TABLE 5

Summary of AEs in cohorts 3 and 4 (safety analysis population)c

System organ class/preferred termNo. (%) of patients with AE for cohortb:
3 (≥2 to <6 yr)(n = 8)4 (≥3 mo to <2 yr)(n = 8)Totala (n = 32)
Any4 (50.0)2 (25.0)6 (18.8)
Cardiac disorders01 (12.5)1 (3.1)
    Sinus tachycardia01 (12.5)1 (3.1)
Gastrointestinal disorders3 (37.5)03 (9.4)
    Constipation1 (12.5)01 (3.1)
    Diarrhea1 (12.5)01 (3.1)
    Vomiting1 (12.5)01 (3.1)
Investigations1 (12.5)01 (3.1)
    Increased alanine aminotransferase1 (12.5)01 (3.1)
    Increased aspartate aminotransferase1 (12.5)01 (3.1)
    Increased blood triglycerides1 (12.5)01 (3.1)
    Increased gamma-glutamyltransferase1 (12.5)01 (3.1)
Injury, poisoning, and procedural complications01 (12.5)1 (3.1)
    Procedural site reaction01 (12.5)1 (3.1)
  • a Total patient number includes cohorts 1 to 4.

  • b Onset on or after the date and time of the first dose of ceftazidime-avibactam and up to and including the day 3 follow-up visit.

  • c No AEs were reported in cohorts 1 and 2.