Table 7
Incidence of any grade adverse events by Child-Pugh Type. Adverse Events reported by Child-Pugh type in patients receiving treatment with the TheraBionic device. Fisher’s exact test used for statistical comparison of reported incidence of AEs. Statistical significance in adverse event incidence reported at a 0.05 significance level.
| Max-grade (post-baseline) |
Baseline adjusted* |
|||||||
|---|---|---|---|---|---|---|---|---|
| Child-Pugh Type |
Fisher’s Exact Test |
Child-Pugh Type |
Fisher’s Exact Test |
|||||
| Type A | Type B | Type C | P-value | Type A | Type B | Type C | P-value | |
| Overall | 24 (75%) | 19 (76%) | 2 (100%) | >0.99 | 10 (31%) | 6 (24%) | 0 (0%) | 0.877 |
| Adverse Events | ||||||||
| Abdominal pain | 1 (3%) | 4 (16%) | 0 (0%) | 0.295 | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Anal hemorrhage | 2 (6%) | 0 (0%) | 0 (0%) | 0.532 | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Anemia | 1 (3%) | 0 (0%) | 0 (0%) | >0.99 | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Anorexia | 7 (22%) | 3 (12%) | 0 (0%) | 0.647 | 1 (3%) | 0 (0%) | 0 (0%) | >0.99 |
| Ascites | 4 (12%) | 8 (32%) | 2 (100%) | 0.012 | 1 (3%) | 0 (0%) | 0 (0%) | >0.99 |
| Asthenia | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Blood in feces | 1 (3%) | 0 (0%) | 0 (0%) | >0.99 | 1 (3%) | 0 (0%) | 0 (0%) | >0.99 |
| Constipation | 1 (3%) | 0 (0%) | 0 (0%) | >0.99 | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Cough | 3 (9%) | 1 (4%) | 0 (0%) | 0.673 | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Cramp | 0 (0%) | 1 (4%) | 0 (0%) | 0.458 | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Dehydration | 0 (0%) | 1 (4%) | 0 (0%) | 0.458 | 0 (0%) | 1 (4%) | 0 (0%) | 0.458 |
| Diarrhea | 3 (9%) | 1 (4%) | 0 (0%) | 0.673 | 1 (3%) | 0 (0%) | 0 (0%) | >0.99 |
| Dyspnea | 6 (19%) | 4 (16%) | 1 (50%) | 0.462 | 0 (0%) | 1 (4%) | 0 (0%) | 0.458 |
| Edema | 1 (3%) | 4 (16%) | 0 (0%) | 0.295 | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Encephalopathy | 2 (6%) | 2 (8%) | 1 (50%) | 0.214 | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Epistaxis | 1 (3%) | 0 (0%) | 0 (0%) | >0.99 | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Fatigue | 11 (34%) | 8 (32%) | 2 (100%) | 0.209 | 2 (6%) | 0 (0%) | 0 (0%) | 0.532 |
| Fever | 0 (0%) | 1 (4%) | 0 (0%) | 0.458 | 0 (0%) | 1 (4%) | 0 (0%) | 0.458 |
| GI bleeding | 0 (0%) | 3 (12%) | 0 (0%) | 0.171 | 0 (0%) | 1 (4%) | 0 (0%) | 0.458 |
| Hand foot syndrome | 1 (3%) | 0 (0%) | 0 (0%) | >0.99 | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Headache | 1 (3%) | 1 (4%) | 0 (0%) | >0.99 | 0 (0%) | 1 (4%) | 0 (0%) | 0.458 |
| Hepatic decompensation | 1 (3%) | 0 (0%) | 0 (0%) | >0.99 | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Hyperoxia | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Insomnia | 0 (0%) | 1 (4%) | 0 (0%) | 0.458 | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Jaundice | 1 (3%) | 1 (4%) | 1 (50%) | 0.1 | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Mucositis | 3 (9%) | 1 (4%) | 0 (0%) | 0.673 | 2 (6%) | 1 (4%) | 0 (0%) | >0.99 |
| Myalgia | 0 (0%) | 1 (4%) | 0 (0%) | 0.458 | 0 (0%) | 1 (4%) | 0 (0%) | 0.458 |
| Nausea | 1 (3%) | 2 (8%) | 0 (0%) | 0.619 | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Pain | 8 (25%) | 8 (32%) | 1 (50%) | 0.517 | 1 (3%) | 2 (8%) | 0 (0%) | 0.619 |
| Pruritus | 1 (3%) | 1 (4%) | 0 (0%) | >0.99 | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Somnolence | 0 (0%) | 1 (4%) | 0 (0%) | 0.458 | 0 (0%) | 1 (4%) | 0 (0%) | 0.458 |
| Urinary tract infection | 1 (3%) | 0 (0%) | 0 (0%) | >0.99 | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Vertigo | 1 (3%) | 1 (4%) | 0 (0%) | >0.99 | 1 (3%) | 0 (0%) | 0 (0%) | >0.99 |
| Vomiting | 1 (3%) | 0 (0%) | 0 (0%) | >0.99 | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Weakness | 8 (25%) | 4 (16%) | 2 (100%) | 0.054 | 1 (3%) | 1 (4%) | 0 (0%) | >0.99 |
Baseline Adjusted AE grades calculated based on method described by Basch et al. [16].
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