Table 3.
Most common adverse reactions
| Adverse event | All | Serious | <75 years (N = 397) | ≥75 years (N = 397) | P-valuesa | P-valuesb | ||
|---|---|---|---|---|---|---|---|---|
| All | Serious | All | Serious | |||||
| Any, n (%) | 766 (96.5) | 408 (51.4) | 384 (96.7) | 193 (48.6) | 382 (96.2) | 215 (54.2) | 0.7004 | 0.1183 |
| Hand and foot skin reaction, n (%) | 463 (58.3) | 48 (6.1) | 241 (60.7) | 26 (6.6) | 222 (55.9) | 22 (5.5) | ||
| Hypertension, n (%) | 280 (35.3) | 18 (2.3) | 132 (33.3) | 7 (1.8) | 148 (37.3) | 11 (2.8) | ||
| Rash, n (%) | 211 (26.6) | 61 (7.7) | 116 (29.2) | 29 (7.3) | 95 (23.9) | 32 (8.1) | ||
| Lipase/ amylase increase, n (%) | 197 (24.8) | 5 (0.6) | 100 (25.2) | 1 (0.3) | 97 (24.4) | 4 (1.0) | ||
| Diarrhoea, n (%) | 170 (21.4) | 15 (1.9) | 93 (23.4) | 4 (1.0) | 77 (19.4) | 11 (2.8) | ||
| Alopecia, n (%) | 122 (15.4) | 0 (0.0) | 75 (18.9) | 0 (0.0) | 47 (11.8) | 0 (0.0) | 0.0059 | |
| Hepatic dysfunction, n (%) | 128 (16.1) | 44 (5.5) | 69 (17.4) | 24 (6.1) | 59 (14.9) | 20 (5.0) | ||
| Cytopenia, n (%) | 107 (13.5) | 42 (5.3) | 55 (13.9) | 22 (5.5) | 52 (13.1) | 20 (5.0) | ||
| Bleeding, n (%) | 84 (10.6) | 59 (7.4) | 41 (10.3) | 26 (6.6) | 43 (10.8) | 33 (8.3) | ||
| Decreased appetite, n (%) | 77 (9.7) | 15 (1.9) | 26 (6.6) | 4 (1.0) | 51 (12.9) | 11 (2.8) | 0.0027 | |
| Mucositis, n (%) | 65 (8.2) | 5 (0.6) | 30 (7.6) | 5 (1.3) | 35 (8.8) | 0 (0.0) | ||
| Hypophosphatemia, n (%) | 59 (7.4) | 0 (0.0) | 38 (9.6) | 0 (0.0) | 21 (5.3) | 0 (0.0) | 0.0214 | |
| Fatigue, n (%) | 14 (1.8) | 2 (0.3) | 8 (2.0) | 2 (0.5) | 6 (1.5) | 0 (0.0) | ||
| Dysphonia, n (%) | 52 (6.6) | 0 (0.0) | 20 (5.0) | 0 (0.0) | 32 (8.1) | 0 (0.0) | ||
| Fever, n (%) | 45 (5.7) | 14 (1.8) | 17 (4.3) | 3 (0.8) | 28 (7.1) | 11 (2.8) | 0.0310 | |
| Renal failure/renal dysfunction, n (%) | 23 (2.9) | 11 (1.4) | 6 (1.5) | 2 (0.5) | 17 (4.3) | 9 (2.3) | 0.0199 | 0.0336 |
aPooled analysis of all AEs in <75 and ≥75 years old.
bPooled analysis of serious AEs in <75 and ≥75 years old