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Table 5

Adverse Events Summary – Phase I/II Study (n = 41). Adverse Events reported by NCI CTCAE grade in patients receiving treatment with the TheraBionic device.

Incidence of Adverse Events (n = 41)
  Max Grade (Post-Baseline)
Baseline Adjusted*
  Grade 1 Grade 2 Grade 3 Grade 4 Any Grade Grade 3 or 4 Grade 1 Grade 2 Grade 3 Grade 4 Any Grade Grade 3 or 4
Overall 16 (39%) 17 (41%) 9 (22%) 1 (2%) 28 (68%) 9 (22%) 6 (15%) 4 (10%) 5 (12%) 1 (2%) 12 (29%) 5 (12%)
Adverse Events                        
Abdominal Pain 2 (5%) 2 (5%) 4 (10%)
Anemia 1 (2%) 1 (2%)
Anorexia 1 (2%) 1 (2%)
Ascites 1 (2%) 6 (15%) 1 (2%) 8 (20%) 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Blood in feces 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Cramp 1 (2%) 1 (2%)
Dehydration 1 (2%) 1 (2%) 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Diarrhea 2 (5%) 2 (5%) 1 (2%) 1 (2%)
Dyspnea 1 (2%) 3 (7%) 4 (10%) 1 (2%) 1 (2%)
Edema 1 (2%) 2 (5%) 1 (2%) 4 (10%) 1 (2%)
Encephalopathy 1 (2%) 2 (5%) 3 (7%)
Epistaxis 1 (2%) 1 (2%)
Fatigue 5 (12%) 3 (7%) 1 (2%) 1 (2%) 9 (22%) 2 (5%) 1 (2%) 1 (2%) 2 (5%) 1 (2%)
Fever 1 (2%) 1 (2%) 1 (2%) 1 (2%) 1 (2%) 1 (2%)
GI Bleeding 2 (5%) 2 (5%)
Headache 2 (5%) 2 (5%) 1 (2%) 1 (2%)
Hepatic Decompensation 1 (2%) 1 (2%)
Insomnia 1 (2%) 1 (2%)
Jaundice 1 (2%) 1 (2%) 1 (2%)
Mucositis 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Myalgia 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Nausea 1 (2%) 1 (2%)
Pain 2 (5%) 7 (17%) 6 (15%) 13 (32%) 6 (15%) 2 (5%) 1 (2%) 3 (7%) 1 (2%)
Pruritus 1 (2%) 1 (2%)
Somnolence 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Urinary Tract Infection 1 (2%) 1 (2%)
Vertigo 2 (5%) 2 (5%) 1 (2%) 1 (2%)
Weakness 1 (2%) 1 (2%) 2 (5%) 1 (2%) 1 (2%) 1 (2%) 2 (5%) 1 (2%)
*

Baseline Adjusted AE grades calculated based on method described by Basch et al. [16].