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Table 4 Summary of TEAEs

From: ASP5094, a humanized monoclonal antibody against integrin alpha-9, did not show efficacy in patients with rheumatoid arthritis refractory to methotrexate: results from a phase 2a, randomized, double-blind, placebo-controlled trial

n (%) Placebo (n = 33) ASP5094 (n = 33)
TEAE 13 (39.4%) 20 (60.6%)
 Mild 9 (27.3%) 13 (39.4%)
 Moderate 4 (12.1%) 6 (18.2%)
 Severe 0 1 (3.0%)
Drug-related TEAE 2 (6.1%) 5 (15.2%)
Serious TEAE 1 (3.0%) 2 (6.1%)
Drug-related serious TEAE 0 1 (3.0%)
TEAE leading to permanent discontinuation 0 2 (6.1%)
Drug-related TEAE leading to discontinuation 0 1 (3.0%)
Serious TEAE leading to permanent discontinuation 0 0
Death 0 0
TEAEs experienced by > 1 patient overall
 Rheumatoid arthritis 4 (12.1%) 6 (18.2%)
 Viral upper respiratory tract infection 3 (9.1%) 4 (12.1%)
 Constipation 1 (3.0%) 3 (9.1%)
 Influenza 1 (3.0%) 2 (6.1%)
 Chest discomfort 2 (6.1%) 1 (3.0%)
 Cystitis 1 (3.0%) 1 (3.0%)
 Pneumonia 1 (3.0%) 1 (3.0%)
  1. TEAE treatment-emergent adverse event