Table 2

Summary of grade 3 or higher adverse events stratified by treatment duration and regimen

n (%)Arm 6Arm 3P value*
mFOLFOX6CAPOXTotalmFOLFOX6CAPOXTotal
All events ≥grade 376 (48)196 (41)272 (43)56 (35)128 (27)184 (29)<0.001
Haematological
 Leucopenia9 (6)12 (3)21 (3)12 (8)7 (2)19 (3)0.75
 Neutropenia54 (34)73 (15)127 (20)43 (27)46 (10)89 (14)0.004
 Anaemia0 (0)0 (0)0 (0)0 (0)2 (0.4)2 (0.3)0.50
 Thrombocytopenia0 (0)26 (6)26 (4)3 (2)16 (3)19 (3)0.29
Non-haematological
 Anorexia2 (1)25 (5)27 (4)4 (3)24 (5)28 (4)1.00
 Diarrhoea1 (1)26 (6)27 (4)3 (2)27 (6)30 (5)0.79
 Nausea1 (1)14 (3)15 (2)2 (1)14 (3)16 (3)1.00
 Vomiting1 (1)4 (1)5 (1)0 (0)10 (2)10 (2)0.30
 HFS0 (0)15 (3.1)15 (2.4)0 (0)4 (0.8)4 (0.6)0.011
 HFS (≥grade 2)4 (3)70 (15)74 (12)2 (1)35 (7)37 (6)<0.001
 PSN8 (5.1)30 (6.3)38(6)1 (0.6)5 (1.0)6 (0.9)<0.001
 PSN (≥grade 2)57 (36)175 (37)232 (37)18 (11)69 (14)87 (14)<0.001
  • *Fisher’s exact test for comparison of all AEs ≥grade 3 between arm 6 and arm 3.

  • AE, adverse event; HFS, hand–foot syndrome; PSN, peripheral sensory neuropathy.