | 1.2 | 138 | 1 |
Fatigue | 429 | 6.0 | 326 | 6.2 | 755 | 6 |
Neutropenia | 275 | 3.9 | 227 | 4.3 | 502 | 4 |
Thrombocytopenia | 10 | 0.1 | 11 | 0.2 | 21 | 1 |
Diarrhoea | 78 | 1.1 | 87 | 1.6 | 165 | 1 |
Neutropenic Sepsisb | 201 | 3 | 145 | 3 | 346 | 3 |
Number of patients c | (n=1004) | (n=1008) | (n=2012) | |||
Nausea | 169*** | 17 | 85 | 8 | 254 | 13 |
Vomiting | 129*** | 13 | 48 | 5 | 177 | 9 |
Stomatitis | 70** | 7 | 33 | 3 | 103 | 5 |
Alopecia | 821*** | 82 | 263 | 26 | 1084 | 54 |
Constipation | 63*** | 6 | 26 | 3 | 89 | 4 |
Infection | 208 | 21 | 163 | 16 | 371 | 18 |
Fatigue | 212 | 21 | 183 | 18 | 395 | 20 |
Neutropenia | 334 | 33 | 347 | 34 | 681 | 34 |
Thrombocytopenia | 26 | 3 | 21 | 2 | 47 | 2 |
Diarrhoea | 72 | 7 | 77 | 8 | 149 | 7 |
Asterisks indicate significantly higher number of patients, after Bonferroni correction (*P<0.05, **P<0.01, ***P<0.001).
Severe=reported CTC grade ⩾3 (⩾2 for alopecia).
Neutropenic Sepsis episodes inferred from incidences, of any grade, of neutropenia and infection reported in the same cycle.
Gleaned from a reported severe grade or cause of treatment delay, reduction or hospitalisation.