Table 2 Occurrence of individual adverse events in both groups
Adverse events n (%) | Before 1st course | Before 2nd course | Before 3rd course | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
Grade | Non intervention | Intervention | P | Non intervention | Intervention | P | Non intervention | Intervention | P | |
Constipation | 2 | 0 (0) | 0 (0) | 0.342 | 2 (10.5) | 2 (10.0) | 0.975 | 3 (15.8) | 3 (15.0) | 0.975 |
1 | 3 (15.8) | 1 (5.0) | 6 (31.6) | 7 (35.0) | 6 (31.6) | 7 (35.0) | ||||
0 | 16 (84.2) | 19 (95.0) | 11 (57.9) | 11 (55.0) | 10 (52.6) | 10 (50.0) | ||||
Nausea | 2 | 0 (0) | 0 (0) | 1.000 | 1 (5.3) | 0 (0) | 0.264 | 0 (0) | 0 (0) | 0.155 |
1 | 1 (5.3) | 1 (5.0) | 9 (47.4) | 6 (30.0) | 7 (36.8) | 3 (15.0) | ||||
0 | 18 (94.7) | 19 (95.0) | 9 (47.4) | 14 (70.0) | 12 (63.2) | 17 (85.0) | ||||
Oral pain | 2 | 0 (0) | 0 (0) | 1.000 | 0 (0) | 0 (0) | 0.523 | 0 (0) | 1 (5.0) | 0.490 |
1 | 0 (0) | 0 (0) | 9 (47.4) | 7 (35.0) | 6 (31.6) | 8 (40.0) | ||||
0 | 19 (100) | 20(100) | 10 (52.6) | 13 (65.0) | 13 (68.4) | 11 (55.0) | ||||
Vomiting | 2 | 0 (0) | 0 (0) | 1.000 | 0(0) | 1 (5.0) | 0.126 | 0 (0) | 0 (0) | 0.342 |
1 | 0 (0) | 0 (0) | 5 (26.3) | 1 (5.0) | 3 (15.8) | 1 (5.0) | ||||
0 | 19 (100) | 20 (100) | 14 (73.7) | 18 (90.0) | 16 (84.2) | 19 (95.0) | ||||
Fever | 2 | 0 (0) | 0 (0) | 1.000 | 2 (10.5) | 1 (5.0) | 0.443 | 0 (0) | 0 (0) | 0.605 |
1 | 0 (0) | 0 (0) | 2 (10.5) | 5 (25.0) | 1 (5.3) | 3 (15.0) | ||||
0 | 19 (100) | 20 (100) | 15 (78.9) | 14 (70.0) | 18 (94.7) | 17 (85.0) | ||||
Malaise | 2 | 0 (0) | 0 (0) | 0.342 | 4 (21.1) | 3 (15.0) | 0.700 | 1 (5.3) | 2 (10.0) | 0.684 |
1 | 3 (15.8) | 1 (5.0) | 8 (42.1) | 7 (35.0) | 11 (57.9) | 9 (45.0) | ||||
0 | 16 (84.2) | 19 (95.0) | 7 (36.8) | 10 (50.0) | 7 (36.8) | 9 (45.0) | ||||
Anorexia | 2 | 0 (0) | 0 (0) | 0.231 | 3 (15.8) | 2 (10.0) | 0.809 | 1 (5.3) | 1 (5.0) | 0.703 |
1 | 2 (10.5) | 0 (0) | 7 (36.8) | 9 (45.0) | 11 (57.9) | 9 (45.0) | ||||
0 | 17 (89.5) | 20 (100) | 9 (47.4) | 9 (45.0) | 7 (36.8) | 10 (50.0) | ||||
Peripheral sensory neuropathy | 2 | 0 (0) | 0 (0) | 1.000 | 0 (0) | 0 (0) | 0.695 | 0 (0) | 0 (0) | 1.000 |
1 | 1 (5.3) | 1 (5.0) | 3 (15.8) | 5 (25.0) | 4 (21.1) | 4 (20.0) | ||||
0 | 18 (94.7) | 19 (95.0) | 16 (84.2) | 15 (75.0) | 15 (78.9) | 16 (80.0) | ||||
Alopecia | 2 | 1 (5.3) | 0 (0) | 0.487 | 14 (73.7) | 11 (55.0) | 0.230 | 16 (84.2) | 17 (85.0) | 0.547 |
1 | 0 (0) | 0 (0) | 3 (15.8) | 8 (40.0) | 3 (15.8) | 2 (10.0) | ||||
0 | 18 (94.7) | 20 (100) | 2 (10.5) | 1 (5.0) | 0 (0) | 1 (5.0) | ||||
Nail ridging | 2 | 0 (0) | 0 (0) | 1.000 | 0 (0) | 0 (0) | 1.000 | 0 (0) | 0 (0) | 0.748 |
1 | 2 (10.5) | 3 (15.0) | 3 (15.8) | 4 (20.0) | 11 (57.9) | 13 (65.0) | ||||
0 | 17 (89.5) | 17 (85.0) | 16 (84.2) | 16 (80.0) | 8 (42.1) | 7 (35.0) | ||||
Skin disorder | 2 | 0 (0) | 0 (0) | 0.342 | 1 (5.3) | 0 (0) | 0.561 | 1 (5.3) | 0 (0) | 0.581 |
1 | 3 (15.8) | 1 (5.0) | 8 (42.1) | 8 (40.0) | 7 (36.8) | 8 (40.0) | ||||
0 | 16 (84.2) | 19 (95.0) | 10 (52.6) | 12 (60.0) | 11 (57.9) | 12 (60.0) | ||||