Table 2.
Adverse events in the safety population.
| S-1 (n = 420) | Standard | CMH test* | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Taxane (n = 290) | Anthracycline (n = 109) | ||||||||||||||||||
| Grade 1–2 | Grade 3 | Grade 4 | Grade 1–2 | Grade 3 | Grade 4 | Grade 1–2 | Grade 3 | Grade 4 | P value | ||||||||||
| n | % | n | % | n | % | n | % | n | % | n | % | n | % | n | % | n | % | ||
| Haematological | |||||||||||||||||||
| Leucopenia | 184 | 43.8% | 7 | 1.7% | 2 | 0.5% | 72 | 24.8% | 6 | 2.1% | 1 | 0.3% | 44 | 40.4% | 7 | 6.4% | 2 | 1.8% | <0.0001 |
| Neutropenia | 148 | 35.2% | 28 | 6.7% | 1 | 0.2% | 58 | 20.0% | 6 | 2.1% | 3 | 1.0% | 25 | 22.9% | 8 | 7.3% | 2 | 1.8% | <0.0001 |
| Thrombocytopenia | 143 | 34.0% | 3 | 0.7% | 2 | 0.5% | 13 | 4.5% | 0 | 0.0% | 0 | 0.0% | 8 | 7.3% | 1 | 0.9% | 0 | 0.0% | 0.0001 |
| Haemoglobin | 213 | 50.7% | 8 | 1.9% | 0 | 0.0% | 159 | 54.8% | 5 | 1.7% | 0 | 0.0% | 62 | 56.9% | 8 | 7.3% | 0 | 0.0% | <0.0001 |
| ALT | 188 | 44.8% | 2 | 0.5% | 0 | 0.0% | 70 | 24.1% | 1 | 0.3% | 1 | 0.3% | 33 | 30.3% | 0 | 0.0% | 1 | 0.9% | <0.0001 |
| Bilirubin | 177 | 42.1% | 2 | 0.5% | 0 | 0.0% | 11 | 3.8% | 1 | 0.3% | 0 | 0.0% | 2 | 1.8% | 2 | 1.8% | 0 | 0.0% | <0.0001 |
| Non-haematological | |||||||||||||||||||
| Fatigue | 166 | 39.5% | 17 | 4.0% | 0 | 0.0% | 141 | 48.6% | 12 | 4.1% | 0 | 0.0% | 59 | 54.1% | 6 | 5.5% | 0 | 0.0% | 0.0256 |
| Alopecia | 18 | 4.3% | 0 | 0.0% | 0 | 0.0% | 220 | 75.9% | 0 | 0.0% | 0 | 0.0% | 85 | 78.0% | 0 | 0.0% | 0 | 0.0% | <0.0001 |
| Oedema | 31 | 7.4% | 1 | 0.2% | 0 | 0.0% | 99 | 34.1% | 12 | 4.1% | 0 | 0.0% | 9 | 8.3% | 0 | 0.0% | 0 | 0.0% | <0.0001 |
| Motor neuropathy | 10 | 2.4% | 3 | 0.7% | 0 | 0.0% | 19 | 6.6% | 2 | 0.7% | 1 | 0.3% | 2 | 1.8% | 0 | 0.0% | 0 | 0.0% | 0.0327 |
| Sensory neuropathy | 42 | 10.0% | 2 | 0.5% | 0 | 0.0% | 134 | 46.2% | 8 | 2.8% | 1 | 0.3% | 15 | 13.8% | 0 | 0.0% | 0 | 0.0% | <0.0001 |
| Arthralgia | 31 | 7.4% | 1 | 0.2% | 0 | 0.0% | 62 | 21.4% | 0 | 0.0% | 0 | 0.0% | 7 | 6.4% | 1 | 0.9% | 0 | 0.0% | <0.0001 |
| Myalgia | 39 | 9.3% | 0 | 0.0% | 0 | 0.0% | 63 | 21.7% | 0 | 0.0% | 1 | 0.3% | 10 | 9.2% | 1 | 0.9% | 0 | 0.0% | <0.0001 |
| Allergy | 19 | 4.5% | 0 | 0.0% | 0 | 0.0% | 19 | 6.6% | 4 | 1.4% | 0 | 0.0% | 2 | 1.8% | 0 | 0.0% | 0 | 0.0% | 0.006 |
| Febrile neutropenia | 0 | 0.0% | 6 | 1.4% | 1 | 0.2% | 0 | 0.0% | 8 | 2.8% | 2 | 0.7% | 0 | 0.0% | 10 | 9.2% | 1 | 0.9% | 0.0002 |
| Fever | 29 | 6.9% | 0 | 0.0% | 0 | 0.0% | 28 | 9.7% | 1 | 0.3% | 0 | 0.0% | 23 | 21.1% | 1 | 0.9% | 0 | 0.0% | <0.0001 |
| Diarrhoea | 133 | 31.7% | 17 | 4.0% | 0 | 0.0% | 53 | 18.3% | 4 | 1.4% | 0 | 0.0% | 14 | 12.8% | 1 | 0.9% | 0 | 0.0% | <0.0001 |
| Mucositis | 109 | 26.0% | 4 | 1.0% | 0 | 0.0% | 45 | 15.5% | 0 | 0.0% | 0 | 0.0% | 41 | 37.6% | 2 | 1.8% | 0 | 0.0% | <0.0001 |
| Nausea | 154 | 36.7% | 6 | 1.4% | 0 | 0.0% | 63 | 21.7% | 3 | 1.0% | 0 | 0.0% | 60 | 55.0% | 3 | 2.8% | 0 | 0.0% | <0.0001 |
| Vomiting | 51 | 12.1% | 3 | 0.7% | 0 | 0.0% | 27 | 9.3% | 2 | 0.7% | 0 | 0.0% | 20 | 18.3% | 4 | 3.7% | 0 | 0.0% | 0.0012 |
| Anorexia | 162 | 38.6% | 16 | 3.8% | 0 | 0.0% | 84 | 29.0% | 4 | 1.4% | 0 | 0.0% | 60 | 55.0% | 2 | 1.8% | 0 | 0.0% | <0.0001 |
*Row mean score test of Cochran–Mantel–Haenszel (CMH) test.