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Table 1 Clinicopathological characteristics of trials included in this study

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

Study Trial phase Underlying malignancy No. of patients enrolled Median age (range), year Gender (Male/ Female) Treatment Median treatment duration (range), month Median follow-up (range), month
Borghaei,2015 [6] 3 Lung cancer 292 61(37–84) 151/141 Nivolumab 3 mg/kg every 14 days 3.0(0.5–26.0) > 13.2
290 64(21–85) 168/122 Docetaxel 75 mg/m2 every 21 days 3.0(0.8–17.3)
Brahmer, 2015 [7] 3 Lung cancer 135 62(39–85) 111/24 Nivolumab 3 mg/kg every 14 days 4.0(0.5–24.0) < 11.0
137 64(42–84) 97/40 Docetaxel 75 mg/m2 every 21 days 2.3(0.8–21.8)
Carbone, 2017 [8] 3 Lung cancer 271 63(32–89) 184/87 Nivolumab 3 mg/kg every 14 days 3.7(0–26.9) 13.5
270 65(29–87) 148/122 Chemotherapy once every 21 days 3.4(0–20.9)
Ferris, 2016 [10] 3 Head and neck cancer 240 59(29–83) 197/43 Nivolumab 3 mg/kg every 14 days 1.9 5.1(0–16.8)
121 61(28–78) 103/18 Systemic therapy single-agent 1.9
Kang, 2017 [9] 3 G/GJC 330 62(54–69) 229/101 Nivolumab 3 mg/kg every 14 days 1.9 8.9
163 61(53–68) 119/44 Placebo 3 mg/kg every 14 days 1.9 8.6
Motzer, 2015 [11] 3 Renal cancer 410 62(23–88) 315/95 Nivolumab 3 mg/kg every 14 days 5.5(0–29.6) > 14.0
411 62(18–86) 304/107 Everolimus 10 mg daily 3.7(0.2–25.7)
Robert, 2015 [12] 3 Melanoma 210 64(18–86) 121/89 Nivolumab 3 mg/kg every 14 days NR < 16.7
205 66(26–87) 125/83 Dacarbazine 1 g/m2 every 21 days NR
Weber, 2017 [13] 3 Melanoma 453 56(19–83) 258/195 Nivolumab 3 mg/kg every 14 days 12.0 > 18.0
453 54(18–86) 269/184 Ipilimumab 10 mg/kg every 21 days 3.0
Wolchok, 2017 [14] 3 Melanoma 314 61(18–88) 206/108 Nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 21 days 6 38
316 60(25–90) 202/114 Nivolumab 3 mg/kg every 14 days 7.5 35.7
315 62(18–89) 202/113 Ipilimumab 3 mg/kg every 21 days 3 18.6
D’angelo, 2018 [15] 2 Sarcoma 43 56(21–76) 22/21 Nivolumab 3 mg/kg every 14 days 2.3 13.6
42 57(27–81) 19/23 Nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 21 days 3.7 14.2
Long, 2018 [16] 2 Melanoma 35 59(53–68) 29/6 Nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 21 days NR 14.0
25 63(52–74) 19/6 Nivolumab 3 mg/kg every 14 days NR 17.0
16 51(48–56) 11/5 Nivolumab 3 mg/kg every 14 days NR 31.0
Motzer, 2015 [19] 2 Renal cancer 60 61 41/19 Nivolumab 0.3 mg/kg every 21 days 4.5(0–21.8) > 24.0
54 61 40/14 Nivolumab 2 mg/kg every 14 days 5.6(0.8–24.0)
54 61 40/14 Nivolumab 10 mg/kg every 14 days 6.0(0.8–23.3)
Hamanishi, 2015 [18] 2 Ovarian cancer 20 60(47–79) 0/20 Nivolumab 1 or 3 mg/kg every 14 days 3.5(1.0–12.0) 11.0(3.0–32)
Hida, 2017 [29] 2 Lung cancer 35 65(31–85) 32/3 Nivolumab 3 mg/kg every 14 days 3.6(0.5–29.3) < 30.0
Kudo, 2017 [30] 2 Esophageal cancer 65 62(49–80) 54/11 Nivolumab 3 mg/kg every 14 days 105(0.5–5.0) 10.8
Maruyama, 2017 [31] 2 Hodgkin lymphoma 17 63(29–83) 13/4 Nivolumab 3 mg/kg every 14 days 7.0(1.4–10.6) 9.8(6.0–11.1)
Nishio, 2017 [32] 2 Lung cancer 76 64(39–78) 49/27 Nivolumab 3 mg/kg every 14 days NR 16.6(0.9–31.9)
Overman, 2017 [33] 2 Colorectal cancer 74 53(44–64) 44/30 Nivolumab 3 mg/kg every 14 days 11.0 12.0
Rizvi, 2015 [34] 2 Lung cancer 117 65(57–71) 85/32 Nivolumab 3 mg/kg every 14 days 2.3 8.0
Yamazaiki, 2017 [35] 2 Melanoma 24 63(26–81) 14/10 Nivolumab 3 mg/kg every 14 days 11.9(0.5–21.0) 18.8(2.0–21.5)
Younes, 2016 [36] 2 Hodgkin lymphoma 80 37(28–48) 51/29 Nivolumab 3 mg/kg every 14 days 8.5 8.9
  1. Abbreviation: G/GJC gastric and gastro-esophageal junction cancer