Table 3.
Adverse events (AEs) and serious adverse events (SAEs) in propensity score-matched patients
| Preferred term | All patients (N = 2430) | eGFR (mL/min/1.73 m2) | p-value (AEs) | p-value (SAEs) | ||||
|---|---|---|---|---|---|---|---|---|
| AEs n (%) |
SAEs | < 60 (N = 1215) | ≥ 60 (N = 1215) | |||||
| AEs | SAEs | AEs | SAEs | |||||
| Any | 2225 (91.6) | 1413 (58.2) | 1110 (91.4) | 711 (58.5) | 1115 (91.8) | 702 (57.8) | 0.7152 | 0.7113 |
| Hand and foot skin reaction | 1351 (55.6) | 124 (5.1) | 651 (53.6) | 66 (5.4) | 700 (57.6) | 58 (4.8) | 0.0454 | 0.4608 |
| Hypertension | 748 (30.8) | 7 (0.3) | 370 (30.5) | 4 (0.3) | 378 (31.1) | 3 (0.3) | 0.7252 | 0.7051 |
| Rash | 566 (23.3) | 139 (5.7) | 301 (24.8) | 80 (6.6) | 265 (21.8) | 59 (4.9) | 0.0840 | 0.0666 |
| Diarrhoea | 514 (21.2) | 33 (1.4) | 273 (22.5) | 19 (1.6) | 241 (19.8) | 14 (1.2) | 0.1119 | 0.3808 |
| Hepatic dysfunction | 508 (20.9) | 270 (11.1) | 261 (21.5) | 126 (10.4) | 247 (20.3) | 144 (11.9) | 0.4849 | 0.2453 |
| Lipase/amylase increased | 401 (16.5) | 11 (0.5) | 223 (18.4) | 6 (0.5) | 178 (14.7) | 5 (0.4) | 0.0139 | 0.7625 |
| Dysphonia | 106 (4.4) | 1(0.0) | 60 (4.9) | 0 | 46 (3.8) | 1 (0.1) | 0.1644 | 0.3172 |
| Alopecia | 359 (14.8) | 1 (0.0) | 188 (15.5) | 0 | 171 (14.1) | 1 (0.1) | 0.3311 | 0.3172 |
| Cytopenia | 273 (11.2) | 92 (3.8) | 136 (11.2) | 44 (3.6) | 137 (11.3) | 48 (4.0) | 0.9488 | 0.6707 |
| Appetite decreased | 254 (10.5) | 44 (1.8) | 138 (11.4) | 27 (2.2) | 116 (9.6) | 17 (1.4) | 0.1446 | 0.1282 |
| Bleeding | 189 (7.8) | 159 (6.5) | 104 (8.6) | 84 (6.9) | 85 (7.0) | 75 (6.2) | 0.1501 | 0.4603 |
| Mucositis | 159 (6.5) | 8 (0.3) | 82 (6.8) | 5 (0.4) | 77 (6.3) | 3 (0.3) | 0.6817 | 0.4788 |
| Hypophosphatemia | 158 (6.5) | 3 (0.1) | 84 (6.9) | 2 (0.2) | 74 (6.1) | 1 (0.1) | 0.4106 | 0.5635 |
| Fever | 152 (6.3) | 42 (1.7) | 78 (6.4) | 22 (1.8) | 74 (6.1) | 20 (1.7) | 0.7376 | 0.77556 |
| Fatigue | 49 (2.0) | 5 (0.2) | 24 (2.0) | 3 (0.3) | 25 (2.1) | 2.0 (0.2) | 0.8852 | 0.6544 |
| Renal failure/dysfunction | 45 (1.9) | 26 (1.1) | 38 (3.1) | 20 (1.7) | 7 (0.6) | 6 (0.5) | < 0.0001 | 0.0058 |
| Proteinuria or protein urine, n (%) | 21 (0.9) | 1 (0.0) | 14 (1.2) | 1 (0.1) | 7 (0.6) | 0 | 0.1250 | 0.3172 |