Adverse events | Median (months) | 95% C.I. of median | P value | Hazard ratio | 95% C.I. of HR | P value |
---|---|---|---|---|---|---|
Skin | Â | Â | .274 | Â | Â | Â |
 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 | Â | Â | .092 | Â | Â | Â |
 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 | Â | Â | .287 | Â | Â | Â |
 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 | Â | Â | .624 | Â | Â | Â |
 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 | Â | Â | .353 | Â | Â | Â |
 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 | Â | Â | .005 | Â | Â | Â |
 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 | Â | Â | .094 | Â | Â | Â |
 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 | Â | Â | .024 | Â | Â | Â |
 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 | Â | Â | .234 | Â | Â | Â |
 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 | Â | Â | .003 | Â | Â | Â |
 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 | Â | Â | .001 | Â | Â | Â |
 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 |