Table III.
Comparison of adverse events between patient groups.
| Adverse events | Total, no. (%) (n=136) | Test group, no. (%) (n=70) | Non-test group, no. (%) (n=66) | P-value |
|---|---|---|---|---|
| Leukopenia | ||||
| Grade ≥3 | 37 (22.1) | 19 (27.1) | 18 (27.2) | 0.99 |
| Grade ≥4 | 8 (5.9) | 7 (10.0) | 1 (1.5) | 0.037 |
| Neutropenia | ||||
| Grade ≥3 | 78 (57.3) | 38 (54.3) | 40 (60.6) | 0.46 |
| Grade ≥4 | 27 (19.9) | 14 (20.0) | 13 (19.7) | 0.96 |
| Thrombocytopenia | ||||
| Grade ≥3 | 28 (20.6) | 14 (20.0) | 14 (21.2) | 0.83 |
| Grade ≥4 | 11 (8.1) | 8 (11.4) | 3 (4.5) | 0.14 |
| Anemia | ||||
| Grade ≥3 | 20 (14.7) | 10 (14.3) | 10 (15.1) | 0.88 |
| Grade ≥4 | 1 (0.7) | 1 (1.4) | 0 (0.0) | 0.51 |
| Hematological toxicities | ||||
| Grade ≥3 | 83 (61.0) | 40 (57.1) | 43 (65.2) | 0.34 |
| Grade ≥4 | 28 (20.6) | 15 (21.4) | 13 (19.6) | 0.80 |
| Febrile neutropeniaa | ||||
| Grade ≥3 | 12 (8.8) | 5 (7.1) | 7 (10.6) | 0.48 |
| Grade ≥4 | 6 (4.4) | 4 (5.7) | 2 (3.0) | 0.37 |
| Diarrhea | ||||
| Grade ≥3 | 9 (6.6) | 6 (8.6) | 3 (4.5) | 0.28 |
| Grade ≥4 | 3 (2.2) | 2 (2.9) | 1 (1.5) | 0.52 |
| Non-hematological toxicities | ||||
| Grade ≥3 | 38 (27.9) | 24 (34.3) | 14 (21.2) | 0.089 |
| Grade ≥4 | 9 (6.6) | 7 (10.0) | 2 (3.0) | 0.097 |
| Treatment-related mortality | 4 (2.9) | 3 (4.3) | 1 (1.5) | 0.33 |
The comparisons between the two groups were performed with the Chi-square test. Adverse events were evaluated with Common Terminology Criteria for Adverse Events, version 4.0.
a
Febrile neutropenia was treated as a non-hematological toxicity.