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Table 2 Adverse events (AEs)

From: Safety, tolerability, pharmacokinetics, and pharmacodynamics of the afucosylated, humanized anti-EPHA2 antibody DS-8895a: a first-in-human phase I dose escalation and dose expansion study in patients with advanced solid tumors

  Step 1 Step 2
(n = 22) (n = 15)
AEs, any grades 21 (95.5) 15 (100)
AEs, grade ≥ 3 5 (22.7) 8 (53.3)
Drug-related AEs, any grades 14 (63.6) 10 (66.7)
Drug-related AEs, grade ≥ 3 2 (9.1) 1 (6.7)
 Syncope 1 (4.5) 0 (0.0)
 Anemia 1 (4.5) 0 (0.0)
 White blood cell count decreased 1 (4.5) 0 (0.0)
 Lymphocyte count decreased 0 (0.0) 1 (6.7)
 Neutrophil count decreased 1 (4.5) 0 (0.0)
 Platelet count decreaseda 1 (4.5) 0 (0.0)
Infusion-related reactionb,c 13 (59.1) 6 (40.0)
 Chills 9 (40.9) 3 (20.0)
  Grade 1 5 (22.7) 3 (20.0)
  Grade 2 4 (18.2) 0 (0.0)
 Pyrexia 5 (22.7) 4 (26.7)
  Grade 1 4 (18.2) 4 (26.7)
  Grade 2 1 (4.5) 0 (0.0)
 Hypotension 5 (22.7) 2 (13.3)
  Grade 1 2 (9.1) 2 (13.3)
  Grade 2 3 (13.6) 0 (0.0)
 Hypoxia 4 (18.2) 1 (6.7)
  Grade 1 1 (4.5) 0 (0.0)
  Grade 2 3 (13.6) 1 (6.7)
 Nausea 4 (18.2) 0 (0.0)
  Grade 1 3 (13.6) 0 (0.0)
  Grade 2 1 (4.5) 0 (0.0)
  1. N (%)
  2. aGrade 4 platelet count decreased was judged as a dose-limiting toxicity
  3. bMajor reactions that occurred in four or more patients were presented
  4. cNo Grade 3 or 4 infusion-related adverse events occurred