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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