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Table 3 Summary of treatment-related grade 3 or 4 adverse events in the intention-to-treat population

From: Irinotecan plus S-1 versus S-1 in patients with previously treated recurrent or metastatic esophageal cancer (ESWN 01): a prospective randomized, multicenter, open-labeled phase 3 trial

Adverse events (grade 3 or 4) Total patients [cases (%)] (N = 123) Treatment groups P value#
Irinotecan plus S-1 group [cases (%)] (n = 61) S-1 monotherapy group [cases (%)] (n = 62)
Anemia 3 (2.4) 2 (3.3) 1 (1.6) 0.619
Leukopenia 10 (8.1) 10 (16.4) 0 (0) 0.001
Neutropenia 10 (8.1) 9 (14.8) 1 (1.6) 0.008
Thrombocytopenia 2 (1.6) 2 (3.3) 0 (0) 0.496
Diarrhea 3 (2.4) 2 (3.3) 1 (1.6) 0.619
Nausea 3 (2.4) 3 (4.9) 0 (0) 0.119
Vomiting 2 (1.6) 1 (1.6) 1 (1.6) 0.748
Fatigue 3 (2.4) 2 (3.3) 1 (1.6) 0.619
Anorexia 1 (0.8) 0 (0) 1 (1.6) 1.000
Elevated bilirubin 1 (0.8) 1 (1.6) 0 (0) 1.000
  1. #Tested by Fisher’s exact test