Table 2.
Vaccine-related toxicities included in the standard abbreviations
| Ad.p53-DC vaccines + ATRA (n = 31) | Ad.p53-DC vaccines (n = 20) | Total (N = 51) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| G1/G2 | G3 | Total | % | G1/G2 | G3 | Total | % | % | ||
| Laboratory, metabolic/chemistry | ||||||||||
| Sodium, serum-low (hyponatremia) | 2 | 2 | 6.45 | 0.00 | 2 | 3.92 | ||||
| Laboratory, hematologic | ||||||||||
| Hemoglobin | 1 | 1 | 3.23 | 1 | 1 | 5.00 | 2 | 3.92 | ||
| Neutrophils/granulocytes | 1 | 1 | 3.23 | 1 | 1 | 5.00 | 2 | 3.92 | ||
| Platelets | 2 | 2 | 6.45 | 0.00 | 2 | 3.92 | ||||
| Constitutional | ||||||||||
| Anorexia | 5 | 5 | 16.13 | 2 | 2 | 10.00 | 7 | 13.73 | ||
| Fatigue (asthenia, lethargy, and malaise) | 9 | 1 | 10 | 32.26 | 2 | 1 | 3 | 15.00 | 13 | 25.49 |
| Edema (limb, head, and neck) | 1 | 1 | 3.23 | 0.00 | 1 | 1.96 | ||||
| Respiratory | ||||||||||
| Cough | 3 | 3 | 9.68 | 1 | 1 | 5.00 | 4 | 7.84 | ||
| Dyspnea (shortness of breath) | 5 | 1 | 6 | 19.35 | 2 | 2 | 10.00 | 8 | 15.69 | |
| Hypoxia | 0.00 | 1 | 1 | 5.00 | 1 | 1.96 | ||||
| Gastrointestinal | ||||||||||
| Constipation | 3 | 3 | 9.68 | 1 | 1 | 5.00 | 4 | 7.84 | ||
| Diarrhea | 6 | 6 | 19.35 | 0.00 | 6 | 11.76 | ||||
| Nausea | 8 | 1 | 9 | 29.03 | 1 | 1 | 5.00 | 10 | 19.61 | |
| Vomiting | 6 | 1 | 7 | 22.58 | 0.00 | 7 | 13.73 | |||
| Neurologic/psychiatric | ||||||||||
| Pain/headache | 19 | 3 | 22 | 70.97 | 0.00 | 22 | 43.14 | |||
| Neuropathy (sensory/motor) | 1 | 1 | 3.23 | 3 | 3 | 15.00 | 4 | 7.84 | ||
| Mood alterations (agitation, anxiety, depression, and euphoria) | 1 | 1 | 3.23 | 1 | 1 | 5.00 | 2 | 3.92 | ||
| Cutaneous | ||||||||||
| Injection site reaction/extravasation changes | 2 | 2 | 6.45 | 3 | 3 | 15.00 | 5 | 9.80 | ||
| Rash (desquamation, acneiform, treatment associated, and hay fever reaction) | 2 | 2 | 6.45 | 0.00 | 2 | 3.92 | ||||
| Dry skin | 4 | 4 | 12.90 | 0.00 | 4 | 7.84 | ||||
| Pruritus/itching | 2 | 2 | 6.45 | 0.00 | 2 | 3.92 | ||||
| Hair loss/alopecia (scalp or body) | 2 | 2 | 6.45 | 0.00 | 2 | 3.92 | ||||
| Musculoskeletal | ||||||||||
| Pain (arthralgia/myalgia) | 3 | 3 | 9.68 | 0.00 | 3 | 5.88 | ||||
| Pain | ||||||||||
| Abdominal and not otherwise specified | 1 | 1 | 3.23 | 0.00 | 1 | 1.96 | ||||
| Back and neck | 1 | 1 | 3.23 | 1 | 1 | 5.00 | 2 | 3.92 | ||
| Extremities and limbs | 2 | 2 | 6.45 | 1 | 1 | 5.00 | 3 | 5.88 | ||
| Other | 2 | 2 | 6.45 | 0.00 | 2 | 3.92 | ||||
| Miscellaneous | ||||||||||
| Urinary retention (including neurogenic bladder) | 1 | 1 | 3.23 | 0.00 | 1 | 1.96 | ||||
Ad.p53-DC, TP53 transfected dendritic cell-based vaccine, ATRA all-trans-retinoic acid, DC dendritic cells, G grade