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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) |
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| 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.