Number of patients (n) |
291 |
258 |
265 |
99 |
112 + 125 + 296 |
97 |
Treatment related AE, % |
91.8 |
85.7 |
84.2 |
NA |
93.8 (91.1–95.8) ▯
|
91.8 |
Treatment related ≥G3 AE, % |
49.8 |
47.7 |
40.8 |
46.0 |
52.3 (47.5–57.0) ▯
|
NA |
Fitness |
Asthenia, % |
NA |
NA |
NA |
20.2 |
NA |
NA |
≥G3 asthenia, % |
NA |
NA |
NA |
7.1 |
NA |
NA |
Fatigue, % (95% CI) |
22.7 |
39.1 |
36.2 |
32.3 |
43.9 (29.8–58.9) |
47.4 |
≥G3 fatigue, % (95% CI) |
4.5 |
6.6 |
6.0 |
2.0 |
5.7 (3.9–8.1) |
8.2 |
Skin, hair, nail and mucosa |
Alopecia, % (95% CI) |
36.4 |
23.6 |
30.6 |
29.3 |
46.3 (42.1–50.6) |
34.0 |
≥G3 alopecia, % |
0 |
0 |
0.4 |
0 |
0 |
NA |
Dry mouth, % |
NA |
NA |
NA |
45.5 |
NA |
NA |
≥G3 dry mouth, % |
NA |
NA |
NA |
0 |
NA |
NA |
Dry skin, % (95% CI) |
NA |
NA |
NA |
32.3 |
21.9 (17.1–27.7) |
NA |
≥G3 dry skin, % |
NA |
NA |
NA |
0 |
0 |
NA |
Hand-foot syndrome, % |
NA |
NA |
NA |
23.2 |
NA |
NA |
≥G3 hand-foot syndrome, % |
NA |
NA |
NA |
5.1 |
NA |
NA |
Maculopapular rash, % (95% CI) |
NA |
NA |
NA |
NA |
20.9 (15.2–27.9) |
NA |
≥G3 maculopapular rash, % (95% CI) |
NA |
NA |
NA |
NA |
6.0 (4.3–8.5) |
NA |
Nail dystrophy, % |
NA |
NA |
NA |
16.2 |
NA |
NA |
≥G3 nail dystrophy, % |
NA |
NA |
NA |
6.1 |
NA |
NA |
Pruritus, % (95% CI) |
NA |
NA |
NA |
NA |
27.6 (18.7–38.7) |
NA |
≥G3 pruritus, % (95% CI) |
NA |
NA |
NA |
NA |
1.1 (0.5–2.6) |
NA |
Stomatitis, % |
NA |
23.3 |
9.1 |
57.6 |
NA |
NA |
≥G3 stomatitis, % |
NA |
3.5 |
0 |
10.1 |
NA |
NA |
Gastrointestinal and urinary tract |
Abdominal pain, % |
NA |
NA |
NA |
NA |
NA |
22.7 |
≥G3 abdominal pain, % |
NA |
NA |
NA |
NA |
NA |
3.1 |
Constipation, % |
NA |
NA |
NA |
28.3 |
NA |
30.9 |
≥G3 constipation, % |
NA |
NA |
NA |
1.0 |
NA |
1.0 |
Decreased appetite/anorexia, % (95% CI) |
23.4 |
22.1 |
17.0 |
38.4 |
38.3 (29.6–47.7) |
NA |
≥G3 decreased appetite/anorexia, % |
1.7 |
1.6 |
0.4 |
0 |
2.4 (1.3–4.3) |
NA |
Diarrhoea, % (95% CI) |
NA |
23.6 |
16.6 |
50.5 |
28.1 (24.5–32.1) |
56.7 |
≥G3 diarrhoea, % (95% CI) |
NA |
3.1 |
1.1 |
4.0 |
2.9 (1.7–4.8) |
9.3 |
Dysgeusia, % (95% CI) |
NA |
NA |
NA |
37.4 |
33.5 (23.4–45.4) |
NA |
≥G3 dysgeusia, % |
NA |
NA |
NA |
1.0 |
0 |
NA |
Nausea, % (95% CI) |
21.6 |
22.1 |
14.0 |
20.2 |
32.3 (21.8–45.0) |
57.7 |
≥G3 nausea, % (95% CI) |
1.4 |
0.8 |
0.8 |
1.0 |
1.4 (0.7–3.0) |
2.1 |
UTI, % |
NA |
NA |
NA |
16.2 |
NA |
NA |
≥G3 UTI, % |
NA |
NA |
NA |
5.1 |
NA |
NA |
Vomiting, % |
NA |
NA |
NA |
NA |
NA |
39.2 |
≥G3 vomiting, % |
NA |
NA |
NA |
NA |
NA |
3.1 |
Laboratory changes |
Anemia, % |
20.3 |
11.6 |
16.2 |
20.2 |
NA |
38.1 |
≥G3 anemia, % |
7.6 |
1.9 |
5.3 |
4.0 |
NA |
11.3 |
Hyponatremia, % |
NA |
NA |
NA |
12.1 |
NA |
NA |
≥G3 hyponatremia, % |
NA |
NA |
NA |
11.1 |
NA |
NA |
Hyperphosphatemia, % |
NA |
NA |
NA |
76.8 |
NA |
NA |
≥G3 hyperphosphatemia, % |
NA |
NA |
NA |
2.0 |
NA |
NA |
Leucopenia, % |
NA |
NA |
NA |
NA |
NA |
NA |
≥G3 leucopenia, % |
NA |
NA |
NA |
NA |
NA |
NA |
White blood cell count decrease, % |
10.7 |
6.6 |
7.5 |
NA |
NA |
17.5 |
≥G3 White blood cell count decrease, % |
6.9 |
4.3 |
6.4 |
NA |
NA |
11.3 |
Neutrophil count decrease, % |
16.8 |
11.6 |
10.6 |
NA |
10.2 (7.7–13.5) |
53.6 |
≥G3 Neutrophil count decrease, % |
13.4 |
8.9 |
10.2 |
NA |
6.7 (4.7–9.5) |
33.0 |
Neutropenia, % |
8.2 |
8.5 |
4.2 |
NA |
NA |
NA |
≥G3 Neutropenia, % |
6.2 |
6.6 |
2.3 |
NA |
NA |
NA |
Neutropenia, febrile, % |
5.5 |
9.3 |
6.0 |
NA |
NA |
NA |
≥G3 neutropenia, febrile, % |
5.5 |
9.3 |
6.0 |
NA |
NA |
6.2 |
Others |
PSN, % (95% CI) |
21.3 |
NA |
NA |
NA |
36.1 (32.1–40.2) |
NA |
≥G3 PSN, % (95% CI) |
2.1 |
NA |
NA |
NA |
2.5 (1.4–4.3) |
NA |