Adverse events | Median (months) | 95% C.I. of median | P value | Hazard ratio | 95% C.I. of HR | P value |
---|---|---|---|---|---|---|
Skin | Â | Â | .054 | Â | Â | Â |
 Grade 0 (n = 32) | 5.7 | 1.3–10.0 |  | 1 |  |  |
 Grade 1–2 (n = 17) | 16.4 | 4.8–28.0 |  | 0.49 | 0.24–1.03 | .059 |
Skin/vitiligo | Â | Â | .047 | Â | Â | Â |
 Grade 0 (n = 30) | 5.1 | 3.1–7.2 |  | 1 |  |  |
 Grade 1–2 (n = 19) | 16.4 | 4.8–28.0 |  | 0.49 | 0.24–1.01 | .052 |
Mucositis | Â | Â | .150 | Â | Â | Â |
 Grade 0 (n = 46) | 11.3 | 5.6–17.0 |  | 1 |  |  |
 Grade 1–2 (n = 3) | 6.0 | 0.1–13.2 |  | 2.36 | 0.71–7.92 | .163 |
Colitis | Â | Â | .773 | Â | Â | Â |
 Grade 0 (n = 43) | 13.1 | 6.9–19.4 |  | 1 |  |  |
 Grade 1–2 (n = 6) | 9.7 | 2.716.6 |  | 1.15 | 0.44–2.98 | .773 |
Liver | Â | Â | .292 | Â | Â | Â |
 Grade 0 (n = 47) | 10.7 | 5.3–16.2 |  | 1 |  |  |
 Grade 1–2 (n = 1) | 9.7 | – |  | 1.55 | 0.21–11.50 | .670 |
 Grade 3–5 (n = 1) | 2.8 | – |  | 4.33 | 0.55–33.91 | .162 |
Lung | Â | Â | .001 | Â | Â | Â |
 Grade 0 (n = 47) | 10.7 | 6.2–15.3 |  | 1 |  |  |
 Grade 3–5 (n = 2) | 0.9 | – |  | 8.90 | 1.83–43.4 | .007 |
Endocrine | Â | Â | .062 | Â | Â | Â |
 Grade 0 (n = 40) | 8.8 | 2.4–15.3 |  | 1 |  |  |
 Grade 1–2 (n = 9) | 18.7 | 2.0–35.3 |  | 0.38 | 0.13–1.09 | .073 |
Fatigue | Â | Â | .019 | Â | Â | Â |
 Grade 0 (n = 42) | 11.3 | 6.1–16.4 |  | 1 |  |  |
 Grade 1–2 (n = 7) | 3.7 | 1.3–6.2 |  | 2.69 | 1.14–6.34 | .024 |
Vitiligo | Â | Â | .856 | Â | Â | Â |
 Grade 0 (n = 47) | 10.7 | 7.3–14.2 |  | 1 |  |  |
 Grade 1–2 (n = 2) | 8.1 | – |  | 0.83 | 0.11–6.16 | .856 |
Skin/vitiligo/endocrine | Â | Â | .002 | Â | Â | Â |
 Grade 0 (n = 26) | 4.5 | 0.9–8.1 |  | 1 |  |  |
 Any grade (n = 23) | 18.7 | 6.2–31.1 |  | 0.34 | 0.17–0.69 | .003 |
Overall | Â | Â | <.001 | Â | Â | Â |
 Grade 0 (n = 19) | 5.7 | 0.1–11.7 |  | 1 |  |  |
 Grade 1–2 (n = 27) | 15.2 | 7.9–22.5 |  | 0.50 | 0.24–1.02 | .058 |
 Grade 3–5 (n = 3) | 2.0 | 0.2–3.8 |  | 5.13 | 1.29–20.34 | .020 |