Table 1.

Incidence of drug-induced lung injury (DLI) during cetuximab therapy according to patient characteristics

Patient characteristic		Safety population	Number of patients with DLI	Incidence of DLI	P value
n		2006	24	1.2%
Sex	Male	1234	18	1.46%	0.2083
	Female	772	6	0.78%
Age	<65 years	1032	6	0.58%	0.0122
	≥65 years	971	18	1.85%
	Unknown	3	0	0.0%
PS	0	1370	19	1.39%	0.3762
	1	630	5	0.79%
	2	2	0	0%
	Other	4	0	0%
Treatment line	Second line	133	2	1.50%	0.6711
	Third line or later	1869	22	1.18%
	Other	4	0	0%
Prior interstitial lung disease (ILD)	–	1955	21	1.07%	0.0442
	+	4	1	25%
	Unknown	47	2	4.26%
Complications	–	1019	11	1.08%	0.6833
	+	974	13	1.33%
	Unknown	13	0	0%
Combination chemotherapy	–	460	2	0.43%	0.2083
	+	1546	22	1.42%
	CPT-11 alone	1255	17	1.35%
	FOLFIRI	256	4	1.56%
	Other	35	1	2.86%