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Table 1 Subgroup analysis and characteristics of the TRAEs

From: The safety and tolerability of combined immune checkpoint inhibitors (anti-PD-1/PD-L1 plus anti-CTLA-4): a systematic review and meta-analysis

 

No. of studies

No. of patients

Incidence

95%CI

Effects model

Heterogeneity

Egger’s test (p)

(I2)

p

Any grade TRAEs

16

2584

0.88

0.84–0.92

Random

90%

< 0.01

0.97

Any grade TRAEs (melanoma)

6

783

0.95

0.93–0.96

Fixed

0%

0.43

 

Any grade TRAEs (NSCLC)

3

755

0.76

0.73–0.79

Fixed

0%

0.51

 

Any grade TRAEs (NIVO1 + IPI3)

8

703

0.92

0.88–0.96

Random

70%

< 0.01

 

Any grade TRAEs (NIVO3 + IPI1)

6

839

0.86

0.75–0.95

Random

90%

< 0.01

 

Any grade TRAEs(Phase II-III trials)

8

1818

0.89

0.81–0.95

Random

95%

< 0.01

 

Grade 3 or higher TRAEs

17

2626

0.41

0.35–0.47

Random

88%

< 0.01

0.83

Grade 3 or higher TRAEs (melanoma)

6

783

0.55

0.51–0.58

Fixed

40%

0.14

 

Grade 3 or higher TRAEs (NSCLC)

3

755

0.33

0.30–0.36

Fixed

38%

0.019

 

Grade 3 or higher TRAEs (NIVO1 + IPI3)

8

703

0.54

0.46–0.62

Random

75%

< 0.01

 

Grade 3 or higher TRAEs (NIVO3 + IPI1)

7

881

0.29

0.20–0.40

Random

86%

< 0.01

 

Grade 3 or higher TRAEs (Phase II-III trials)

9

1860

0.40

0.31–0.50

Random

93%

< 0.01

 

Any grade TRAEs leading to discontinuation of treatment

17

2626

0.20

0.16–0.24

Random

82%

< 0.01

0.09

Any grade TRAEs leading to discontinuation of treatment (melanoma)

6

783

0.30

0.20–0.39

Random

89%

< 0.01

 

Any grade TRAEs leading to discontinuation of treatment (NSCLC)

3

755

0.18

0.13–0.27

Random

70%

0.02

 

Any grade TRAEs leading to discontinuation of treatment(NIVO1 + IPI3)

8

703

0.27

0.19–0.35

Random

81%

< 0.01

 

Any grade TRAEs leading to discontinuation of treatment(NIVO3 + IPI1)

7

881

0.14

0.10–0.20

Random

63%

0.01

 

Any grade TRAEs leading to discontinuation of treatment (Phase II-III trials)

9

1860

0.22

0.16–0.29

Random

90%

< 0.01

 

Grade 3 or higher TRAEs leading to discontinuation of treatment

10

1538

0.16

0.12–0.23

Random

83%

< 0.01

0.28

Grade 3 or higher TRAEs leading to discontinuation of treatment(melanoma)

4

595

0.28

0.24–0.31

Fixed

36%

0.20

 

Grade 3 or higher TRAEs leading to discontinuation of treatment(NSCLC)

2

653

0.12

0.09–0.14

Fixed

0%

0.38

 

Any grade TRAEs leading to discontinuation of treatment (Phase II-III trials)

6

1236

0.17

0.11–0.27

Random

91%

< 0.01

 

Any grade treatment-related serious adverse events

10

1270

0.32

0.27–0.39

Random

71%

< 0.01

0.28

Treatment-related deaths

17

2626

0.0043

0.0014

−0.0084

Fixed

0%

0.77

0.95

Any grade fatigue

15

2484

0.38

0.30–0.46

Random

92%

< 0.01

0.40

Any grade diarrhea

15

2551

0.29

0.24–0.35

Random

87%

< 0.01

0.25

Any grade pruritus

14

2450

0.26

0.20–0.31

Random

90%

< 0.01

0.26

Any grade rash

16

2586

0.22

0.17–0.29

Random

92%

< 0.01

0.04

Any grade nausea

13

2348

0.20

0.16–0.25

Random

82%

< 0.01

> 0.99

Any grade hypothyroidism

12

2331

0.14

0.13–0.16

Fixed

40%

0.06

0.86

Any grade decreased appetite

11

2135

0.14

0.11–0.17

Random

52%

< 0.01

0.15

Grade 3 or higher increased lipase

13

1790

0.09

0.06–0.12

Random

80%

< 0.01

0.43

Grade 3 or higher colitis

10

1166

0.06

0.04–0.08

Random

50%

0.02

0.65

Grade 3 or higher increased ALT

13

1428

0.06

0.04–0.09

Random

72%

< 0.01

0.93

Grade 3 or higher increased AST

13

1428

0.05

0.02–0.07

Random

72%

< 0.01

0.75

Grade 3 or higher diarrhea

15

2551

0.05

0.03–0.07

Random

79%

< 0.01

0.38

Grade 3 or higher fatigue

15

2484

0.02

0.01–0.03

Random

58%

< 0.01

0.52

Grade 3 or higher rash

16

2586

0.01

0.01–0.02

Fixed

24%

0.15

0.79

  1. TRAEs Treatment-related adverse events, NSCLC Non-small cell lung cancer, NIVO1 + IPI3 Nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, every 3 weeks for 4 doses (induction phase), followed by nivolumab 3 mg/kg, every 2 weeks until disease progression or unacceptable toxicity incidence of TRAEs (maintenance phase); NIVO3 + IPI1, nivolumab 3 mg/kg plus ipilimumab 1 mg/kg, every 3 weeks for 4 doses (induction phase), followed by nivolumab 3 mg/kg, every 2 weeks until disease progression or unacceptable toxicity incidence of TRAEs (maintenance phase)
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