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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