Table 4.
Adverse Events [n(%)].
| Arm A (N = 109) | Arm B (N = 110) | P value | |
|---|---|---|---|
| Common adverse events (any grade) | |||
| Leukopenia | 87(79.8%) | 89(80.9%) | 0.8387 |
| Neutropenia | 73(67.0%) | 75(68.2%) | 0.8484 |
| Thrombocytopenia | 62(56.9%) | 53(48.2%) | 0.1974 |
| Anemia | 76(69.7%) | 71(64.5%) | 0.4146 |
| Abnormal ALT | 14(12.8%) | 15(13.6%) | 0.8627 |
| Abnormal plasma creatinine | 14(12.8%) | 10(9.1%) | 0.3740 |
| Nausea | 23(21.1%) | 13(11.8%) | 0.0638 |
| Vomiting | 14(12.8%) | 9(8.2%) | 0.2605 |
| Diarrhea | 9(8.3%) | 1(0.9%) | 0.0098 |
| Dermal and subcutaneous disease | 9(8.3%) | 1(0.9%) | 0.0098 |
| Adverse Events (Frequency of ≥10%*) of CTCAE grade > 3 | |||
| All AEs, n(%) | 59(54.1%) | 55(50.0%) | 0.5409 |
| Leukopenia | 17(15.6%) | 26(23.6%) | 0.1342 |
| Neutropenia | 28(25.7%) | 25(22.7%) | 0.6090 |
| Anemia | 15(13.8%) | 9(8.2%) | 0.1863 |
| Thrombocytopenia | 41(37.6%) | 26(23.6%) | 0.0248 |
NOTE: Arm A: gemcitabine + carboplatin + gefitinib; Arm B: gemcitabine + carboplatin. *Frequency >10%: authors only chose to report an CTCAE (grade > 3) if it occurs in > 10% of the population.