Open Access
Table 3
Adverse Events Summary – Current Study + Phase I/II (n = 59). Adverse events reported by NCI CTCAE grade in all patients receiving treatment with the TheraBionic device.
| Incidence of adverse events (n = 59) |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 32 (54%) | 28 (47%) | 10 (17%) | 1 (2%) | 46 (78%) | 10 (17%) | 10 (17%) | 4 (7%) | 5 (8%) | 1 (2%) | 16 (27%) | 5 (8%) |
| Adverse events | ||||||||||||
| Abdominal pain | 3 (5%) | 2 (3%) | – | – | 5 (8%) | – | – | – | – | – | – | – |
| Anal hemorrhage | 2 (3%) | 1 (2%) | – | – | 2 (3%) | – | – | – | – | – | – | – |
| Anemia | 1 (2%) | – | – | – | 1 (2%) | – | – | – | – | – | – | – |
| Anorexia | 10 (17%) | 1 (2%) | 1 (2%) | – | 10 (17%) | 1 (2%) | 1 (2%) | – | – | – | 1 (2%) | – |
| Ascites | 4 (7%) | 9 (15%) | 1 (2%) | – | 14 (24%) | 1 (2%) | – | – | 1 (2%) | – | 1 (2%) | 1 (2%) |
| Blood in feces | 1 (2%) | – | – | – | 1 (2%) | – | 1 (2%) | – | – | – | 1 (2%) | – |
| Constipation | 1 (2%) | – | – | – | 1 (2%) | – | – | – | – | – | – | – |
| Cough | 4 (7%) | 1 (2%) | – | – | 4 (7%) | – | – | – | – | – | – | – |
| Cramp | 1 (2%) | – | – | – | 1 (2%) | – | – | – | – | – | – | – |
| Dehydration | – | – | 1 (2%) | – | 1 (2%) | 1 (2%) | – | – | 1 (2%) | – | 1 (2%) | 1 (2%) |
| Diarrhea | 2 (3%) | 2 (3%) | – | – | 4 (7%) | – | – | 1 (2%) | – | – | 1 (2%) | – |
| Dyspnea | 5 (8%) | 8 (14%) | – | – | 11 (19%) | – | – | 1 (2%) | – | – | 1 (2%) | – |
| Edema | 2 (3%) | 2 (3%) | 1 (2%) | – | 5 (8%) | 1 (2%) | – | – | – | – | – | – |
| Encephalopathy | 2 (3%) | 3 (5%) | – | – | 5 (8%) | – | – | – | – | – | – | – |
| Epistaxis | 1 (2%) | – | – | – | 1 (2%) | – | – | – | – | – | – | – |
| Fatigue | 15 (25%) | 7 (12%) | 1 (2%) | 1 (2%) | 21 (36%) | 2 (3%) | 1 (2%) | – | – | 1 (2%) | 2 (3%) | 1 (2%) |
| Fever | – | – | 1 (2%) | – | 1 (2%) | 1 (2%) | – | – | 1 (2%) | – | 1 (2%) | 1 (2%) |
| GI Bleeding | 1 (2%) | 3 (5%) | – | – | 3 (5%) | – | 1 (2%) | – | – | – | 1 (2%) | – |
| Hand foot syndrome | 1 (2%) | – | – | – | 1 (2%) | – | – | – | – | – | – | – |
| Headache | 2 (3%) | – | – | – | 2 (3%) | – | 1 (2%) | – | – | – | 1 (2%) | – |
| Hepatic Decompensation | 1 (2%) | – | – | – | 1 (2%) | – | – | – | – | – | – | – |
| Insomnia | 1 (2%) | – | – | – | 1 (2%) | – | – | – | – | – | – | – |
| Jaundice | 1 (2%) | 1 (2%) | 1 (2%) | – | 3 (5%) | 1 (2%) | – | – | – | – | – | – |
| Mucositis | 4 (7%) | – | – | – | 4 (7%) | – | 3 (5%) | – | – | – | 3 (5%) | – |
| Myalgia | 1 (2%) | – | – | – | 1 (2%) | – | 1 (2%) | – | – | – | 1 (2%) | – |
| Nausea | 2 (3%) | 1 (2%) | – | – | 3 (5%) | – | – | – | – | – | – | – |
| Pain | 6 (10%) | 9 (15%) | 6 (10%) | – | 18 (31%) | 6 (10%) | – | 2 (3%) | 1 (2%) | – | 3 (5%) | 1 (2%) |
| Pruritus | – | 2 (3%) | – | – | 2 (3%) | – | – | – | – | – | – | – |
| Somnolence | 1 (2%) | – | – | – | 1 (2%) | – | 1 (2%) | – | – | – | 1 (2%) | – |
| Urinary Tract Infection | 1 (2%) | – | – | – | 1 (2%) | – | – | – | – | – | – | – |
| Vertigo | 2 (3%) | – | – | – | 2 (3%) | – | 1 (2%) | – | – | – | 1 (2%) | – |
| Vomiting | 1 (2%) | – | – | – | 1 (2%) | – | – | – | – | – | – | – |
| Weakness | 11 (19%) | 4 (7%) | 1 (2%) | – | 14 (24%) | 1 (2%) | 1 (2%) | – | 1 (2%) | – | 2 (3%) | 1 (2%) |
*
Baseline Adjusted AE grades calculated based on method described by Basch et al. [16].