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Table 5 Summary of AEs (safety population)

From: Analysis of patients with diabetes and complicated intra-abdominal infection or complicated urinary tract infection in phase 3 trials of ceftolozane/tazobactam

Parameter, n (%) Diabetes n = 245 No diabetes n = 1802 P valuea
Any AE 120 (49.0) 673 (37.3) 0.00046
Any serious AE 26 (10.6) 82 (4.6) 0.00007
Any treatment-related AE 20 (8.2) 182 (10.1) 0.34038
Any treatment-related serious AE 0 (0.0) 4 (0.2) 0.46052
Any AE leading to discontinuation of study drug 8 (3.3) 32 (1.8) 0.11411
Any treatment-related AE leading to discontinuation of study drug 3 (1.2) 13 (0.7) 0.40162
Any AE resulting in death 6 (2.4) 14 (0.8) 0.01256
Any treatment-related AE resulting in death 0 (0.0) 0 (0.0) 1.00000
System organ class AEs with significant difference between groups
 Infections and infestations 29 (11.8) 137 (7.6) 0.02277
  Differencea (95% CI) −4.2 (−9.0, −0.5)
 Vascular disorders 18 (7.3) 69 (3.8) 0.01046
  Differencea (95% CI) −3.5 (−7.6, −0.7)
  1. AE adverse event, CI confidence interval
  2. aCalculated for patients with diabetes compared with those without diabetes