Table 2.
Adverse eventsa (gradeb) |
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---|---|---|---|---|---|---|---|---|
Patient number | Erythema | Pain | Pruritus | Fatigue | Nausea | Fever | Total | |
Aex | A1 | +(1-2) | 0 | 0 | 0 | 0 | 0 | 1 |
A2 | +(1-2) | +(1-2) | 0 | 0 | 0 | 0 | 2 | |
A3 | 0 | 0 | +(1-2) | 0 | 0 | 0 | 1 | |
A4 | +(1-2) | 0 | 0 | 0 | 0 | 0 | 1 | |
A5 | +(1-2) | 0 | +(1-2) | 0 | 0 | 0 | 2 | |
B1 | +(1-2) | 0 | +(1-2) | 0 | 0 | 0 | 2 | |
B2 | 0 | +(1-2) | 0 | 0 | 0 | 0 | 1 | |
B3 | +(1-2) | 0 | 0 | 0 | 0 | 0 | 1 | |
B4 | +(1-2) | 0 | +(1-2) | 0 | 0 | 0 | 2 | |
B5 | +(1-2) | 0 | 0 | 0 | 0 | 0 | 1 | |
C1 | +(1-2) | +(1-2) | 0 | 0 | 0 | 0 | 2 | |
C2 | +(1-2) | 0 | +(1-2) | 0 | 0 | 0 | 2 | |
C3 | +(1-2) | 0 | +(1-2) | 0 | 0 | 0 | 2 | |
C4 | +(1-2) | +(1-2) | 0 | 0 | 0 | 0 | 2 | |
C5 | +(1-2) | 0 | +(1-2) | 0 | 0 | 0 | 2 | |
D1 | +(1-2) | 0 | +(1-2) | +(1-2) | 0 | 0 | 3 | |
D2 | +(1-2) | 0 | +(1-2) | 0 | 0 | 0 | 2 | |
D3 | +(1-2) | +(1-2) | +(1-2) | 0 | 0 | 0 | 3 | |
D4 | +(1-2) | +(1-2) | 0 | 0 | 0 | 0 | 2 | |
D5 | +(1-2) | +(1-2) | +(1-2) | 0 | 0 | 0 | 3 | |
18 | 7 | 11 | 1 | 0 | 0 | 37c | ||
Aex + GM-CSF | E1 | +(1-2) | 0 | 0 | 0 | 0 | 0 | 1 |
E2 | +(1-2) | 0 | 0 | 0 | 0 | 0 | 1 | |
E3 | +(1-2) | 0 | 0 | 0 | 0 | 0 | 1 | |
E4 | +(1-2) | 0 | +(1-2) | 0 | 0 | 0 | 2 | |
E5 | 0 | +(1-2) | 0 | 0 | 0 | 0 | 1 | |
F1 | +(1-2) | 0 | +(1-2) | 0 | 0 | 0 | 2 | |
F2 | +(1-2) | +(1-2) | 0 | 0 | 0 | 0 | 2 | |
F3 | +(1-2) | 0 | 0 | 0 | 0 | 0 | 1 | |
F4 | +(1-2) | 0 | +(1-2) | 0 | 0 | 0 | 2 | |
F5 | +(1-2) | +(1-2) | +(1-2) | 0 | 0 | 0 | 3 | |
G1 | +(1-2) | +(1-2) | +(1-2) | 0 | 0 | 0 | 3 | |
G2 | +(1-2) | 0 | 0 | +(1-2) | 0 | 0 | 2 | |
G3 | +(1-2) | 0 | +(1-2) | 0 | 0 | 0 | 2 | |
G4 | +(1-2) | +(1-2) | 0 | 0 | 0 | 0 | 2 | |
G5 | +(1-2) | 0 | +(1-2) | 0 | 0 | 0 | 2 | |
H1 | +(1-2) | +(1-2) | +(1-2) | 0 | 0 | 0 | 3 | |
H2 | +(1-2) | +(1-2) | 0 | 0 | 0 | +(1-2) | 3 | |
H3 | +(1-2) | +(1-2) | +(1-2) | 0 | 0 | 0 | 3 | |
H4 | +(1-2) | 0 | +(1-2) | 0 | +(1-2) | 0 | 3 | |
H5 | +(1-2) | 0 | +(1-2) | +(1-2) | 0 | 0 | 3 | |
19 | 8 | 11 | 2 | 1 | 1 | 42d |
Abbreviations: Aex, ascites-derived exosomes; GM-CSF, granulocyte-macrophage colony-stimulating factor.
The adverse events were recorded from the day of the first immunization of 2 weeks after the last immunization. Toxicity was assessed throughout the study using the National Cancer Institute Common Toxicity Criteria version 2.0. cThe total adverse events in the Aex-treated groups were summarized and presented. dThe total adverse events in the Aex + GM-CSF-treated groups were summarized and presented.