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Table 5
Adverse Events Summary – Phase I/II Study (n = 41). Adverse Events reported by NCI CTCAE grade in patients receiving treatment with the TheraBionic device.
| Incidence of Adverse Events (n = 41) |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 (39%) | 17 (41%) | 9 (22%) | 1 (2%) | 28 (68%) | 9 (22%) | 6 (15%) | 4 (10%) | 5 (12%) | 1 (2%) | 12 (29%) | 5 (12%) |
| Adverse Events | ||||||||||||
| Abdominal Pain | 2 (5%) | 2 (5%) | – | – | 4 (10%) | – | – | – | – | – | – | – |
| Anemia | 1 (2%) | – | – | – | 1 (2%) | – | – | – | – | – | – | – |
| Anorexia | 1 (2%) | – | – | – | 1 (2%) | – | – | – | – | – | – | – |
| Ascites | 1 (2%) | 6 (15%) | 1 (2%) | – | 8 (20%) | 1 (2%) | – | – | 1 (2%) | – | 1 (2%) | 1 (2%) |
| Blood in feces | 1 (2%) | – | – | – | 1 (2%) | – | 1 (2%) | – | – | – | 1 (2%) | – |
| Cramp | 1 (2%) | – | – | – | 1 (2%) | – | – | – | – | – | – | – |
| Dehydration | – | – | 1 (2%) | – | 1 (2%) | 1 (2%) | – | – | 1 (2%) | – | 1 (2%) | 1 (2%) |
| Diarrhea | – | 2 (5%) | – | – | 2 (5%) | – | – | 1 (2%) | – | – | 1 (2%) | – |
| Dyspnea | 1 (2%) | 3 (7%) | – | – | 4 (10%) | – | – | 1 (2%) | – | – | 1 (2%) | – |
| Edema | 1 (2%) | 2 (5%) | 1 (2%) | – | 4 (10%) | 1 (2%) | – | – | – | – | – | – |
| Encephalopathy | 1 (2%) | 2 (5%) | – | – | 3 (7%) | – | – | – | – | – | – | – |
| Epistaxis | 1 (2%) | – | – | – | 1 (2%) | – | – | – | – | – | – | – |
| Fatigue | 5 (12%) | 3 (7%) | 1 (2%) | 1 (2%) | 9 (22%) | 2 (5%) | 1 (2%) | – | – | 1 (2%) | 2 (5%) | 1 (2%) |
| Fever | – | – | 1 (2%) | – | 1 (2%) | 1 (2%) | – | – | 1 (2%) | – | 1 (2%) | 1 (2%) |
| GI Bleeding | – | 2 (5%) | – | – | 2 (5%) | – | – | – | – | – | – | – |
| Headache | 2 (5%) | – | – | – | 2 (5%) | – | 1 (2%) | – | – | – | 1 (2%) | – |
| Hepatic Decompensation | 1 (2%) | – | – | – | 1 (2%) | – | – | – | – | – | – | – |
| Insomnia | 1 (2%) | – | – | – | 1 (2%) | – | – | – | – | – | – | – |
| Jaundice | – | – | 1 (2%) | – | 1 (2%) | 1 (2%) | – | – | – | – | – | – |
| Mucositis | 1 (2%) | – | – | – | 1 (2%) | – | 1 (2%) | – | – | – | 1 (2%) | – |
| Myalgia | 1 (2%) | – | – | – | 1 (2%) | – | 1 (2%) | – | – | – | 1 (2%) | – |
| Nausea | – | 1 (2%) | – | – | 1 (2%) | – | – | – | – | – | – | – |
| Pain | 2 (5%) | 7 (17%) | 6 (15%) | – | 13 (32%) | 6 (15%) | – | 2 (5%) | 1 (2%) | – | 3 (7%) | 1 (2%) |
| Pruritus | – | 1 (2%) | – | – | 1 (2%) | – | – | – | – | – | – | – |
| Somnolence | 1 (2%) | – | – | – | 1 (2%) | – | 1 (2%) | – | – | – | 1 (2%) | – |
| Urinary Tract Infection | 1 (2%) | – | – | – | 1 (2%) | – | – | – | – | – | – | – |
| Vertigo | 2 (5%) | – | – | – | 2 (5%) | – | 1 (2%) | – | – | – | 1 (2%) | – |
| Weakness | 1 (2%) | – | 1 (2%) | – | 2 (5%) | 1 (2%) | 1 (2%) | – | 1 (2%) | – | 2 (5%) | 1 (2%) |
*
Baseline Adjusted AE grades calculated based on method described by Basch et al. [16].
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