Risk factors for severe rash with use of vemurafenib alone or in combination with cobimetinib for advanced melanoma: pooled analysis of clinical trials

Table 2 Univariable association between patient characteristics and risk of severe (grade 3 or 4) rash for patients using vemurafenib alone or in combination with cobimetinib for advanced melanoma

	Events/Patients (%)	OR	95% CI	P-value
Sex				< 0.001
Male	64/565 (11%)	1.00
Female	86/397 (22%)	2.17	1.52 to 3.09
Age (years)				0.462
< 50	46/345 (13%)	1.00
50 to 59	42/253 (17%)	1.31	0.83 to 2.07
60 to 69	39/219 (18%)	1.42	0.89 to 2.27
≥ 70	23/145 (16%)	1.24	0.72 to 2.15
ECOG PS				0.597
0	102/639 (16%)	1.00
1+	47/317 (15%)	0.90	0.61 to 1.32
Weight (kg)				0.002
< 66	52/233 (22%)	1.00
66–78	38/242 (16%)	0.64	0.40 to 1.02
79–90	23/247 (9%)	0.36	0.21 to 0.62
≥ 91	36/233 (15%)	0.63	0.39 to 1.01
Body mass index (kg/m²)				0.385
18.5–25.0	64/345 (19%)	1.00
< 18.5	3/21 (14%)	0.74	0.21 to 2.59
25.1–29.9	47/340 (14%)	0.71	0.47 to 1.08
≥ 30.0	33/226 (15%)	0.75	0.47 to 1.18
eGFR (ml/min/1.73 m²)				0.228
> 90	71/517 (14%)	1.00
60–89	67/388 (17%)	1.30	0.91 to 1.88
45–59	8/41 (20%)	1.46	0.64 to 3.30
30–44	4/13 (31%)	2.81	0.84 to 9.38
Bilirubin				0.225
≤ ULN	146/913 (16%)	1.00
> ULN	3/36 (8%)	0.48	0.14 to 1.58
AST				0.901
≤ ULN	132/843 (16%)	1.00
> ULN	16/103 (16%)	0.96	0.55 to 1.70
ALT				0.108
≤ ULN	138/843 (16%)	1.00
> ULN	11/106 (10%)	0.58	0.30 to 1.12
History of atopy				0.279
No	125/767 (16%)	1.00
Yes	22/176 (13%)	0.77	0.48 to 1.24

ALT alanine aminotransferase, AST aspartate aminotransferase, CI confidence interval, ECOG PS Eastern Cooperative Oncology Group performance status, eGFR Estimated glomerular filtration rate, OR odds ratio, ULN upper limit of normal

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