Table 3.
Adverse Events | CTCAE Grade |
All Grade |
Grade ≥3 |
||||||
---|---|---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | Total | % | Total | % | |
Pneumonitis | 1 | 0 | 3 | 0 | 1 | 5 | 29.4 | 4 | 23.5 |
Dyspnea | 2 | 0 | 4 | 0 | 0 | 6 | 35.3 | 4 | 23.5 |
Hypoalbuminemia | 11 | 3 | 2 | 0 | 0 | 16 | 94.1 | 2 | 11.8 |
Lung infection | 0 | 0 | 2 | 0 | 0 | 2 | 11.8 | 2 | 11.8 |
Hyponatremia | 10 | 1 | 0 | 1 | 0 | 12 | 70.6 | 1 | 5.9 |
General fatigue | 3 | 3 | 1 | 0 | 0 | 7 | 41.2 | 1 | 5.9 |
Anemia | 6 | 6 | 0 | 0 | 0 | 12 | 70.6 | 0 | 0.0 |
AST increased | 10 | 1 | 0 | 0 | 0 | 11 | 64.7 | 0 | 0.0 |
ALT increased | 8 | 2 | 0 | 0 | 0 | 10 | 58.8 | 0 | 0.0 |
Cough | 4 | 4 | 0 | 0 | 0 | 8 | 47.1 | 0 | 0.0 |
Appetite loss | 5 | 2 | 0 | 0 | 0 | 7 | 41.2 | 0 | 0.0 |
Fever | 4 | 2 | 0 | 0 | 0 | 6 | 35.3 | 0 | 0.0 |
Hyperglycemia | 5 | 1 | 0 | 0 | 0 | 6 | 35.3 | 0 | 0.0 |
ALP increased | 3 | 2 | 0 | 0 | 0 | 5 | 29.4 | 0 | 0.0 |
Creatinine increased | 5 | 0 | 0 | 0 | 0 | 5 | 29.4 | 0 | 0.0 |
Serum amylase increased | 5 | 0 | 0 | 0 | 0 | 5 | 29.4 | 0 | 0.0 |
Hypereosinophilia | 4 | 0 | 0 | 0 | 0 | 4 | 23.5 | 0 | 0.0 |
CPK increased | 2 | 1 | 0 | 0 | 0 | 3 | 17.6 | 0 | 0.0 |
Proteinuria | 2 | 1 | 0 | 0 | 0 | 3 | 17.6 | 0 | 0.0 |
Hyperkalemia | 3 | 0 | 0 | 0 | 0 | 3 | 17.6 | 0 | 0.0 |
Hypothyroidism | 3 | 0 | 0 | 0 | 0 | 3 | 17.6 | 0 | 0.0 |
Nausea | 3 | 0 | 0 | 0 | 0 | 3 | 17.6 | 0 | 0.0 |
Diarrhea | 1 | 1 | 0 | 0 | 0 | 2 | 11.8 | 0 | 0.0 |
Thrombocytopenia | 2 | 0 | 0 | 0 | 0 | 2 | 11.8 | 0 | 0.0 |
Blood bilirubin increased | 2 | 0 | 0 | 0 | 0 | 2 | 11.8 | 0 | 0.0 |
Hypokalemia | 2 | 0 | 0 | 0 | 0 | 2 | 11.8 | 0 | 0.0 |
Palpitations | 2 | 0 | 0 | 0 | 0 | 2 | 11.8 | 0 | 0.0 |
Vomiting | 2 | 0 | 0 | 0 | 0 | 2 | 11.8 | 0 | 0.0 |
Constipation | 2 | 0 | 0 | 0 | 0 | 2 | 11.8 | 0 | 0.0 |
Abdominal pain | 2 | 0 | 0 | 0 | 0 | 2 | 11.8 | 0 | 0.0 |
Pruritus | 2 | 0 | 0 | 0 | 0 | 2 | 11.8 | 0 | 0.0 |
Peripheral sensory neuropathy | 2 | 0 | 0 | 0 | 0 | 2 | 11.8 | 0 | 0.0 |
Radiation recall pneumonitisa | 1 | 0 | 0 | 0 | 0 | 1 | 5.9 | 0 | 0.0 |
ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CPK, creatine phosphokinase; CTCAE, Common Terminology Criteria for Adverse Event.
In the patient where the exclusion criteria were violated owing to a history of thoracic radiotherapy, an adverse event determined by the central judgment to be radiation recall pneumonitis with a CTCAE grade of 1 occurred. This was treated separately from pneumonitis in this report.