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Table 3

Adverse Events Summary – Current Study + Phase I/II (n = 59). Adverse events reported by NCI CTCAE grade in all patients receiving treatment with the TheraBionic device.

Incidence of adverse events (n = 59)
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 32 (54%) 28 (47%) 10 (17%) 1 (2%) 46 (78%) 10 (17%) 10 (17%) 4 (7%) 5 (8%) 1 (2%) 16 (27%) 5 (8%)
Adverse events                        
Abdominal pain 3 (5%) 2 (3%) 5 (8%)
Anal hemorrhage 2 (3%) 1 (2%) 2 (3%)
Anemia 1 (2%) 1 (2%)
Anorexia 10 (17%) 1 (2%) 1 (2%) 10 (17%) 1 (2%) 1 (2%) 1 (2%)
Ascites 4 (7%) 9 (15%) 1 (2%) 14 (24%) 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Blood in feces 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Constipation 1 (2%) 1 (2%)
Cough 4 (7%) 1 (2%) 4 (7%)
Cramp 1 (2%) 1 (2%)
Dehydration 1 (2%) 1 (2%) 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Diarrhea 2 (3%) 2 (3%) 4 (7%) 1 (2%) 1 (2%)
Dyspnea 5 (8%) 8 (14%) 11 (19%) 1 (2%) 1 (2%)
Edema 2 (3%) 2 (3%) 1 (2%) 5 (8%) 1 (2%)
Encephalopathy 2 (3%) 3 (5%) 5 (8%)
Epistaxis 1 (2%) 1 (2%)
Fatigue 15 (25%) 7 (12%) 1 (2%) 1 (2%) 21 (36%) 2 (3%) 1 (2%) 1 (2%) 2 (3%) 1 (2%)
Fever 1 (2%) 1 (2%) 1 (2%) 1 (2%) 1 (2%) 1 (2%)
GI Bleeding 1 (2%) 3 (5%) 3 (5%) 1 (2%) 1 (2%)
Hand foot syndrome 1 (2%) 1 (2%)
Headache 2 (3%) 2 (3%) 1 (2%) 1 (2%)
Hepatic Decompensation 1 (2%) 1 (2%)
Insomnia 1 (2%) 1 (2%)
Jaundice 1 (2%) 1 (2%) 1 (2%) 3 (5%) 1 (2%)
Mucositis 4 (7%) 4 (7%) 3 (5%) 3 (5%)
Myalgia 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Nausea 2 (3%) 1 (2%) 3 (5%)
Pain 6 (10%) 9 (15%) 6 (10%) 18 (31%) 6 (10%) 2 (3%) 1 (2%) 3 (5%) 1 (2%)
Pruritus 2 (3%) 2 (3%)
Somnolence 1 (2%) 1 (2%) 1 (2%) 1 (2%)
Urinary Tract Infection 1 (2%) 1 (2%)
Vertigo 2 (3%) 2 (3%) 1 (2%) 1 (2%)
Vomiting 1 (2%) 1 (2%)
Weakness 11 (19%) 4 (7%) 1 (2%) 14 (24%) 1 (2%) 1 (2%) 1 (2%) 2 (3%) 1 (2%)
*

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