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Table 2 Summary of AEs by ADA category after pembrolizumab treatment

From: Immunogenicity of pembrolizumab in patients with advanced tumors

  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)
  1. ADA Antidrug antibody, AE Adverse event, NAb Neutralizing antibody, Non-TE Non–treatment-emergent ADA positive, TE Treatment emergent ADA positive
  2. aDetermined by the investigator to be related to the drug
  3. 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