Table 2.

Summary of AEs by ADA category after pembrolizumab treatment

	ADA-negative patients	ADA-positive patients, n = 57				Total patients
		Non-TE NAb negative	Non-TE NAb positive	TE NAb negative	TE NAb positive
Patients in population	1943	19	2	27	9	2000
Patients with drug-relateda AE, n (%)	1338 (68.9)	11 (57.9)	2 (100)	21 (77.8)	6 (66.7)	1378 (68.9)
Patients with infusion-related reaction,b n (%)	43 (2.2)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	43 (2.2)

ADA Antidrug antibody, AE Adverse event, NAb Neutralizing antibody, Non-TE Non–treatment-emergent ADA positive, TE Treatment emergent ADA positive

^aDetermined by the investigator to be related to the drug

^bInfusion-related reaction is defined as the occurrence of 1 or more of the following preferred terms (MedDRA Version 21) [19]: hypersensitivity, drug hypersensitivity, anaphylactic reaction, anaphylactoid reaction, cytokine release syndrome, serum sickness, serum sickness-like reaction, infusion-related reaction