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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