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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