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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].