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. 2020 Dec 3;11:571747. doi: 10.3389/fphar.2020.571747

TABLE 8.

Summary of treatment-emergent adverse events.

Parameter Fasting conditions Postprandial conditions
T R Total T R Total
No. of subjects dosed 36 36 71 72
No. (%) of subjects with at least 1 TEAE 6 (16.7) 6 (16.7) 10 (27.8) 10 (14.1) 10 (13.9) 19 (26.4)
No. of TEAEs 6 11 17 14 23 37
 Grade 1 5 7 12 11 17 28
 Grade 2 1 4 5 2 5 7
 ≥Grade 3 0 0 0 1 1 2
No. of subjects discontinued due to TEAE 0 0 0 1 0 1
Adverse event [no. (%) of subjects, no. of AEs]
 Hypertriglyceridemia 3 (8.3) 3 1 (2.8) 1 3 (4.2) 3 4 (5.6) 4
  Hyperkalemia 0 (0) 0 0 (0) 0 1 (1.4) 1 0 (0) 0
  Monocytopenia 0 (0) 0 0 (0) 0 2 (2.8) 2 0 (0) 0
  Eosinophil count increased 0 (0) 0 0 (0) 0 0 (0) 0 4 (5.6) 4
  Proteinuria 0 (0) 0 0 (0) 0 2 (2.8) 2 0 (0) 0
  Positive acetone in the urine 0 (0) 0 0 (0) 0 0 (0) 0 1 (1.4) 1
 Urine leukocytes increased 1 (2.8) 1 1 (2.8) 1 0 (0) 0 1 (1.4) 1
  Alanine aminotransferase increased 0 (0) 0 1 (2.8) 1 0 (0) 0 0 (0) 0
  Blood basophils increased 0 (0) 0 1 (2.8) 1 0 (0) 0 0 (0) 0
 Aspartate aminotransferase increased 0 (0) 0 1 (2.8) 1 0 (0) 0 0 (0) 0
 Blood conjugated bilirubin increased 0 (0) 0 2 (5.6) 2 0 (0) 0 2 (2.8) 2
 Blood unconjugated bilirubin increased 0 (0) 0 1 (2.8) 1 1 (1.4) 1 2 (2.8) 2
 Blood total bilirubin increased 0 (0) 0 1 (2.8) 1 1 (1.4) 1 2 (2.8) 2
  Diarrhea 1 (2.8) 1 1 (2.8) 1 0 (0) 0 0 (0) 0
  Hypertension 1 (2.8) 1 1 (2.8) 1 2 (2.8) 2 2 (2.8) 2
  Rapid pulse 0 (0) 0 0 (0) 0 1 (1.4) 2 2 (2.8) 3
  Upper respiratory tract infection 0 (0) 0 0 (0) 0 0 (0) 0 1 (1.4) 1
  Eczema 0 (0) 0 0 (0) 0 0 (0) 0 1 (1.4) 1