Cetuximab plus platinum-based chemotherapy in head and neck squamous cell carcinoma: a randomized, double-blind safety study comparing cetuximab produced from two manufacturing processes using the EXTREME study regimen

Table 5 Treatment-emergent adverse events of special interest for cetuximab

Adverse event	Relatedness of adverse event	US commercial cetuximab Arm A (N = 77) n (%)	BI-manufactured cetuximab Arm B (N = 71) n (%)	Arm A vs Arm B p value (95 % CI)
Acneiform rash^a	Regardless of causality	42 (54.5)	40 (56.3)	0.826 (−0.142, 0.178)
	Possibly related to study drug	41 (53.2)	40 (56.3)	0.706 (−0.129, 0.191)
Cardiac event^b	Regardless of causality	5 (6.5)	10 (14.1)	0.128 (−0.022, 0.174)
	Possibly related to study drug	2 (2.6)	6 (8.5)	0.120 (−0.015, 0.132)
Infusion reaction^c	Regardless of causality	6 (7.8)	5 (7.0)	0.862 (−0.077, 0.092)
	Possibly related to study drug	5 (6.5)	4 (5.6)	0.826 (−0.068, 0.085)
Hypo-magnesemia	Regardless of causality	29 (37.7)	29 (40.8)	0.692 (−0.126, 0.189)
	Possibly related to study drug	26 (33.8)	23 (32.4)	0.859 (−0.138, 0.165)

^a Composite term of 16 MedDRA Preferred Terms including dermatitis acneiform and rash
^b Composite term of 39 MedDRA Preferred Terms including cardiac arrest and myocardial infarction
^c Composite term of 9 MedDRA Preferred Terms including infusion-related reaction and anaphylactic shock
Abbreviations: BI Boehringer Ingelheim, CI confidence interval, MedDRA Medical Dictionary for Regulatory Activities, US United States

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