Table 4.
Treatment-related AEs NCI-CTC grade (≥ 10% of patients) |
Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | |||||
---|---|---|---|---|---|---|---|---|---|---|
n | % | n | % | n | % | n | % | n | % | |
Trabectedin-related AEs | ||||||||||
Nausea | 5 | 6.5 | 13 | 16.9 | 4 | 5.2 | 22 | 28.6 | ||
Vomiting | 3 | 3.9 | 4 | 5.2 | 4 | 5.2 | 11 | 14.3 | ||
ALT increased | 2 | 2.6 | 5 | 6.50 | 1 | 1.3 | 8 | 10.4 | ||
AST increased | 2 | 2.6 | 2 | 2.6 | 4 | 5.2 | 1 | 1.3 | 9 | 11.7 |
Neutropenia | 1 | 1.3 | 2 | 2.6 | 8 | 10.4 | 4 | 5.2 | 15 | 19.5 |
Thrombocytopenia | 2 | 2.6 | 3 | 3.9 | 2 | 2.6 | 5 | 6.5 | 12 | 15.6 |
Leukopenia | 1 | 1.3 | 5 | 6.5 | 10 | 13.0 | 4 | 5.2 | 20 | 26.0 |
PLD-related AEs | ||||||||||
Nausea | 5 | 6.5 | 13 | 16.9 | 4 | 5.2 | 22 | 28.6 | ||
Vomiting | 3 | 3.9 | 5 | 6.50 | 4 | 5.2 | 12 | 15.6 | ||
Neutropenia | 1 | 1.3 | 2 | 2.6 | 8 | 10.4 | 6 | 7.8 | 17 | 22.1 |
Thrombocytopenia | 2 | 2.6 | 3 | 3.9 | 2 | 2.6 | 6 | 7.8 | 13 | 16.9 |
Leukopenia | 2 | 2.6 | 6 | 7.8 | 8 | 10.4 | 4 | 5.2 | 20 | 26.0 |
Data shown are numbers and percentage of patients with available data
AE adverse event, ALT alanine aminotransferase, AST aspartate aminotransferase, NCI-CTC National Cancer Institute Common Toxicity Criteria