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Table 4

Adverse Events Summary – Current Study real-world patients (n = 18). Adverse Events reported by NCI CTCAE grade in real-world patients receiving treatment with the TheraBionic device.

Incidence of adverse events (n = 18)
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 (89%) 11 (61%) 1 (6%) 18 (100%) 1 (6%) 4 (22%) 4 (22%)
Adverse events                        
Abdominal pain 1 (6%) 1 (6%)
Anal Hemorrhage 2 (11%) 1 (6%) 2 (11%)
Anorexia 9 (50%) 1 (6%) 1 (6%) 9 (50%) 1 (6%) 1 (6%) 1 (6%)
Ascites 3 (17%) 3 (17%) 6 (33%)
Constipation 1 (6%) 1 (6%)
Cough 4 (22%) 1 (6%) 4 (22%)
Diarrhea 2 (11%) 2 (11%)
Dyspnea 4 (22%) 5 (28%) 7 (39%)
Edema 1 (6%) 1 (6%)
Encephalopathy 1 (6%) 1 (6%) 2 (11%)
Fatigue 10 (56%) 4 (22%) 12 (67%)
GI Bleeding 1 (6%) 1 (6%) 1 (6%) 1 (6%) 1 (6%)
Hand foot syndrome 1 (6%) 1 (6%)
Jaundice 1 (6%) 1 (6%) 2 (11%)
Mucositis 3 (17%) 3 (17%) 2 (11%) 2 (11%)
Nausea 2 (11%) 2 (11%)
Pain 4 (22%) 2 (11%) 5 (28%)
Pruritus 1 (6%) 1 (6%)
Vomiting 1 (6%) 1 (6%)
Weakness 10 (56%) 4 (22%) 12 (67%)
*

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