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Table 2 The risk and benefit of nivolumab treatment in cancer

From: Serious adverse events and fatal adverse events associated with nivolumab treatment in cancer patients

Study Underlying malignancy No. of patients enrolled Median OS (95% CI), month HR (95% CI) P value No. of patients (safety) FAE SAE
Borghaei,2015 [6] Lung cancer 292 12.2(9.7–15.0) 0.73(0.59–0.89) 0.002 287 1 21
290 9.4(8.1–10.7) 268 1 53
Brahmer, 2015 [7] Lung cancer 135 9.2(7.3–13.3) 0.59(0.44–0.79) < 0.001 131 0 9
137 6.0(5.1–7.3) 129 3 31
Carbone, 2017 [8] Lung cancer 271 14.4(11.7–17.4) 1.02(0.80–1.30) NR 267 2 46
270 13.2(10.7–17.1) 263 3 48
Ferris, 2016 [10] Head and neck cancer 240 7.5(5.5–9.1) 0.70(0.51–0.96) 0.01 236 2 NR
121 5.1(4.0–6.0) 111 1 NR
Kang, 2017 [9] G/GJC 330 5.3(4.6–6.4) 0.63(0.51–0.78) < 0.0001 330 5 33
163 4.1(3.4–4.9) 161 2 8
Motzer, 2015 [11] Renal cancer 410 25.0(21.8-not reached) 0.73(0.57–0.93) 0.002 406 0 NR
411 19.6(17.6–23.1) 397 2 NR
Robert, 2015 [12] Melanoma 210 Not reached 0.42(0.25–0.73) < 0.001 206 0 19
205 10.8(9.3–12.1) 205 0 18
Weber, 2017 [13] Melanoma 453 NR NR NR 452 0 NR
453 NR NR NR 453 2 NR
Wolchok, 2017 [14] Melanoma 314 Not reached NR NR 313 2 NR
316 37.6(29.1-not reached) NR NR 313 1 NR
315 19.9(16.9–24.6) NR NR 311 1 NR
D’angelo, 2018 [15] Sarcoma 43 10.7(5.5–15.4) NR NR 42 0 8
42 14.3(9.6-not reached) NR NR 42 0 11
Long, 2018 [16] Melanoma 35 NR NR NR 35 0 16
25 NR NR NR 25 0 1
16 NR NR NR 16 0 2
Motzer, 2015 [19] Renal cancer 60 18.2 NR NR 59 0 NR
54 25.5 NR NR 54 0 NR
54 24.7 NR NR 54 0 NR
Hamanishi, 2015 [18] Ovarian cancer 20 20.0 NR NR 20 0 5
Hida, 2017 [29] Lung cancer 35 16.3(12.4–25.4) NR NR 35 0 3
Kudo, 2017 [30] Esophageal cancer 65 10.8(7.4–13.3) NR NR 65 0 10
Maruyama, 2017 [31] Hodgkin lymphoma 17 NR NR NR 17 0 6
Nishio, 2017 [32] Lung cancer 76 17.1(13.3–23.0) NR NR 76 0 15
Overman, 2017 [33] Colorectal cancer 74 NR NR NR 74 0 9
Rizvi, 2015 [34] Lung cancer 117 8.2(6.1–10.9) NR NR 117 2 NR
Yamazaiki, 2017 [35] Melanoma 24 NR NR NR 24 0 4
Younes, 2016 [36] Hodgkin lymphoma 80 NR NR NR 80 0 5
  1. Abbreviation: G/GJC gastric and gastro-esophageal junction cancer FAE, fatal adverse event SAE Serious adverse event; OS overall survival; CI confidence interval; HR hazard ratio; NR not reported