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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].
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