Table 2 Treatment-related adverse events in patients
From: A therapeutic peptide vaccine for fibrolamellar hepatocellular carcinoma: a phase 1 trial
Adverse event (CTCAE term) | Grade 1 | Grade 2 | Grade 3 | Total N = 16 |
|---|---|---|---|---|
N (%) | N (%) | N (%) | N (%) | |
Alanine aminotransferase increased | 1 (6) | 4 (25) | 1 (6) | 6 (38) |
Arthralgia | 2 (13) | 0 (0) | 0 (0) | 2 (13) |
Aspartate aminotransferase increased | 1 (6) | 2 (13) | 3 (19) | 6 (38) |
Blood bilirubin increased | 1 (6) | 0 (0) | 0 (0) | 1 (6) |
Chills | 2 (13) | 0 (0) | 0 (0) | 2 (13) |
Creatinine increased | 1 (6%) | 0 (0) | 0 (0) | 1 (6) |
Diarrhea | 0 (0) | 1 (6) | 0 (0) | 1 (6) |
Dry mouth | 1 () | 0 (0) | 0 (0) | 1 (6) |
Eosinophilia | 0 (0) | 0 (0) | 1 (6) | 1 (6) |
Fatigue | 4 (25) | 4 (25) | 0 (0) | 8 (50) |
Fever | 4 (25) | 1 (6) | 0 (0) | 5 (31) |
Flu-like symptoms | 1 (6) | 0 (0) | 0 (0) | 1 (6) |
Headache | 5 (31) | 3 (19) | 0 (0) | 8 (50) |
Hyperthyroidism | 2 (12) | 0 (0) | 0 (0) | 2 (13) |
Hypophysitis | 0 (0) | 0 (0) | 1 (6) | 1 (6) |
Hypothyroidism | 1 (6 | 1 (6) | 0 (0) | 2 (13) |
Infusion-related reaction | 0 (0) | 2 (13) | 0 (0) | 2 (13) |
Diabetic ketoacidosis | 0 (0) | 0 (0) | 1 (6) | 1 (6) |
Mucositis oral | 1 (6) | 0 (0) | 0 (0) | 1 (6) |
Myalgia | 1 (6) | 0 (0) | 0 (0) | 1 (6) |
Pain | 0 (0) | 0 (0) | 1 (6) | 1 (6) |
Pruritus | 2 (13) | 1 (6) | 0 (0) | 3 (19) |
Rash maculo-papular | 6 (38) | 0 (0) | 0 (0) | 6 (38) |
Oral lichen planus | 2 (13) | 0 (0) | 0 (0) | 2 (13) |
Skin induration | 1 (6) | 0 (0) | 0 (0) | 1 (6) |
White blood cell decreased | 0 (0) | 0 (0) | 1 (6) | 1 (6) |
Vaccine injection site reaction | 14 (88) | 2 (2) | 0 (0) | 16 (100%) |
