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Table 4 Summary of treatment-emergent adverse events in the safety population

From: Carglumic acid enhances rapid ammonia detoxification in classical organic acidurias with a favourable risk-benefit profile: a retrospective observational study

  Events (%) Patients (%)n = 57
Any AEs 74 25 (43.9)
All severe AEs 23 (31.1) 13 (22.8)
All serious AEs 22 (29.7) 13 (22.8)
All drug-related AEsa 24 (32.4) 9 (15.8)
All serious drug-related AEsb 6 (8.1) 5 (8.8)
All AEs leading to death 11 (14.9) 7 (12.3)
  1. aAEs with an investigator’s causality assessment of either ‘related’ or ‘unknown’. Of these, none were assessed as ‘related’
  2. bAll serious drug-related AEs with an investigator assessment of ‘related’ or ‘unknown’. Of these, only one was assessed by the investigator as ‘related’ and this was neurological damage that resulted in death
  3. AEs, adverse events