Skip to main content
. 2023 May 26;40(7):3186–3198. doi: 10.1007/s12325-023-02521-1

Table 2.

Summary of adverse events

Events, n (%) Placebo (N = 6) Kukoamine B
0.06 mg/kg (N = 6) 0.12 mg/kg (N = 6) 0.24 mg/kg (N = 6) All (N = 18)
With any AE, n (%) 4 (66.67%) 4 (66.67%) 3 (50%) 5 (83.33%) 12 (66.67%)
With any TRAE, n (%) 2 (33.33%) 2 (33.33%) 1 (16.67%) 5 (83.33%) 8 (44.44%)
AE, n (%)
 Investigations 0 (0%) 0 (0%) 0 (0%) 4 (66.67%) 4 (22.22%)
  γ-Glutamyl transferase increased 0 (0%) 0 (0%) 0 (0%) 1 (16.67%) 1 (5.56%)
 Alanine aminotransferase increased 0 (0%) 0 (0%) 0 (0%) 1 (16.67%) 1 (5.56%)
 Blood alkaline phosphatase increased 0 (0%) 0 (0%) 0 (0%) 1 (16.67%) 1 (5.56%)
  Aspartate aminotransferase increased 0 (0%) 0 (0%) 0 (0%) 1 (16.67%) 1 (5.56%)
 Metabolism and nutrition disorders 2 (33.33%) 2 (33.33%) 1 (16.67%) 3 (50%) 6 (33.33%)
  Hypocalcemia 0 (0%) 0 (0%) 0 (0%) 1 (16.67%) 1 (5.56%)
  Hypertriglyceridemia 2 (33.33%) 2 (33.33%) 1 (16.67%) 1 (16.67%) 4 (22.22%)
  Hypokalemia 0 (0%) 0 (0%) 0 (0%) 1 (16.67%) 1 (5.56%)
 Skin and subcutaneous tissue disorders 1 (16.67%) 1 (16.67%) 1 (16.67%) 0 (0%) 2 (11.11%)
  Skin exfoliation 1 (16.67%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
  Rash maculopapular 0 (0%) 1 (16.67%) 0 (0%) 0 (0%) 1 (5.56%)
  Pruritus 0 (0%) 0 (0%) 1 (16.67%) 0 (0%) 1 (5.56%)
 Gastrointestinal disorders 0 (0%) 0 (0%) 0 (0%) 2 (33.33%) 2 (11.11%)
  Gingival pain 0 (0%) 0 (0%) 0 (0%) 1 (16.67%) 1 (5.56%)
  Mouth ulcer 0 (0%) 0 (0%) 0 (0%) 1 (16.67%) 1 (5.56%)
 Renal and urinary disorders 0 (0%) 0 (0%) 0 (0%) 1 (16.67%) 1 (5.56%)
  Proteinuria 0 (0%) 0 (0%) 0 (0%) 1 (16.67%) 1 (5.56%)
 Blood and lymphatic system disorders 0 (0%) 1 (16.67%) 0 (0%) 0 (0%) 1 (5.56%)
  Anemia 0 (0%) 1 (16.67%) 0 (0%) 0 (0%) 1 (5.56%)
 Nervous system disorders 1 (16.67%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
  Orthostatic hypotension 1 (16.67%) 0 (0%) 0 (0%) 0 (0%) 0 (0%)
 Cardiac disorders 0 (0%) 2 (33.33%) 1 (16.67%) 0 (0%) 3 (16.67%)
  Sinus bradycardia 0 (0%) 2 (33.33%) 1 (16.67%) 0 (0%) 3 (16.67%)

AE adverse event, TRAE treatment-related adverse event