Adjuvant chemo + CHMF (N = 114) n (%) | Adjuvant chemo+ Placebo (N = 115) n (%) | |||||
---|---|---|---|---|---|---|
Grade 1/2 | Grade 3/4 | Total | Grade 1/2 | Grade 3/4 | Total | |
Fatigue | 90 (78.9%) | 1 (0.8%) | 91 (79.7%) | 89 (77.45%) | 0 | 89 (77.45%) |
Loss of appetite | 88 (77.2%) | 0 | 88 (77.2%) | 94 (81.7%) | 0 | 94 (81.7%) |
Nausea | 77 (67.5%) | 1 (0.8%) | 78 (68.3%) | 77 (67%) | 0 | 77 (67%) |
Leucopenia | 49 (43.6%) | 8 (7%) | 57 (50.6%) | 40 (34.8%) | 15 (13%) | 55 (47.8%) |
Vomiting | 43 (37.3%) | 6 (4.4%) | 49 (41.7%) | 47 (40.9%) | 1 (0.8%) | 48 (41.7%) |
Elevated TB | 37 (32.5%) | 1 (0.8%) | 38 (33.3%) | 40 (34.8%) | 0 | 40 (34.8%) |
Constipation | 37 (32.5%) | 1 (0.8%) | 38 (33.3%) | 39 (33.9%) | 0 | 39 (33.9%) |
Neutropenia | 34 (29.8%) | 11 (9.7%) | 45 (39.5%) | 37 (32.2%) | 17 (14.8%) | 54 (47%) |
Anaemia | 29 (25.4%) | 0 | 29 (25.4%) | 28 (24.3%) | 1 (0.8%) | 29 (25.1%) |
Dry mouth | 28 (24.6%) | 0 | 28 (24.6%) | 45 (39.1%) | 0 | 45 (39.1%) |
Pain | 28 (24.7%) | 0 | 28 (24.7%) | 37 (32.2%) | 0 | 37 (32.2%) |
Alopecia | 13 (11.4%) | 0 | 13 (11.4%) | 14 (12.2%) | 0 | 14 (12.2%) |
ALT/AST increased | 12 (10.5%) | 1 (0.8%) | 13 (11.3%) | 15 (11.3%) | 0 | 15 (11.3%) |
Elevated GGT | 11 (9.6%) | 2 (1.8%) | 13 (11.4%) | 9 (7.8%) | 1 (0.8%) | 10 (8.6%) |
Diarrhoea | 9 (7.9%) | 0 | 9 (7.9%) | 20 (17.4%) | 0 | 20 (17.4%) |
Thrombocytopaenia | 6 (5.3%) | 0 | 6 (5.3%) | 15 (13%) | 1 (0.8%) | 16 (13.8%) |
Elevated CRE | 4 (3.5%) | 0 | 4 (3.5%) | 1 (0.9%) | 0 | 1 (0.9%) |
Weight-decrease | 4 (3.5%) | 0 | 4 (3.5%) | 7 (6.1%) | 0 | 7 (6.1%) |
Rash | 3 (2.6%) | 0 | 3 (2.6%) | 2 (1.7%) | 0 | 2 (1.7%) |
Arhythmia | 2 (1.8%) | 0 | 2 (1.8%) | 2 (1.7%) | 1 (0.8%) | 3 (2.5%) |
Pruritus | 2 (1.8%) | 0 | 2 (1.8%) | 4 (3.5%) | 0 | 4 (3.5%) |
Elevated ALP | 1 (0.8%) | 0 | 1 (0.8%) | 1 (0.9%) | 0 | 1 (0.9%) |