Table 5.
Summary of adverse events in the safety analysis set.
Adverse events | MTX + HQT (n = 45) | MTX + LEF (n = 45) | P |
---|---|---|---|
All | 11 (24.4%) | 17 (37.8%) | |
ALT/AST elevation | 0 (0%) | 4 (8.9%) | 0.117 |
Gastrointestinal reactions | 9 (20.0%) | 10 (22.2%) | 0.796 |
Rash | 1 (2.2%) | 1 (2.2%) | 1.000 |
Atrial fibrillation | 1 (2.2%) | 0 (0%) | 1.000 |
Leukopenia | 0 (0%) | 1 (2.2%) | 1.000 |
Hypertension | 0 (0%) | 1 (2.2%) | 1.000 |
Data are presented as n (%).
ALT, alanine aminotransferase; AST, aspartate aminotransferase.