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Table 6 Comparison of individual AEs of >grade 3 for dabrafenib plus trametinib versus vemurafenib plus cobimetinib

From: Indirect treatment comparison of dabrafenib plus trametinib versus vemurafenib plus cobimetinib in previously untreated metastatic melanoma patients

 

Incidence (% patients)

ITC results

COMBI-v

coBRIM

AE type

D + T (n = 350)

V (n = 349)

V (n = 239)

V + T (n = 254)

RR

LCI

UCI

p value

Alopecia

0(0)

1(<1)

1(<1)

1(<1)

0.35

0.01

24.22

0.6295

Anemia

7(2.0)

4(1.2)

6(2.4)

4(1.6)

2.63

0.46

15.10

0.2787

Arthralgia

3(<1)

15(4.3)

12(4.9)

6(2.4)

0.40

0.08

1.91

0.2513

Asthenia

5(1.4)

4(1.2)

3(1.2)

5(2.0)

0.75

0.11

5.17

0.7711

Cutaneous squamous cell carcinoma

5(1.4)

62(17.8)

27(11.3)

6(2.4)

0.38

0.11

1.34

0.1337

Dermatitis acneiform

0(0)

4(1.2)

3(1.2)

6(2.4)

0.06

0.00

1.40

0.0792

Diarrhea

4(1.1)

2(<1)

2(<1)

16(6.5)

0.25

0.03

2.34

0.2242

Fatigue

4(1.1)

7(2.0)

7(2.9)

10(4.1)

0.40

0.09

1.88

0.2459

Hyperkeratosis

0(0)

2(<1)

6(2.4)

0(0)

2.60

0.04

169.50

0.6534

Hypertension

54(15.4)

33(9.5)

6(2.4)

11(4.5)

0.89

0.31

2.58

0.8353

Increased ALT

9(2.6)

15(4.3)

15(6.1)

28(11.3)

0.32

0.12

0.88

0.0280

Increased AST

5(1.4)

9(2.6)

5(2.0)

21(8.5)

0.13

0.03

0.56

0.0062

Increased blood ALP

7(2.0)

5(1.4)

4(1.6)

10(4.1)

0.56

0.11

2.82

0.4826

Increased blood CPK

6(1.7)

1(<1)

0(0)

28(11.3)

0.11

0.00

3.49

0.2076

Increased GGT

19(5.4)

17(4.9)

25(10.2)

32(13.0)

0.87

0.39

1.96

0.7436

Keratocanthoma

2(<1)

35(10.0)

20(8.1)

3(1.2)

0.38

0.06

2.44

0.3091

Maculopapular rash

2(<1)

13(3.7)

13(5.3)

17(6.9)

0.12

0.02

0.61

0.0105

Myalgia

0(0)

4(1.2)

6(2.4)

1(<1)

0.67

0.02

24.45

0.8258

Nausea

1(<1)

1(<1)

2(<1)

2(<1)

0.53

0.02

11.65

0.6871

Pain in extremity

4(1.1)

2(<1)

6(2.4)

3(1.2)

4.00

0.45

35.40

0.2121

Photosensitivity reaction

0(0)

1(<1)

0(0)

7(2.8)

0.02

0.00

1.62

0.0820

Pyrexia

16(4.6)

2(<1)

0(0)

4(1.6)

0.94

0.04

24.60

0.9712

Rash

3(<1)

30(8.6)

14(5.7)

13(5.3)

0.11

0.03

0.43

0.0017

SCC of skin

2(<1)

20(5.7)

31(12.6)

7(2.8)

0.44

0.08

2.32

0.3349

Vomiting

4(1.1)

3(<1)

3(1.3)

3(1.2)

0.94

0.09

9.60

0.9598

  1. AE adverse event, ALP alkaline phosphatase, ALT alanine aminotransferase, AST aspartate aminotransferase, CI confidence interval, CPK creatine phosphokinase, GGT gamma-glutamyltransferase, LCI lower 95% CI, RR risk ratio, SCC squamous cell carcinoma, UCI upper 95% CI