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Table 3 The adverse event rates (all grades) and 95% confidence interval of fixed model and random model in single-arm trials

From: Safety and efficacy profile of Trastuzumab deruxtecan in solid cancer: pooled reanalysis based on clinical trials

Model

Group by

All grade

Event rate (%)

Lower limit (%)

Upper limit (%)

Z-Value

p-Value

Fixed

Abdominal pain

13.6

10.7

17.3

−12.907

0.000

Fixed

Alanine aminotransferase increased

17.9

14.8

21.4

−13.234

0.000

Fixed

Cholangitis

5.5

1.8

15.9

−4.765

0.000

Fixed

Cough

16.5

13.5

20.1

−13.286

0.000

Fixed

Dizziness

13.3

8.2

20.9

−6.768

0.000

Fixed

Dysgeusia

15.1

11.0

20.5

−9.120

0.000

Fixed

Dyspnea

14.8

7.6

26.9

−4.566

0.000

Fixed

Electrocardiogram QT prolonged

6.7

3.9

11.5

−8.749

0.000

Fixed

Epistaxis

11.6

7.6

17.3

−8.546

0.000

Fixed

Hypoalbuminaemia

12.3

8.5

17.4

−9.382

0.000

Fixed

Hypokalaemia

15.3

11.9

19.4

−11.667

0.000

Fixed

Hyponatraemia

8.2

4.8

13.6

−8.334

0.000

Fixed

Increased alanine aminotransferase

9.0

4.3

17.6

−5.848

0.000

Fixed

Increased blood alkaline phosphatase

11.3

5.8

21.1

−5.473

0.000

Fixed

Increased blood bilirubin

4.2

2.4

7.4

−10.347

0.000

Fixed

Infusion-related reactions

1.7

0.6

4.7

−7.536

0.000

Fixed

Intestinal perforation

3.8

0.2

40.3

−2.232

0.026

Fixed

Malaise

24.3

20.6

28.5

−10.369

0.000

Fixed

Nasopharyngitis

10.3

6.6

15.8

−8.675

0.000

Fixed

Nausea

72.3

69.8

74.6

15.856

0.000

Fixed

Neutropenia

6.4

2.7

14.5

−5.800

0.000

Fixed

Oedema

12.2

8.8

16.7

−10.609

0.000

Fixed

Pneumonitis

8.2

5.6

11.9

−11.503

0.000

Fixed

Pyrexia

20.4

17.0

24.3

−11.903

0.000

Fixed

Rush

13.0

8.0

20.5

−6.852

0.000

Fixed

Stomatitis

22.9

17.9

28.7

−7.797

0.000

Fixed

Upper respiratory tract infection

11.1

6.7

17.9

−7.319

0.000

Fixed

Weight decreased

14.3

10.3

19.5

−9.352

0.000

Random

Abdominal distension

19.0

6.4

44.7

−2.296

0.022

Random

Alopecia

35.6

29.8

41.8

−4.422

0.000

Random

Anaemia

37.2

32.2

42.5

−4.648

0.000

Random

Constipation

26.9

22.4

31.8

−8.174

0.000

Random

Decreased appetite

44.3

35.0

54.1

−1.135

0.256

Random

Decreased lymphocyte count

12.6

7.3

20.8

−6.325

0.000

Random

Decreased neutrophil count

36.4

30.6

42.7

−4.131

0.000

Random

Decreased platelet count

29.0

25.0

33.4

−8.565

0.000

Random

Decreased white blood cell count

26.1

22.4

30.0

−10.345

0.000

Random

Diarrhoea

29.5

25.5

33.9

−8.382

0.000

Random

Ejection fraction decreased

3.0

0.6

14.1

−4.075

0.000

Random

Fatigue

38.5

32.4

45.0

−3.426

0.001

Random

Headache

14.6

8.4

24.2

−5.535

0.000

Random

Increased aspartate aminotransferase

19.5

14.8

25.2

−8.386

0.000

Random

Interstitial lung disease

7.5

4.5

12.1

−9.151

0.000

Random

Vomiting

39.2

33.8

44.9

−3.698

0.000