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. Author manuscript; available in PMC: 2025 Jan 3.
Published in final edited form as: NEJM Evid. 2024 Jun 25;3(7):EVIDoa2300238. doi: 10.1056/EVIDoa2300238

Table 2.

Treatment-Emergent Adverse Events and Posttreatment Adverse Events by Number of Participants When There Were Two or More Reported in Either Group by Preferred Term.*

Adverse Events AVT001 (N=16) Placebo (N=9)
TEAEs by preferred term
 Participants with any TEAE 9 (56.3) 6 (66.7)
  Neutrophil count decreased 4 (25.0) 1 (11.1)
  Hyponatremia 3 (18.8) 1 (11.1)
  Cough 3 (18.8) 0 (0.0)
  White blood-cell count decreased 2 (12.5) 1 (11.1)
  Ear pain 2 (12.5) 0 (0.0)
  Lymphocyte count decreased 2 (12.5) 0 (0.0)
  Dizziness 1 (6.3) 2 (22.2)
  Headache 0 (0.0) 2 (22.2)
PTAEs by preferred term
 Participants with any PTAE 16 (100.0) 8 (88.9)
  White blood-cell count decreased 5 (31.3) 4 (44.4)
  Neutrophil count decreased 4 (25.0) 1 (11.1)
  Blood alkaline phosphatase increased 3 (18.8) 1 (11.1)
  Blood bicarbonate decreased 3 (18.8) 0 (0.0)
  Lymphocyte count decreased 3 (18.8) 0 (0.0)
  Corona virus infection 2 (12.5) 1 (11.1)
  Anemia 2 (12.5) 0 (0.0)
  Hypocalcemia 2 (12.5) 0 (0.0)
  Blood bilirubin increased 1 (6.3) 2 (22.2)
*

Treatment-emergent adverse events (TEAEs) are defined as adverse events that started on or after the first dose of study medication through 30 days following the last dose. Posttreatment adverse events (PTAEs) are defined as adverse events that started more than 30 days following the last dose through day 360.