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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].