Open Access

Table 8

Adverse Events Summary – Comparison to Sorafenib Trials. Adverse Events reported by phase I/II study patients receiving treatment with the TheraBionic device or Sorafenib (SHARP/Asian-Pacific). Statistical significance in adverse event incidence reported at a 0.05 significance level.

Incidence of any grade AEs
  TheraBionic (N = 41)
SHARP study [17] (N = 297)
Asian-Pacific study [18] (N = 149)
Adverse event N (%) N (%) P-value N (%) P-value
Abdominal pain 4 (10%) 24 (8%) 0.761
Anorexia 1 (2%) 41 (14%) 0.041 19 (13%) 0.081
Diarrhea 2 (5%) 116 (39%) <0.001 38 (26%) 0.004
Fatigue 9 (22%) 65 (22%) 1 30 (20%) 0.828
Hand foot syndrome 0 (0%) 62 (21%) <0.001 67 (45%) <0.001
Nausea 1 (2%) 33 (11%) 0.099 17 (11%) 0.129

Note: P-values based on Fisher’s Exact Test comparing TheraBionic and each Sorafenib Trial.

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