Table 2.
Adverse events | Median (months) | 95% C.I. of median | P value | Hazard ratio | 95% C.I. of HR | P value |
---|---|---|---|---|---|---|
Skin | .274 | |||||
Grade 0 (n = 32) | 2.8 | 1.9–3.8 | 1 | |||
Grade 1–2 (n = 17) | 3.6 | 1.6–5.6 | 0.71 | 0.38–1.32 | .278 | |
Skin/vitiligo | .092 | |||||
Grade 0 (n = 30) | 2.5 | 1.6–3.4 | 1 | |||
Grade 1–2 (n = 19) | 4.6 | 2.5–6.7 | 0.59 | 0.32–1.10 | .096 | |
Mucositis | .287 | |||||
Grade 0 (n = 46) | 3.1 | 2.5–3.8 | 1 | |||
Grade 1–2 (n = 3) | 3.0 | 0.4–5.6 | 1.90 | 0.57–6.29 | .296 | |
Colitis | .624 | |||||
Grade 0 (n = 43) | 3.2 | 2.6–3.7 | 1 | |||
Grade 1–2 (n = 6) | 3.0 | 2.3–3.7 | 1.24 | 0.52–2.96 | .626 | |
Liver | .353 | |||||
Grade 0 (n = 47) | 3.2 | 2.7–3.6 | 1 | |||
Grade 1–2 (n = 1) | 3.1 | – | 1.48 | 0.20–10.99 | .700 | |
Grade 3–5 (n = 1) | 2.1 | – | 3.89 | 0.50–30.19 | .194 | |
Lung | .005 | |||||
Grade 0 (n = 47) | 3.2 | 2.8–3.5 | 1 | |||
Grade 3–5 (n = 2) | 0.9 | – | 6.71 | 1.44–31.38 | .016 | |
Endocrine | .094 | |||||
Grade 0 (n = 40) | 2.7 | 2.1–3.3 | 1 | |||
Grade 1–2 (n = 9) | 6.1 | 2.7–9.6 | 0.52 | 0.24–1.13 | .100 | |
Fatigue | .024 | |||||
Grade 0 (n = 42) | 3.2 | 2.7–3.7 | 1 | |||
Grade 1–2 (n = 7) | 2.4 | 1.5–3.4 | 2.56 | 1.09–6.00 | .030 | |
Vitiligo | .234 | |||||
Grade 0 (n = 47) | 3.0 | 2.5–3.4 | 1 | |||
Grade 1–2 (n = 2) | 4.7 | – | 0.32 | 0.04–2.33 | .261 | |
Skin/vitiligo/endocrine | .003 | |||||
Grade 0 (n = 26) | 2.3 | 1.7–2.8 | 1 | |||
Any grade (n = 23) | 4.8 | 4.3–5.3 | 0.40 | 0.21–0.74 | .003 | |
Overall | .001 | |||||
Grade 0 (n = 19) | 2.5 | 1.7–3.3 | 1 | |||
Grade 1–2 (n = 27) | 4.6 | 2.8–6.4 | 0.52 | 0.27–0.98 | .042 | |
Grade 3–5 (n = 3) | 2.0 | 0.2–3.8 | 4.24 | 1.1–16.3 | .035 |
C.I. confidence interval