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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
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Orphanet Journal of Rare Diseases

ISSN: 1750-1172