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].
Current usage metrics show cumulative count of Article Views (full-text article views including HTML views, PDF and ePub downloads, according to the available data) and Abstracts Views on Vision4Press platform.
Data correspond to usage on the plateform after 2015. The current usage metrics is available 48-96 hours after online publication and is updated daily on week days.
Initial download of the metrics may take a while.