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Table 6
Adverse Events Summary – Child-Pugh A Patients Only (n = 32). Adverse Events reported by NCI CTCAE grade in Child-Pugh A patients receiving treatment with the TheraBionic device.
| Incidence of adverse events (n = 32) |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 20 (62%) | 10 (31%) | 5 (16%) | 1 (3%) | 24 (75%) | 5 (16%) | 7 (22%) | 1 (3%) | 2 (6%) | 1 (3%) | 10 (31%) | 2 (6%) |
| Adverse events | ||||||||||||
| Abdominal pain | 1 (3%) | – | – | – | 1 (3%) | – | – | – | – | – | – | – |
| Anal hemorrhage | 2 (6%) | 1 (3%) | – | – | 2 (6%) | – | – | – | – | – | – | – |
| Anemia | 1 (3%) | – | – | – | 1 (3%) | – | – | – | – | – | – | – |
| Anorexia | 7 (22%) | 1 (3%) | 1 (3%) | – | 7 (22%) | 1 (3%) | 1 (3%) | – | – | – | 1 (3%) | – |
| Ascites | 2 (6%) | 1 (3%) | 1 (3%) | – | 4 (12%) | 1 (3%) | – | – | 1 (3%) | – | 1 (3%) | 1 (3%) |
| Blood in feces | 1 (3%) | – | – | – | 1 (3%) | – | 1 (3%) | – | – | – | 1 (3%) | – |
| Constipation | 1 (3%) | – | – | – | 1 (3%) | – | – | – | – | – | – | – |
| Cough | 3 (9%) | 1 (3%) | – | – | 3 (9%) | – | – | – | – | – | – | – |
| Diarrhea | 2 (6%) | 1 (3%) | – | – | 3 (9%) | – | – | 1 (3%) | – | – | 1 (3%) | – |
| Dyspnea | 4 (12%) | 3 (9%) | – | – | 6 (19%) | – | – | – | – | – | – | – |
| Edema | 1 (3%) | – | – | – | 1 (3%) | – | – | – | – | – | – | – |
| Encephalopathy | 1 (3%) | 1 (3%) | – | – | 2 (6%) | – | – | – | – | – | – | – |
| Epistaxis | 1 (3%) | – | – | – | 1 (3%) | – | – | – | – | – | – | – |
| Fatigue | 10 (31%) | 2 (6%) | – | 1 (3%) | 11 (34%) | 1 (3%) | 1 (3%) | – | – | 1 (3%) | 2 (6%) | 1 (3%) |
| Hand foot syndrome | 1 (3%) | – | – | – | 1 (3%) | – | – | – | – | – | – | – |
| Headache | 1 (3%) | – | – | – | 1 (3%) | – | – | – | – | – | – | – |
| Hepatic Decompensation | 1 (3%) | – | – | – | 1 (3%) | – | – | – | – | – | – | – |
| Jaundice | – | 1 (3%) | – | – | 1 (3%) | – | – | – | – | – | – | – |
| Mucositis | 3 (9%) | – | – | – | 3 (9%) | – | 2 (6%) | – | – | – | 2 (6%) | – |
| Nausea | 1 (3%) | – | – | – | 1 (3%) | – | – | – | – | – | – | – |
| Pain | 4 (12%) | 1 (3%) | 3 (9%) | – | 8 (25%) | 3 (9%) | – | – | 1 (3%) | – | 1 (3%) | 1 (3%) |
| Pruritus | – | 1 (3%) | – | – | 1 (3%) | – | – | – | – | – | – | – |
| Urinary Tract Infection | 1 (3%) | – | – | – | 1 (3%) | – | – | – | – | – | – | – |
| Vertigo | 1 (3%) | – | – | – | 1 (3%) | – | 1 (3%) | – | – | – | 1 (3%) | – |
| Vomiting | 1 (3%) | – | – | – | 1 (3%) | – | – | – | – | – | – | – |
| Weakness | 8 (25%) | 2 (6%) | – | – | 8 (25%) | – | 1 (3%) | – | – | – | 1 (3%) | – |
*
Baseline Adjusted AE grades calculated based on method described by Basch et al. [16].