Table 2.
Maximum grade of adverse event during treatment
|
3 months of treatment (n=434) |
6 months of treatment (n=434) |
Comparisons of 6 months vs 3 months |
|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0 | 1–2 | 3 | 4 | 5 | Patients with missing data | 0 | 1–2 | 3 | 4 | 5 | Patients with missing data | Ordered categories (p value) | Proportion of patients with grade 3–5 adverse event (p value) | Frequency of grade 3–5 event (odds ratio [95% CI]) | |
| Alopecia | 345 (83%) | 69 (17%) | 0 | 0 | 0 | 20 | 309 (76%) | 97 (24%) | 0 | 0 | 0 | 28 | 0·0094 | .. | Not estimable |
| Anaemia | 270 (65%) | 143 (34%) | 2 (<1%) | 2 (<1%) | 0 | 17 | 212 (52%) | 190 (47%) | 3 (<1%) | 1 (<1%) | 0 | 28 | 0·00013 | 1·00 | 1·027 (0·255–4·136) |
| Anorexia | 312 (76%) | 92 (22%) | 7 (2%) | 0 | 0 | 23 | 262 (65%) | 140 (35%) | 3 (<1%) | 0 | 0 | 29 | 0·00043 | 0·34 | 0·431 (0·111–1·677) |
| Constipation | 289 (70%) | 122 (29%) | 2 (<1%) | 1 (<1%) | 0 | 20 | 268 (66%) | 135 (33%) | 3 (<1%) | 0 | 0 | 28 | 0·28 | 1·00 | 1·010 (0·205–5·083) |
| Diarrhoea | 128 (31%) | 243 (58%) | 44 (11%) | 2 (<1%) | 0 | 17 | 99 (24%) | 241 (59%) | 63 (16%) | 2 (<1%) | 1 (<1%) | 28 | 0·0079 | 0·033 | 1·566 (1·045–2·345) |
| Fatigue | 58 (14%) | 320 (77%) | 35 (8%) | 2 (<1%) | 0 | 19 | 41 (10%) | 333 (82%) | 32 (8%) | 0 | 0 | 28 | 0·022 | 0·62 | 0·874 (0·533–1·433) |
| Hand-foot syndrome | 277 (67%) | 129 (31%) | 8 (2%) | 0 | 0 | 20 | 218 (54%) | 169 (42%) | 18 (4%) | 1 (<1%) | 0 | 28 | <0·0001 | 0·031 | 2·492 (1·078–5·758) |
| Mucositis (clinical examination) | 355 (86%) | 56 (14%) | 2 (<1%) | 0 | 0 | 21 | 320 (79%) | 83 (20%) | 1 (<1%) | 0 | 1 (<1%) | 29 | 0·013 | 1·00 | 1·020 (0·143–7·275) |
| Mucositis (functional or symptomatic) | 283 (68%) | 127 (31%) | 4 (1%) | 0 | 0 | 20 | 242 (60%) | 159 (39%) | 4 (1%) | 0 | 1 (<1%) | 28 | 0·0066 | 0·75 | 1·278 (0·341–4·794) |
| Nausea | 147 (35%) | 249 (60%) | 20 (5%) | 0 | 0 | 18 | 120 (30%) | 277 (68%) | 9 (2%) | 0 | 0 | 28 | 0·26 | 0·057 | 0·449 (0·202–0·998) |
| Sensory neuropathy | 37 (9%) | 365 (87%) | 18 (4%) | 0 | 0 | 14 | 28 (7%) | 314 (77%) | 65 (16%) | 2 (<1%) | 0 | 25 | <0·0001 | <0·0001 | 4·375 (2·550–7·508) |
| Neutropenia | 287 (69%) | 90 (22%) | 23 (6%) | 16 (4%) | 0 | 18 | 221 (54%) | 127 (31%) | 43 (11%) | 14 (3%) | 1 (<1%) | 28 | <0·0001 | 0·031 | 1·611 (1·046–2·480) |
| Pain, other | 311 (74%) | 99 (24%) | 10 (2%) | 0 | 0 | 14 | 278 (68%) | 107 (26%) | 24 (6%) | 0 | 0 | 25 | 0·026 | 0·014 | 2·556 (1·206–5·415) |
| Rash | 359 (87%) | 52 (13%) | 2 (<1%) | 0 | 0 | 21 | 320 (79%) | 84 (21%) | 1 (<1%) | 0 | 0 | 29 | 0·00061 | 1·00 | 0·509 (0·046–5·632) |
| Taste alteration | 231 (56%) | 180 (44%) | 1 (<1%) | 0 | 0 | 22 | 179 (44%) | 222 (55%) | 2 (<1%) | 0 | 0 | 31 | 0·0021 | 0·57 | 2·050 (0·185–22·696) |
| Thrombocytopenia | 290 (70%) | 117 (28%) | 5 (1%) | 4 (1%) | 0 | 18 | 253 (62%) | 145 (36%) | 5 (1%) | 2 (<1%) | 1 (<1%) | 28 | 0·020 | 1·00 | 0·909 (0·347–2·380) |
| Vomiting | 304 (73%) | 98 (24%) | 14 (3%) | 0 | 0 | 18 | 270 (67%) | 126 (31%) | 10 (2%) | 0 | 0 | 28 | 0·056 | 0·54 | 0·725 (0·318–1·652) |
| Watery eye | 339 (83%) | 71 (17%) | 0 | 0 | 0 | 24 | 310 (77%) | 92 (23%) | 2 (<1%) | 0 | 0 | 30 | 0·028 | 0·25 | Not estimable |
Data are n (%) or n unless specified otherwise. No grade 5 events occurred in the 3 month group. Adverse events with an incidence ≥10% are shown. Percentages are calculated from the total number of patients minus the number of patients with missing data in each row. Odds ratios are calculated from logistic regression as 6 months vs 3 months. Adverse events were graded in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events.